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Metformin hydrochloride

Pharmaceutical Secondary Standard; Certified Reference Material

1,1-Dimethylbiguanide hydrochloride, Metformin
Linear Formula:
NH2C(=NH)NHC(=NH)N(CH3)2 · HCl
CAS Number:
Molecular Weight:
EC Number:
MDL number:
PubChem Substance ID:

Quality Level


certified reference material
pharmaceutical secondary standard


traceable to Ph. Eur. M0605000
traceable to USP 1396309


current certificate can be downloaded


HPLC: suitable
gas chromatography (GC): suitable


223-226 °C (lit.)


pharmaceutical (small molecule)



storage temp.


SMILES string




InChI key


Gene Information

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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.


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, 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.


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Hazard Statements

Precautionary Statements

Hazard Classifications

Acute Tox. 4 Oral

Storage Class Code

11 - Combustible Solids



Certificate of Analysis

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Certificate of Origin

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More Documents

Quotes and Ordering

Simultaneous determination of metformin and pioglitazone by reversed phase HPLC in pharmaceutical dosage forms
Lakshmi SK, et al.
International Journal of Pharmacy and Pharmaceutical Sciences, 1(2), 162-166 (2009)
Stability-indicating HPTLC method for simultaneous determination of nateglinide and metformin hydrochloride in pharmaceutical dosage form
Thomas BA, et al.
Saudi Pharmaceutical Journal : SPJ : The Official Publication of the Saudi Pharmaceutical Society, 19(4), 221-231 (2011)
Simultaneous estimation of metformin hydrochloride and pioglitazone hydrochloride by RPHPLC method from combined tablet dosage form
Sahoo KP, et al.
Indian Journal of Pharmaceutical Sciences, 70(3), 383-383 (2008)
Leyuan Li et al.
Nature communications, 10(1), 4146-4146 (2019-09-14)
In vitro gut microbiome models could provide timely and cost-efficient solutions to study microbiome responses to drugs. For this purpose, in vitro models that maintain the functional and compositional profiles of in vivo gut microbiomes would be extremely valuable. Here
J Radziuk et al.
Diabetes/metabolism research and reviews, 17(4), 250-272 (2001-09-07)
Hepatic glycogen is replenished during the absorptive period postprandially. This repletion is prompted partly by an increased hepatic uptake of glucose by the liver, partly by metabolite and hormonal signals in the portal vein, and partly by an increased gluconeogenic


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

Separation of Melamine; 1,1-Dimethylbiguanide hydrochloride

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