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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:
Molecular Weight:
165.62
EC Number:
MDL number:
PubChem Substance ID:
NACRES:
NA.24

grade

certified reference material
pharmaceutical secondary standard

Quality Level

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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This Item
M06050001396309M-072
Metformin hydrochloride Pharmaceutical Secondary Standard; Certified Reference Material

PHR1084

Metformin hydrochloride

Metformin hydrochloride European Pharmacopoeia (EP) Reference Standard

M0605000

Metformin hydrochloride

Metformin hydrochloride United States Pharmacopeia (USP) Reference Standard

1396309

Metformin hydrochloride

Metformin hydrochloride solution 1.0 mg/mL in methanol (as free base), ampule of 1 mL, certified reference material, Cerilliant®

M-072

Metformin hydrochloride solution

technique(s)

HPLC: suitable, gas chromatography (GC): suitable

technique(s)

-

technique(s)

-

technique(s)

gas chromatography (GC): suitable, liquid chromatography (LC): suitable

format

neat

format

neat

format

neat

format

single component solution

Quality Level

300

Quality Level

-

Quality Level

-

Quality Level

-

grade

certified reference material, pharmaceutical secondary standard

grade

pharmaceutical primary standard

grade

pharmaceutical primary standard

grade

certified reference material

storage temp.

2-30°C, 2-8°C

storage temp.

-

storage temp.

-

storage temp.

−20°C

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.

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

Signal Word

Warning

Hazard Statements

Precautionary Statements

Hazard Classifications

Acute Tox. 4 Oral

Storage Class Code

11 - Combustible Solids

WGK

WGK 3


Certificates of Analysis (COA)

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Y0001590

Metformin impurity A

Phenformin hydrochloride analytical standard

Supelco

P7045

Phenformin hydrochloride

AICAR ≥98% (HPLC), powder

Sigma-Aldrich

A9978

AICAR

Metformin Related Compound A United States Pharmacopeia (USP) Reference Standard

USP

1396310

Metformin Related Compound A

Metformin Impurity F Pharmaceutical Secondary Standard; Certified Reference Material

Supelco

PHR1532

Metformin Impurity F

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
J De Jager et al.
Journal of internal medicine, 257(1), 100-109 (2004-12-21)
The UK Prospective Diabetes Study (UKPDS) showed that treatment with metformin decreases macrovascular morbidity and mortality independent of glycaemic control. We hypothesized that metformin may achieve this by improving endothelial function and chronic, low-grade inflammation. Data on this issue are

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