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经验公式（希尔记法）:
C19H21N3OS
化学文摘社编号:
分子量:
339.45
MDL number:
UNSPSC Code:
12352200
NACRES:
NA.24
InChI key
OFLMIXVKBNAUIB-UHFFFAOYSA-N
InChI
1S/C19H21N3OS/c23-14-13-21-9-11-22(12-10-21)19-15-5-1-3-7-17(15)24-18-8-4-2-6-16(18)20-19/h1-8,23H,9-14H2
SMILES string
[s]1c2c(nc(c4c1cccc4)N3CCN(CC3)CCO)cccc2
grade
pharmaceutical analytical impurity (PAI)
agency
USP
API family
quetiapine
manufacturer/tradename
USP
application(s)
pharmaceutical small molecule
format
neat
storage temp.
2-8°C
General description
QUETIAPINE DESETHOXY 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: Quetiapine fumarate
Therapeutic Area: Psychiatrics
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: Quetiapine fumarate
Therapeutic Area: Psychiatrics
Application
QUETIAPINE DESETHOXY (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.
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.
signalword
Warning
hcodes
Hazard Classifications
Acute Tox. 4 Oral - Repr. 2 - STOT SE 3
target_organs
Central nervous system
存储类别
10 - Combustible liquids
wgk
WGK 1
法规信息
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