Bictegravir Related Compounds & Impurities

Bictegravir is a second-generation HIV integrase strand transfer inhibitor with a high genetic barrier to resistance, formulated exclusively as part of a fixed-dose single-tablet antiretroviral combination.

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 Bictegravir reference standards, pharmacopeial and non-pharmacopeial Bictegravir 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 Bictegravir-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

Bictegravir
Trifluoro hydroxyl impurity
Methyl Bictegravir
2-fluoro bictegravir
4-Fluoro Bictegravir
2,4-difluoro impurity
Bictegravir Impurity 3
Benzyl impurity
(2R,5S,13aS) isomer
Bictegravir Sodium
Bictegravir Impurity 7
Bictegravir Impurity 6
(1R,3S)-3-Aminocyclopentanol hydrochloride
(1S,3R)-3-Aminocyclopentanol hydrochloride
(1R,3R)-3-aminocyclopentanol
(1S,3S)-3-Aminocyclopentanol
Bictegravir Impurity 5
Bictegravir Enantiomer
Bictegravir Impurity 11
Bictegravir Impurity 12
Bictegravir Impurity 13
Bictegravir Impurity 9
Bictegravir Impurity 8
Bictegravir Impurity 2
Bictegravir Impurity 4
Bictegravir Impurity 10
Bictegravir Impurity 14
Bictegravir Impurity 15
Bictegravir Impurity 16
Bictegravir Impurity 17

Metabolites

Bictegravir Metabolite M15

Isotope Labelled Compounds

Bictegravir 13C,15N-D2
Bictegravir 15N D2
Bictegravir-D5
Bictegravir D5 Isomer
Bictegravir D4