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Essential USP Chapters for Solid Dosage Form Development

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16 views

Essential USP Chapters for Solid Dosage Form Development

Uploaded by

singleelectron.quantum
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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ESSENTIAL USP

CHAPTERS FOR
SOLID DOSAGE
FORM
DEVELOPMENT
A guide to key USP
chapters for quality and
compliance in
pharmaceutical product
development

Tareq
Formulation Scientist
Product Quality &
Performance Testing
<2> Oral Drug Products—Product
Quality Tests: Standards for quality
testing of oral medications

<701> Disintegration: Tests for the


disintegration of tablets and capsules.

<711> Dissolution: Guidelines for


dissolution testing of drug products.

<905> Uniformity of Dosage Units:


Standards for dosage unit uniformity.

<1711> Oral Dosage Forms—


Performance Tests: Covers
comprehensive performance tests for
oral dosage forms.
Packaging & Storage

<659> Packaging and Storage


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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