PHR1857

Sitagliptin Phosphate

Pharmaceutical Secondary Standard; Certified Reference Material

• Synonyme(s) : Sitagliptin phosphate monohydrate, 7-[(3R)-3-amino-1-oxo-4-(2,4,5-trifluorophenyl)butyl]-5,6,7,8-tetrahydro-3-(trifluoromethyl)-1,2,4-triazolo[4,3-a]pyrazine phosphate, MK-0431
• Formule empirique (notation de Hill): C₁₆H₁₅F₆N₅O · H₃PO₄ · H₂O
• Numéro CAS: 654671-77-9
• Poids moléculaire : 523.32
• Code UNSPSC : 41116107
• Nomenclature NACRES : NA.24

Propriétés

• Qualité: certified reference material; pharmaceutical secondary standard
• Niveau de qualité: 300
• Agence: traceable to Ph. Eur. Y0001812; traceable to USP 1612903
• Famille d'API: sitagliptin
• Forme: powder
• CofA (certificat d'analyse): current certificate can be downloaded
• Conditionnement: pkg of 1 g
• Technique(s): HPLC: suitable; gas chromatography (GC): suitable
• Application(s): pharmaceutical (small molecule)
• Température de stockage: 2-8°C
• InChI: 1S/C16H15F6N5O.H3O4P.H2O/c17-10-6-12(19)11(18)4-8(10)3-9(23)5-14(28)26-1-2-27-13(7-26)24-25-15(27)16(20,21)22;1-5(2,3)4;/h4,6,9H,1-3,5,7,23H2;(H3,1,2,3,4);1H2/t9-;;/m1../s1
• Clé InChI: GQPYTJVDPQTBQC-KLQYNRQASA-N

Description

Description générale

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.

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.

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 formulations
• ¹⁹F nuclear magnetic resonance (¹⁹F-NMR) spectroscopy-based quantitative analysis of sitagliptin phosphate and validation of the method using proton 1H-NMR
• Determination of sitagliptin phosphate in tablet dosage forms using RP-HPLC and following International Conference on Harmonization (ICH) guidelines
• Simultaneous estimation of sitagliptin and four of its impurities in pharmaceutical formulations by micellar electrokinetic chromatography (MEKC) following a quality-by-design (QbD) approach
• Multi-analysis of sitagliptin phosphate, metformin hydrochloride, pioglitazone hydrochloride, gliclazide, glibenclamide, and repaglinide in pharmaceutical tablets using reversed phase-liquid chromatography (RP-LC)

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 LRAC0251 in the Documents slot below. This is an example certificate only and may not be the lot that you receive.

Informations sur la sécurité

• Pictogrammes: GHS07,GHS08
• Mention d'avertissement: Warning
• Mentions de danger: H319 - H373
• Conseils de prudence: P260 - P264 - P280 - P305 + P351 + P338 - P314 - P337 + P313
• Classification des risques: Eye Irrit. 2 - STOT RE 2
• Organes cibles: Liver
• Code de la classe de stockage: 11 - Combustible Solids
• Classe de danger pour l'eau (WGK): WGK 3
• Point d'éclair (°F): Not applicable
• Point d'éclair (°C): Not applicable