PHR1084
Metformin hydrochloride
Pharmaceutical Secondary Standard; Certified Reference Material
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
NACRES:
NA.24
PubChem Substance ID:
UNSPSC Code:
41116107
EC Number:
214-230-6
MDL number:
Product Name
Metformin hydrochloride, Pharmaceutical Secondary Standard; Certified Reference Material
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
Gene Information
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Analysis Note
These secondary standards offer multi-traceability to the USP and EP (PhEur) primary standards, where they are available.
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.
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.
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.
signalword
Warning
hcodes
Hazard Classifications
Acute Tox. 4 Oral
Storage Class
11 - Combustible Solids
wgk
WGK 3
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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Simultaneous determination of metformin and pioglitazone by reversed phase HPLC in pharmaceutical dosage forms
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