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Key Documents

PHR1331

Supelco

Metformin Related Compound A

Pharmaceutical Secondary Standard; Certified Reference Material

Synonyme(s) :

Dicyandiamide, Cyanoguanidine, Dicyanodiamide

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About This Item

Formule linéaire :
NH2C(=NH)NHCN
Numéro CAS:
Poids moléculaire :
84.08
Numéro Beilstein :
605637
Numéro CE :
Numéro MDL:
Code UNSPSC :
41116107
ID de substance PubChem :
Nomenclature NACRES :
NA.24

Qualité

certified reference material
pharmaceutical secondary standard

Niveau de qualité

Agence

traceable to USP 1396310

Famille d'API

metformin

CofA (certificat d'analyse)

current certificate can be downloaded

Technique(s)

HPLC: suitable
gas chromatography (GC): suitable

Pf

208-211 °C (lit.)

Application(s)

pharmaceutical (small molecule)

Format

neat

Température de stockage

2-8°C

Chaîne SMILES 

NC(=N)NC#N

InChI

1S/C2H4N4/c3-1-6-2(4)5/h(H4,4,5,6)

Clé InChI

QGBSISYHAICWAH-UHFFFAOYSA-N

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Description générale

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 antidiabetic drug, metformin, that belongs to the biguanide class of compounds.

Application

This pharmaceutical secondary standard can also be used as follows:
  • Separation and estimation of metformin along with other antidiabetics from meglitinides class in the presence of metformin impurity cyanoguanidine using a liquid chromatography method in pharmaceutical formulations
  • Development of a reversed phase-high performance liquid chromatographic (RP-HPLC) method combined with a UV-diode array detector (PDA) for the impurity analysis of combined dosage tablet of metformin hydrochloride and teneligliptin hydrobromide hydrate
  • Estimation of empagliflozin, linagliptin, along with metformin and its related impurities cyanoguanidine and melamine using HPLC-DAD and high-performance thin layer chromatography (HPTLC) methods in their combined tablets
  • Development and validation of a stability indicating capillary zone electrophoresis (CZE) method for the quantification of metformin and its major impurity in pharmaceutical formulation
  • 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)

Remarque sur l'analyse

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

Note de bas de page

To see an example of a Certificate of Analysis for this material enter LRAA0834 in the slot below. This is an example certificate only and may not be the lot that you receive.

Code de la classe de stockage

11 - Combustible Solids

Classe de danger pour l'eau (WGK)

WGK 1

Point d'éclair (°F)

Not applicable

Point d'éclair (°C)

Not applicable


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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
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Journal of the Iranian Chemical Society, 15, 61-74 (2018)
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)
Green chromatographic methods for simultaneous micro-determination of empagliflozin, linagliptin with metformin and its pharmacopoeial impurities in pure form and triple combination tablets: A comparative study
El-Kafrawy DS, et al.
Sustainable Chemistry and Pharmacy, 25, 100560-100560 (2022)
Impurity profiling method development and validation of metformin hydrochloride and teneligliptin hydrobromide hydrate in their combination tablet dosage form by using RP-HPLC with UV/PDA detector
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