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:Development of a reversed-phase high-performance liquid chromatographic (RP-HPLC) method to determine sitagliptin phosphate and metformin hydrochloride in combined pharmaceutical formulations¹⁹F nuclear magnetic resonance (¹⁹F-NMR) spectroscopy-based quantitative analysis of sitagliptin phosphate and validation of the method using proton 1H-NMRDetermination of sitagliptin phosphate in tablet dosage forms using RP-HPLC and following International Conference on Harmonization (ICH) guidelinesSimultaneous estimation of sitagliptin and four of its impurities in pharmaceutical formulations by micellar electrokinetic chromatography (MEKC) following a quality-by-design (QbD) approachMulti-analysis of sitagliptin phosphate, metformin hydrochloride, pioglitazone hydrochloride, gliclazide, glibenclamide, and repaglinide in pharmaceutical tablets using reversed phase-liquid chromatography (RP-LC)

Footnote

To see an example of a Certificate of Analysis for this material enter LRAC0251 in the Documents slot below. This is an example certificate only and may not be the lot that you receive.

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.Sitagliptin phosphate, a dipeptidyl peptidase IV (DPPIV) inhibitor, is an antidiabetic drug used in the treatment of diabetes type II mellitus.

An anti-diabetic (antihyperglycemic) drug of the dipeptidyl peptidase-4 (DPP-4) class. Inhibition of the enzyme DPP-4 is thought to increase Glucagon-like peptide-1 (GLP-1) which inhibits glucagon release, stimulates insulin release and lowers blood glucose.