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Quantitative in-line monitoring of powder blending by near infrared reflection spectroscopy

✍ Scribed by O. Berntsson; L.-G. Danielsson; B. Lagerholm; S. Folestad

Book ID
114079494
Publisher
Elsevier Science
Year
2002
Tongue
English
Weight
229 KB
Volume
123
Category
Article
ISSN
0032-5910

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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 Considering also, the U.S. Food and Drug Administration's draft guidance published in 1999 (Guidance for Industry, ANDAs: Blend Uniformity Analysis; http://www.fda.gov/cder/guidance/index.htm), the import