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Key Documents

PHR1857

Supelco

Sitagliptin Phosphate

Pharmaceutical Secondary Standard; Certified Reference Material

Sinonimo/i:

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

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About This Item

Formula empirica (notazione di Hill):
C16H15F6N5O · H3PO4 · H2O
Numero CAS:
Peso molecolare:
523.32
Codice UNSPSC:
41116107
NACRES:
NA.24

Grado

certified reference material
pharmaceutical secondary standard

Livello qualitativo

agenzia

traceable to Ph. Eur. Y0001812
traceable to USP 1612903

Famiglia di API

sitagliptin

Forma fisica

powder

CdA

current certificate can be downloaded

Confezionamento

pkg of 1 g

tecniche

HPLC: suitable
gas chromatography (GC): suitable

applicazioni

pharmaceutical (small molecule)

Temperatura di conservazione

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
GQPYTJVDPQTBQC-KLQYNRQASA-N

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Descrizione generale

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.

Applicazioni

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)

Risultati analitici

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

Nota a piè di pagina

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.

Pittogrammi

Health hazardExclamation mark

Avvertenze

Warning

Indicazioni di pericolo

Classi di pericolo

Eye Irrit. 2 - STOT RE 2

Organi bersaglio

Liver

Codice della classe di stoccaggio

11 - Combustible Solids

Classe di pericolosità dell'acqua (WGK)

WGK 3

Punto d’infiammabilità (°F)

Not applicable

Punto d’infiammabilità (°C)

Not applicable


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Certificati d'analisi (COA)

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