Daclatasvir Dihydrochloride Related Compounds & Impurities

Daclatasvir Dihydrochloride is a first-in-class NS5A replication complex inhibitor used in combination with sofosbuvir for pan-genotypic hepatitis C treatment.

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 Daclatasvir Dihydrochloride reference standards, pharmacopeial and non-pharmacopeial Daclatasvir Dihydrochloride 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 Daclatasvir Dihydrochloride-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

Daclatasvir Dihydrochloride
N-Acetyl Daclatasvir
N-(tert-Butoxycarbonyl)-N-methyl-L-valine
Daclatasvir Impurity 5
Daclatasvir Impurity I
Daclatasvir Chloro Acid Compound
Daclatasvir SSRS Isomer
Daclatasvir Dihydrochloride N-Moc-L-Isoleucine analogue
Daclatasvir SSRR Isomer
Daclatasvir RRRR Isomer Enantiomer
Daclatasvir Dihydrochloride mono impurity
Daclatasvir dihydrochloride acetyl impurity
Daclatasvir SRSS Isomer
Daclatasvir RSSR Isomer
(S)-tert-Butyl 2-(5-(4-bromophenyl)-1H-imidazol-2-yl)pyrrolidine-1-carboxylate
Daclatasvir Impurity A
Daclatasvir Impurity B(RSSS Diastereomer)
Daclatasvir EP Impurity E
Monodes N-carboxymethylvaline Daclatasvir
Daclatasvir EP Impurity G
Daclatasvir EP Impurity H
Daclatasvir Impurity J
Daclatasvir Impurity L
Daclatasvir EP Impurity C
Daclatasvir SRRS Isomer
Daclatasvir MOC-D-Valine
2-[2-(4-{2-[(2S)-1-[(tertbutoxy)carbonyl]pyrrolid
Daclatasvir
Daclatasvir Impurity B
Daclatasvir SRSS Isomer Hydrochloride
Daclatasvir RSSS Isomer.Hydrochloride
Daclatasvir Impurity 11
Daclatasvir Impurity 8 Tetrahydrochloride
Daclatasvir Nitroso Impurity
Daclatasvir Nitroso Impurity 1
Daclatasvir RSSS Isomer
Daclatasvir Oxazolidine impurity
Daclatasvir Nitroso Impurity 3
Daclatasvir Nitroso Impurity 4
Daclatasvir Nitroso Impurity 5
Daclatasvir Impurity 3

Metabolites

Daclatasvir Impurity 4

Isotope Labelled Compounds

Daclatasvir-D6
Daclatasvir 13C2D6