Analysis Note

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

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 metforminHILIC-tandem mass spectrometry (MS/MS) based determination of metformin and vildagliptin in human plasma samplesAnalysis of metformin and its related impurities in bulk samples by normal phase high-performance liquid chromatographic (HPLC) method

Footnote

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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.