U.S. Department of Health & Human Services Divider Arrow National Institutes of Health Divider Arrow NCATS

Details

Stereochemistry ABSOLUTE
Molecular Formula C10H13N5O4
Molecular Weight 267.2417
Optical Activity UNSPECIFIED
Defined Stereocenters 3 / 3
E/Z Centers 0
Charge 0

SHOW SMILES / InChI
Structure of ZIDOVUDINE

SMILES

Cc1cn([C@@]2([H])C[C@@]([H])([C@@]([H])(CO)O2)N=[N+]=[N-])c(=O)nc1O

InChI

InChIKey=HBOMLICNUCNMMY-XLPZGREQSA-N
InChI=1S/C10H13N5O4/c1-5-3-15(10(18)12-9(5)17)8-2-6(13-14-11)7(4-16)19-8/h3,6-8,16H,2,4H2,1H3,(H,12,17,18)/t6-,7+,8+/m0/s1

HIDE SMILES / InChI

Molecular Formula C10H13N5O4
Molecular Weight 267.2417
Charge 0
Count
Stereochemistry ABSOLUTE
Additional Stereochemistry No
Defined Stereocenters 3 / 3
E/Z Centers 0
Optical Activity UNSPECIFIED

Description
Curator's Comment:: Description was created based on several sources, including https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019910s033lbl.pdf

Zidovudine is a nucleoside reverse transcriptase inhibitor (NRTI) with activity against Human Immunodeficiency Virus Type 1 (HIV-1). Zidovudine is phosphorylated to active metabolites that compete for incorporation into viral DNA. They inhibit the HIV reverse transcriptase enzyme competitively and act as a chain terminator of DNA synthesis. The lack of a 3'-OH group in the incorporated nucleoside analogue prevents the formation of the 5' to 3' phosphodiester linkage essential for DNA chain elongation, and therefore, the viral DNA growth is terminated. Zidovudine, a structural analog of thymidine, is a prodrug that must be phosphorylated to its active 5′-triphosphate metabolite, zidovudine triphosphate (ZDV-TP). It inhibits the activity of HIV-1 reverse transcriptase (RT) via DNA chain termination after incorporation of the nucleotide analogue. It competes with the natural substrate dGTP and incorporates itself into viral DNA. It is also a weak inhibitor of cellular DNA polymerase α and γ. Zidovudine is used in combination with other antiretroviral agents for the treatment of human immunovirus (HIV) infections. Zidovudine is marketed as Retrovir.

Originator

Curator's Comment:: Zidovudine had initially been synthesized by Dr. Jerome Horwitz and associates in 1964 at the Michigan Cancer Foundation as a potential anticancer agent

Approval Year

TargetsConditions

Conditions

ConditionModalityTargetsHighest PhaseProduct
Primary
RETROVIR

Approved Use

RETROVIR is a nucleoside analogue reverse transcriptase inhibitor indicated for: -- Treatment of Human Immunodeficiency Virus (HIV-1) infection in combination with other antiretroviral agents. (1.1) -- Prevention of maternal-fetal HIV-1 transmission. (1.2)

Launch Date

5.43023989E11
Cmax

Cmax

ValueDoseCo-administeredAnalytePopulation
1.1 μg/mL
2.5 mg/kg 6 times / day steady-state, intravenous
dose: 2.5 mg/kg
route of administration: Intravenous
experiment type: STEADY-STATE
co-administered:
ZIDOVUDINE plasma
Homo sapiens
population: UNHEALTHY
age: ADULT
sex: UNKNOWN
food status: UNKNOWN
0.2 μg/mL
50 mg 6 times / day steady-state, oral
dose: 50 mg
route of administration: Oral
experiment type: STEADY-STATE
co-administered:
ZIDOVUDINE serum
Homo sapiens
population: UNHEALTHY
age: ADULT
sex: FEMALE / MALE
food status: FASTED
0.55 μg/mL
100 mg 6 times / day steady-state, oral
dose: 100 mg
route of administration: Oral
experiment type: STEADY-STATE
co-administered:
ZIDOVUDINE serum
Homo sapiens
population: UNHEALTHY
age: ADULT
sex: FEMALE / MALE
food status: FASTED
1 μg/mL
250 mg 6 times / day steady-state, oral
dose: 250 mg
route of administration: Oral
experiment type: STEADY-STATE
co-administered:
ZIDOVUDINE serum
Homo sapiens
population: UNHEALTHY
age: ADULT
sex: FEMALE / MALE
food status: FASTED
1.8 μg/mL
150 mg 6 times / day steady-state, intravenous
dose: 150 mg
route of administration: Intravenous
experiment type: STEADY-STATE
co-administered:
ZIDOVUDINE serum
Homo sapiens
population: UNHEALTHY
age: ADULT
sex: FEMALE / MALE
food status: UNKNOWN
0.16 μg/mL
50 mg single, oral
dose: 50 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
ZIDOVUDINE serum
Homo sapiens
population: UNHEALTHY
age: ADULT
sex: FEMALE / MALE
food status: FASTED
0.74 μg/mL
100 mg single, oral
dose: 100 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
ZIDOVUDINE serum
Homo sapiens
population: UNHEALTHY
age: ADULT
sex: FEMALE / MALE
food status: FASTED
1.72 μg/mL
150 mg single, intravenous
dose: 150 mg
route of administration: Intravenous
experiment type: SINGLE
co-administered:
ZIDOVUDINE serum
Homo sapiens
population: UNHEALTHY
age: ADULT
sex: FEMALE / MALE
food status: UNKNOWN
1 μg/mL
250 mg single, oral
dose: 250 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
ZIDOVUDINE serum
Homo sapiens
population: UNHEALTHY
age: ADULT
sex: FEMALE / MALE
food status: FASTED
AUC

AUC

ValueDoseCo-administeredAnalytePopulation
1400 ng × h/mL
200 mg single, oral
dose: 200 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
ZIDOVUDINE plasma
Homo sapiens
population: UNKNOWN
age: ADULT
sex: UNKNOWN
food status: UNKNOWN
0.32 mg × h/L
50 mg 6 times / day steady-state, oral
dose: 50 mg
route of administration: Oral
experiment type: STEADY-STATE
co-administered:
ZIDOVUDINE serum
Homo sapiens
population: UNHEALTHY
age: ADULT
sex: FEMALE / MALE
food status: FASTED
0.65 mg × h/L
100 mg 6 times / day steady-state, oral
dose: 100 mg
route of administration: Oral
experiment type: STEADY-STATE
co-administered:
ZIDOVUDINE serum
Homo sapiens
population: UNHEALTHY
age: ADULT
sex: FEMALE / MALE
food status: FASTED
1.28 mg × h/L
250 mg 6 times / day steady-state, oral
dose: 250 mg
route of administration: Oral
experiment type: STEADY-STATE
co-administered:
ZIDOVUDINE serum
Homo sapiens
population: UNHEALTHY
age: ADULT
sex: FEMALE / MALE
food status: FASTED
1.31 mg × h/L
150 mg 6 times / day steady-state, intravenous
dose: 150 mg
route of administration: Intravenous
experiment type: STEADY-STATE
co-administered:
ZIDOVUDINE serum
Homo sapiens
population: UNHEALTHY
age: ADULT
sex: FEMALE / MALE
food status: UNKNOWN
0.26 mg × h/L
50 mg single, oral
dose: 50 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
ZIDOVUDINE serum
Homo sapiens
population: UNHEALTHY
age: ADULT
sex: FEMALE / MALE
food status: FASTED
0.39 mg × h/L
60 mg single, intravenous
dose: 60 mg
route of administration: Intravenous
experiment type: SINGLE
co-administered:
ZIDOVUDINE serum
Homo sapiens
population: UNHEALTHY
age: ADULT
sex: FEMALE / MALE
food status: UNKNOWN
0.74 mg × h/L
100 mg single, oral
dose: 100 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
ZIDOVUDINE serum
Homo sapiens
population: UNHEALTHY
age: ADULT
sex: FEMALE / MALE
food status: FASTED
1.22 mg × h/L
150 mg single, intravenous
dose: 150 mg
route of administration: Intravenous
experiment type: SINGLE
co-administered:
ZIDOVUDINE serum
Homo sapiens
population: UNHEALTHY
age: ADULT
sex: FEMALE / MALE
food status: UNKNOWN
1.33 mg × h/L
250 mg single, oral
dose: 250 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
ZIDOVUDINE serum
Homo sapiens
population: UNHEALTHY
age: ADULT
sex: FEMALE / MALE
food status: FASTED
T1/2

T1/2

ValueDoseCo-administeredAnalytePopulation
1 h
200 mg single, oral
dose: 200 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
ZIDOVUDINE plasma
Homo sapiens
population: UNKNOWN
age: ADULT
sex: UNKNOWN
food status: UNKNOWN
1.4 h
50 mg 6 times / day steady-state, oral
dose: 50 mg
route of administration: Oral
experiment type: STEADY-STATE
co-administered:
ZIDOVUDINE serum
Homo sapiens
population: UNHEALTHY
age: ADULT
sex: FEMALE / MALE
food status: FASTED
1.1 h
100 mg 6 times / day steady-state, oral
dose: 100 mg
route of administration: Oral
experiment type: STEADY-STATE
co-administered:
ZIDOVUDINE serum
Homo sapiens
population: UNHEALTHY
age: ADULT
sex: FEMALE / MALE
food status: FASTED
1.1 h
250 mg 6 times / day steady-state, oral
dose: 250 mg
route of administration: Oral
experiment type: STEADY-STATE
co-administered:
ZIDOVUDINE serum
Homo sapiens
population: UNHEALTHY
age: ADULT
sex: FEMALE / MALE
food status: FASTED
1.4 h
150 mg 6 times / day steady-state, intravenous
dose: 150 mg
route of administration: Intravenous
experiment type: STEADY-STATE
co-administered:
ZIDOVUDINE serum
Homo sapiens
population: UNHEALTHY
age: ADULT
sex: FEMALE / MALE
food status: UNKNOWN
1.5 h
50 mg single, oral
dose: 50 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
ZIDOVUDINE serum
Homo sapiens
population: UNHEALTHY
age: ADULT
sex: FEMALE / MALE
food status: FASTED
1.3 h
60 mg single, intravenous
dose: 60 mg
route of administration: Intravenous
experiment type: SINGLE
co-administered:
ZIDOVUDINE serum
Homo sapiens
population: UNHEALTHY
age: ADULT
sex: FEMALE / MALE
food status: UNKNOWN
1.6 h
100 mg single, oral
dose: 100 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
ZIDOVUDINE serum
Homo sapiens
population: UNHEALTHY
age: ADULT
sex: FEMALE / MALE
food status: FASTED
1.7 h
150 mg single, intravenous
dose: 150 mg
route of administration: Intravenous
experiment type: SINGLE
co-administered:
ZIDOVUDINE serum
Homo sapiens
population: UNHEALTHY
age: ADULT
sex: FEMALE / MALE
food status: UNKNOWN
1.5 h
250 mg single, oral
dose: 250 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
ZIDOVUDINE serum
Homo sapiens
population: UNHEALTHY
age: ADULT
sex: FEMALE / MALE
food status: FASTED
Funbound

Funbound

ValueDoseCo-administeredAnalytePopulation
62%
2.5 mg/kg 6 times / day steady-state, intravenous
dose: 2.5 mg/kg
route of administration: Intravenous
experiment type: STEADY-STATE
co-administered:
ZIDOVUDINE plasma
Homo sapiens
population: UNHEALTHY
age: ADULT
sex: UNKNOWN
food status: UNKNOWN
Doses

Doses

DosePopulationAdverse events​
20000 mg single, oral
Overdose
Dose: 20000 mg
Route: oral
Route: single
Dose: 20000 mg
Sources:
unhealthy, 28 years
n = 1
Health Status: unhealthy
Condition: HIV-1
Age Group: 28 years
Sex: M
Population Size: 1
Sources:
Disc. AE: Anemia...
AEs leading to
discontinuation/dose reduction:
Anemia (grade 1, 1 patient)
Sources:
1000 mg 1 times / day steady, oral
Highest studied dose
Dose: 1000 mg, 1 times / day
Route: oral
Route: steady
Dose: 1000 mg, 1 times / day
Sources:
unhealthy, 34 years
n = 1
Health Status: unhealthy
Condition: HIV-1, homosexual
Age Group: 34 years
Sex: M
Population Size: 1
Sources:
Other AEs: Depression...
Other AEs:
Depression (1 patient)
Sources:
22.5 g single, oral
Overdose
Dose: 22.5 g
Route: oral
Route: single
Dose: 22.5 g
Sources:
unhealthy, 34 years
n = 1
Health Status: unhealthy
Condition: HIV-1, homosexual
Age Group: 34 years
Sex: M
Population Size: 1
Sources:
Disc. AE: Dizziness, Diarrhoea...
AEs leading to
discontinuation/dose reduction:
Dizziness (1 patient)
Diarrhoea (1 patient)
Sources:
20000 mg single, oral
Overdose
Dose: 20000 mg
Route: oral
Route: single
Dose: 20000 mg
Co-administed with::
temazepam
Sources:
unhealthy, 34 years
n = 1
Health Status: unhealthy
Condition: HIV-1
Age Group: 34 years
Sex: M
Population Size: 1
Sources:
Disc. AE: Drowsiness...
AEs leading to
discontinuation/dose reduction:
Drowsiness (1 patient)
Sources:
36 g single, oral
Overdose
Dose: 36 g
Route: oral
Route: single
Dose: 36 g
Sources:
unhealthy, 35 years
n = 1
Health Status: unhealthy
Condition: HIV-1
Age Group: 35 years
Sex: M
Population Size: 1
Sources:
Disc. AE: Seizure...
AEs leading to
discontinuation/dose reduction:
Seizure (1 patient)
Sources:
134 mg single, oral
Overdose
Dose: 134 mg
Route: oral
Route: single
Dose: 134 mg
Sources:
healthy, 4 day
n = 1
Health Status: healthy
Condition: HIV postnatal prophylaxis
Age Group: 4 day
Sex: F
Population Size: 1
Sources:
Disc. AE: Metabolic acidosis exacerbated...
AEs leading to
discontinuation/dose reduction:
Metabolic acidosis exacerbated (1 patient)
Sources:
8000 mg/m2 multiple, intravenous
MTD
Dose: 8000 mg/m2
Route: intravenous
Route: multiple
Dose: 8000 mg/m2
Co-administed with::
5-fluorouracil(500 mg/m2)
Sources:
unhealthy, adult
n = 29
Health Status: unhealthy
Condition: metastatic colorectal cancer
Age Group: adult
Sex: unknown
Population Size: 29
Sources:
Disc. AE: Cardiac arrhythmia...
Other AEs: Diarrhea...
AEs leading to
discontinuation/dose reduction:
Cardiac arrhythmia (grade 5, 1 patient)
Other AEs:
Diarrhea (grade 3-4, 17%)
Sources:
40 g single, oral
Overdose
Dose: 40 g
Route: oral
Route: single
Dose: 40 g
Sources:
unhealthy, adult
n = 1
Health Status: unhealthy
Condition: HIV-1
Age Group: adult
Sex: unknown
Population Size: 1
Sources:
Disc. AE: Nystagmus...
AEs leading to
discontinuation/dose reduction:
Nystagmus (1 patient)
Sources:
500 mg 1 times / day steady, oral
Recommended
Dose: 500 mg, 1 times / day
Route: oral
Route: steady
Dose: 500 mg, 1 times / day
Sources:
unhealthy, adult
n = 453
Health Status: unhealthy
Condition: HIV-1
Age Group: adult
Sex: unknown
Population Size: 453
Sources:
Other AEs: Asthenia, Headache...
Other AEs:
Asthenia (9%)
Headache (63%)
Malaise (53%)
Anorexia (20%)
Constipation (6%)
Nausea (51%)
Vomiting (17%)
Anemia (1%)
Granulocytopenia (2%)
Sources:
160 mg/m2 3 times / day steady, oral
Recommended
Dose: 160 mg/m2, 3 times / day
Route: oral
Route: steady
Dose: 160 mg/m2, 3 times / day
Co-administed with::
EPIVIR(4 mg/kg twice daily)
Sources:
unhealthy, children
n = 236
Health Status: unhealthy
Condition: HIV-1
Age Group: children
Sex: unknown
Population Size: 236
Sources:
Other AEs: Fever, Hepatomegaly...
Other AEs:
Fever (25%)
Hepatomegaly (11%)
Nausea and vomiting (8%)
Diarrhea (8%)
Stomatitis (6%)
Splenomegaly (5%)
Cough (15%)
Breath sounds abnormal (7%)
Ear disorders NEC (7%)
Congestion nasal (8%)
Skin rash (12%)
Lymphadenopathy (9%)
Neutropenia (8%)
Thrombocytopenia (1%)
ALT (grade 3, 1%)
Lipase (3%)
Sources:
AEs

AEs

AESignificanceDosePopulation
Anemia grade 1, 1 patient
Disc. AE
20000 mg single, oral
Overdose
Dose: 20000 mg
Route: oral
Route: single
Dose: 20000 mg
Sources:
unhealthy, 28 years
n = 1
Health Status: unhealthy
Condition: HIV-1
Age Group: 28 years
Sex: M
Population Size: 1
Sources:
Depression 1 patient
1000 mg 1 times / day steady, oral
Highest studied dose
Dose: 1000 mg, 1 times / day
Route: oral
Route: steady
Dose: 1000 mg, 1 times / day
Sources:
unhealthy, 34 years
n = 1
Health Status: unhealthy
Condition: HIV-1, homosexual
Age Group: 34 years
Sex: M
Population Size: 1
Sources:
Diarrhoea 1 patient
Disc. AE
22.5 g single, oral
Overdose
Dose: 22.5 g
Route: oral
Route: single
Dose: 22.5 g
Sources:
unhealthy, 34 years
n = 1
Health Status: unhealthy
Condition: HIV-1, homosexual
Age Group: 34 years
Sex: M
Population Size: 1
Sources:
Dizziness 1 patient
Disc. AE
22.5 g single, oral
Overdose
Dose: 22.5 g
Route: oral
Route: single
Dose: 22.5 g
Sources:
unhealthy, 34 years
n = 1
Health Status: unhealthy
Condition: HIV-1, homosexual
Age Group: 34 years
Sex: M
Population Size: 1
Sources:
Drowsiness 1 patient
Disc. AE
20000 mg single, oral
Overdose
Dose: 20000 mg
Route: oral
Route: single
Dose: 20000 mg
Co-administed with::
temazepam
Sources:
unhealthy, 34 years
n = 1
Health Status: unhealthy
Condition: HIV-1
Age Group: 34 years
Sex: M
Population Size: 1
Sources:
Seizure 1 patient
Disc. AE
36 g single, oral
Overdose
Dose: 36 g
Route: oral
Route: single
Dose: 36 g
Sources:
unhealthy, 35 years
n = 1
Health Status: unhealthy
Condition: HIV-1
Age Group: 35 years
Sex: M
Population Size: 1
Sources:
Metabolic acidosis exacerbated 1 patient
Disc. AE
134 mg single, oral
Overdose
Dose: 134 mg
Route: oral
Route: single
Dose: 134 mg
Sources:
healthy, 4 day
n = 1
Health Status: healthy
Condition: HIV postnatal prophylaxis
Age Group: 4 day
Sex: F
Population Size: 1
Sources:
Diarrhea grade 3-4, 17%
8000 mg/m2 multiple, intravenous
MTD
Dose: 8000 mg/m2
Route: intravenous
Route: multiple
Dose: 8000 mg/m2
Co-administed with::
5-fluorouracil(500 mg/m2)
Sources:
unhealthy, adult
n = 29
Health Status: unhealthy
Condition: metastatic colorectal cancer
Age Group: adult
Sex: unknown
Population Size: 29
Sources:
Cardiac arrhythmia grade 5, 1 patient
Disc. AE
8000 mg/m2 multiple, intravenous
MTD
Dose: 8000 mg/m2
Route: intravenous
Route: multiple
Dose: 8000 mg/m2
Co-administed with::
5-fluorouracil(500 mg/m2)
Sources:
unhealthy, adult
n = 29
Health Status: unhealthy
Condition: metastatic colorectal cancer
Age Group: adult
Sex: unknown
Population Size: 29
Sources:
Nystagmus 1 patient
Disc. AE
40 g single, oral
Overdose
Dose: 40 g
Route: oral
Route: single
Dose: 40 g
Sources:
unhealthy, adult
n = 1
Health Status: unhealthy
Condition: HIV-1
Age Group: adult
Sex: unknown
Population Size: 1
Sources:
Anemia 1%
500 mg 1 times / day steady, oral
Recommended
Dose: 500 mg, 1 times / day
Route: oral
Route: steady
Dose: 500 mg, 1 times / day
Sources:
unhealthy, adult
n = 453
Health Status: unhealthy
Condition: HIV-1
Age Group: adult
Sex: unknown
Population Size: 453
Sources:
Vomiting 17%
500 mg 1 times / day steady, oral
Recommended
Dose: 500 mg, 1 times / day
Route: oral
Route: steady
Dose: 500 mg, 1 times / day
Sources:
unhealthy, adult
n = 453
Health Status: unhealthy
Condition: HIV-1
Age Group: adult
Sex: unknown
Population Size: 453
Sources:
Granulocytopenia 2%
500 mg 1 times / day steady, oral
Recommended
Dose: 500 mg, 1 times / day
Route: oral
Route: steady
Dose: 500 mg, 1 times / day
Sources:
unhealthy, adult
n = 453
Health Status: unhealthy
Condition: HIV-1
Age Group: adult
Sex: unknown
Population Size: 453
Sources:
Anorexia 20%
500 mg 1 times / day steady, oral
Recommended
Dose: 500 mg, 1 times / day
Route: oral
Route: steady
Dose: 500 mg, 1 times / day
Sources:
unhealthy, adult
n = 453
Health Status: unhealthy
Condition: HIV-1
Age Group: adult
Sex: unknown
Population Size: 453
Sources:
Nausea 51%
500 mg 1 times / day steady, oral
Recommended
Dose: 500 mg, 1 times / day
Route: oral
Route: steady
Dose: 500 mg, 1 times / day
Sources:
unhealthy, adult
n = 453
Health Status: unhealthy
Condition: HIV-1
Age Group: adult
Sex: unknown
Population Size: 453
Sources:
Malaise 53%
500 mg 1 times / day steady, oral
Recommended
Dose: 500 mg, 1 times / day
Route: oral
Route: steady
Dose: 500 mg, 1 times / day
Sources:
unhealthy, adult
n = 453
Health Status: unhealthy
Condition: HIV-1
Age Group: adult
Sex: unknown
Population Size: 453
Sources:
Constipation 6%
500 mg 1 times / day steady, oral
Recommended
Dose: 500 mg, 1 times / day
Route: oral
Route: steady
Dose: 500 mg, 1 times / day
Sources:
unhealthy, adult
n = 453
Health Status: unhealthy
Condition: HIV-1
Age Group: adult
Sex: unknown
Population Size: 453
Sources:
Headache 63%
500 mg 1 times / day steady, oral
Recommended
Dose: 500 mg, 1 times / day
Route: oral
Route: steady
Dose: 500 mg, 1 times / day
Sources:
unhealthy, adult
n = 453
Health Status: unhealthy
Condition: HIV-1
Age Group: adult
Sex: unknown
Population Size: 453
Sources:
Asthenia 9%
500 mg 1 times / day steady, oral
Recommended
Dose: 500 mg, 1 times / day
Route: oral
Route: steady
Dose: 500 mg, 1 times / day
Sources:
unhealthy, adult
n = 453
Health Status: unhealthy
Condition: HIV-1
Age Group: adult
Sex: unknown
Population Size: 453
Sources:
Thrombocytopenia 1%
160 mg/m2 3 times / day steady, oral
Recommended
Dose: 160 mg/m2, 3 times / day
Route: oral
Route: steady
Dose: 160 mg/m2, 3 times / day
Co-administed with::
EPIVIR(4 mg/kg twice daily)
Sources:
unhealthy, children
n = 236
Health Status: unhealthy
Condition: HIV-1
Age Group: children
Sex: unknown
Population Size: 236
Sources:
Hepatomegaly 11%
160 mg/m2 3 times / day steady, oral
Recommended
Dose: 160 mg/m2, 3 times / day
Route: oral
Route: steady
Dose: 160 mg/m2, 3 times / day
Co-administed with::
EPIVIR(4 mg/kg twice daily)
Sources:
unhealthy, children
n = 236
Health Status: unhealthy
Condition: HIV-1
Age Group: children
Sex: unknown
Population Size: 236
Sources:
Skin rash 12%
160 mg/m2 3 times / day steady, oral
Recommended
Dose: 160 mg/m2, 3 times / day
Route: oral
Route: steady
Dose: 160 mg/m2, 3 times / day
Co-administed with::
EPIVIR(4 mg/kg twice daily)
Sources:
unhealthy, children
n = 236
Health Status: unhealthy
Condition: HIV-1
Age Group: children
Sex: unknown
Population Size: 236
Sources:
Cough 15%
160 mg/m2 3 times / day steady, oral
Recommended
Dose: 160 mg/m2, 3 times / day
Route: oral
Route: steady
Dose: 160 mg/m2, 3 times / day
Co-administed with::
EPIVIR(4 mg/kg twice daily)
Sources:
unhealthy, children
n = 236
Health Status: unhealthy
Condition: HIV-1
Age Group: children
Sex: unknown
Population Size: 236
Sources:
Fever 25%
160 mg/m2 3 times / day steady, oral
Recommended
Dose: 160 mg/m2, 3 times / day
Route: oral
Route: steady
Dose: 160 mg/m2, 3 times / day
Co-administed with::
EPIVIR(4 mg/kg twice daily)
Sources:
unhealthy, children
n = 236
Health Status: unhealthy
Condition: HIV-1
Age Group: children
Sex: unknown
Population Size: 236
Sources:
Lipase 3%
160 mg/m2 3 times / day steady, oral
Recommended
Dose: 160 mg/m2, 3 times / day
Route: oral
Route: steady
Dose: 160 mg/m2, 3 times / day
Co-administed with::
EPIVIR(4 mg/kg twice daily)
Sources:
unhealthy, children
n = 236
Health Status: unhealthy
Condition: HIV-1
Age Group: children
Sex: unknown
Population Size: 236
Sources:
Splenomegaly 5%
160 mg/m2 3 times / day steady, oral
Recommended
Dose: 160 mg/m2, 3 times / day
Route: oral
Route: steady
Dose: 160 mg/m2, 3 times / day
Co-administed with::
EPIVIR(4 mg/kg twice daily)
Sources:
unhealthy, children
n = 236
Health Status: unhealthy
Condition: HIV-1
Age Group: children
Sex: unknown
Population Size: 236
Sources:
Stomatitis 6%
160 mg/m2 3 times / day steady, oral
Recommended
Dose: 160 mg/m2, 3 times / day
Route: oral
Route: steady
Dose: 160 mg/m2, 3 times / day
Co-administed with::
EPIVIR(4 mg/kg twice daily)
Sources:
unhealthy, children
n = 236
Health Status: unhealthy
Condition: HIV-1
Age Group: children
Sex: unknown
Population Size: 236
Sources:
Breath sounds abnormal 7%
160 mg/m2 3 times / day steady, oral
Recommended
Dose: 160 mg/m2, 3 times / day
Route: oral
Route: steady
Dose: 160 mg/m2, 3 times / day
Co-administed with::
EPIVIR(4 mg/kg twice daily)
Sources:
unhealthy, children
n = 236
Health Status: unhealthy
Condition: HIV-1
Age Group: children
Sex: unknown
Population Size: 236
Sources:
Ear disorders NEC 7%
160 mg/m2 3 times / day steady, oral
Recommended
Dose: 160 mg/m2, 3 times / day
Route: oral
Route: steady
Dose: 160 mg/m2, 3 times / day
Co-administed with::
EPIVIR(4 mg/kg twice daily)
Sources:
unhealthy, children
n = 236
Health Status: unhealthy
Condition: HIV-1
Age Group: children
Sex: unknown
Population Size: 236
Sources:
Congestion nasal 8%
160 mg/m2 3 times / day steady, oral
Recommended
Dose: 160 mg/m2, 3 times / day
Route: oral
Route: steady
Dose: 160 mg/m2, 3 times / day
Co-administed with::
EPIVIR(4 mg/kg twice daily)
Sources:
unhealthy, children
n = 236
Health Status: unhealthy
Condition: HIV-1
Age Group: children
Sex: unknown
Population Size: 236
Sources:
Diarrhea 8%
160 mg/m2 3 times / day steady, oral
Recommended
Dose: 160 mg/m2, 3 times / day
Route: oral
Route: steady
Dose: 160 mg/m2, 3 times / day
Co-administed with::
EPIVIR(4 mg/kg twice daily)
Sources:
unhealthy, children
n = 236
Health Status: unhealthy
Condition: HIV-1
Age Group: children
Sex: unknown
Population Size: 236
Sources:
Nausea and vomiting 8%
160 mg/m2 3 times / day steady, oral
Recommended
Dose: 160 mg/m2, 3 times / day
Route: oral
Route: steady
Dose: 160 mg/m2, 3 times / day
Co-administed with::
EPIVIR(4 mg/kg twice daily)
Sources:
unhealthy, children
n = 236
Health Status: unhealthy
Condition: HIV-1
Age Group: children
Sex: unknown
Population Size: 236
Sources:
Neutropenia 8%
160 mg/m2 3 times / day steady, oral
Recommended
Dose: 160 mg/m2, 3 times / day
Route: oral
Route: steady
Dose: 160 mg/m2, 3 times / day
Co-administed with::
EPIVIR(4 mg/kg twice daily)
Sources:
unhealthy, children
n = 236
Health Status: unhealthy
Condition: HIV-1
Age Group: children
Sex: unknown
Population Size: 236
Sources:
Lymphadenopathy 9%
160 mg/m2 3 times / day steady, oral
Recommended
Dose: 160 mg/m2, 3 times / day
Route: oral
Route: steady
Dose: 160 mg/m2, 3 times / day
Co-administed with::
EPIVIR(4 mg/kg twice daily)
Sources:
unhealthy, children
n = 236
Health Status: unhealthy
Condition: HIV-1
Age Group: children
Sex: unknown
Population Size: 236
Sources:
ALT grade 3, 1%
160 mg/m2 3 times / day steady, oral
Recommended
Dose: 160 mg/m2, 3 times / day
Route: oral
Route: steady
Dose: 160 mg/m2, 3 times / day
Co-administed with::
EPIVIR(4 mg/kg twice daily)
Sources:
unhealthy, children
n = 236
Health Status: unhealthy
Condition: HIV-1
Age Group: children
Sex: unknown
Population Size: 236
Sources:
OverviewDrug as perpetrator​

Drug as perpetrator​

TargetModalityActivityMetaboliteClinical evidence
no [IC50 <400 uM]
no [IC50 <500 uM]
no [IC50 >10 uM]
no [IC50 >10 uM]
no [IC50 >10 uM]
no [IC50 >10 uM]
no [IC50 >10 uM]
no [IC50 >10 uM]
no [IC50 >10 uM]
no [IC50 >133 uM]
no [IC50 >133 uM]
no [IC50 >133 uM]
no
no
no
no
no
weak [IC50 31.34 uM]
yes [Ki 1200 uM]
yes
yes
yes
yes
yes
Drug as victim

Drug as victim

TargetModalityActivityMetaboliteClinical evidence
major [Km 770 uM]
yes (pharmacogenomic study)
Comment: Km (Pooled HLMs) = 1.4 mM; The carriers of UGT2B7*1c had 57% lower mean AUC (P = 0.029, unpaired t-test), 196% higher mean CL/F (P = 0.004, unpaired t-test) (Figure 3B), and 67% shorter mean elimination half-life (P = 0.030, unpaired t-test) compared with non-carriers.
minor
minor
no
no
no
no
no
no
no
no
no
yes [Km 145.1 uM]
yes [Km 151.8 uM]
yes [Km 2400 uM]
yes [Km 26.8 uM]
yes [Km 45.9 uM]
yes
yes
yes
yes
yes
yes
yes
yes
yes
Tox targets
PubMed

PubMed

TitleDatePubMed
Synthesis and anti-HIV activity of unusual nucleoside oxanosine derivatives.
1999
Synthesis and anti-HIV and anti-HBV activities of 2'-fluoro-2', 3'-unsaturated L-nucleosides.
1999 Apr 8
Antiviral nucleoside drug delivery via amino acid phosphoramidates.
1999 Apr-May
"Mixed inhibitors" of HIV-reverse transcriptase: synthesis and antiviral activity.
1999 Apr-May
Inhibition of beta-globin gene expression by 3'-azido-3'-deoxythymidine in human erythroid progenitor cells.
1999 Dec 31
Zidovudine (AZT) induced alterations in mitochondrial biogenesis in rat striated muscles.
1999 Jan
PMTI, a broadly active unusual single-stranded polyribonucleotide, inhibits human immunodeficiency virus replication by multiple mechanisms.
1999 Jan
Relation of peripheral neuropathy to HIV treatment in four randomized clinical trials including didanosine.
1999 Jul
Biological evaluation of proanthocyanidin dimers and related polyphenols.
1999 Jul
Anti-AIDS agents. 37. Synthesis and structure-activity relationships of (3'R,4'R)-(+)-cis-khellactone derivatives as novel potent anti-HIV agents.
1999 Jul 15
Nucleosides and nucleotides. 185. Synthesis and biological activities of 4'alpha-C-branched-chain sugar pyrimidine nucleosides.
1999 Jul 29
In vitro anti-human immunodeficiency virus activities of Z- and E-methylenecyclopropane nucleoside analogues and their phosphoro-L-alaninate diesters.
1999 Jun
Pyrido [1,2a] indole derivatives identified as novel non-nucleoside reverse transcriptase inhibitors of human immunodeficiency virus type 1.
1999 Mar
Inhibition of human immunodeficiency virus replication by RD6-Y664, a novel benzylhydroxylamine derivative.
1999 Mar
Synthesis, characterization and preclinical formulation of a dual-action phenyl phosphate derivative of bromo-methoxy zidovudine (compound WHI-07) with potent anti-HIV and spermicidal activities.
1999 May
Multiorgan transplacental and neonatal carcinogenicity of 3'-azido-3'-deoxythymidine in mice.
1999 Nov 15
Resistance of the human immunodeficiency virus to the inhibitory action of negatively charged albumins on virus binding to CD4.
1999 Nov 20
N-[2-(1-cyclohexenyl)ethyl]-N'-[2-(5-bromopyridyl)]-thiourea and N'-[2-(1-cyclohexenyl)ethyl]-N'-[2-(5-chloropyridyl)]-thiourea as potent inhibitors of multidrug-resistant human immunodeficiency virus-1.
1999 Sep 20
Prophylactic contraceptives for HIV/AIDS.
1999 Sep-Oct
Long-term exposure of HIV type 1-infected cell cultures to combinations of the novel quinoxaline GW420867X with lamivudine, abacavir, and a variety of nonnucleoside reverse transcriptase inhibitors.
2000 Apr 10
In vitro selection of mutations in the human immunodeficiency virus type 1 reverse transcriptase that decrease susceptibility to (-)-beta-D-dioxolane-guanosine and suppress resistance to 3'-azido-3'-deoxythymidine.
2000 Jul
3-year suppression of HIV viremia with indinavir, zidovudine, and lamivudine.
2000 Jul 4
'Double-Drugs'--a new class of prodrug form of an HIV protease inhibitor conjugated with a reverse transcriptase inhibitor by a spontaneously cleavable linker.
2000 Jun 5
Structure-activity relationship studies on potential non-nucleoside DABO-like inhibitors of HIV-1 reverse transcriptase.
2000 Mar
Patents

Sample Use Guides

Treatment of HIV-1 infection: Adults: 600 mg/day in divided doses with other antiretroviral agents. Pediatric patients (6 weeks to <18 years of age): Dosage should be calculated based on body weight not to exceed adult dose.
Route of Administration: Oral
The antiviral activity of CD8(+) cells from 2 LTSs was inhibited by 5 uM of zidovudine.
Substance Class Chemical
Created
by admin
on Fri Jun 25 20:54:21 UTC 2021
Edited
by admin
on Fri Jun 25 20:54:21 UTC 2021
Record UNII
4B9XT59T7S
Record Status Validated (UNII)
Record Version
  • Download
Name Type Language
ZIDOVUDINE
EMA EPAR   EP   HSDB   INN   JAN   MART.   MI   ORANGE BOOK   USAN   USP   USP-RS   VANDF   WHO-DD   WHO-IP  
INN   USAN  
Official Name English
ZIDOVUDINE [EP MONOGRAPH]
Common Name English
BW-A509U
Code English
AZIDOTHYMIDINE
Systematic Name English
3'-DEOXY-3'-AZIDOTHYMIDINE
Systematic Name English
THYMIDINE, 3'-AZIDO-3'-DEOXY-
Systematic Name English
ZDV
Common Name English
ZIDOVUDINE [MI]
Common Name English
COMBIVIR COMPONENT ZIDOVUDINE
Common Name English
ZIDOVUDINE [USP-RS]
Common Name English
AZT
Common Name English
ZIDOVUDINE COMPONENT OF TRIZIVIR
Brand Name English
TRIZIVIR COMPONENT ZIDOVUDINE
Brand Name English
ZIDOVUDINE [IARC]
Common Name English
ZIDOVUDINE [WHO-DD]
Common Name English
ZIDOVUDINE COMPONENT OF LAMIVUDINE/ZIDOVUDINE TEVA
Brand Name English
ZIDOVUDINE COMPONENT OF COMBIVIR
Common Name English
ZIDOVUDINE [EP]
Common Name English
ZIDOVUDINE [USAN]
Common Name English
ZIDOVUDINE [JAN]
Common Name English
COMPOUND S
Code English
ZIDOVUDINE [EMA EPAR]
Common Name English
ZIDOVUDINE [ORANGE BOOK]
Common Name English
ZIDOVUDINE [VANDF]
Common Name English
RETROVIR
Brand Name English
3'-AZIDO-3'-DEOXYTHYMIDINE
Systematic Name English
ZIDOVUDINE [MART.]
Common Name English
ZIDOVUDINE [USP MONOGRAPH]
Common Name English
3'-AZT
Common Name English
ZIDOVUDINE [WHO-IP]
Common Name English
3'-AZIDOTHYMIDINE
Systematic Name English
ZIDOVUDINE [HSDB]
Common Name English
ZIDOVUDINE [INN]
Common Name English
BW-A-509U
Code English
NSC-602670
Code English
ZIDOVUDINUM [WHO-IP LATIN]
Common Name English
LAMIVUDINE/ZIDOVUDINE TEVA COMPONENT ZIDOVUDINE
Brand Name English
Classification Tree Code System Code
EMA ASSESSMENT REPORTS COMBIVIR (AUTHORIZED: HIV INFECTIONS)
Created by admin on Fri Jun 25 20:54:21 UTC 2021 , Edited by admin on Fri Jun 25 20:54:21 UTC 2021
FDA ORPHAN DRUG 8185
Created by admin on Fri Jun 25 20:54:21 UTC 2021 , Edited by admin on Fri Jun 25 20:54:21 UTC 2021
WHO-VATC QJ05AR04
Created by admin on Fri Jun 25 20:54:21 UTC 2021 , Edited by admin on Fri Jun 25 20:54:21 UTC 2021
WHO-ATC J05AR05
Created by admin on Fri Jun 25 20:54:21 UTC 2021 , Edited by admin on Fri Jun 25 20:54:21 UTC 2021
WHO-ATC J05AF01
Created by admin on Fri Jun 25 20:54:21 UTC 2021 , Edited by admin on Fri Jun 25 20:54:21 UTC 2021
NDF-RT N0000175462
Created by admin on Fri Jun 25 20:54:21 UTC 2021 , Edited by admin on Fri Jun 25 20:54:21 UTC 2021
WHO-VATC QJ05AR01
Created by admin on Fri Jun 25 20:54:21 UTC 2021 , Edited by admin on Fri Jun 25 20:54:21 UTC 2021
WHO-ATC J05AR04
Created by admin on Fri Jun 25 20:54:21 UTC 2021 , Edited by admin on Fri Jun 25 20:54:21 UTC 2021
NCI_THESAURUS C1557
Created by admin on Fri Jun 25 20:54:21 UTC 2021 , Edited by admin on Fri Jun 25 20:54:21 UTC 2021
NDF-RT N0000175459
Created by admin on Fri Jun 25 20:54:21 UTC 2021 , Edited by admin on Fri Jun 25 20:54:21 UTC 2021
NCI_THESAURUS C97452
Created by admin on Fri Jun 25 20:54:21 UTC 2021 , Edited by admin on Fri Jun 25 20:54:21 UTC 2021
NDF-RT N0000009947
Created by admin on Fri Jun 25 20:54:21 UTC 2021 , Edited by admin on Fri Jun 25 20:54:21 UTC 2021
NDF-RT N0000175459
Created by admin on Fri Jun 25 20:54:21 UTC 2021 , Edited by admin on Fri Jun 25 20:54:21 UTC 2021
EMA ASSESSMENT REPORTS LAMIVUDINE/ZIDOVUDINE TEVA (AUTHORIZED: HIV INFECTIONS)
Created by admin on Fri Jun 25 20:54:21 UTC 2021 , Edited by admin on Fri Jun 25 20:54:21 UTC 2021
WHO-ESSENTIAL MEDICINES LIST 6.4.2.1
Created by admin on Fri Jun 25 20:54:21 UTC 2021 , Edited by admin on Fri Jun 25 20:54:21 UTC 2021
WHO-ATC J05AR01
Created by admin on Fri Jun 25 20:54:21 UTC 2021 , Edited by admin on Fri Jun 25 20:54:21 UTC 2021
WHO-VATC QJ05AR05
Created by admin on Fri Jun 25 20:54:21 UTC 2021 , Edited by admin on Fri Jun 25 20:54:21 UTC 2021
WHO-VATC QJ05AF01
Created by admin on Fri Jun 25 20:54:21 UTC 2021 , Edited by admin on Fri Jun 25 20:54:21 UTC 2021
LIVERTOX 1047
Created by admin on Fri Jun 25 20:54:21 UTC 2021 , Edited by admin on Fri Jun 25 20:54:21 UTC 2021
NDF-RT N0000175459
Created by admin on Fri Jun 25 20:54:21 UTC 2021 , Edited by admin on Fri Jun 25 20:54:21 UTC 2021
Code System Code Type Description
WHO INTERNATIONAL PHARMACOPEIA
ZIDOVUDINE
Created by admin on Fri Jun 25 20:54:21 UTC 2021 , Edited by admin on Fri Jun 25 20:54:21 UTC 2021
PRIMARY Description: A white or brownish powder. Solubility: Soluble in ethanol (~750 g/l) TS, sparingly soluble in water. Category: Antiretroviral (Nucleoside Reverse Transcriptase Inhibitor). Storage: Zidovudine should be kept in a tightly closed container, protected from light. Additional information: Zidovudine may exhibit polymorphism. Definition: Zidovudine contains not less than 97.0% and not more than 103.0% of C10H13N5O4, calculated with reference to the dried substance.
NCI_THESAURUS
C947
Created by admin on Fri Jun 25 20:54:21 UTC 2021 , Edited by admin on Fri Jun 25 20:54:21 UTC 2021
PRIMARY
DRUG CENTRAL
2861
Created by admin on Fri Jun 25 20:54:21 UTC 2021 , Edited by admin on Fri Jun 25 20:54:21 UTC 2021
PRIMARY
INN
6118
Created by admin on Fri Jun 25 20:54:21 UTC 2021 , Edited by admin on Fri Jun 25 20:54:21 UTC 2021
PRIMARY
CAS
30516-87-1
Created by admin on Fri Jun 25 20:54:21 UTC 2021 , Edited by admin on Fri Jun 25 20:54:21 UTC 2021
PRIMARY
MESH
D015215
Created by admin on Fri Jun 25 20:54:21 UTC 2021 , Edited by admin on Fri Jun 25 20:54:21 UTC 2021
PRIMARY
LACTMED
Zidovudine
Created by admin on Fri Jun 25 20:54:21 UTC 2021 , Edited by admin on Fri Jun 25 20:54:21 UTC 2021
PRIMARY
IUPHAR
4825
Created by admin on Fri Jun 25 20:54:21 UTC 2021 , Edited by admin on Fri Jun 25 20:54:21 UTC 2021
PRIMARY
FDA UNII
4B9XT59T7S
Created by admin on Fri Jun 25 20:54:21 UTC 2021 , Edited by admin on Fri Jun 25 20:54:21 UTC 2021
PRIMARY
RXCUI
11413
Created by admin on Fri Jun 25 20:54:21 UTC 2021 , Edited by admin on Fri Jun 25 20:54:21 UTC 2021
PRIMARY RxNorm
DRUG BANK
DB00495
Created by admin on Fri Jun 25 20:54:21 UTC 2021 , Edited by admin on Fri Jun 25 20:54:21 UTC 2021
PRIMARY
USP_CATALOG
1724500
Created by admin on Fri Jun 25 20:54:21 UTC 2021 , Edited by admin on Fri Jun 25 20:54:21 UTC 2021
PRIMARY USP-RS
EPA CompTox
30516-87-1
Created by admin on Fri Jun 25 20:54:21 UTC 2021 , Edited by admin on Fri Jun 25 20:54:21 UTC 2021
PRIMARY
EVMPD
SUB00153MIG
Created by admin on Fri Jun 25 20:54:21 UTC 2021 , Edited by admin on Fri Jun 25 20:54:21 UTC 2021
PRIMARY
MERCK INDEX
M11592
Created by admin on Fri Jun 25 20:54:21 UTC 2021 , Edited by admin on Fri Jun 25 20:54:21 UTC 2021
PRIMARY Merck Index
WIKIPEDIA
ZIDOVUDINE
Created by admin on Fri Jun 25 20:54:21 UTC 2021 , Edited by admin on Fri Jun 25 20:54:21 UTC 2021
PRIMARY
ChEMBL
CHEMBL129
Created by admin on Fri Jun 25 20:54:21 UTC 2021 , Edited by admin on Fri Jun 25 20:54:21 UTC 2021
PRIMARY
PUBCHEM
35370
Created by admin on Fri Jun 25 20:54:21 UTC 2021 , Edited by admin on Fri Jun 25 20:54:21 UTC 2021
PRIMARY
HSDB
6515
Created by admin on Fri Jun 25 20:54:21 UTC 2021 , Edited by admin on Fri Jun 25 20:54:21 UTC 2021
PRIMARY
Related Record Type Details
BASIS OF STRENGTH->SUBSTANCE
ASSAY (HPLC)
USP
TARGET ORGANISM->INHIBITOR
TRANSPORTER -> SUBSTRATE
TRANSPORTER -> SUBSTRATE
BASIS OF STRENGTH->SUBSTANCE
ASSAY (HPLC)
EP
TRANSPORTER -> NON-SUBSTRATE
METABOLIC ENZYME -> SUBSTRATE
TRANSPORTER -> SUBSTRATE
TRANSPORTER -> NON-SUBSTRATE
TRANSPORTER -> SUBSTRATE
TRANSPORTER -> SUBSTRATE
TARGET -> INHIBITOR
Related Record Type Details
METABOLITE ACTIVE -> PARENT
METABOLITE ACTIVE -> PARENT
AMOUNT FORMED FOLLOWING ADMINISTRATION
MINOR
METABOLITE TOXIC -> PARENT
METABOLITE INACTIVE -> PARENT
METABOLITE INACTIVE -> PARENT
AMOUNT OF EXCRETED
MAJOR
Related Record Type Details
IMPURITY -> PARENT
The impurity peaks are eluted at the following relative retention times with reference to zidovudine (retention time about 12 to 13 minutes): impurity C (thymine) about 0.3. The test is not valid unless the resolution factor between the peaks due to zidovudine and impurity B is at least 2. In the chromatogram obtained with solution (1): - the area of any peak corresponding to impurity C, when multiplied by a correction factor of 0.6, is not greater than four times the area of the principal peak in the chromatogram obtained with solution (2) (2.0%).
IMPURITY -> PARENT
IMPURITY -> PARENT
The impurity peaks are eluted at the following relative retention times with reference to zidovudine (retention time about 12 to 13 minutes): impurity B about 1.2. The test is not valid unless the resolution factor between the peaks due to zidovudine and impurity B is at least 2. In the chromatogram obtained with solution (1):- the area of any peak corresponding to impurity B, is not greater than twice the area of the principal peak in the chromatogram obtained with solution (2) (1.0%).
IMPURITY -> PARENT
CHROMATOGRAPHIC PURITY (TLC)
IMPURITY -> PARENT
CHROMATOGRAPHIC PURITY (HPLC/UV)
EP
IMPURITY -> PARENT
CHROMATOGRAPHIC PURITY (HPLC/UV)
IMPURITY -> PARENT
CHROMATOGRAPHIC PURITY (HPLC/UV)
IMPURITY -> PARENT
CHROMATOGRAPHIC PURITY (HPLC/UV)
IMPURITY -> PARENT
CHROMATOGRAPHIC PURITY (HPLC/UV)
IMPURITY -> PARENT
IMPURITY -> PARENT
CHROMATOGRAPHIC PURITY (HPLC/UV)
EP
IMPURITY -> PARENT
The impurity peaks are eluted at the following relative retention times with reference to zidovudine (retention time about 12 to 13 minutes): impurity A (stavudine) about 0.4;. The test is not valid unless the resolution factor between the peaks due to zidovudine and impurity B is at least 2. In the chromatogram obtained with solution (1):- the area of any peak corresponding to impurity A, when multiplied by a correction factor of 0.9, is not greater than the area of the principal peak in the chromatogram obtained with solution (2) (0.5%).
IMPURITY -> PARENT
IMPURITY -> PARENT
Not Specified
IMPURITY -> PARENT
Name Property Type Amount Referenced Substance Defining Parameters References
Biological Half-life PHARMACOKINETIC Population
PHARMACOKINETIC
CSF/PLASMA RATIO PHARMACOKINETIC Population
PHARMACOKINETIC
Tmax PHARMACOKINETIC
Biological Half-life PHARMACOKINETIC Population
PHARMACOKINETIC
Biological Half-life PHARMACOKINETIC Populations
PHARMACOKINETIC
CSF/PLASMA RATIO PHARMACOKINETIC Population
PHARMACOKINETIC
Biological Half-life PHARMACOKINETIC
Route of Elimination PHARMACOKINETIC
Route of Elimination PHARMACOKINETIC
Volume of Distribution PHARMACOKINETIC
Biological Half-life PHARMACOKINETIC Population
PHARMACOKINETIC
Biological Half-life PHARMACOKINETIC Polpulation
PHARMACOKINETIC