Nirmatrelvir Related Compounds & Impurities

Nirmatrelvir is a SARS-CoV-2 3CL protease inhibitor, the antiviral component of Paxlovid used for COVID-19 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 Nirmatrelvir reference standards, pharmacopeial and non-pharmacopeial Nirmatrelvir 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 Nirmatrelvir-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

Nirmatrelvir
Nirmatrelvir Impurity 1
Nirmatrelvir R-Isomer
Nirmatrelvir Impurity 4
Nirmatrelvir Impurity 5
Nirmatrelvir Impurity 7
Nirmatrelvir Impurity 36
(S)-2-amino-3-((S)-2-oxopyrrolidin-3-yl)propanenitrile Hydrochloride
Nirmatrelvir Impurity B
(2S)-2-Amino-3-[(3S)-2-oxopyrrolidin-3-yl]propanamide hydrochloride
(S)-methyl-2-amino-3-((S)-2-oxopyrrolidin-3-yl)propanoate Hydrochloride
(R)-2-Amino-3-((S)-2-oxopyrrolidin-3-yl)propanamide Hydrochloride
Methyl(1S,2R,5R)-6,6-dimethyl-3-azabicyclo[3.1.0]hexane-2-carboxylate
(S)-2-Amino-3-((R)-2-oxopyrrolidin-3-yl)propanamide Hydrochloride
Nirmatrelvir Impurity 39
Nirmatrelvir Impurity 34
(R)-2-amino-3-((R)-2-oxopyrrolidin-3-yl)propanamide hydrochloride
Nirmatrelvir Impurity D
Nirmatrelvir Impurity 41
Nirmatrelvir Impurity 43
Nirmatrelvir Impurity 42
Nirmatrelvir Impurity 44
Nirmatrelvir Impurity 40
Nirmatrelvir Impurity 45
Nirmatrelvir Impurity 30
Nirmatrelvir Impurity 2
Nirmatrelvir Impurity 6
Nirmatrelvir Impurity 8
Nirmatrelvir Impurity 9
Nirmatrelvir Impurity 10
Nirmatrelvir Impurity 11
Nirmatrelvir Impurity 12
Nirmatrelvir Impurity 3
Nirmatrelvir Impurity 13

Isotope Labelled Compounds

Nirmatrelvir D9