PHR1505

Metformin Related Compound B

Pharmaceutical Secondary Standard; Certified Reference Material

• Synonyme(s) : 1-Methylbiguanide monohydrochloride, 1-Methylbiguanide hydrochloride
• Formule empirique (notation de Hill): C₃H₉N₅ · HCl
• Numéro CAS: 1674-62-0
• Poids moléculaire : 151.60
• Code UNSPSC : 41116107
• Nomenclature NACRES : NA.24

Propriétés

• Qualité: certified reference material; pharmaceutical secondary standard
• Niveau de qualité: 300
• Agence: traceable to USP 1396331
• Famille d'API: metformin
• CofA (certificat d'analyse): current certificate can be downloaded
• Conditionnement: pkg of 50 mg
• Technique(s): HPLC: suitable; gas chromatography (GC): suitable
• Application(s): pharmaceutical (small molecule)
• Format: neat
• Température de stockage: 2-8°C
• InChI: 1S/C3H9N5.ClH/c1-7-3(6)8-2(4)5;/h1H3,(H6,4,5,6,7,8);1H
• Clé InChI: AAYCPBAOUJRPIC-UHFFFAOYSA-N

Description

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 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

Remarque sur l'analyse

These secondary standards offer multi-traceability to the USP, EP 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 LRAB5020 in the slot below. This is an example certificate only and may not be the lot that you receive.

Produits recommandés

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.

Informations sur la sécurité

• Pictogrammes: GHS07
• Mention d'avertissement: Warning
• Mentions de danger: H302
• Conseils de prudence: P264 - P270 - P301 + P312 - P501
• Classification des risques: Acute Tox. 4 Oral
• 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