PHR1084

Metformin hydrochloride

Pharmaceutical Secondary Standard; Certified Reference Material

• Synonym(s): 1,1-Dimethylbiguanide hydrochloride, Metformin
• Linear Formula: NH₂C(=NH)NHC(=NH)N(CH₃)₂ · HCl
• CAS Number: 1115-70-4
• Molecular Weight: 165.62
• EC Number: 214-230-6
• MDL number: MFCD00012582
• UNSPSC Code: 41116107
• PubChem Substance ID: 329823106
• NACRES: NA.24

Properties

• grade: certified reference material; pharmaceutical secondary standard
• Quality Level: 300
• Agency: traceable to Ph. Eur. M0605000; traceable to USP 1396309
• API family: metformin
• CofA: current certificate can be downloaded
• packaging: pkg of 500 mg
• technique(s): HPLC: suitable; gas chromatography (GC): suitable
• mp: 223-226 °C (lit.)
• application(s): pharmaceutical (small molecule)
• format: neat
• storage temp.: 2-8°C
• 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
• InChI key: OETHQSJEHLVLGH-UHFFFAOYSA-N

Description

General description

Metformin is a biguanide hypoglycaemic agent[1] and an oral antidiabetic medication[2] widely used in the treatment of type 2 diabetes.[3] It is effective in glycemic control and decreases the intestinal absorption of glucose,[1] without the problem of serious lactic acidosis.[3]

Pharmaceutical secondary standards for application in quality control, provide pharma laboratories and manufacturers with a convenient and cost-effective alternative to the preparation of in-house working standards.

Application

Metformin hydrochloride may be used as a pharmaceutical reference standard for the quantification of the analyte in pharmaceutical formulations[1][2] 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.

Footnote

For chromatography information for this material, please follow the link:https://www.sigmaaldrich.com/US/en/technical-documents/chromatograms/hplc/hplc-dad-analysis-of-metformin-hydrochloride-on-ascentis-express-c18-hplc-column/supelco/app788

Recommended products

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Safety Information

• Pictograms: GHS07
• Signal Word: Warning
• Hazard Statements: H302
• Precautionary Statements: P264 - P270 - P301 + P312 - P501
• Hazard Classifications: Acute Tox. 4 Oral
• Storage Class Code: 11 - Combustible Solids
• WGK: WGK 3