Entecavir Related Compounds & Impurities

Entecavir is a guanosine nucleoside analogue with potent and selective anti-hepatitis B virus activity, used as a first-line treatment for chronic HBV infection.

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 Entecavir reference standards, pharmacopeial and non-pharmacopeial Entecavir 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 Entecavir-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

Entecavir
Entecavir Monohydrate
4-epi-Entecavir
Entecavir EP Impurity C
8-Methoxy Entecavir
Entecavir EP Impurity F
Furoentecavir
Entecavir Enantiomer
(1R,3R,4R)-Entecavir
Entecavir EP Impurity A
Furoentecavir
Entecavir EP Impurity B
Entecavir-3-Epimer Hydrochloride
3`,5`-di-O-Benzyl Entecavir
Entecavir EP Impurity F
4-Dimethylsilyl Entecavir
Entecavir Impurity 18
2-Amino-9-((1S,3S,4S)-4-(benzyloxy)-3-((benzyloxy)methyl)-2-methylenecyclopentyl)-1H-purin-6(9H)-one
ent-Entecavir-di-o-benzyl Ether
Entecavir Impurity 23
Entecavir Impurity 19
2-Amino-1,9-dihydro-9-[(1S.3R,4R)-4-(benzyloxy)-3-((benzyloxy)methyl)-2-methylenecyclopentyl]-6H-purin-6-one
Entecavir 3-Epimer Hydrochloride
Entecvir lactose Adduct Impurity-1
Entecvir lactose Adduct Impurity-2
Entecavir Impurity 24
O-6-Benzyl Guanine
Entecavir Impurity 25
(1R,3S,4S)-Entecavir
Entecavir Impurity 26
Entecavir Impurity 27
Entecavir epimer 2
Entecavir impurity 5
Entecavir impurity 6

Isotope Labelled Compounds

Entecavir-D2
Entecavir-13C2,15N
Entecavir-13C3-15N