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PHR1505

Metformin Related Compound B

Pharmaceutical Secondary Standard; Certified Reference Material

Synonym(s):

1-Methylbiguanide monohydrochloride, 1-Methylbiguanide hydrochloride

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About This Item

Empirical Formula (Hill Notation):
C3H9N5 · HCl
CAS Number:
1674-62-0
Molecular Weight:
151.60
UNSPSC Code:
41116107
NACRES:
NA.24
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Quality Level

300

grade

certified reference material, pharmaceutical secondary standard

agency

traceable to USP 1396331

API family

metformin

CofA

current certificate can be downloaded

packaging

pkg of 50 mg

technique(s)

HPLC: suitable, gas chromatography (GC): suitable

application(s)

pharmaceutical (small molecule)

format

neat

storage temp.

2-8°C

SMILES string

Cl.N(C)C(=N)N=C(N)N

InChI

1S/C3H9N5.ClH/c1-7-3(6)8-2(4)5;/h1H3,(H6,4,5,6,7,8);1H

InChI key

AAYCPBAOUJRPIC-UHFFFAOYSA-N

General description

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.

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.

It is an impurity of the widely used anti-diabetic drug, metformin, that belongs to the biguanide class of compounds.

Application

This pharmaceutical secondary standard can also be used as follows:
  • Simultaneous determination of vildagliptin, metformin, and metformin-related compounds (A, B, and C) in tablets using a high-performance liquid chromatography-tandem mass spectrometry method (HPLC-MS/MS)
  • Development of a hydrophilic interaction liquid chromatography method combined with diode array detection (HILIC-DAD) for the simultaneous quantification of impurities in the combined dosage tablet of rosuvastatin and metformin
  • HILIC-tandem mass spectrometry (MS/MS) based determination of metformin and vildagliptin in human plasma samples
  • Analysis of metformin and its related impurities in bulk samples by normal phase high-performance liquid chromatographic (HPLC) method

Analysis Note

These secondary standards offer multi-traceability to the USP and EP primary standards, where they are available.

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.
To see an example of a Certificate of Analysis for this material enter LRAB5020 in the slot below. This is an example certificate only and may not be the lot that you receive.

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pictograms

Exclamation mark
GHS07

signalword

Warning

hcodes

H302

Hazard Classifications

Acute Tox. 4 Oral

Storage Class

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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A new rapid and economic liquid chromatographic method for simultaneous determination of meglitinides with metformin: application in the presence of metformin and repaglinide impurities and related compounds
El-Zaher AA, et al.
Journal of the Iranian Chemical Society, 15, 61-74 (2018)

Global Trade Item Number

SKUGTIN
PHR1505-50MG04061834417545