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About This Item
grade
pharmaceutical analytical impurity (PAI)
agency
USP
form
liquid
manufacturer/tradename
USP
application(s)
pharmaceutical
pharmaceutical
pharmaceutical small molecule
format
neat
storage temp.
-10 to -25°C
SMILES string
N1(CCCC1)N=O
InChI key
WNYADZVDBIBLJJ-UHFFFAOYSA-N
General description
USP PAI are a product line of impurities suitable for research and analytical purposes, which help to ensure the quality and safety of medicines.
For more information about this PAI, visit here.
Application
Features and Benefits
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
Other Notes
1 of 1
This Item | ||
|---|---|---|
| description Pharmaceutical Analytical Impurity (PAI) | description certified reference material, TraceCERT®, Manufactured by: Sigma-Aldrich Production GmbH, Switzerland | description analytical standard |
| application(s) pharmaceutical small molecule | application(s) - | application(s) - |
| form liquid | form - | form - |
| format neat | format neat | format neat |
| grade pharmaceutical analytical impurity (PAI) | grade certified reference material, TraceCERT® | grade analytical standard |
| storage temp. -10 to -25°C | storage temp. −20°C | storage temp. 2-8°C |
| manufacturer/tradename USP | manufacturer/tradename Manufactured by: Sigma-Aldrich Production GmbH, Switzerland | manufacturer/tradename Manufactured by: Sigma-Aldrich Production GmbH, Switzerland |
Signal Word
Danger
Hazard Codes
Precautionary Statements
Hazard Classifications
Acute Tox. 3 Dermal - Acute Tox. 3 Inhalation - Acute Tox. 3 Oral - Carc. 2 - Flam. Liq. 2 - STOT SE 1
Target Organs
Eyes,Central nervous system
Storage Class
3 - Flammable liquids
WGK
WGK 2
Regulatory Listings
Regulatory Listings are mainly provided for chemical products. Only limited information can be provided here for non-chemical products. No entry means none of the components are listed. It is the user’s obligation to ensure the safe and legal use of the product.
67-56-1
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