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

Details

Stereochemistry ABSOLUTE
Molecular Formula 2C14H18N6O.H2O4S
Molecular Weight 670.7453
Optical Activity UNSPECIFIED
Defined Stereocenters 4 / 4
E/Z Centers 0
Charge 0

SHOW SMILES / InChI
Structure of ABACAVIR SULFATE

SMILES

C1=C[C@@]([H])(C[C@]1([H])CO)n2cnc3c(NC4CC4)[nH]c(=N)nc32.C1=C[C@@]([H])(C[C@]1([H])CO)n2cnc3c(NC4CC4)[nH]c(=N)nc32.OS(=O)(=O)O

InChI

InChIKey=WMHSRBZIJNQHKT-FFKFEZPRSA-N
InChI=1S/2C14H18N6O.H2O4S/c2*15-14-18-12(17-9-2-3-9)11-13(19-14)20(7-16-11)10-4-1-8(5-10)6-21;1-5(2,3)4/h2*1,4,7-10,21H,2-3,5-6H2,(H3,15,17,18,19);(H2,1,2,3,4)/t2*8-,10+;/m11./s1

HIDE SMILES / InChI

Molecular Formula C14H18N6O
Molecular Weight 286.3329
Charge 0
Count
Stereochemistry ABSOLUTE
Additional Stereochemistry No
Defined Stereocenters 2 / 2
E/Z Centers 0
Optical Activity UNSPECIFIED

Molecular Formula H2O4S
Molecular Weight 98.0796
Charge 0
Count
Stereochemistry ACHIRAL
Additional Stereochemistry No
Defined Stereocenters 0 / 0
E/Z Centers 0
Optical Activity NONE

Abacavir is a nucleoside reverse transcriptase inhibitor used for treatment of HIV infection (either alone or in combination with other antiviral drugs). It was shown that abacavir exerts its antiviral activity through its active metabolite, carbovir triphosphate. Carbovir triphosphate is a guanine analogue and a potent and selective inhibitor of viral reverse transcriptases. Upon administration, abacavir is first converted to abacavir monophosphate by ADK, then the monophosphate is deaminated to carbovir monophosphate, which is then anabolized by cellular kinases to carbovir diphosphate and then finally to carbovir triphosphate. Abacavir causes hypersensitivity reaction in patients with HLA-B*57:01 allele.

Approval Year

Targets

Targets

Primary TargetPharmacologyConditionPotency
21 nM [Ki]
Conditions

Conditions

ConditionModalityTargetsHighest PhaseProduct
Primary
ZIAGEN

Approved Use

ZIAGEN, a nucleoside analogue human immunodeficiency virus (HIV-1) reverse transcriptase inhibitor, is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection.

Launch Date

913852800000
Cmax

Cmax

ValueDoseCo-administeredAnalytePopulation
3 μg/mL
300 mg 2 times / day steady-state, oral
dose: 300 mg
route of administration: Oral
experiment type: STEADY-STATE
co-administered:
ABACAVIR SULFATE plasma
Homo sapiens
population: UNKNOWN
age: UNKNOWN
sex: UNKNOWN
food status: UNKNOWN
4.26 μg/mL
600 mg single, oral
dose: 600 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
ABACAVIR SULFATE plasma
Homo sapiens
population: UNKNOWN
age: UNKNOWN
sex: UNKNOWN
food status: UNKNOWN
AUC

AUC

ValueDoseCo-administeredAnalytePopulation
6.02 μg × h/mL
300 mg 2 times / day steady-state, oral
dose: 300 mg
route of administration: Oral
experiment type: STEADY-STATE
co-administered:
ABACAVIR SULFATE plasma
Homo sapiens
population: UNKNOWN
age: UNKNOWN
sex: UNKNOWN
food status: UNKNOWN
11.95 μg × h/mL
600 mg single, oral
dose: 600 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
ABACAVIR SULFATE plasma
Homo sapiens
population: UNKNOWN
age: UNKNOWN
sex: UNKNOWN
food status: UNKNOWN
T1/2

T1/2

ValueDoseCo-administeredAnalytePopulation
1.54 h
600 mg single, oral
dose: 600 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
ABACAVIR SULFATE plasma
Homo sapiens
population: UNKNOWN
age: UNKNOWN
sex: UNKNOWN
food status: UNKNOWN
Funbound

Funbound

ValueDoseCo-administeredAnalytePopulation
50%
300 mg 2 times / day steady-state, oral
dose: 300 mg
route of administration: Oral
experiment type: STEADY-STATE
co-administered:
ABACAVIR SULFATE plasma
Homo sapiens
population: UNKNOWN
age: UNKNOWN
sex: UNKNOWN
food status: UNKNOWN
Doses

Doses

DosePopulationAdverse events​
150 mg single, intravenous
Dose: 150 mg
Route: intravenous
Route: single
Dose: 150 mg
Sources:
unhealthy, 27–39 years
Health Status: unhealthy
Age Group: 27–39 years
Sex: M
Sources:
1200 mg single, oral
Highest studied dose
Dose: 1200 mg
Route: oral
Route: single
Dose: 1200 mg
Sources:
unhealthy, 38 years (range: 24–48 years)
Health Status: unhealthy
Age Group: 38 years (range: 24–48 years)
Sex: M+F
Sources:
Other AEs: Asthenia, Abdominal pain...
Other AEs:
Asthenia (33%)
Abdominal pain (33%)
Headache (25%)
Diarrhea (17%)
Dyspepsia (17%)
Sources:
600 mg 3 times / day steady, oral
Highest studied dose
Dose: 600 mg, 3 times / day
Route: oral
Route: steady
Dose: 600 mg, 3 times / day
Sources:
unhealthy, > 13 years
Health Status: unhealthy
Age Group: > 13 years
Sex: M+F
Sources:
600 mg 1 times / day steady, oral
Recommended
Dose: 600 mg, 1 times / day
Route: oral
Route: steady
Dose: 600 mg, 1 times / day
Sources:
unhealthy
Other AEs: Hypersensitivity reaction...
Other AEs:
Hypersensitivity reaction (serious|grade 5, 8%)
Sources:
AEs

AEs

AESignificanceDosePopulation
Diarrhea 17%
1200 mg single, oral
Highest studied dose
Dose: 1200 mg
Route: oral
Route: single
Dose: 1200 mg
Sources:
unhealthy, 38 years (range: 24–48 years)
Health Status: unhealthy
Age Group: 38 years (range: 24–48 years)
Sex: M+F
Sources:
Dyspepsia 17%
1200 mg single, oral
Highest studied dose
Dose: 1200 mg
Route: oral
Route: single
Dose: 1200 mg
Sources:
unhealthy, 38 years (range: 24–48 years)
Health Status: unhealthy
Age Group: 38 years (range: 24–48 years)
Sex: M+F
Sources:
Headache 25%
1200 mg single, oral
Highest studied dose
Dose: 1200 mg
Route: oral
Route: single
Dose: 1200 mg
Sources:
unhealthy, 38 years (range: 24–48 years)
Health Status: unhealthy
Age Group: 38 years (range: 24–48 years)
Sex: M+F
Sources:
Abdominal pain 33%
1200 mg single, oral
Highest studied dose
Dose: 1200 mg
Route: oral
Route: single
Dose: 1200 mg
Sources:
unhealthy, 38 years (range: 24–48 years)
Health Status: unhealthy
Age Group: 38 years (range: 24–48 years)
Sex: M+F
Sources:
Asthenia 33%
1200 mg single, oral
Highest studied dose
Dose: 1200 mg
Route: oral
Route: single
Dose: 1200 mg
Sources:
unhealthy, 38 years (range: 24–48 years)
Health Status: unhealthy
Age Group: 38 years (range: 24–48 years)
Sex: M+F
Sources:
Hypersensitivity reaction serious|grade 5, 8%
600 mg 1 times / day steady, oral
Recommended
Dose: 600 mg, 1 times / day
Route: oral
Route: steady
Dose: 600 mg, 1 times / day
Sources:
unhealthy
PubMed

PubMed

TitleDatePubMed
Four new antiretroviral medications will soon offer more options to HIV patients.
1998 Jul-Aug
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
Prevalence and characteristics of multinucleoside-resistant human immunodeficiency virus type 1 among European patients receiving combinations of nucleoside analogues.
2000 Aug
Increasing cerebrospinal fluid chemokine concentrations despite undetectable cerebrospinal fluid HIV RNA in HIV-1-infected patients receiving antiretroviral therapy.
2000 Dec 15
Mutational patterns in the HIV genome and cross-resistance following nucleoside and nucleotide analogue drug exposure.
2001
A near-fatal hypersensitivity reaction to abacavir: case report and literature review.
2001 Apr
A comparison of the steady-state pharmacokinetics and safety of abacavir, lamivudine, and zidovudine taken as a triple combination tablet and as abacavir plus a lamivudine-zidovudine double combination tablet by HIV-1-infected adults.
2001 Apr
Amino acid deletion at codon 67 and Thr-to-Gly change at codon 69 of human immunodeficiency virus type 1 reverse transcriptase confer novel drug resistance profiles.
2001 Apr
HIV-1 reverse transcriptase sequence in plasma and cerebrospinal fluid of patients with AIDS dementia complex treated with Abacavir.
2001 Apr 13
A pilot study of the use of mycophenolate mofetil as a component of therapy for multidrug-resistant HIV-1 infection.
2001 Apr 15
[Determining resistance in HIV therapy. Careful interpretation only].
2001 Apr 2
[Observational study with abacavir. Decreased viral load and quality of life improves].
2001 Apr 2
Simultaneous determination of Ziagen and its phosphorylated metabolites by ion-pairing high-performance liquid chromatography-tandem mass spectrometry.
2001 Apr 25
Antiviral drugs: current state of the art.
2001 Aug
Tenofovir, adefovir, and zidovudine susceptibilities of primary human immunodeficiency virus type 1 isolates with non-B subtypes or nucleoside resistance.
2001 Aug 10
Simplification with abacavir-based triple nucleoside therapy versus continued protease inhibitor-based highly active antiretroviral therapy in HIV-1-infected patients with undetectable plasma HIV-1 RNA.
2001 Aug 17
Editorial comment: the challenge of prescribing abacavir.
2001 Dec
Agranulocytosis and fever seven weeks after starting abacavir.
2001 Dec 7
Intensification of stable background therapy with abacavir in antiretroviral therapy experienced patients: 48-week data from a randomized, double-blind trial.
2001 Jan
Trizivir on the market.
2001 Jan
Patterns of resistance mutations to antiretroviral drugs in extensively treated HIV-1-infected patients with failure of highly active antiretroviral therapy.
2001 Jan 1
Severe anaphylactic shock after rechallenge with abacavir without preceding hypersensitivity.
2001 Jan 26
Liquid chromatographic assay for simultaneous determination of abacavir and mycophenolic acid in human plasma using dual spectrophotometric detection.
2001 Jan 5
Resistance and cross-resistance to abacavir.
2001 Jul
The abacavir hypersensitivity reaction and interruptions in therapy.
2001 Jul 6
A dose-ranging study to evaluate the antiretroviral activity and safety of amprenavir alone and in combination with abacavir in HIV-infected adults with limited antiretroviral experience.
2001 Jun
Treatment intensification with abacavir in HIV-infected patients with at least 12 weeks previous lamivudine/zidovudine treatment.
2001 Jun
Increased drug susceptibility of HIV-1 reverse transcriptase mutants containing M184V and zidovudine-associated mutations: analysis of enzyme processivity, chain-terminator removal and viral replication.
2001 Jun
Differential susceptibility of retroviruses to nucleoside analogues.
2001 Mar
Phase III trials for new PI.
2001 Mar
Mutations in the non-nucleoside binding-pocket interfere with the multi-nucleoside resistance phenotype.
2001 Mar 30
Drifting agenda for federal treatment research.
2001 May
Choosing which nuke to use first.
2001 May
Toxicity of antiviral nucleoside analogs and the human mitochondrial DNA polymerase.
2001 Nov 2
Lipodystrophy in HIV-1-positive patients is associated with insulin resistance in multiple metabolic pathways.
2001 Nov 9
Abacavir sulfate, lamivudine, and zidovudine (Trizivir).
2001 Nov-Dec
Penetration of the nucleoside analogue abacavir into the genital tract of men infected with human immunodeficiency virus type 1.
2001 Oct 15
Prevalence of adverse events associated with potent antiretroviral treatment: Swiss HIV Cohort Study.
2001 Oct 20
Pharmacokinetics of abacavir in HIV-1-infected patients with impaired renal function.
2001 Sep
Transport characteristics of the anti-human immunodeficiency virus nucleoside analog, abacavir, into brain and cerebrospinal fluid.
2001 Sep
Comparison of genotypic and phenotypic resistance patterns of human immunodeficiency virus type 1 isolates from patients treated with stavudine and didanosine or zidovudine and lamivudine.
2001 Sep 15
Triple nuke therapy--results after one year.
2001 Winter
Role of sequencing in therapy selection.
2002 Feb 1
Response to lamivudine-zidovudine plus abacavir twice daily in antiretroviral-naive, incarcerated patients with HIV infection taking directly observed treatment.
2002 Feb 15
Easier abacavir regimen has promising results.
2002 Jan
Dioxolane guanosine, the active form of the prodrug diaminopurine dioxolane, is a potent inhibitor of drug-resistant HIV-1 isolates from patients for whom standard nucleoside therapy fails.
2002 Jan 1
Kawasaki-like syndrome: abacavir hypersensitivity?
2002 Jan 1
Evidence of immune reconstitution in antiretroviral drug-experienced patients with advanced HIV disease.
2002 Jan 20
[Mutations of resistance of HIV-1 in previously untreated patients at penitentiary centers of the Autonomous Community of Valencia, Spain. REPRICOVA study].
2002 Mar 2
Parallel decline of CD8+/CD38++ T cells and viraemia in response to quadruple highly active antiretroviral therapy in primary HIV infection.
2002 Mar 8
Patents

Sample Use Guides

Adults: 600 mg daily, administered as either 300 mg twice daily or 600 mg once daily. Pediatric Patients Aged 3 Months and Older: Administered either once or twice daily. Dose should be calculated on body weight (kg) and should not exceed 600 mg daily.
Route of Administration: Oral
In order to study the inhibitory effect of abacavir on HIV strains, MT-2 cell line was infected with HIV-1 strain IIIB and was treated with increasing concentrations of the drug (up to 100 uM).
Substance Class Chemical
Created
by admin
on Fri Jun 25 21:07:59 UTC 2021
Edited
by admin
on Fri Jun 25 21:07:59 UTC 2021
Record UNII
J220T4J9Q2
Record Status Validated (UNII)
Record Version
  • Download
Name Type Language
ABACAVIR SULFATE
HSDB   JAN   MART.   MI   ORANGE BOOK   USAN   USP-RS   VANDF   WHO-DD   WHO-IP  
USAN  
Official Name English
ZIAGEN
Brand Name English
1592U89 SULFATE
Code English
(1S,4R)-4-(2-AMINO-6-(CYCLOPROPYLAMINO)-9H-PURIN-9-YL)-2-CYCLOPENTENE-1-METHANOL SULPHATE (SALT) (2:1)
Common Name English
ABACAVIR (AS SULFATE) [EMA EPAR]
Common Name English
ABACAVIR SULFATE [ORANGE BOOK]
Common Name English
ABACAVIR SULFATE [EP MONOGRAPH]
Common Name English
ABACAVIR SULFATE [MART.]
Common Name English
ABAMUNE
Common Name English
EPZICOM COMPONENT ABACAVIR SULFATE
Common Name English
(1S,4R)-4-(2-AMINO-6-(CYCLOPROPYLAMINO)-9H-PURIN-9-YL)-2-CYCLOPENTENE-1-METHANOL SULFATE (SALT) (2:1)
Common Name English
ABACAVIR SULFATE [USP-RS]
Common Name English
ABACAVIR SULFATE COMPONENT OF EPZICOM
Common Name English
ABACAVIR SULFATE [USP MONOGRAPH]
Common Name English
ABACAVIR SULFATE [VANDF]
Common Name English
NSC-760063
Code English
2-CYCLOPENTENE-1-METHANOL, 4-(2-AMINO-6-(CYCLOPROPYLAMINO)-9H-PURIN-9-YL)-, (1S,4R)-, SULFATE (2:1)
Systematic Name English
ABACAVIR SULFATE COMPONENT OF TRIZIVIR
Brand Name English
ABACAVIR SULFATE [WHO-DD]
Common Name English
ABACAVIR SULFATE [WHO-IP]
Common Name English
ABACAVIR SULFATE COMPONENT OF TRIUMEQ
Brand Name English
DRG-0257
Code English
KIVEXA COMPONENT ABACAVIR SULFATE
Common Name English
TRIUMEQ COMPONENT ABACAVIR SULFATE
Brand Name English
ABACAVIR SULPHATE
Common Name English
TRIZIVIR COMPONENT ABACAVIR SULFATE
Brand Name English
1592U89
Code English
ABACAVIRI SULFAS [WHO-IP LATIN]
Common Name English
ABACAVIR HEMISULFATE
Common Name English
ABACAVIR SULFATE [MI]
Common Name English
ABACAVIR (AS SULFATE)
EMA EPAR  
Common Name English
ABACAVIR SULFATE [JAN]
Common Name English
ABACAVIR SULPHATE COMPONENT OF TRIZIVIR
Common Name English
ABACAVIR SULFATE [HSDB]
Common Name English
ABACAVIR SULFATE [USAN]
Common Name English
ABACAVIR SULFATE RACEMIC [USP-RS]
Common Name English
Classification Tree Code System Code
EMA ASSESSMENT REPORTS TRIZIVIR (AUTHORIZED: HIV INFECTIONS)
Created by admin on Fri Jun 25 21:07:59 UTC 2021 , Edited by admin on Fri Jun 25 21:07:59 UTC 2021
EMA ASSESSMENT REPORTS TRIUMEQ (AUTHORIZED: HIV INFECTIONS)
Created by admin on Fri Jun 25 21:07:59 UTC 2021 , Edited by admin on Fri Jun 25 21:07:59 UTC 2021
EMA ASSESSMENT REPORTS ZIAGEN (AUTHORIZED: HIV INFECTIONS)
Created by admin on Fri Jun 25 21:07:59 UTC 2021 , Edited by admin on Fri Jun 25 21:07:59 UTC 2021
EMA ASSESSMENT REPORTS KIVEXA (AUTHORIZED: HIV INFECTIONS)
Created by admin on Fri Jun 25 21:07:59 UTC 2021 , Edited by admin on Fri Jun 25 21:07:59 UTC 2021
NCI_THESAURUS C97452
Created by admin on Fri Jun 25 21:07:59 UTC 2021 , Edited by admin on Fri Jun 25 21:07:59 UTC 2021
Code System Code Type Description
NCI_THESAURUS
C28804
Created by admin on Fri Jun 25 21:07:59 UTC 2021 , Edited by admin on Fri Jun 25 21:07:59 UTC 2021
PRIMARY
PUBCHEM
441384
Created by admin on Fri Jun 25 21:07:59 UTC 2021 , Edited by admin on Fri Jun 25 21:07:59 UTC 2021
PRIMARY
DRUG BANK
DBSALT000871
Created by admin on Fri Jun 25 21:07:59 UTC 2021 , Edited by admin on Fri Jun 25 21:07:59 UTC 2021
PRIMARY
USP_CATALOG
1000408
Created by admin on Fri Jun 25 21:07:59 UTC 2021 , Edited by admin on Fri Jun 25 21:07:59 UTC 2021
PRIMARY USP-RS
ChEMBL
CHEMBL1380
Created by admin on Fri Jun 25 21:07:59 UTC 2021 , Edited by admin on Fri Jun 25 21:07:59 UTC 2021
PRIMARY
FDA UNII
J220T4J9Q2
Created by admin on Fri Jun 25 21:07:59 UTC 2021 , Edited by admin on Fri Jun 25 21:07:59 UTC 2021
PRIMARY
HSDB
7154
Created by admin on Fri Jun 25 21:07:59 UTC 2021 , Edited by admin on Fri Jun 25 21:07:59 UTC 2021
PRIMARY
USP_CATALOG
1000419
Created by admin on Fri Jun 25 21:07:59 UTC 2021 , Edited by admin on Fri Jun 25 21:07:59 UTC 2021
PRIMARY USP-RS
RXCUI
221052
Created by admin on Fri Jun 25 21:07:59 UTC 2021 , Edited by admin on Fri Jun 25 21:07:59 UTC 2021
PRIMARY RxNorm
MERCK INDEX
M1271
Created by admin on Fri Jun 25 21:07:59 UTC 2021 , Edited by admin on Fri Jun 25 21:07:59 UTC 2021
PRIMARY Merck Index
EVMPD
SUB00231MIG
Created by admin on Fri Jun 25 21:07:59 UTC 2021 , Edited by admin on Fri Jun 25 21:07:59 UTC 2021
PRIMARY
WHO INTERNATIONAL PHARMACOPEIA
ABACAVIR SULFATE
Created by admin on Fri Jun 25 21:07:59 UTC 2021 , Edited by admin on Fri Jun 25 21:07:59 UTC 2021
PRIMARY Description: White to almost white powder. Solubility: Soluble in water. Category: Antiretroviral (Nucleoside Reverse Transcriptase Inhibitor). Storage: Abacavir sulfate should be kept in a well-closed container. Definition: Abacavir sulfate contains not less than 99.0% and not more than 101.0% of (C14H18N6O)2,H2SO4 calculated with reference to the anhydrous substance. Manufacture: The production method is validated to demonstrate that the substance, if tested, would comply with a limit of not more than 0.5% for (1R, 4S)-abacavir enantiomer using a suitable chiral chromatographic method.
CAS
188062-50-2
Created by admin on Fri Jun 25 21:07:59 UTC 2021 , Edited by admin on Fri Jun 25 21:07:59 UTC 2021
PRIMARY
Related Record Type Details
ENANTIOMER -> ENANTIOMER
PARENT -> SALT/SOLVATE
BASIS OF STRENGTH->SUBSTANCE
ASSAY (HPLC)
USP
RACEMATE -> ENANTIOMER
Related Record Type Details
IMPURITY -> PARENT
ABACAVIR SULFATE Impurity C In the chromatogram obtained with solution (3) the impurity peaks are eluted at the following relative retention with reference to abacavir (retention time about 19 minutes): impurity C about 0.6. The test is not valid unless the resolution between the peaks corresponding to abacavir and impurity D is at least 1.5.In the chromatogram obtained with solution (1) the area of any individual peak corresponding to impurity C is not greater than 0.3 times the area of the principal peak obtained with solution (2) (0.3%).
IMPURITY -> PARENT
IMPURITY -> PARENT
CHROMATOGRAPHIC PURITY (HPLC/UV)
EP
IMPURITY -> PARENT
ABACAVIR SULFATE Impurity F In the chromatogram obtained with solution (3) the impurity peaks are eluted at the following relative retention with reference to abacavir (retention time about 19 minutes): impurity F about 1.7. The test is not valid unless the resolution between the peaks corresponding to abacavir and impurity D is at least 1.5. In the chromatogram obtained with solution (1) the area of any individual peak corresponding to impurity F is not greater than 0.3 times the area of the principal peak obtained with solution (2) (0.3%).
CHROMATOGRAPHIC PURITY (HPLC/UV)
INTERNATIONAL PHARMACOPEIA
IMPURITY -> PARENT
IMPURITY -> PARENT
CHROMATOGRAPHIC PURITY (HPLC/UV)
USP
IMPURITY -> PARENT
ABACAVIR SULFATE Impurity A Amount not specified.
CHROMATOGRAPHIC PURITY (HPLC/UV)
INTERNATIONAL PHARMACOPEIA
IMPURITY -> PARENT
CHROMATOGRAPHIC PURITY (HPLC/UV)
EP
IMPURITY -> PARENT
CHROMATOGRAPHIC PURITY (HPLC/UV)
EP
IMPURITY -> PARENT
CHROMATOGRAPHIC PURITY (HPLC/UV)
EP
IMPURITY -> PARENT
CHROMATOGRAPHIC PURITY (HPLC/UV)
EP
IMPURITY -> PARENT
CHROMATOGRAPHIC PURITY (HPLC/UV)
EP
IMPURITY -> PARENT
Abacavir sulfate Impurity D In the chromatogram obtained with solution (3) the impurity peaks are eluted at the following relative retention with reference to abacavir (retention time about 19 minutes): impurity D about 1.05. The test is not valid unless the resolution between the peaks corresponding to abacavir and impurity D is at least 1.5. In the chromatogram obtained with solution (1) the area of any individual peak corresponding to impurity D is not greater than 0.3 times the area of the principal peak obtained with solution (2) (0.3%).
CHROMATOGRAPHIC PURITY (HPLC/UV)
INTERNATIONAL PHARMACOPEIA
IMPURITY -> PARENT
ABACAVIR SULFATE Impurity B In the chromatogram obtained with solution (3) the impurity peaks are eluted at the following relative retention with reference to abacavir (retention time about 19 minutes): impurity B about 1.3. The test is not valid unless the resolution between the peaks corresponding to abacavir and impurity D is at least 1.5.In the chromatogram obtained with solution (1) the area of any individual peak corresponding to impurity B is not greater than 0.3 times the area of the principal peak obtained with solution (2) (0.3%).
CHROMATOGRAPHIC PURITY (HPLC/UV)
INTERNATIONAL PHARMACOPEIA
Related Record Type Details
ACTIVE MOIETY