Pharma Reference Standard; Pharmaceutical/API Drug Impurities/Metabolites
API
Diclofenac
CAS Number
59-48-3
HS Code
29339900
Molecular formula
C8H7NO
Molecular Weight
133.2 g/mol
Synonyms
Diclofenac EP Impurity E ; Oxindole
Chemical Name
1,3-Dihydro-2H-indol-2-one
Appearance
White To Light Yellow To Light Orange Powder To crystal
Melting Point
125.0 to 130.0 °C
Storage
2°C to 8°C
Solubility
Soluble In Methanol, Ether, Ethanol
Stability
No Data Available
Boiling Point
No Data Available
Applications
Diclofenac EP Impurity E is supplied with detailed characterization data compliant with regulatory guideline. Diclofenac EP Impurity E can be used for the analytical method development, method validation (AMV), Quality Controlled (QC) application for Abbreviated New Drug Application (ANDA) or during commercial production of Diclofenac.