The Process Analytical Technology (PAT) initiative, undertaken by the Food and Drug Administration (FDA), paves the way for improvement of drug manufacturing through real-time measurements that allow better process understanding. This study is the third and final Part in a series of studies that rep
Near-infrared spectroscopic characterization of pharmaceutical powder blends
β Scribed by David J. Wargo; James K. Drennen
- Publisher
- Elsevier Science
- Year
- 1996
- Tongue
- English
- Weight
- 652 KB
- Volume
- 14
- Category
- Article
- ISSN
- 0731-7085
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The successful implementation of near-infrared spectroscopy (NIRS) in process control of powder blending requires constructing an inclusive spectral database that reflects the anticipated voluntary or involuntary changes in processing conditions, thereby minimizing bias in prediction of blending beh
In-process testing requirements for adequacy of mixing are established in 21 CFR 211.110(a)(3). Considering also, the U.S. Food and Drug Administration's draft guidance published in 1999 (Guidance for Industry, ANDAs: Blend Uniformity Analysis; http://www.fda.gov/cder/guidance/index.htm), the import
Experimental design, multivariate data acquisition, and analysis in addition to real time monitoring and control through process analyzers, represent an integrated approach for implementation of Process Analytical Technology (PAT) in the pharmaceutical industry. This study, which is the first in a s