Fenofibrate Related Compounds & Impurities

Fenofibrate is a fibric acid derivative PPAR-alpha agonist that reduces triglycerides and raises HDL cholesterol, used for mixed dyslipidaemia and hypertriglyceridaemia.

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 Fenofibrate reference standards, pharmacopeial and non-pharmacopeial Fenofibrate 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 Fenofibrate-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

Fenofibrate
Fenofibrate EP Impurity E
Fenofibrate EP Impurity D
Fenofibrate EP Impurity B
Fenofibrate EP Impurity F
Fenofibrate EP Impurity C
Fenofibrate EP Impurity A
Fenofibrate EP Impurity G
Fenofibrate Impurity 5
Fenofibric Acid1-Carboxyl-1-methylethyl Ester
Choline Fenofibrate
4-Methoxy-4`-chlorobenzophenone
3-Chloro-4`-hydroxybenzophenone
2-Chloro-4`-hydroxybenzophenone
Fenofibric Acid 1-Carboxyl-1-methylethyl Ester
Fenofibrate Impurity 6
2-Chloro Fenofibric Acid
3-Chloro Fenofibric Acid
Isopropyl 2-bromopropionate
3,4-dihydroxy-5-(1,2,3-trihydroxypropyl)oxolan-2-one
Fenofibrate Impurity 16
Fenofibrate Impurity 10
Fenofibrate Impurity 17

Metabolites

Fenofibric acid acyl-Beta-D-glucuronide

Isotope Labelled Compounds

Fenofibric-D6 Acid
Fenofibrate-D6