PHR1331

Metformin Related Compound A

Pharmaceutical Secondary Standard; Certified Reference Material

• Synonym(s): Dicyandiamide, Cyanoguanidine, Dicyanodiamide
• Linear Formula: NH₂C(=NH)NHCN
• CAS Number: 461-58-5
• Molecular Weight: 84.08
• Beilstein: 605637
• EC Number: 207-312-8
• MDL number: MFCD00008066
• UNSPSC Code: 41116107
• PubChem Substance ID: 329823316
• NACRES: NA.24

Properties

• grade: certified reference material; pharmaceutical secondary standard
• Quality Level: 300
• Agency: traceable to USP 1396310
• API family: metformin
• CofA: current certificate can be downloaded
• technique(s): HPLC: suitable; gas chromatography (GC): suitable
• mp: 208-211 °C (lit.)
• application(s): pharmaceutical (small molecule)
• format: neat
• storage temp.: 2-8°C
• SMILES string: NC(=N)NC#N
• InChI: 1S/C2H4N4/c3-1-6-2(4)5/h(H4,4,5,6)
• InChI key: QGBSISYHAICWAH-UHFFFAOYSA-N

Description

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 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)

Analysis Note

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

Footnote

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.

Safety Information

• Storage Class Code: 11 - Combustible Solids
• WGK: WGK 1
• Flash Point(F): Not applicable
• Flash Point(C): Not applicable