Determination of organic volatile impurities in nepafenac by GC method.
The methods for controlling volatile impurities, including reagent and starting material, in Nepafenac active pharmaceutical ingredient, are reported. The proposed methods were developed using gas chromatography (GC) and gas chromatography with headspace injection (GC-HS) and validated according to the requirements of the ICH (International Conference of Harmonization) validation guidelines Q2R1 and the guideline for residual solvents Q3C.
Mariola
M
Mucha
Aleksandra
A
Groman
Joanna
J
Zagrodzka
Marcin
M
Cybulski
D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000032:analysis* / Q000592:standards; D044482:Benzeneacetamides / Q000032:analysis* / Q000592:standards; D002849:Chromatography, Gas / Q000379:methods*; D004340:Drug Contamination / Q000517:prevention & control; D057230:Limit of Detection; D010648:Phenylacetates / Q000032:analysis* / Q000592:standards; D015203:Reproducibility of Results; D012997:Solvents / Q000302:isolation & purification*; D055549:Volatile Organic Compounds / Q000302:isolation & purification*
D000894:Anti-Inflammatory Agents, Non-Steroidal; D044482:Benzeneacetamides; D010648:Phenylacetates; D012997:Solvents; D055549:Volatile Organic Compounds; C414203:nepafenac