Search research articles

ABOUT JoVE

Overview Leadership Blog JoVE Help Center

AUTHORS

Publishing Process Editorial Board Scope & Policies Peer Review FAQ Submit

LIBRARIANS

Testimonials Subscriptions Access Resources Library Advisory Board FAQ

RESEARCH

JoVE Journal Methods Collections JoVE Encyclopedia of Experiments Archive

EDUCATION

JoVE Core JoVE Business JoVE Science Education JoVE Lab Manual Faculty Resource Center Faculty Site

Terms & Conditions of Use

Related Concept Videos

Pharmaceutical Alternatives: Polymorphic Form-Related and Particle Size-Related Therapeutic Nonequivalence

Pharmaceutical Alternatives: Polymorphic Form-Related and Particle Size-Related Therapeutic Nonequivalence

Changes in polymorphic forms can significantly influence the bioavailability of poorly soluble drugs. Although the FDA defines pharmaceutical equivalence based on having the same active ingredient, dosage form, and route of administration, it does not automatically disqualify products with different polymorphic forms. This means two products with different polymorphs can still be deemed pharmaceutically equivalent. However, polymorphic differences can affect properties like wettability,...

Drug Dissolution: Requirements and Profile Comparison

The acceptance criteria for dissolution profile data are anchored in Q values, representing the percentage of drug dissolved within a specified period. This assessment unfolds in three stages:First Stage: The test passes if all six drug dosage units are equal to or greater than Q plus 5%; otherwise, the sample proceeds to the second stage.Second Stage: The average of twelve units must be equal to or greater than Q, with no unit falling below Q - 15% to pass; if not, it progresses to the final...

Formulation and Manufacturing Process: Physical Attributes of Generic Tablets and Capsules

Formulation and Manufacturing Process: Physical Attributes of Generic Tablets and Capsules

Bioequivalence in generic drugs, such as tablets and capsules, refers to their pharmaceutical equivalence to the brand-name counterparts. However, for therapeutic equivalence, manufacturers must also consider physical attributes like size, shape, and weight (FDA Guidance for Industry, December 2003). Discrepancies in these aspects could impact patient compliance and cause medication errors. For instance, swallowing difficulties, often experienced with larger tablets or capsules, can lead to...

Pharmaceutical Alternatives: Excipients and Impurities-Related Therapeutic Nonequivalence

Pharmaceutical Alternatives: Excipients and Impurities-Related Therapeutic Nonequivalence

Pharmaceutical products contain more than just the active drug; they also contain various excipients such as binders, solubilizers, stabilizers, preservatives, and other elements. In some cases, impurities or contaminants might be present. Traditionally, quality control in pharmaceuticals has primarily focused on the analysis of the active drug, often overlooking the impact of these additional components. The recent issue with heparin contamination by over-sulfated chondroitin sulfate, a...

Clinically Relevant Drug Product Specifications: Methods of Establishment

Clinically Relevant Drug Product Specifications: Methods of Establishment

Product specifications define the acceptable quality of a pharmaceutical product by ensuring identity, purity, potency, and strength. These specifications serve as benchmarks during development, manufacturing, and post-approval quality control. Clinically relevant specifications are particularly important because they directly relate to a drug's safety and efficacy in clinical use.Dissolution studies are critical biopharmaceutic tools that link in vitro behavior to in vivo performance. They...

In Vitro Drug Dissolution: Compendial Testing Models I

In Vitro Drug Dissolution: Compendial Testing Models I

Compendial dissolution methods are standardized procedures defined by pharmacopeias to evaluate the rate at which a drug dissolves in a specific medium. These methods ensure batch-to-batch consistency, enable quality control, and support the prediction of drug bioavailability. They are critical for both immediate and modified-release drug products.The apparatuses used for dissolution testing differ in their design and mechanical function, but all aim to simulate the physiological environment of...

You might also read

Related Articles

Articles linked to this work by shared authors, journal, and citation graph.

Sort by

Same author

Compounding Pharmacies for 0.5% Timolol Nasal Spray for Acute Migraine.

Missouri medicine·2025

Same author

Prescription - Transparency and the Evolution of Compounding.

International journal of pharmaceutical compounding·2025

Same author

Physical Compatibility of Cefiderocol with Selected Intravenous Drugs During Simulated Y-site Administration.

International journal of pharmaceutical compounding·2021

Same author

Serum Monitoring and Phenotype Identification of Stage I Non-Small Cell Lung Cancer Patients.

Cancer investigation·2017

Same author

Topical Metered-dosing Dispenser Performance Evaluation.

International journal of pharmaceutical compounding·2017

Same author

Adolescent and young adult women's opinions of common eating disorder prevention messages.

Eating disorders·2017

Search research articles

Related Experiment Video

Updated: May 8, 2026

Validated LC-MS/MS Panel for Quantifying 11 Drug-Resistant TB Medications in Small Hair Samples

Validated LC-MS/MS Panel for Quantifying 11 Drug-Resistant TB Medications in Small Hair Samples

Published on: May 19, 2020

Quality-control analytical methods: homogeneity of dosage forms.

Thomas C Kupiec¹, Nicole Vu, David Branscum

¹Analytical Research Laboratories, Oklahoma City, Oklahoma.

International Journal of Pharmaceutical Compounding

|August 24, 2013

Summary

Content uniformity ensures consistent drug amounts in dosages. Pharmacists must understand United States Pharmacopeial Chapter 905 methods, Content Uniformity and Weight Variation, for accurate pharmaceutical compounding.

More Related Videos

An In Vitro Dissolution Determination of Multi-Index Components in Tibetan Medicine Rhodiola Granules

An In Vitro Dissolution Determination of Multi-Index Components in Tibetan Medicine Rhodiola Granules

Published on: November 4, 2022

A Package of Established Analytical Tools to Investigate the Solid-State Alteration of Lipid-Based Excipients

A Package of Established Analytical Tools to Investigate the Solid-State Alteration of Lipid-Based Excipients

Published on: August 9, 2022

Related Experiment Videos

Last Updated: May 8, 2026

Validated LC-MS/MS Panel for Quantifying 11 Drug-Resistant TB Medications in Small Hair Samples

Validated LC-MS/MS Panel for Quantifying 11 Drug-Resistant TB Medications in Small Hair Samples

Published on: May 19, 2020

An In Vitro Dissolution Determination of Multi-Index Components in Tibetan Medicine Rhodiola Granules

An In Vitro Dissolution Determination of Multi-Index Components in Tibetan Medicine Rhodiola Granules

Published on: November 4, 2022

A Package of Established Analytical Tools to Investigate the Solid-State Alteration of Lipid-Based Excipients

A Package of Established Analytical Tools to Investigate the Solid-State Alteration of Lipid-Based Excipients

Published on: August 9, 2022

Area of Science:

Pharmaceutical Science
Drug Compounding
Quality Control

Background:

Content uniformity is critical for ensuring consistent drug dosage.
Dosage unit consistency is vital for patient safety and therapeutic efficacy.
United States Pharmacopeial Chapter 905 outlines standards for drug product quality.

Purpose of the Study:

To elucidate the importance of content uniformity in pharmaceutical compounding.
To explain the two primary methods for assessing content uniformity as per USP Chapter 905.
To guide compounding pharmacists on selecting the appropriate method for their specific needs.

Main Methods:

Explanation of the Content Uniformity method.
Description of the Weight Variation method.
Comparison of the applicability of each method in pharmaceutical compounding.

Main Results:

Content uniformity ensures consistent drug amounts across dosage units.
United States Pharmacopeial Chapter 905 details Content Uniformity and Weight Variation methods.
Understanding these methods is essential for compounding pharmacists.

Conclusions:

Compounding pharmacists require knowledge of both Content Uniformity and Weight Variation methods.
Appropriate application of these methods ensures the quality and safety of compounded medications.
Accurate content uniformity assessment is a cornerstone of good pharmaceutical practice.