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XL. Segregation 72 72
XLI. Sifting Ingredients and Granules 72 72
XLII. Specifications 72 72
XLIII. Stability Testing 72 72
XLIV. Storage of In-Process Material 73 73
Contents xiii 0
XLV. Tablet Friability 73 73
XLVI. Tablet Manufacturing 73 73
XLVII. Tablets 73 73
XLVIII. Water-Purified USP 74 74
XLIX. Weight Variation and Content Uniformity 74 74
L. Wet Granulation vs. Dry Granulation or Direct Compression 74 74
LI. Multivariate Methods in Tablet Formulation 74 74
LII. Physical Properties 75 75
LIII. Particle Size Studies 76 76
A. Particle Size Distribution 76 76
LIV. Surface Area 77 77
LV. Porosity 77 77
LVI. True Density 78 78
LVII. Flow and Compaction of Powders 78 78
LVIII. Color 79 79
LIX. Electrostaticity 79 79
LX. Caking 80 80
LXI. Polymorphism 80 80
LXII. Stability Studies to Select Optimal Drug and Excipient Combinations 80 80
Appendix I Dissolution Testing Requirements of Compressed Dosage Forms 82 82
Appendix II Approved Excipients in Compressed Solid Dosage Forms 99 99
PART II. MANUFACTURING FORMULATIONS Pharmaceutical Manufacturing Formulations 171 171
Acetaminophen and Caffeine Tablets 171 171
Acetaminophen and Caffeine Tablets 172 172
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