Validation of a near-infrared transmission spectroscopic procedure. Part B: Application to alternate content uniformity and release assay methods for pharmaceutical solid dosage forms |
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| Authors: | Ritchie Gary E Roller Robert W Ciurczak Emil W Mark Howard Tso Cindy MacDonald Stacy A |
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| Affiliation: | Purdue Pharma LP, Building 444, Saw Mill River Road, Ardsley, NY 10502, USA. |
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| Abstract: | 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. |
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