Merck
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PHR1505

Supelco

Metformin Related Compound B

Pharmaceutical Secondary Standard; Certified Reference Material

Synonym(s):
1-Methylbiguanide monohydrochloride, 1-Methylbiguanide hydrochloride
Empirical Formula (Hill Notation):
C3H9N5 · HCl
CAS Number:
Molecular Weight:
151.60
NACRES:
NA.24

grade

certified reference material
pharmaceutical secondary standard

Quality Level

Agency

traceable to USP 1396331

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

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

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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.[1]

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)[2]
  • 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[3]
  • Analysis of metformin and its related impurities in bulk samples by normal phase high-performance liquid chromatographic (HPLC) method[4]

Analysis Note

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

Footnote

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.

Pictograms

Exclamation mark

Signal Word

Warning

Hazard Statements

Precautionary Statements

Hazard Classifications

Acute Tox. 4 Oral

Storage Class Code

11 - Combustible Solids

WGK

WGK 1

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable

Certificate of Analysis

Enter Lot Number to search for Certificate of Analysis (COA).

Certificate of Origin

Enter Lot Number to search for Certificate of Origin (COO).

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