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PHR1505

Supelco

Metformin Related Compound B

Pharmaceutical Secondary Standard; Certified Reference Material

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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

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

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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This Item
PHR1331PHR1506PHR1642
Supelco

PHR1505

Metformin Related Compound B

Metformin Related Compound A Pharmaceutical Secondary Standard; Certified Reference Material

PHR1331

Metformin Related Compound A

Supelco

PHR1506

Metformin Related Compound C

Supelco

PHR1642

Acetaminophen Related Compound B

technique(s)

HPLC: suitable, gas chromatography (GC): suitable

technique(s)

HPLC: suitable, gas chromatography (GC): suitable

technique(s)

HPLC: suitable, gas chromatography (GC): suitable

technique(s)

HPLC: suitable, gas chromatography (GC): suitable

Quality Level

300

Quality Level

300

Quality Level

300

Quality Level

300

grade

certified reference material, pharmaceutical secondary standard

grade

certified reference material, pharmaceutical secondary standard

grade

certified reference material, pharmaceutical secondary standard

grade

certified reference material, pharmaceutical secondary standard

storage temp.

2-8°C

storage temp.

2-8°C

storage temp.

2-8°C

storage temp.

2-30°C

packaging

pkg of 50 mg

packaging

-

packaging

pkg of 50 mg

packaging

pkg of 50 mg

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, 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.

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

signalword

Warning

hcodes

Hazard Classifications

Acute Tox. 4 Oral

Storage Class

11 - Combustible Solids

wgk_germany

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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Pack Size/Quantity

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705578-5MG-PW

PL860-CGA/SHF-1EA

MMYOMAG-74K-13

1000309185

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HPLC-MS/MS method for simultaneous quantification of vildagliptin, metformin, and metformin-related compounds in tablets
Uber CP, et al.
International Journal of Pharmacy and Pharmaceutical Sciences, 6, 203-207 (2014)
Development of normal phase high-performance liquid chromatographic method for determination of metformin and its related impurities in bulk material
Reid IOA
The pharma innovation journal, 6, 157-157 (2017)
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)
Roberto Pontarolo et al.
Journal of chromatography. B, Analytical technologies in the biomedical and life sciences, 965, 133-141 (2014-07-13)
The objective of this work was to develop and validate a HILIC-MS/MS method for the simultaneous determination of metformin and vildagliptin in human plasma. Chromatographic separation was achieved using an Atlantis HILIC Silica 150-mm × 2.1-mm, 3-μm particle size column

Our team of scientists has experience in all areas of research including Life Science, Material Science, Chemical Synthesis, Chromatography, Analytical and many others.

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