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PHR1857

Supelco

Sitagliptin Phosphate

Pharmaceutical Secondary Standard; Certified Reference Material

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Synonym(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
Empirical Formula (Hill Notation):
C16H15F6N5O · H3PO4 · H2O
CAS Number:
654671-77-9
Molecular Weight:
523.32
UNSPSC Code:
41116107
NACRES:
NA.24

grade

certified reference material
pharmaceutical secondary standard

Quality Level

300

Agency

traceable to Ph. Eur. Y0001812
traceable to USP 1612903

API family

sitagliptin

form

powder

CofA

current certificate can be downloaded

packaging

pkg of 1 g

technique(s)

HPLC: suitable
gas chromatography (GC): suitable

application(s)

pharmaceutical (small molecule)

storage temp.

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

InChI key

GQPYTJVDPQTBQC-KLQYNRQASA-N

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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.
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)

Analysis Note

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

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.

related product

Product No.
Description
Pricing

Pictograms

Health hazardExclamation mark
GHS08,GHS07

Signal Word

Warning

Hazard Statements

H319,H373

Hazard Classifications

Eye Irrit. 2 - STOT RE 2

Target Organs

Liver

WGK

WGK 3

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable

Certificates of Analysis (COA)

Search for Certificates of Analysis (COA) by entering the products Lot/Batch Number. Lot and Batch Numbers can be found on a product’s label following the words ‘Lot’ or ‘Batch’.

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Validated liquid chromatographic method for simultaneous determination of metformin, pioglitazone, sitagliptin, repaglinide, glibenclamide and gliclazide-application for counterfeit drug analysis
Elkady EF, et al.
Journal of Analytical and Bioanalytical Techniques , 1-1 (2015)
A validated HPLC stability indicating method for the determination of sitagliptin in bulk drug substance and tablets
Qassas MK, et al.
International Journal of Pharmaceutical Sciences Review and Research, 32, 194-198 (2015)

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