PHR1857

Sitagliptina

Pharmaceutical Secondary Standard; Certified Reference Material

• Sinônimo(s): 7-[(3R)-3-amino-1-oxo-4-(2,4,5-trifluorofenil)butil]-5,6,7,8-tetra-hidro-3-(trifluorometil)-1,2,4-triazolo[4,3-a]pirazina fosfato, MK-0431
• Fórmula empírica (Notação de Hill): C₁₆H₁₅F₆N₅O · H₃PO₄ · H₂O
• Número CAS: 654671-77-9
• Peso molecular: 523.32
• Código UNSPSC: 41116107
• NACRES: NA.24

Propriedades

• grau: certified reference material; pharmaceutical secondary standard
• Nível de qualidade: 300
• Agency: traceable to Ph. Eur. Y0001812; traceable to USP 1612903
• família API: sitagliptin
• forma: powder
• Certificado de análise (CofA): current certificate can be downloaded
• embalagem: pkg of 1 g
• técnica(s): HPLC: suitable; gas chromatography (GC): suitable
• aplicação(ões): pharmaceutical (small molecule)
• temperatura de armazenamento: 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
• chave InChI: GQPYTJVDPQTBQC-KLQYNRQASA-N

Descrição

Descrição geral

Medicamento antidiabético (anti-hiperglicêmico) da classe da dipeptidil peptidase-4 (DPP-4). Acredita-se que a inibição da enzima DPP-4 aumente o peptídeo semelhante ao glucagon 1 (GLP-1), o que inibe a liberação de glucagon, estimula a liberação de insulina e diminui a glicemia.

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.

Aplicação

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)

Nota de análise

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

Nota de rodapé

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.

Informações de segurança

• Pictogramas: GHS08,GHS07
• Palavra indicadora: Warning
• Frases de perigo: H319,H373
• Declarações de precaução: P260 - P264 - P280 - P305 + P351 + P338 - P314 - P337 + P313
• Classificações de perigo: Eye Irrit. 2 - STOT RE 2
• Órgãos-alvo: Liver
• Código de classe de armazenamento: 11 - Combustible Solids
• Classe de risco de água (WGK): WGK 3
• Ponto de fulgor (°F): Not applicable
• Ponto de fulgor (°C): Not applicable