Requirements: Requirements for packaging and storing pharmaceuticals.
<660> Containers—Glass: Standards
for the use of glass containers in pharmaceuticals.
<661> Plastic Packaging Systems:
Safety guidelines for plastic materials used in packaging.
<671> Containers—Performance Testing: Tests for container integrity and suitability. Impurities & Contaminants
<232> Elemental Impurities—Limits:
Limits for elemental impurities in drug products.
<467> Residual Solvents: Guidelines for
acceptable levels of residual solvents.
<1086> Impurities in Drug Substances
and Products: Standards for identifying and quantifying impurities.
<1469> Nitrosamine Impurities: Testing
for nitrosamine impurities in pharmaceuticals. Microbial Testing
<61> Microbiological Examination of
Nonsterile Products: Microbial Enumeration Tests: Procedures for counting microorganisms in nonsterile products.
<62> Tests for Specified
Microorganisms: Tests for detecting specific microorganisms in nonsterile products. Material & Powder Properties <616> Bulk Density and Tapped Density of Powders: Methods for measuring the bulk and tapped density of powders.
<699> Density of Solids: defines the
density of solids, crucial for characterizing pharmaceutical powders.
<1059> Excipient Performance: provides
guidelines on excipient performance.
<1062> Tablet Compression
Characterization: provides guidelines for tablet compression characterization, detailing methodologies to standardize the tablet compression process. Physical & Chemical Characterization <731> Loss on Drying: Methods for determining moisture content.
<786> Particle Size Distribution
Estimation by Analytical Sieving
<791> pH: Guidelines for measuring pH.
<841> Specific Gravity: Methods for
determining specific gravity.
<1216> Tablet Friability: Tests for tablet
friability.
<1217> Tablet Breaking Force: Methods
for measuring tablet breaking force. Documentation & Guidelines <1029> Good Documentation Guidelines: Best practices for maintaining clear, compliant documentation.
<1088> in Vitro and in Vivo Evaluation of
Oral Dosage Forms:Guidelines for testing dosage forms in lab settings and in the body.
<1090> Bioavailability, Bioequivalence,
and Dissolution: Standards for assessing drug product performance.
<1151> Pharmaceutical Dosage Forms:
Comprehensive guidelines for various dosage forms. Did I Miss Any Important Chapters?
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