Metformin Related Compounds & Impurities

Metformin is a biguanide that reduces hepatic glucose production and improves insulin sensitivity, the first-line oral agent for type 2 diabetes mellitus.

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 Metformin reference standards, pharmacopeial and non-pharmacopeial Metformin 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 Metformin-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

Metformin Hydrochloride
Metformin Hydrochloride
Metformin Hydrochloride -Traceable to IP
Metformin EP Impurity A
Metformin
Metformin EP Impurity D
Metformin EP Impurity C
Metformin EP Impurity E sulfate
Metformin EP Impurity E Hydrochloride
Metformin Impurity E
Metformin EP Impurity B Hydrochloride
Metformin EP Impurity B
Metformin Hydroxy Analog 2 (sulfuiric acid Salt)
Metformin Hydroxy Analog 2
Metformin Hydroxy Analog 1
Metformin(Nitrate Salt)-Impurity B
Metformin Impurity 6
Metformin Pamoate
3-Carbamimidoyl-1,1-Dimethylurea Hydrochloride
Didesmethyl Metformin Hydroxy Analog Hydrochloride
N-Nitroso Metformin
Guanylurea Sulfate
N-Ethyl-N-methylimidodicarbonimidic diamide
Metformin Impurity 7
Metformin Impurity 5
N-(N-(N-(N,N-Dimethylcarbamimidoyl)carbamimidoyl)carbamimidoyl)carbamimidoylamine
N-Nitroso Metformin EP Impurity A
Metformin Impurity 8
Metformin Impurity 9
Nitrosocarbamylcyanomethane
N-Nitroso Metformin Impurity 1
N-Nitroso Metformin Impurity 2
N-Nitroso Metformin EP Impurity B
N-Nitroso Metformin EP Impurity E
Metformin Impurity 3
Metformin Impurity 4
Metformin Impurity 10
Metformin Impurity 11
Metformin Impurity 12

Isotope Labelled Compounds

Metformin-D6 Hydrochloride
Melamine 13C3