Validation of a near-infrared transmission spectroscopic procedure. Part B: Application to alternate content uniformity and release assay methods for pharmaceutical solid dosage forms.
NIR analytical methods can be validated to meet the requirement of demonstrating that it is suitable for the analysis of the materials for which it is being used. Applying previously described protocols for NIR methods to the analysis of two types of pharmaceutical products shows that for these products, NIR is suitable as an alternate analytical method for assay and for content uniformity.
Ritchie
Gary E
GE
Purdue Pharma LP, Building 444, Saw Mill River Road, Ardsley, NY 10502, USA.
Roller
Robert W
RW
Ciurczak
Emil W
EW
Mark
Howard
H
Tso
Cindy
C
MacDonald
Stacy A
SA
D000704:Analysis of Variance; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D004304:Dosage Forms; D004364:Pharmaceutical Preparations / Q000032:analysis*; D015203:Reproducibility of Results; D019265:Spectroscopy, Near-Infrared / Q000379:methods*; D013678:Technology, Pharmaceutical / Q000379:methods
D004304:Dosage Forms; D004364:Pharmaceutical Preparations