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PHR1084 Supelco

Metformin hydrochloride

Pharmaceutical Secondary Standard; Certified Reference Material

Synonym: 1,1-Dimethylbiguanide hydrochloride, Metformin



Related Categories Analytical Standards, Analytical/Chromatography, K-O, Pharmaceutical Secondary Standards, Pharmacopeia & Metrological Institutes Standards More...
Quality Level   300
grade   certified reference material
  pharmaceutical secondary standard
form   neat
mp   223-226 °C (lit.)
Featured Industry   Pharmaceutical (small molecule)
format   neat
pharmacopeia traceability   traceable to PhEur M0605000
  traceable to USP 1396309
SMILES string   Cl[H].CN(C)C(=N)NC(N)=N
InChI   1S/C4H11N5.ClH/c1-9(2)4(7)8-3(5)6;/h1-2H3,(H5,5,6,7,8);1H


General description

Metformin is a biguanide hypoglycaemic agent and an oral antidiabetic medication widely used in the treatment of type 2 diabetes. It is effective in glycemic control and decreases the intestinal absorption of glucose, without the problem of serious lactic acidosis.


Metformin hydrochloride may be used as a pharmaceutical reference standard for the quantification of the analyte in pharmaceutical formulations using different chromatography techniques.

These Secondary Standards are qualified as Certified Reference Materials. These are suitable for use in several analytical applications including but not limited to pharma release testing, pharma method development for qualitative and quantitative analyses, food and beverage quality control testing, and other calibration requirements.

Biochem/physiol Actions

Metformin is an antidiabetic agent that reduces blood glucose levels and improves insulin sensitivity. Its metabolic effects, including the inhibition of hepatic gluconeogenesis, are mediated at least in part by activation of the LKB1-AMPK (AMP-activated protein kinase) pathway. Activation of this pathway also appears to be involved in the antiproliferative and proapoptotic actions of metformin in cancer cell lines.

Analysis Note

These secondary standards offer multi-traceability to the USP, EP (PhEur) and BP primary standards, where they are available.

Other Notes

This Certified Reference Material (CRM) is produced and certified in accordance with ISO 17034 and ISO/IEC 17025. All information regarding the use of this CRM can be found on the certificate of analysis.


To see an example of a Certificate of Analysis for this material enter LRAB3694 in the slot below. This is an example certificate only and may not be the lot that you receive.

Safety & Documentation

Safety Information

GHS07  GHS07
Signal word 
Hazard statements 
Precautionary statements 
NONH for all modes of transport
WGK Germany 


Certificate of Analysis (COA)

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Protocols & Articles


LC/MS Analysis of Melamine and Metformin on Ascentis® Express HILIC

From our library of Articles, Sigma-Aldrich presents LC/MS Analysis of Melamine and Metformin on Ascentis® Express HILIC
Keywords: Chromatography, High performance liquid chromatography

Metformin Hydrochloride European Pharmacopoeia Identification Test C using Silica gel G TLC Plates

Metformin Hydrochloride is primarily used for treatment of type 2 diabetes, but is increasingly being used in polycystic ovary syndrome.
Dr Sanjay Poman
Merck KGaA, Darmstadt, Germany, Life Science Application Centre (GAC), Mumbai, India
Keywords: Diabetes, Solvents, Thin layer chromatography

Peer-Reviewed Papers


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