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Monitoring powder blending in pharmaceutical processes by use of near infrared spectroscopy

✍ Scribed by M Blanco; R Gozález Bañó; E Bertran

Book ID
117222804
Publisher
Elsevier Science
Year
2002
Tongue
English
Weight
176 KB
Volume
56
Category
Article
ISSN
0039-9140

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 Considering also, the U.S. Food and Drug Administration's draft guidance published in 1999 (Guidance for Industry, ANDAs: Blend Uniformity Analysis; http://www.fda.gov/cder/guidance/index.htm), the import