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

Details

Stereochemistry ABSOLUTE
Molecular Formula C8H11N3O3S
Molecular Weight 229.256
Optical Activity UNSPECIFIED
Defined Stereocenters 2 / 2
E/Z Centers 0
Charge 0

SHOW SMILES / InChI
Structure of LAMIVUDINE

SMILES

NC1=NC(=O)N(C=C1)[C@@H]2CS[C@H](CO)O2

InChI

InChIKey=JTEGQNOMFQHVDC-NKWVEPMBSA-N
InChI=1S/C8H11N3O3S/c9-5-1-2-11(8(13)10-5)6-4-15-7(3-12)14-6/h1-2,6-7,12H,3-4H2,(H2,9,10,13)/t6-,7+/m0/s1

HIDE SMILES / InChI

Molecular Formula C8H11N3O3S
Molecular Weight 229.256
Charge 0
Count
Stereochemistry ABSOLUTE
Additional Stereochemistry No
Defined Stereocenters 2 / 2
E/Z Centers 0
Optical Activity UNSPECIFIED

Description
Curator's Comment: Description was created based on several sources, including: http://www.drugbank.ca/drugs/DB00709 https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2df7349c-f5d7-47b5-d29b-1b6b31985591

Lamivudine is a reverse transcriptase inhibitor used alone or in combination with other classes of anti-human immunodeficiency virus (HIV) drugs in the treatment of HIV infection. This molecule has two stereo-centers, thus giving rise to four stereoisomers: (+/-)-cis-lamivudine and (+/-)-trans-lamivudine. The latter is considered to be impurity of the pharmaceutically active isomer, (-)-cis-lamivudine.

CNS Activity

Curator's Comment: Known to be CNS penetrant in rat, guinea pig. Human data not available. http://www.ncbi.nlm.nih.gov/pubmed/9593963 http://www.ncbi.nlm.nih.gov/pubmed/18042828 http://www.ncbi.nlm.nih.gov/pubmed/12766261

Approval Year

TargetsConditions

Conditions

ConditionModalityTargetsHighest PhaseProduct
Primary
EPIVIR

Approved Use

EPIVIR is a nucleoside analogue indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection.

Launch Date

2004
Primary
EPIVIR

Approved Use

EPIVIR-HBV is a nucleoside analogue reverse transcriptase inhibitor indicated for the treatment of chronic hepatitis B virus infection associated with evidence of hepatitis B viral replication and active liver inflammation

Launch Date

2004
Cmax

Cmax

ValueDoseCo-administeredAnalytePopulation
3.3 μg/mL
300 mg single, oral
dose: 300 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
LAMIVUDINE blood
Homo sapiens
population: HEALTHY
age: ADULT
sex: FEMALE / MALE
food status: FASTED
1.4 μg/mL
150 mg 2 times / day multiple, oral
dose: 150 mg
route of administration: Oral
experiment type: MULTIPLE
co-administered:
LAMIVUDINE unknown
Homo sapiens
population: UNHEALTHY
age: ADULT
sex: UNKNOWN
food status: UNKNOWN
AUC

AUC

ValueDoseCo-administeredAnalytePopulation
12.4 μg × h/mL
300 mg single, oral
dose: 300 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
LAMIVUDINE blood
Homo sapiens
population: HEALTHY
age: ADULT
sex: FEMALE / MALE
food status: FASTED
5.53 μg × h/mL
150 mg 2 times / day multiple, oral
dose: 150 mg
route of administration: Oral
experiment type: MULTIPLE
co-administered:
LAMIVUDINE unknown
Homo sapiens
population: UNHEALTHY
age: ADULT
sex: UNKNOWN
food status: UNKNOWN
T1/2

T1/2

ValueDoseCo-administeredAnalytePopulation
13.9 h
300 mg single, oral
dose: 300 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
LAMIVUDINE blood
Homo sapiens
population: HEALTHY
age: ADULT
sex: FEMALE / MALE
food status: FASTED
Doses

Doses

DosePopulationAdverse events​
100 mg 1 times / day multiple, oral
Dose: 100 mg, 1 times / day
Route: oral
Route: multiple
Dose: 100 mg, 1 times / day
Sources:
unhealthy, 14.6
n = 12
Health Status: unhealthy
Condition: Chronic hepatitis B
Age Group: 14.6
Sex: M+F
Population Size: 12
Sources:
Other AEs: Malaise and fatigue, Ear, nose and throat infection...
Other AEs:
Malaise and fatigue (25%)
Ear, nose and throat infection (17%)
Cough (8%)
Headache (17%)
Nausea and vomiting (8%)
Ear, nose and throat infection (8%)
Sources:
10 mg/kg 2 times / day multiple, oral
Highest studied dose
Dose: 10 mg/kg, 2 times / day
Route: oral
Route: multiple
Dose: 10 mg/kg, 2 times / day
Sources:
unhealthy, 37 years (range: 23-63 years)
n = 14
Health Status: unhealthy
Condition: HIV infection
Age Group: 37 years (range: 23-63 years)
Population Size: 14
Sources:
Other AEs: Coughing, Diarrhea...
Other AEs:
Coughing (6 patients)
Diarrhea (9 patients)
Abdominal discomfort (2 patients)
Nausea and vomiting (1 patient)
Malaise and fatigue (6 patients)
Headache (6 patients)
Disorder sleep (4 patients)
Cognitive disorders (2 patients)
Oral ulceration (2 patients)
Oral lesion (2 patients)
Muscle pain (3 patients)
Arthralgia (1 patient)
Temperature regulation disorder (2 patients)
Sources:
4 mg/kg 2 times / day multiple, oral
Highest studied dose
Dose: 4 mg/kg, 2 times / day
Route: oral
Route: multiple
Dose: 4 mg/kg, 2 times / day
Sources:
unhealthy, 7.6
n = 11
Health Status: unhealthy
Condition: Chronic hepatitis B
Age Group: 7.6
Sex: M+F
Population Size: 11
Sources:
Other AEs: Malaise and fatigue, Cough...
Other AEs:
Malaise and fatigue (27%)
Cough (27%)
Temperature regulation disorder NOS (27%)
Nausea and vomiting (9%)
Ear, nose and throat infection (18%)
Ear disorder (9%)
Pharyngitis (18%)
Sources:
150 mg 1 times / day multiple, oral
Recommended
Dose: 150 mg, 1 times / day
Route: oral
Route: multiple
Dose: 150 mg, 1 times / day
Co-administed with::
zidovudine(200 mg; 3/day)
Sources:
unhealthy
n = 251
Health Status: unhealthy
Condition: HIV-1 infection
Population Size: 251
Sources:
Other AEs: Headache, Malaise and fatigue...
Other AEs:
Headache (35%)
Malaise and fatigue (27%)
Chills & fever (10%)
Nausea (33%)
Diarrhea (18%)
Nausea and vomiting (13%)
Decreased appetite (10%)
Abdominal pain (9%)
Abdominal cramps (6%)
Dyspepsia (5%)
Neuropathy (12%)
Insomnia disorder (11%)
Dizziness (10%)
Depressive disorders (9%)
Nasal disorders NEC (20%)
Cough (18%)
Skin rash (9%)
Musculoskeletal pain (12%)
Myalgia (8%)
Arthralgia (5%)
Sources:
AEs

AEs

AESignificanceDosePopulation
Ear, nose and throat infection 17%
100 mg 1 times / day multiple, oral
Dose: 100 mg, 1 times / day
Route: oral
Route: multiple
Dose: 100 mg, 1 times / day
Sources:
unhealthy, 14.6
n = 12
Health Status: unhealthy
Condition: Chronic hepatitis B
Age Group: 14.6
Sex: M+F
Population Size: 12
Sources:
Headache 17%
100 mg 1 times / day multiple, oral
Dose: 100 mg, 1 times / day
Route: oral
Route: multiple
Dose: 100 mg, 1 times / day
Sources:
unhealthy, 14.6
n = 12
Health Status: unhealthy
Condition: Chronic hepatitis B
Age Group: 14.6
Sex: M+F
Population Size: 12
Sources:
Malaise and fatigue 25%
100 mg 1 times / day multiple, oral
Dose: 100 mg, 1 times / day
Route: oral
Route: multiple
Dose: 100 mg, 1 times / day
Sources:
unhealthy, 14.6
n = 12
Health Status: unhealthy
Condition: Chronic hepatitis B
Age Group: 14.6
Sex: M+F
Population Size: 12
Sources:
Cough 8%
100 mg 1 times / day multiple, oral
Dose: 100 mg, 1 times / day
Route: oral
Route: multiple
Dose: 100 mg, 1 times / day
Sources:
unhealthy, 14.6
n = 12
Health Status: unhealthy
Condition: Chronic hepatitis B
Age Group: 14.6
Sex: M+F
Population Size: 12
Sources:
Ear, nose and throat infection 8%
100 mg 1 times / day multiple, oral
Dose: 100 mg, 1 times / day
Route: oral
Route: multiple
Dose: 100 mg, 1 times / day
Sources:
unhealthy, 14.6
n = 12
Health Status: unhealthy
Condition: Chronic hepatitis B
Age Group: 14.6
Sex: M+F
Population Size: 12
Sources:
Nausea and vomiting 8%
100 mg 1 times / day multiple, oral
Dose: 100 mg, 1 times / day
Route: oral
Route: multiple
Dose: 100 mg, 1 times / day
Sources:
unhealthy, 14.6
n = 12
Health Status: unhealthy
Condition: Chronic hepatitis B
Age Group: 14.6
Sex: M+F
Population Size: 12
Sources:
Arthralgia 1 patient
10 mg/kg 2 times / day multiple, oral
Highest studied dose
Dose: 10 mg/kg, 2 times / day
Route: oral
Route: multiple
Dose: 10 mg/kg, 2 times / day
Sources:
unhealthy, 37 years (range: 23-63 years)
n = 14
Health Status: unhealthy
Condition: HIV infection
Age Group: 37 years (range: 23-63 years)
Population Size: 14
Sources:
Nausea and vomiting 1 patient
10 mg/kg 2 times / day multiple, oral
Highest studied dose
Dose: 10 mg/kg, 2 times / day
Route: oral
Route: multiple
Dose: 10 mg/kg, 2 times / day
Sources:
unhealthy, 37 years (range: 23-63 years)
n = 14
Health Status: unhealthy
Condition: HIV infection
Age Group: 37 years (range: 23-63 years)
Population Size: 14
Sources:
Abdominal discomfort 2 patients
10 mg/kg 2 times / day multiple, oral
Highest studied dose
Dose: 10 mg/kg, 2 times / day
Route: oral
Route: multiple
Dose: 10 mg/kg, 2 times / day
Sources:
unhealthy, 37 years (range: 23-63 years)
n = 14
Health Status: unhealthy
Condition: HIV infection
Age Group: 37 years (range: 23-63 years)
Population Size: 14
Sources:
Cognitive disorders 2 patients
10 mg/kg 2 times / day multiple, oral
Highest studied dose
Dose: 10 mg/kg, 2 times / day
Route: oral
Route: multiple
Dose: 10 mg/kg, 2 times / day
Sources:
unhealthy, 37 years (range: 23-63 years)
n = 14
Health Status: unhealthy
Condition: HIV infection
Age Group: 37 years (range: 23-63 years)
Population Size: 14
Sources:
Oral lesion 2 patients
10 mg/kg 2 times / day multiple, oral
Highest studied dose
Dose: 10 mg/kg, 2 times / day
Route: oral
Route: multiple
Dose: 10 mg/kg, 2 times / day
Sources:
unhealthy, 37 years (range: 23-63 years)
n = 14
Health Status: unhealthy
Condition: HIV infection
Age Group: 37 years (range: 23-63 years)
Population Size: 14
Sources:
Oral ulceration 2 patients
10 mg/kg 2 times / day multiple, oral
Highest studied dose
Dose: 10 mg/kg, 2 times / day
Route: oral
Route: multiple
Dose: 10 mg/kg, 2 times / day
Sources:
unhealthy, 37 years (range: 23-63 years)
n = 14
Health Status: unhealthy
Condition: HIV infection
Age Group: 37 years (range: 23-63 years)
Population Size: 14
Sources:
Temperature regulation disorder 2 patients
10 mg/kg 2 times / day multiple, oral
Highest studied dose
Dose: 10 mg/kg, 2 times / day
Route: oral
Route: multiple
Dose: 10 mg/kg, 2 times / day
Sources:
unhealthy, 37 years (range: 23-63 years)
n = 14
Health Status: unhealthy
Condition: HIV infection
Age Group: 37 years (range: 23-63 years)
Population Size: 14
Sources:
Muscle pain 3 patients
10 mg/kg 2 times / day multiple, oral
Highest studied dose
Dose: 10 mg/kg, 2 times / day
Route: oral
Route: multiple
Dose: 10 mg/kg, 2 times / day
Sources:
unhealthy, 37 years (range: 23-63 years)
n = 14
Health Status: unhealthy
Condition: HIV infection
Age Group: 37 years (range: 23-63 years)
Population Size: 14
Sources:
Disorder sleep 4 patients
10 mg/kg 2 times / day multiple, oral
Highest studied dose
Dose: 10 mg/kg, 2 times / day
Route: oral
Route: multiple
Dose: 10 mg/kg, 2 times / day
Sources:
unhealthy, 37 years (range: 23-63 years)
n = 14
Health Status: unhealthy
Condition: HIV infection
Age Group: 37 years (range: 23-63 years)
Population Size: 14
Sources:
Coughing 6 patients
10 mg/kg 2 times / day multiple, oral
Highest studied dose
Dose: 10 mg/kg, 2 times / day
Route: oral
Route: multiple
Dose: 10 mg/kg, 2 times / day
Sources:
unhealthy, 37 years (range: 23-63 years)
n = 14
Health Status: unhealthy
Condition: HIV infection
Age Group: 37 years (range: 23-63 years)
Population Size: 14
Sources:
Headache 6 patients
10 mg/kg 2 times / day multiple, oral
Highest studied dose
Dose: 10 mg/kg, 2 times / day
Route: oral
Route: multiple
Dose: 10 mg/kg, 2 times / day
Sources:
unhealthy, 37 years (range: 23-63 years)
n = 14
Health Status: unhealthy
Condition: HIV infection
Age Group: 37 years (range: 23-63 years)
Population Size: 14
Sources:
Malaise and fatigue 6 patients
10 mg/kg 2 times / day multiple, oral
Highest studied dose
Dose: 10 mg/kg, 2 times / day
Route: oral
Route: multiple
Dose: 10 mg/kg, 2 times / day
Sources:
unhealthy, 37 years (range: 23-63 years)
n = 14
Health Status: unhealthy
Condition: HIV infection
Age Group: 37 years (range: 23-63 years)
Population Size: 14
Sources:
Diarrhea 9 patients
10 mg/kg 2 times / day multiple, oral
Highest studied dose
Dose: 10 mg/kg, 2 times / day
Route: oral
Route: multiple
Dose: 10 mg/kg, 2 times / day
Sources:
unhealthy, 37 years (range: 23-63 years)
n = 14
Health Status: unhealthy
Condition: HIV infection
Age Group: 37 years (range: 23-63 years)
Population Size: 14
Sources:
Ear, nose and throat infection 18%
4 mg/kg 2 times / day multiple, oral
Highest studied dose
Dose: 4 mg/kg, 2 times / day
Route: oral
Route: multiple
Dose: 4 mg/kg, 2 times / day
Sources:
unhealthy, 7.6
n = 11
Health Status: unhealthy
Condition: Chronic hepatitis B
Age Group: 7.6
Sex: M+F
Population Size: 11
Sources:
Pharyngitis 18%
4 mg/kg 2 times / day multiple, oral
Highest studied dose
Dose: 4 mg/kg, 2 times / day
Route: oral
Route: multiple
Dose: 4 mg/kg, 2 times / day
Sources:
unhealthy, 7.6
n = 11
Health Status: unhealthy
Condition: Chronic hepatitis B
Age Group: 7.6
Sex: M+F
Population Size: 11
Sources:
Cough 27%
4 mg/kg 2 times / day multiple, oral
Highest studied dose
Dose: 4 mg/kg, 2 times / day
Route: oral
Route: multiple
Dose: 4 mg/kg, 2 times / day
Sources:
unhealthy, 7.6
n = 11
Health Status: unhealthy
Condition: Chronic hepatitis B
Age Group: 7.6
Sex: M+F
Population Size: 11
Sources:
Malaise and fatigue 27%
4 mg/kg 2 times / day multiple, oral
Highest studied dose
Dose: 4 mg/kg, 2 times / day
Route: oral
Route: multiple
Dose: 4 mg/kg, 2 times / day
Sources:
unhealthy, 7.6
n = 11
Health Status: unhealthy
Condition: Chronic hepatitis B
Age Group: 7.6
Sex: M+F
Population Size: 11
Sources:
Temperature regulation disorder NOS 27%
4 mg/kg 2 times / day multiple, oral
Highest studied dose
Dose: 4 mg/kg, 2 times / day
Route: oral
Route: multiple
Dose: 4 mg/kg, 2 times / day
Sources:
unhealthy, 7.6
n = 11
Health Status: unhealthy
Condition: Chronic hepatitis B
Age Group: 7.6
Sex: M+F
Population Size: 11
Sources:
Ear disorder 9%
4 mg/kg 2 times / day multiple, oral
Highest studied dose
Dose: 4 mg/kg, 2 times / day
Route: oral
Route: multiple
Dose: 4 mg/kg, 2 times / day
Sources:
unhealthy, 7.6
n = 11
Health Status: unhealthy
Condition: Chronic hepatitis B
Age Group: 7.6
Sex: M+F
Population Size: 11
Sources:
Nausea and vomiting 9%
4 mg/kg 2 times / day multiple, oral
Highest studied dose
Dose: 4 mg/kg, 2 times / day
Route: oral
Route: multiple
Dose: 4 mg/kg, 2 times / day
Sources:
unhealthy, 7.6
n = 11
Health Status: unhealthy
Condition: Chronic hepatitis B
Age Group: 7.6
Sex: M+F
Population Size: 11
Sources:
Chills & fever 10%
150 mg 1 times / day multiple, oral
Recommended
Dose: 150 mg, 1 times / day
Route: oral
Route: multiple
Dose: 150 mg, 1 times / day
Co-administed with::
zidovudine(200 mg; 3/day)
Sources:
unhealthy
n = 251
Health Status: unhealthy
Condition: HIV-1 infection
Population Size: 251
Sources:
Decreased appetite 10%
150 mg 1 times / day multiple, oral
Recommended
Dose: 150 mg, 1 times / day
Route: oral
Route: multiple
Dose: 150 mg, 1 times / day
Co-administed with::
zidovudine(200 mg; 3/day)
Sources:
unhealthy
n = 251
Health Status: unhealthy
Condition: HIV-1 infection
Population Size: 251
Sources:
Dizziness 10%
150 mg 1 times / day multiple, oral
Recommended
Dose: 150 mg, 1 times / day
Route: oral
Route: multiple
Dose: 150 mg, 1 times / day
Co-administed with::
zidovudine(200 mg; 3/day)
Sources:
unhealthy
n = 251
Health Status: unhealthy
Condition: HIV-1 infection
Population Size: 251
Sources:
Insomnia disorder 11%
150 mg 1 times / day multiple, oral
Recommended
Dose: 150 mg, 1 times / day
Route: oral
Route: multiple
Dose: 150 mg, 1 times / day
Co-administed with::
zidovudine(200 mg; 3/day)
Sources:
unhealthy
n = 251
Health Status: unhealthy
Condition: HIV-1 infection
Population Size: 251
Sources:
Musculoskeletal pain 12%
150 mg 1 times / day multiple, oral
Recommended
Dose: 150 mg, 1 times / day
Route: oral
Route: multiple
Dose: 150 mg, 1 times / day
Co-administed with::
zidovudine(200 mg; 3/day)
Sources:
unhealthy
n = 251
Health Status: unhealthy
Condition: HIV-1 infection
Population Size: 251
Sources:
Neuropathy 12%
150 mg 1 times / day multiple, oral
Recommended
Dose: 150 mg, 1 times / day
Route: oral
Route: multiple
Dose: 150 mg, 1 times / day
Co-administed with::
zidovudine(200 mg; 3/day)
Sources:
unhealthy
n = 251
Health Status: unhealthy
Condition: HIV-1 infection
Population Size: 251
Sources:
Nausea and vomiting 13%
150 mg 1 times / day multiple, oral
Recommended
Dose: 150 mg, 1 times / day
Route: oral
Route: multiple
Dose: 150 mg, 1 times / day
Co-administed with::
zidovudine(200 mg; 3/day)
Sources:
unhealthy
n = 251
Health Status: unhealthy
Condition: HIV-1 infection
Population Size: 251
Sources:
Cough 18%
150 mg 1 times / day multiple, oral
Recommended
Dose: 150 mg, 1 times / day
Route: oral
Route: multiple
Dose: 150 mg, 1 times / day
Co-administed with::
zidovudine(200 mg; 3/day)
Sources:
unhealthy
n = 251
Health Status: unhealthy
Condition: HIV-1 infection
Population Size: 251
Sources:
Diarrhea 18%
150 mg 1 times / day multiple, oral
Recommended
Dose: 150 mg, 1 times / day
Route: oral
Route: multiple
Dose: 150 mg, 1 times / day
Co-administed with::
zidovudine(200 mg; 3/day)
Sources:
unhealthy
n = 251
Health Status: unhealthy
Condition: HIV-1 infection
Population Size: 251
Sources:
Nasal disorders NEC 20%
150 mg 1 times / day multiple, oral
Recommended
Dose: 150 mg, 1 times / day
Route: oral
Route: multiple
Dose: 150 mg, 1 times / day
Co-administed with::
zidovudine(200 mg; 3/day)
Sources:
unhealthy
n = 251
Health Status: unhealthy
Condition: HIV-1 infection
Population Size: 251
Sources:
Malaise and fatigue 27%
150 mg 1 times / day multiple, oral
Recommended
Dose: 150 mg, 1 times / day
Route: oral
Route: multiple
Dose: 150 mg, 1 times / day
Co-administed with::
zidovudine(200 mg; 3/day)
Sources:
unhealthy
n = 251
Health Status: unhealthy
Condition: HIV-1 infection
Population Size: 251
Sources:
Nausea 33%
150 mg 1 times / day multiple, oral
Recommended
Dose: 150 mg, 1 times / day
Route: oral
Route: multiple
Dose: 150 mg, 1 times / day
Co-administed with::
zidovudine(200 mg; 3/day)
Sources:
unhealthy
n = 251
Health Status: unhealthy
Condition: HIV-1 infection
Population Size: 251
Sources:
Headache 35%
150 mg 1 times / day multiple, oral
Recommended
Dose: 150 mg, 1 times / day
Route: oral
Route: multiple
Dose: 150 mg, 1 times / day
Co-administed with::
zidovudine(200 mg; 3/day)
Sources:
unhealthy
n = 251
Health Status: unhealthy
Condition: HIV-1 infection
Population Size: 251
Sources:
Arthralgia 5%
150 mg 1 times / day multiple, oral
Recommended
Dose: 150 mg, 1 times / day
Route: oral
Route: multiple
Dose: 150 mg, 1 times / day
Co-administed with::
zidovudine(200 mg; 3/day)
Sources:
unhealthy
n = 251
Health Status: unhealthy
Condition: HIV-1 infection
Population Size: 251
Sources:
Dyspepsia 5%
150 mg 1 times / day multiple, oral
Recommended
Dose: 150 mg, 1 times / day
Route: oral
Route: multiple
Dose: 150 mg, 1 times / day
Co-administed with::
zidovudine(200 mg; 3/day)
Sources:
unhealthy
n = 251
Health Status: unhealthy
Condition: HIV-1 infection
Population Size: 251
Sources:
Abdominal cramps 6%
150 mg 1 times / day multiple, oral
Recommended
Dose: 150 mg, 1 times / day
Route: oral
Route: multiple
Dose: 150 mg, 1 times / day
Co-administed with::
zidovudine(200 mg; 3/day)
Sources:
unhealthy
n = 251
Health Status: unhealthy
Condition: HIV-1 infection
Population Size: 251
Sources:
Myalgia 8%
150 mg 1 times / day multiple, oral
Recommended
Dose: 150 mg, 1 times / day
Route: oral
Route: multiple
Dose: 150 mg, 1 times / day
Co-administed with::
zidovudine(200 mg; 3/day)
Sources:
unhealthy
n = 251
Health Status: unhealthy
Condition: HIV-1 infection
Population Size: 251
Sources:
Abdominal pain 9%
150 mg 1 times / day multiple, oral
Recommended
Dose: 150 mg, 1 times / day
Route: oral
Route: multiple
Dose: 150 mg, 1 times / day
Co-administed with::
zidovudine(200 mg; 3/day)
Sources:
unhealthy
n = 251
Health Status: unhealthy
Condition: HIV-1 infection
Population Size: 251
Sources:
Depressive disorders 9%
150 mg 1 times / day multiple, oral
Recommended
Dose: 150 mg, 1 times / day
Route: oral
Route: multiple
Dose: 150 mg, 1 times / day
Co-administed with::
zidovudine(200 mg; 3/day)
Sources:
unhealthy
n = 251
Health Status: unhealthy
Condition: HIV-1 infection
Population Size: 251
Sources:
Skin rash 9%
150 mg 1 times / day multiple, oral
Recommended
Dose: 150 mg, 1 times / day
Route: oral
Route: multiple
Dose: 150 mg, 1 times / day
Co-administed with::
zidovudine(200 mg; 3/day)
Sources:
unhealthy
n = 251
Health Status: unhealthy
Condition: HIV-1 infection
Population Size: 251
Sources:
Overview

Overview

CYP3A4CYP2C9CYP2D6hERG



Drug as perpetrator​

Drug as perpetrator​

TargetModalityActivityMetaboliteClinical evidence
no
no
no
no
no
no
weak to no
weak to no
weak to no
yes
yes
Drug as victim
PubMed

PubMed

TitleDatePubMed
Liver transplantation for chronic hepatitis B infection with the use of combination lamivudine and low-dose hepatitis B immune globulin.
1999 Nov
Lamivudine therapy in patients undergoing liver transplantation for hepatitis B virus precore mutant-associated infection: high resistance rates in treatment of recurrence but universal prevention if used as prophylaxis with very low dose hepatitis B immune globulin.
1999 Nov
Intramuscular hepatitis B immune globulin combined with lamivudine for prophylaxis against hepatitis B recurrence after liver transplantation.
1999 Nov
In vitro induction of human immunodeficiency virus type 1 variants resistant to phosphoralaninate prodrugs of Z-methylenecyclopropane nucleoside analogues.
1999 Oct
A novel genotype encoding a single amino acid insertion and five other substitutions between residues 64 and 74 of the HIV-1 reverse transcriptase confers high-level cross-resistance to nucleoside reverse transcriptase inhibitors. Abacavir CNA2007 International Study Group.
1999 Oct 1
Prevention of de novo hepatitis B infection in recipients of hepatic allografts from anti-HBc positive donors.
1999 Oct 15
Additional interferon alpha for lamivudine resistant hepatitis B infection after liver transplantation: a preliminary report.
2000 Apr 27
Beneficial effects of lamivudine in hepatitis B virus-related decompensated cirrhosis.
2000 Aug
Increasing cerebrospinal fluid chemokine concentrations despite undetectable cerebrospinal fluid HIV RNA in HIV-1-infected patients receiving antiretroviral therapy.
2000 Dec 15
Outcome of lamivudine resistant hepatitis B virus infection in the liver transplant recipient.
2000 Jan
Differential transport of cytosine-containing nucleosides by recombinant human concentrative nucleoside transporter protein hCNT1.
2000 Jan-Feb
Synthesis and anti-HIV evaluation of new 2',3'-dideoxy-3'-thiacytidine prodrugs.
2000 Jul
Drug resistance and drug combination features of the human immunodeficiency virus inhibitor, BCH-10652 [(+/-)-2'-deoxy-3'-oxa-4'-thiocytidine, dOTC].
2000 Jul
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
Synthesis and antiviral evaluation of some beta-L-2', 3'-dideoxy-5-chloropyrimidine nucleosides and pronucleotides.
2000 Mar
Selection of resistance-conferring mutations in HIV-1 by the nucleoside reverse transcriptase inhibitors (+/-)dOTC and (+/-)dOTFC.
2000 Nov
An efficacy and cost-effectiveness analysis of combination hepatitis B immune globulin and lamivudine to prevent recurrent hepatitis B after orthotopic liver transplantation compared with hepatitis B immune globulin monotherapy.
2000 Nov
Synthesis and antiviral activity of oxaselenolane nucleosides.
2000 Oct 19
Anti-HBV specific beta-L-2'-deoxynucleosides.
2001 Apr-Jul
Acyclic/carbocyclic guanosine analogues as anti-herpesvirus agents.
2001 Apr-Jul
Outcome of liver transplantation for hepatitis B: report of a single center's experience.
2001 Aug
Prenatal AZT or 3TC and mouse development of locomotor activity and hot-plate responding upon administration of the GABA(A) receptor agonist muscimol.
2001 Feb
Liver transplantation in Asian patients with chronic hepatitis B using lamivudine prophylaxis.
2001 Feb
[Treatment of chronic viral hepatitis B with lamivudine].
2001 Jan 27
Efficacy and tolerability of long-term therapy using high lamivudine doses for the treatment of chronic hepatitis B.
2001 Jul
Updated U.S. Public Health Service Guidelines for the Management of Occupational Exposures to HBV, HCV, and HIV and Recommendations for Postexposure Prophylaxis.
2001 Jun 29
4'-Ethynyl nucleoside analogs: potent inhibitors of multidrug-resistant human immunodeficiency virus variants in vitro.
2001 May
Differential human immunodeficiency virus-suppressive activity of reverse transcription inhibitors in resting and activated peripheral blood lymphocytes: implications for therapy.
2001 May-Jun
Novel 5-vinyl pyrimidine nucleosides with potent anti-hepatitis B virus activity.
2001 Nov 19
Patents

Sample Use Guides

In Vivo Use Guide
Curator's Comment: Pediatric dose should be calculated on body weight (kg) and should not exceed 300 mg daily. Dosage of this product is for HIV-1 and not for HBV
Adults: 300 mg daily, administered as either 150 mg twice daily or 300 mg once daily.
Route of Administration: Oral
The antiviral activity of lamivudine against HIV-1 was assessed in a number of cell lines including monocytes and fresh human peripheral blood lymphocytes (PBMCs) using standard susceptibility assays. EC50 values were in the range of 0.003 to 15 microM (1 microM = 0.23 mcg per mL).
Substance Class Chemical
Created
by admin
on Sat Dec 16 05:16:11 GMT 2023
Edited
by admin
on Sat Dec 16 05:16:11 GMT 2023
Record UNII
2T8Q726O95
Record Status Validated (UNII)
Record Version
  • Download
Name Type Language
LAMIVUDINE
EMA EPAR   EP   HSDB   INN   JAN   MART.   MI   ORANGE BOOK   USAN   USP   USP-RS   VANDF   WHO-DD   WHO-IP  
USAN   INN  
Official Name English
TEMIXYS COMPONENT LAMIVUDINE
Common Name English
EPIVIR
Brand Name English
LAMIVUDINE [EP MONOGRAPH]
Common Name English
4-AMINO-1-((2R,5S)-2-(HYDROXYMETHYL)-1,3-OXATHIOLAN-5-YL)PYRIMIDIN-2(1H)-ONE [WHO-IP]
Systematic Name English
EMTRICITABINE IMPURITY C [WHO-IP]
Common Name English
KIVEXA COMPONENT LAMIVUDINE
Common Name English
LAMIVUDINUM [WHO-IP LATIN]
Common Name English
GR-109714X
Code English
COMBIVIR COMPONENT LAMIVUDINE
Common Name English
LAMIVUDINE/ZIDOVUDINE TEVA COMPONENT LAMIVUDINE
Brand Name English
TRIZIVIR COMPONENT LAMIVUDINE
Brand Name English
VIROLAM
Common Name English
LAMIVUDINE [WHO-IP]
Common Name English
NSC-760061
Code English
LAMIVUDINE [USP-RS]
Common Name English
3TC
Code English
TELURA COMPONENT OF LAMIVUDINE
Common Name English
LAMIVUDINE COMPONENT OF TRIUMEQ
Brand Name English
LAMIVUDINE COMPONENT OF TRIZIVIR
Brand Name English
LAMIVUDINE COMPONENT OF DUTREBIS
Brand Name English
GR109714X
Code English
LAMIVUDINE COMPONENT OF DELSTRIGO
Brand Name English
LAMIVUDINE COMPONENT OF COMBIVIR
Common Name English
DELSTRIGO COMPONENT LAMIVUDINE
Brand Name English
LAMIVUDINE COMPONENT OF TEMIXYS
Common Name English
LAMIVUDINE [ORANGE BOOK]
Common Name English
Lamivudine [WHO-DD]
Common Name English
LAMIVUDINE TEVA
Brand Name English
lamivudine [INN]
Common Name English
LAMIVUDINE [EP IMPURITY]
Common Name English
ZEFFIX
Brand Name English
LAMIVUDINE [HSDB]
Common Name English
LAMIVUDINE [JAN]
Common Name English
LAMIVUDINE TEVA PHARMA B.V.
Brand Name English
(-)-1-((2R,5S)-2-(HYDROXYMETHYL)-1,3-OXATHIOLAN-5-YL)CYTOSINE
Systematic Name English
LAMIVUDINE [EMA EPAR]
Common Name English
LAMIVUDINE COMPONENT OF EPZICOM
Common Name English
BCH 189, (-)-
Code English
TRIUMEQ COMPONENT LAMIVUDINE
Brand Name English
LAMIVUDINE COMPONENT OF LAMIVUDINE/ZIDOVUDINE TEVA
Brand Name English
LAMIVUDINE [MART.]
Common Name English
EPZICOM COMPONENT LAMIVUDINE
Common Name English
LAMIVUDINE [USAN]
Common Name English
LAMIVUDINE [VANDF]
Common Name English
2(1H)-PYRIMIDINONE, 4-AMINO-1-(2-(HYDROXYMETHYL)-1,3-OXATHIOLAN-5-YL)-, (2R-CIS)-
Common Name English
LAMIVUDINE [USP MONOGRAPH]
Common Name English
LAMIVUDINE [MI]
Common Name English
Classification Tree Code System Code
NDF-RT N0000175462
Created by admin on Sat Dec 16 05:16:11 GMT 2023 , Edited by admin on Sat Dec 16 05:16:11 GMT 2023
WHO-VATC QJ05AR04
Created by admin on Sat Dec 16 05:16:11 GMT 2023 , Edited by admin on Sat Dec 16 05:16:11 GMT 2023
WHO-ATC J05AR05
Created by admin on Sat Dec 16 05:16:11 GMT 2023 , Edited by admin on Sat Dec 16 05:16:11 GMT 2023
WHO-VATC QJ05AR02
Created by admin on Sat Dec 16 05:16:11 GMT 2023 , Edited by admin on Sat Dec 16 05:16:11 GMT 2023
NCI_THESAURUS C97452
Created by admin on Sat Dec 16 05:16:11 GMT 2023 , Edited by admin on Sat Dec 16 05:16:11 GMT 2023
EMA ASSESSMENT REPORTS LAMIVUDINE TEVA PHARMA B.V. (AUTHORIZED: HIV INFECTIONS)
Created by admin on Sat Dec 16 05:16:11 GMT 2023 , Edited by admin on Sat Dec 16 05:16:11 GMT 2023
WHO-VATC QJ05AR05
Created by admin on Sat Dec 16 05:16:11 GMT 2023 , Edited by admin on Sat Dec 16 05:16:11 GMT 2023
EMA ASSESSMENT REPORTS KIVEXA (AUTHORIZED: HIV INFECTIONS)
Created by admin on Sat Dec 16 05:16:11 GMT 2023 , Edited by admin on Sat Dec 16 05:16:11 GMT 2023
WHO-VATC QJ05AR11
Created by admin on Sat Dec 16 05:16:11 GMT 2023 , Edited by admin on Sat Dec 16 05:16:11 GMT 2023
WHO-ATC J05AR02
Created by admin on Sat Dec 16 05:16:11 GMT 2023 , Edited by admin on Sat Dec 16 05:16:11 GMT 2023
WHO-ATC J05AR11
Created by admin on Sat Dec 16 05:16:11 GMT 2023 , Edited by admin on Sat Dec 16 05:16:11 GMT 2023
WHO-ESSENTIAL MEDICINES LIST 6.4.2.3 (LAM/NEV/ZID)
Created by admin on Sat Dec 16 05:16:11 GMT 2023 , Edited by admin on Sat Dec 16 05:16:11 GMT 2023
WHO-ESSENTIAL MEDICINES LIST 6.4.2.1
Created by admin on Sat Dec 16 05:16:11 GMT 2023 , Edited by admin on Sat Dec 16 05:16:11 GMT 2023
WHO-ATC J05AR16
Created by admin on Sat Dec 16 05:16:11 GMT 2023 , Edited by admin on Sat Dec 16 05:16:11 GMT 2023
NDF-RT N0000175459
Created by admin on Sat Dec 16 05:16:11 GMT 2023 , Edited by admin on Sat Dec 16 05:16:11 GMT 2023
NDF-RT N0000175656
Created by admin on Sat Dec 16 05:16:11 GMT 2023 , Edited by admin on Sat Dec 16 05:16:11 GMT 2023
NDF-RT N0000175459
Created by admin on Sat Dec 16 05:16:11 GMT 2023 , Edited by admin on Sat Dec 16 05:16:11 GMT 2023
EMA ASSESSMENT REPORTS ZEFFIX (AUTHORIZED: HEPTATIS B, CHRONIC)
Created by admin on Sat Dec 16 05:16:11 GMT 2023 , Edited by admin on Sat Dec 16 05:16:11 GMT 2023
WHO-ATC J05AR24
Created by admin on Sat Dec 16 05:16:11 GMT 2023 , Edited by admin on Sat Dec 16 05:16:11 GMT 2023
WHO-ATC J05AR12
Created by admin on Sat Dec 16 05:16:11 GMT 2023 , Edited by admin on Sat Dec 16 05:16:11 GMT 2023
WHO-ATC J05AR07
Created by admin on Sat Dec 16 05:16:11 GMT 2023 , Edited by admin on Sat Dec 16 05:16:11 GMT 2023
NDF-RT N0000009947
Created by admin on Sat Dec 16 05:16:11 GMT 2023 , Edited by admin on Sat Dec 16 05:16:11 GMT 2023
EMA ASSESSMENT REPORTS EPIVIR (AUTHORIZED: HIV INFECTIONS)
Created by admin on Sat Dec 16 05:16:11 GMT 2023 , Edited by admin on Sat Dec 16 05:16:11 GMT 2023
WHO-ESSENTIAL MEDICINES LIST 6.4.2.3 (LAM/NEV/STA)
Created by admin on Sat Dec 16 05:16:11 GMT 2023 , Edited by admin on Sat Dec 16 05:16:11 GMT 2023
LIVERTOX NBK548553
Created by admin on Sat Dec 16 05:16:11 GMT 2023 , Edited by admin on Sat Dec 16 05:16:11 GMT 2023
WHO-ATC J05AR01
Created by admin on Sat Dec 16 05:16:11 GMT 2023 , Edited by admin on Sat Dec 16 05:16:11 GMT 2023
WHO-ATC J05AR13
Created by admin on Sat Dec 16 05:16:11 GMT 2023 , Edited by admin on Sat Dec 16 05:16:11 GMT 2023
WHO-ATC J05AR04
Created by admin on Sat Dec 16 05:16:11 GMT 2023 , Edited by admin on Sat Dec 16 05:16:11 GMT 2023
EMA ASSESSMENT REPORTS TRIUMEQ (AUTHORIZED: HIV INFECTIONS)
Created by admin on Sat Dec 16 05:16:11 GMT 2023 , Edited by admin on Sat Dec 16 05:16:11 GMT 2023
WHO-VATC QJ05AR01
Created by admin on Sat Dec 16 05:16:11 GMT 2023 , Edited by admin on Sat Dec 16 05:16:11 GMT 2023
EMA ASSESSMENT REPORTS LAMIVUDINE/ZIDOVUDINE TEVA (AUTHORIZED: HIV INFECTIONS)
Created by admin on Sat Dec 16 05:16:11 GMT 2023 , Edited by admin on Sat Dec 16 05:16:11 GMT 2023
NDF-RT N0000175459
Created by admin on Sat Dec 16 05:16:11 GMT 2023 , Edited by admin on Sat Dec 16 05:16:11 GMT 2023
WHO-ATC J05AF05
Created by admin on Sat Dec 16 05:16:11 GMT 2023 , Edited by admin on Sat Dec 16 05:16:11 GMT 2023
WHO-VATC QJ05AR07
Created by admin on Sat Dec 16 05:16:11 GMT 2023 , Edited by admin on Sat Dec 16 05:16:11 GMT 2023
EMA ASSESSMENT REPORTS COMBIVIR (AUTHORIZED: HIV INFECTIONS)
Created by admin on Sat Dec 16 05:16:11 GMT 2023 , Edited by admin on Sat Dec 16 05:16:11 GMT 2023
EMA ASSESSMENT REPORTS TRIZIVIR (AUTHORIZED: HIV INFECTIONS)
Created by admin on Sat Dec 16 05:16:11 GMT 2023 , Edited by admin on Sat Dec 16 05:16:11 GMT 2023
WHO-ESSENTIAL MEDICINES LIST 6.4.2.3 (LAM/ZID)
Created by admin on Sat Dec 16 05:16:11 GMT 2023 , Edited by admin on Sat Dec 16 05:16:11 GMT 2023
EMA ASSESSMENT REPORTS LAMIVUDINE TEVA (AUTHORIZED: HEPATITIS B, CHRONIC)
Created by admin on Sat Dec 16 05:16:11 GMT 2023 , Edited by admin on Sat Dec 16 05:16:11 GMT 2023
EMA ASSESSMENT REPORTS DUTREBIS (AUTHORIZED: HIV INFECTIONS)
Created by admin on Sat Dec 16 05:16:11 GMT 2023 , Edited by admin on Sat Dec 16 05:16:11 GMT 2023
WHO-VATC QJ05AF05
Created by admin on Sat Dec 16 05:16:11 GMT 2023 , Edited by admin on Sat Dec 16 05:16:11 GMT 2023
Code System Code Type Description
SMS_ID
100000085444
Created by admin on Sat Dec 16 05:16:11 GMT 2023 , Edited by admin on Sat Dec 16 05:16:11 GMT 2023
PRIMARY
INN
6908
Created by admin on Sat Dec 16 05:16:11 GMT 2023 , Edited by admin on Sat Dec 16 05:16:11 GMT 2023
PRIMARY
RXCUI
68244
Created by admin on Sat Dec 16 05:16:11 GMT 2023 , Edited by admin on Sat Dec 16 05:16:11 GMT 2023
PRIMARY RxNorm
CHEBI
63577
Created by admin on Sat Dec 16 05:16:11 GMT 2023 , Edited by admin on Sat Dec 16 05:16:11 GMT 2023
PRIMARY
CAS
134678-17-4
Created by admin on Sat Dec 16 05:16:11 GMT 2023 , Edited by admin on Sat Dec 16 05:16:11 GMT 2023
PRIMARY
FDA UNII
2T8Q726O95
Created by admin on Sat Dec 16 05:16:11 GMT 2023 , Edited by admin on Sat Dec 16 05:16:11 GMT 2023
PRIMARY
LACTMED
Lamivudine
Created by admin on Sat Dec 16 05:16:11 GMT 2023 , Edited by admin on Sat Dec 16 05:16:11 GMT 2023
PRIMARY
WHO INTERNATIONAL PHARMACOPEIA
LAMIVUDINE
Created by admin on Sat Dec 16 05:16:11 GMT 2023 , Edited by admin on Sat Dec 16 05:16:11 GMT 2023
PRIMARY Description: A white or almost white powder.Solubility: Soluble in water; sparingly soluble in methanol R; practically insoluble in acetone R. Category: Antiretroviral (Nucleoside Reverse Transcriptase Inhibitor). Storage: Lamivudine should be kept in a well-closed container, protected from light. Additional information: Lamivudine may exhibit polymorphism. Definition: Lamivudine contains not less than 97.0% and not more than 103.0% of C8H11N3O3S, calculated with reference to the dried substance.
MESH
D019259
Created by admin on Sat Dec 16 05:16:11 GMT 2023 , Edited by admin on Sat Dec 16 05:16:11 GMT 2023
PRIMARY
ChEMBL
CHEMBL141
Created by admin on Sat Dec 16 05:16:11 GMT 2023 , Edited by admin on Sat Dec 16 05:16:11 GMT 2023
PRIMARY
NCI_THESAURUS
C1471
Created by admin on Sat Dec 16 05:16:11 GMT 2023 , Edited by admin on Sat Dec 16 05:16:11 GMT 2023
PRIMARY
HSDB
7155
Created by admin on Sat Dec 16 05:16:11 GMT 2023 , Edited by admin on Sat Dec 16 05:16:11 GMT 2023
PRIMARY
USAN
DD-86
Created by admin on Sat Dec 16 05:16:11 GMT 2023 , Edited by admin on Sat Dec 16 05:16:11 GMT 2023
PRIMARY
EPA CompTox
DTXSID7023194
Created by admin on Sat Dec 16 05:16:11 GMT 2023 , Edited by admin on Sat Dec 16 05:16:11 GMT 2023
PRIMARY
WIKIPEDIA
LAMIVUDINE
Created by admin on Sat Dec 16 05:16:11 GMT 2023 , Edited by admin on Sat Dec 16 05:16:11 GMT 2023
PRIMARY
DRUG BANK
DB00709
Created by admin on Sat Dec 16 05:16:11 GMT 2023 , Edited by admin on Sat Dec 16 05:16:11 GMT 2023
PRIMARY
NSC
760061
Created by admin on Sat Dec 16 05:16:11 GMT 2023 , Edited by admin on Sat Dec 16 05:16:11 GMT 2023
PRIMARY
EVMPD
SUB08392MIG
Created by admin on Sat Dec 16 05:16:11 GMT 2023 , Edited by admin on Sat Dec 16 05:16:11 GMT 2023
PRIMARY
MERCK INDEX
m6672
Created by admin on Sat Dec 16 05:16:11 GMT 2023 , Edited by admin on Sat Dec 16 05:16:11 GMT 2023
PRIMARY Merck Index
DAILYMED
2T8Q726O95
Created by admin on Sat Dec 16 05:16:11 GMT 2023 , Edited by admin on Sat Dec 16 05:16:11 GMT 2023
PRIMARY
PUBCHEM
60825
Created by admin on Sat Dec 16 05:16:11 GMT 2023 , Edited by admin on Sat Dec 16 05:16:11 GMT 2023
PRIMARY
DRUG CENTRAL
1539
Created by admin on Sat Dec 16 05:16:11 GMT 2023 , Edited by admin on Sat Dec 16 05:16:11 GMT 2023
PRIMARY
RS_ITEM_NUM
1356836
Created by admin on Sat Dec 16 05:16:11 GMT 2023 , Edited by admin on Sat Dec 16 05:16:11 GMT 2023
PRIMARY
Related Record Type Details
SOLVATE->ANHYDROUS
SALT/SOLVATE -> PARENT
BASIS OF STRENGTH->SUBSTANCE
ASSAY (HPLC)
USP
BASIS OF STRENGTH->SUBSTANCE
ASSAY (HPLC)
EP
TARGET ORGANISM->INHIBITOR
TARGET -> INHIBITOR
TARGET ORGANISM->INHIBITOR
Related Record Type Details
METABOLITE ACTIVE -> PARENT
METABOLITE -> PARENT
URINE
Related Record Type Details
IMPURITY -> PARENT
UNSPECIFIED
EP
IMPURITY -> PARENT
CHROMATOGRAPHIC PURITY (HPLC/UV)
EP
IMPURITY -> PARENT
UNSPECIFIED
EP
IMPURITY -> PARENT
UNSPECIFIED
EP
IMPURITY -> PARENT
IMPURITY -> PARENT
IMPURITY -> PARENT
UNSPECIFIED
EP
IMPURITY -> PARENT
IMPURITY -> PARENT
UNSPECIFIED
EP
IMPURITY -> PARENT
Use the chromatogram supplied with lamivudine for system suitability RS and the chromatogram obtained with solutions (4) and (3) to identify the peaks due to impurity F. The impurity peaks are eluted at the following relative retention times with reference to lamivudine (retention time about 11 to 12 minutes): impurity F (uracil) about 0.36.
PARENT -> IMPURITY
IMPURITY -> PARENT
IMPURITY -> PARENT
Use the chromatogram supplied with lamivudine for system suitability RS and the chromatogram obtained with solutions (4) and (3) to identify the peaks due to impurity C. The impurity peaks are eluted at the following relative retention times with reference to lamivudine (retention time about 11 to 12 minutes): impurity C (salicylic acid) about 2.6. In the chromatogram obtained with solution (1): - the area of any peak corresponding to impurity C is not greater than that of the principal peak in the chromatogram obtained with solution (3) (0.1%).
IMPURITY -> PARENT
IMPURITY -> PARENT
CHROMATOGRAPHIC PURITY (HPLC/UV)
EP
IMPURITY -> PARENT
IMPURITY -> PARENT
Use the chromatogram supplied with lamivudine for system suitability RS and the chromatogram obtained with solutions (4) and (3) to identify the peaks due to impurity F. The impurity peaks are eluted at the following relative retention times with reference to lamivudine (retention time about 11 to 12 minutes): impurity E (cytosine) about 0.31. In the chromatogram obtained with solution (1):- the area of any individual peak corresponding to impurity E, when multiplied by a correction factor of 0.6, is not greater than the area of the peak in the chromatogram obtained with solution (2) (0.1%).
IMPURITY -> PARENT
IMPURITY -> PARENT
IMPURITY -> PARENT
CHROMATOGRAPHIC PURITY (HPLC/UV)
EP
IMPURITY -> PARENT
IMPURITY -> PARENT
CHROMATOGRAPHIC PURITY (HPLC/UV)
EP
IMPURITY -> PARENT
CHROMATOGRAPHIC PURITY (HPLC/UV)
EP
IMPURITY -> PARENT
UNSPECIFIED
EP
Related Record Type Details
ACTIVE MOIETY
Name Property Type Amount Referenced Substance Defining Parameters References
Volume of Distribution PHARMACOKINETIC
Biological Half-life PHARMACOKINETIC Intercellular
PHARMACOKINETIC
Elimination
PHARMACOKINETIC
Elimination
PHARMACOKINETIC