Sitagliptin Phosphate

SIAL/PHR1857 - Pharmaceutical Secondary Standard; Certified Reference Material

Synonym: 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

CAS Number: 654671-77-9
Empirical Formula (Hill Notation): C₁₆H₁₅F₆N₅O · H₃PO₄ · H₂O
Molecular Weight: 523.32
Linear Formula: C₁₆H₁₅F₆N₅O · H₃PO₄ · H₂O
Product Type: Chemical

Catalog Number	PKG Qty.	Price


45-PHR1857-1G	1 g	$186.00 1/EA	Add To Favorites

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Properties
Descriptions
Safety Info.
Basic Data

agency	traceable to Ph. Eur. Y0001812
	traceable to USP 1612903
API family	sitagliptin
application(s)	pharmaceutical (small molecule)
CofA	current certificate can be downloaded
form	powder
grade	certified reference material
	pharmaceutical secondary standard
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
InChI key	GQPYTJVDPQTBQC-KLQYNRQASA-N
packaging	pkg of 1 g
Quality Level	300
SMILES string	FC(F)(F)c1[n]2c(nn1)CN(CC2)C(=O)C[C@H](N)Cc3c(cc(c(c3)F)F)F.[P](=O)(O)(O)O.O
storage temp.	2-8°C
technique(s)	gas chromatography (GC): suitable
	HPLC: suitable

Analysis Note:	These secondary standards offer multi-traceability to the USP and EP 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 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)
General description:	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.
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.
Other Notes:	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.

RIDADR	NONH for all modes of transport
WGK Germany	WGK 3
Flash Point(F)	Not applicable
Flash Point(C)	Not applicable

Storage Temp.	2-8°C
UNSPSC	41116107

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