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PHR1084

Supelco

Metformin hydrochloride

Pharmaceutical Secondary Standard; Certified Reference Material

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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
PubChem Substance ID:
329823106
NACRES:
NA.24

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.

2-30°C
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

Gene Information

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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.
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 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

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.

Pictograms

Exclamation mark
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

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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)
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)
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
Nicolas Musi et al.
Diabetes, 51(7), 2074-2081 (2002-06-28)
Metformin is an effective hypoglycemic drug that lowers blood glucose concentrations by decreasing hepatic glucose production and increasing glucose disposal in skeletal muscle; however, the molecular site of metformin action is not well understood. AMP-activated protein kinase (AMPK) activity increases
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