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Related Concept Videos

Drug Dissolution: Requirements and Profile Comparison01:14

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...
Bioequivalence studies: Biowaivers01:13

Bioequivalence studies: Biowaivers

In certain scenarios, in vitro dissolution tests can replace in vivo bioequivalence studies. This is particularly true when a drug product, though available in varying strengths, maintains proportional similarity in its active and inactive ingredients. In such cases, the need for in vivo bioequivalence studies for lower strength variants may be waived, provided dissolution tests and in vivo studies on the highest strength yield satisfactory results.Bioequivalence can be indicated through...
Pharmaceutical Alternatives: Polymorphic Form-Related and Particle Size-Related Therapeutic Nonequivalence01:27

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 Elimination: The Concept of Clearance01:06

Drug Elimination: The Concept of Clearance

Drug elimination refers to removing drugs from the body, either through urine by the kidneys or through bile by the liver. Drug clearance is a pharmacokinetic parameter that measures the efficiency of drug removal from the bloodstream within a specific time frame. It is calculated as the rate at which a drug is eliminated from plasma divided by the plasma concentration of the drug.
Drug clearance is not limited to renal excretion but encompasses all organs involved in drug elimination,...
Clinically Relevant Drug Product Specifications: Methods of Establishment01:29

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...
Factors Influencing Drug Absorption: Pharmaceutical Parameters01:28

Factors Influencing Drug Absorption: Pharmaceutical Parameters

Solid dosage forms such as tablets and capsules undergo rigorous manufacturing processes to ensure stability and effectiveness. Their dissolution and absorption properties are influenced significantly by the choice of excipients (inactive ingredients that serve various roles in the formulation), and the methodology applied during production. The manufacturing parameters, such as compression force and granulation techniques, significantly affect dissolution rates. Elevated compression forces...

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Related Experiment Video

Updated: Jun 21, 2026

A Package of Established Analytical Tools to Investigate the Solid-State Alteration of Lipid-Based Excipients
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Published on: August 9, 2022

Leachables evaluation for bulk drug substance.

Victor Tsui1, Maria S Somma, Linda A Zitzner

  • 1VaxGen, Inc., South San Francisco, CA 94080, USA. victor_tsui@hotmail.com

PDA Journal of Pharmaceutical Science and Technology
|July 29, 2009
PubMed
Summary

This study developed an analytical method to detect leachables in bulk drug substance (BDS). The method confirmed that potential impurities were not present, ensuring the safety and stability of parenteral products.

Area of Science:

  • Pharmaceutical Manufacturing
  • Analytical Chemistry
  • Drug Safety

Background:

  • Parenteral products require stringent control over impurities.
  • Leachables from manufacturing equipment can compromise drug substance quality.
  • A robust analytical strategy is essential for parenteral drug substance safety.

Purpose of the Study:

  • To establish a comprehensive analytical approach for evaluating potential leachables.
  • To assess leachables from product-contacting materials in bulk drug substance (BDS) manufacture.
  • To ensure the safety and stability of BDS for parenteral products.

Main Methods:

  • Qualitative evaluation of the BDS manufacturing process stream.
  • Prioritization of equipment surfaces based on leachable risk.

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High-throughput and Comprehensive Drug Surveillance Using Multisegment Injection-Capillary Electrophoresis-Mass Spectrometry
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  • Identification and classification of 13 potential leachable species (VOCs, SVOCs, anions, cations, trace metals).
  • Screening of BDS using qualified analytical methods.
  • Spike-recovery studies in BDS and Water for Injection (WFI).

    • Main Results:

    • Potential leachables were not detected in the BDS, except for trace silicon.
    • Residual solvent concentrations were below International Council for Harmonisation (ICH) limits.
    • Analytical methods demonstrated effective leachable compound detection.
    • No complex formation between contaminants and the BDS protein was observed.

    Conclusions:

    • The developed analytical approach effectively assesses leachables in BDS.
    • The manufacturing process for this BDS does not pose a risk of leachable contamination.
    • The BDS is safe and stable for use in parenteral products.