PHR1857
Sitagliptin Phosphate
Pharmaceutical Secondary Standard; Certified Reference Material
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
About This Item
Recommended Products
grade
certified reference material
pharmaceutical secondary standard
Quality Level
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
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
- 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
Footnote
related product
signalword
Warning
hcodes
Hazard Classifications
Eye Irrit. 2 - STOT RE 2
target_organs
Liver
Storage Class
11 - Combustible Solids
wgk_germany
WGK 3
flash_point_f
Not applicable
flash_point_c
Not applicable
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