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
• NACRES: NA.24
• PubChem Substance ID: 329823106
• UNSPSC Code: 41116107
• EC Number: 214-230-6
• MDL number: MFCD00012582

Properties

• InChI key: OETHQSJEHLVLGH-UHFFFAOYSA-N
• InChI: 1S/C4H11N5.ClH/c1-9(2)4(7)8-3(5)6;/h1-2H3,(H5,5,6,7,8);1H
• SMILES string: Cl[H].CN(C)C(=N)NC(N)=N
• grade: certified reference material, pharmaceutical secondary standard
• 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
• Quality Level: 300
• Gene Information: —

Description

General description

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.

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.

Application

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.

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

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 and EP (PhEur) primary standards, where they are available.

Other Notes

Find a digital Reference Material for this product available on our online platform ChemisTwin® for NMR. You can use this digital equivalent on ChemisTwin® for your sample identity confirmation and compound quantification (with digital external standard). An NMR spectrum of this substance can be viewed and an online comparison against your sample can be performed with a few mouseclicks. Learn more here and start your free trial.

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

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.

Safety Information

• pictograms: GHS07
• signalword: Warning
• hcodes: H302
• pcodes: P264 - P270 - P301 + P312 - P501
• Hazard Classifications: Acute Tox. 4 Oral
• Storage Class: 11 - Combustible Solids
• wgk: WGK 3