Dolutegravir Sodium Related Compounds & Impurities

Dolutegravir Sodium is a second-generation HIV integrase strand transfer inhibitor with high genetic barrier to resistance, used as a preferred first-line antiretroviral.

Simson Pharma Limited along with its subsidiary offices Simson Pharma Global Ltd. (UK) and Simson Pharma Global LLC (USA) is a trusted manufacturer and supplier of high-quality pharmaceutical reference standards, offering a comprehensive portfolio of Dolutegravir Sodium reference standards, pharmacopeial and non-pharmacopeial Dolutegravir Sodium impurities, related compounds, related substances, metabolites, stable isotope-labelled compounds, deuterium labelled compounds and nitrosamine (N-NO) reference standards.

These materials support pharmaceutical research and development, product development, ANDA and DMF submissions, quality control (QC), analytical method development and validation, stability studies, impurity identification, and genotoxic impurity assessment.

Our Dolutegravir Sodium-related reference standards are thoroughly characterized using advanced analytical techniques and are supplied with comprehensive Certificates of Analysis (COA) and supporting analytical data from our USFDA certified, ISO 17025 and ISO 17034 accredited Lab, to meet global regulatory expectations. EP and USP traceable reference standards can also be provided upon request, subject to availability. Simson is also a provider of EP and USP traceable standards. To ensure consistent quality and reliability, our reference standards are periodically re-tested according to established quality management procedures.

Pharmaceutical Reference Standards / Impurity Standards

Dolutegravir Sodium
Dolutegravir
Dolutegravir Diastereomer Sodium
3-Amino-1-butanol
(S)-3-Aminobutan-1-ol
O-Methyl Dolutegravir
Dolutegravir Impurity A
Dolutegravir Impurity B
2,6-Difluoro dolutegravir
Dolutegravir Amide
Dolutegravir Impurity C
4-Fluoro Dolutegravir
Desdifluoro Dolutegravir
Dolutegravir impurity F
Dimethyl-1-(2,2-dimethoxyethyl)-3-methoxy-4-oxo-1,4-dihydropyridine-2,5-dicarboxylate
Dimethyl3-(benzyloxy)-4-oxo-4h-pyran-2,5-dicarboxylate
(Z)-Methyl2-[(Dimethylamino)methylene]-4-methoxy-3-oxobutanoate
(E)-Methyl 2-(((2,2-dimethoxyethyl)amino)methylene)-4-methoxy-3-oxobutanoate
(Z)-methyl-4-(benzyloxy)-2-((dimethylamino)methylene)-3-oxobutanoate
bis(2,4-difluorobenzyl)amine
(E)-N-(2,4-difluorobenzylidene)-1-(2,4-difluorophenyl)methanamine
Dolutegravir Impurity 21
Dolutegravir Impurity C
Dolutegravir RR Isomer
Dolutegravir SR Isomer
Dolutegravir Ring Open Chain Impurity
Dolutegravir Impurity F
Dolutegravir impurity H
Dolutegravir Impurity 6 Sodium
Dolutegravir Impurity 1
4-epi-Dolutegravir
Dolutegravir Impurity 14
Dolutegravir Impurity 15
Dolutegravir Impurity 8
Dolutegravir Impurity 19
Dolutegravir Impurity 12
Dolutegravir oxidative degradation product B
Dolutegravir Enantiomer Impurity
4-Desfluoro-6-fluoro Dolutegravir
(R)-ethyl-3-acetamidobutanoate
(R)-N-(4-hydroxybutan-2-yl)acetamide
Dolutegravir Carbamate Impurity
4-Desfluoro-6-Fluoro Dolutegravir Sodium
Dolutegravir Impurity 16
Dolutegravir Impurity 18
9-hydroxy-2-[(2R)-4-hydroxybutan-2-yl]-1,8-dioxo-1,8-dihydro-2H-pyrido[1,2-a]pyrazine-7-carboxylic acid
Dolutegravir Impurity 20
5-Methoxy-6-(methoxycarbonyl)-4-oxo-1-(2-oxoethyl)-1,4-dihydropyridine-3-carboxylic acid
Dolutegravir Impurity 22
(E/Z)-methyl-2-((dimethylamino)methylene)-4-methoxy-3-Oxobutanoate
Dolutegravir impurity D
Dolutegravir Impurity 2
Methyl 5-((2,4-difluorobenzyl)carbamoyl)-1-(2,2-dihydroxyethyl)-3-methoxy-4-oxo-1,4-dihydropyridine-2-carboxylate(TAUTOMER)
Dolutegravir Isomer 1
N-(2,4-Difluorobenzyl)-carbonyl-imidazole
4-Defluoro Dolutegravir Sodium Salt
N-Nitroso Dolutegravir
Dolutegravir Nitroso Impurity 1
Dolutegravir Sodium Isomer Mixture
Dolutegravir Impurity 29
Dolutegravir Nitroso Impurity 1
(4R,9aS)-8-formyl-4-methyl-6-oxooctahydropyrazino[2,1-b][1,3]oxazine-7-carboxylic acid
Dolutegravir Impurity 38
Dolutegravir Impurity 24
Defluoro O-Methyl Dolutegravir
Dolutegravir Impurity 42
4-Fluoro Dolutegravir Sodium Salt
(4S,12aS) Dolutegravir 9-carboxylic acid
Dolutegravir Impurity 44
Dolutegravir Carbamate Impurity Sodium
Dolutegravir Impurity 34
Dolutegravir Impurity 5
Dolutegravir Impurity 7
Dolutegravir Impurity 9
Dolutegravir Impurity 10
Dolutegravir Impurity 11
Dolutegravir Impurity 13
Dolutegravir Impurity 17
Dolutegravir Impurity 23
Dolutegravir Impurity 25
Dolutegravir Impurity 26
Dolutegravir Impurity 27
Dolutegravir Impurity 28
Dolutegravir Impurity 30
Dolutegravir Impurity 3 Sodium
Dolutegravir Impurity 31
Dolutegravir Impurity 32

Metabolites

Dolutegravir O-b-D-Glucuronide
Dolutegravir Metabolite (M1)

Isotope Labelled Compounds

Dolutegravir D5
Dolutegravir D3
Dolutegravir-d6