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1396309

USP

Metformin hydrochloride

United States Pharmacopeia (USP) Reference Standard

Synonym(s):

1,1-Dimethylbiguanide hydrochloride, Metformin

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About This Item

Linear Formula:
NH2C(=NH)NHC(=NH)N(CH3)2 · HCl
CAS Number:
Molecular Weight:
165.62
MDL number:
UNSPSC Code:
41116107
PubChem Substance ID:
NACRES:
NA.24

grade

pharmaceutical primary standard

API family

metformin

manufacturer/tradename

USP

mp

223-226 °C (lit.)

application(s)

pharmaceutical (small molecule)

format

neat

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

This product is provided as delivered and specified by the issuing Pharmacopoeia. All information provided in support of this product, including SDS and any product information leaflets have been developed and issued under the Authority of the issuing Pharmacopoeia. For further information and support please go to the website of the issuing Pharmacopoeia.

Application

Metformin hydrochloride USP reference standard for specified tests and assay use.

Also used to prepare standard, mixed standard stock and system suitability solutions for the assay, impurity analysis and performance tests according to the given below monographs of United States Pharmacopeia (USP):
  • Metformin Hydrochloride
  • Pioglitazone and Metformin Hydrochloride Tablets
  • Metformin Hydrochloride Tablets
  • Glyburide and Metformin Hydrochloride Tablets

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 products are for test and assay use only. They are not meant for administration to humans or animals and cannot be used to diagnose, treat, or cure diseases of any kind.  ​

Other Notes

Sales restrictions may apply.

Pictograms

Exclamation mark

Signal Word

Warning

Hazard Statements

Hazard Classifications

Acute Tox. 4 Oral - Eye Irrit. 2

Storage Class Code

11 - Combustible Solids

WGK

WGK 1

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable


Certificates of Analysis (COA)

Search for Certificates of Analysis (COA) by entering the products Lot/Batch Number. Lot and Batch Numbers can be found on a product’s label following the words ‘Lot’ or ‘Batch’.

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Determination of metformin in human plasma by high-performance liquid chromatography with spectrophotometric detection
Cheng CL and Chou CH
Journal of Chromatography. B, Biomedical Sciences and Applications, 762(1), 51-58 (2001)
Quantitative determination and validation of metformin hydrochloride in pharmaceutical using quantitative nuclear magnetic resonance spectroscopy
Gadape HH and Parikh KS
E-Journal of Chemistry, 8(2), 767-781 (2011)
Development and validation of a stability indicating capillary electrophoresis method for the determination of metformin hydrochloride in tablets
Hamdan II, et al.
Journal of Pharmaceutical and Biomedical Analysis, 53(5), 1254-1257 (2010)
Pioglitazone and Metformin Hydrochloride Tablets
United States Pharmacopeia and National Formulary
United States Pharmacopeia, 42(4), 3558-3558 (2020)
Metformin Hydrochloride Tablets
United States Pharmacopeia and National Formulary
United States Pharmacopeia, 40(4), 2822-2822 (2020)

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