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Key Documents

1A02630

USP

(S)-Sitagliptin Phosphate

Pharmaceutical Analytical Impurity (PAI)

Synonym(s):

(S)-Sitagliptin Phosphate, (S)-3-amino-1-(3-(trifluoromethyl)-5,6-dihydro-[1,2,4]triazolo[4,3-a]pyrazin-7(8H)-yl)-4-(2,4,5-trifluorophenyl)butan-1-one phosphate

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About This Item

Empirical Formula (Hill Notation):
C16H18F6N5O5P
CAS Number:
Molecular Weight:
505.31
UNSPSC Code:
41116107
NACRES:
NA.24

grade

pharmaceutical analytical impurity (PAI)

agency

USP

API family

sitagliptin

manufacturer/tradename

USP

application(s)

pharmaceutical

format

neat

storage temp.

2-8°C

InChI

1S/C16H15F6N5O.HO4P.H2/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;1-4-5(2)3;/h4,6,9H,1-3,5,7,23H2;1H;1H/t9-;;/m0../s1

InChI key

SHWZYHNHAUKDOV-WWPIYYJJSA-N

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General description

(S)-(+)-N-(2,3-Epoxypropyl)phthalimide is a USP Pharmaceutical Analytical Impurity (PAI).

USP PAI are a product line of impurities suitable for research and analytical purposes, which help to ensure the quality and safety of medicines.

Associated Drug Substance: Sitagliptin

For more information about this PAI, visit here.

Application

(S)-(+)-N-(2,3-Epoxypropyl)phthalimide (USP PAI) is intended for use in analytical testing to detect, identify, and measure pharmaceutical impurities.

Features and Benefits

USP PAI advance your early analytical R&D and process development. PAI can be used in the following applications:

1. Conduct analytical tests during early formulation feasibility studies.
2. Determine degradation impurities produced during stress studies.
3. Develop, validate, and transfer analytical methods.
4. Perform spiking studies during process R&D to demonstrate depletion upon recrystallization.
5. Record retention times and/or spectra
6. Determine relative response factors.
7. Identify unknown impurities that formed during ICH stability conditions.
8. Identify impurities that are present in the Reference Listed Drug
9. Test for and profile impurities not listed in drug substance and drug product monographs.

Analysis Note

These products are for test and assay use only. They are not meant for administration to humans or animals and cannot be used to diagnose, treat, or cure diseases of any kind.  

Other Notes

Sales restrictions may apply.

pictograms

Exclamation mark

signalword

Warning

hcodes

Hazard Classifications

Skin Irrit. 2

Storage Class

11 - Combustible Solids

wgk_germany

WGK 3

flash_point_f

Not applicable

flash_point_c

Not applicable


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