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PHR1505

Supelco

Metformin Related Compound B

Pharmaceutical Secondary Standard; Certified Reference Material

Sinónimos:

1-Methylbiguanide monohydrochloride, 1-Methylbiguanide hydrochloride

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About This Item

Fórmula empírica (notación de Hill):
C3H9N5 · HCl
Número de CAS:
Peso molecular:
151.60
Código UNSPSC:
41116107
NACRES:
NA.24

grado

certified reference material
pharmaceutical secondary standard

Nivel de calidad

Agency

traceable to USP 1396331

familia API

metformin

CofA

current certificate can be downloaded

envase

pkg of 50 mg

técnicas

HPLC: suitable
gas chromatography (GC): suitable

aplicaciones

pharmaceutical (small molecule)

formato

neat

temp. de almacenamiento

2-8°C

InChI

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

Clave InChI

AAYCPBAOUJRPIC-UHFFFAOYSA-N

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Descripción general

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.

Aplicación

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

Nota de análisis

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

Nota al pie de página

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.

Productos recomendados

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.

Producto relacionado

Pictogramas

Exclamation mark

Palabra de señalización

Warning

Frases de peligro

Clasificaciones de peligro

Acute Tox. 4 Oral

Código de clase de almacenamiento

11 - Combustible Solids

Clase de riesgo para el agua (WGK)

WGK 1

Punto de inflamabilidad (°F)

Not applicable

Punto de inflamabilidad (°C)

Not applicable


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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)
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)
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)
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

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