Fluvastatin Related Compounds & Impurities

Fluvastatin is a synthetic HMG-CoA reductase inhibitor (statin) used for hypercholesterolaemia and secondary cardiovascular prevention.

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 Fluvastatin reference standards, pharmacopeial and non-pharmacopeial Fluvastatin 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 Fluvastatin-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

Fluvastatin Sodium Salt
(3R,5S)-Fluvastatin Sodium Salt
3-keto Fluvastatin Sodium Salt
Fluvastatin Lactone
(3S,5R)-Fluvastatin Sodium Salt
Fluvastatin EP Impurity F Sodium Salt
Fluvastatin EP Impurity G
Fluvastatin EP Impurity D
Fluvastatin Sodium EP Impurity D
Fluvastatin t-butyl Ester
Fluvastatin Acetone Adduct
(3S,5S)-Fluvastatin Sodium Salt
(3R,5R)-Fluvastatin Sodium Salt
Fluvastatin EP Impurity A Sodium Salt
Fluvastatin EP Impurity A Calcium Salt
Fluvastatin N-Ethyl Sodium Salt
Fluvastatin EP Impurity B
Fluvastatin EP Impurity E
Fluvastatin EP Impurity F
Fluvastatin Sodium EP Impurity F
Fluvastatin Sodium Anti-Isomer (Racemic Mixture)
5-Hydroxy Fluvastatin sodium salt
Fluvastatin Impurity 9
Fluvastatin Impurity 8
Fluvastatin Impurity 10
Fluvastatin Impurity 11
Fluvastatin Impurity 12
Fluvastatin Impurity 13
Fluvastatin Impurity 17
Fluvastatin EP Impurity C Sodium salt
Fluvastatin Impurity 2
Fluvastatin Sodium (Polymorph form B)
6-Hydroxy Fluvastatin

Isotope Labelled Compounds

(3S,5R)-Fluvastatin-D6 Sodium Salt
Fluvastatin D6 Sodium
Fluvastatin D6