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usp-1088-in-vitro-dissolution-profile-comparison-for-generic-drugs
Dissolution and Disintegration Testing EMA Guideline on the Investigation of Bioequivalence—Dissolution CriteriaFDA Guidance for Industry: Dissolution Testing of Immediate Release Solid Oral Dosage FormsFDA QbD Dissolution Modeling for PAT IntegrationICH M9 Biopharmaceutics Classification System-based BiowaiversICH Q1A(R2) Stability Testing Impacting Dissolution RateICH Q3C (R8) Residual Solvent Impact on DissolutionICH Q6A Dissolution Testing as Part of SpecificationsICH Q8(R2) Design Space and Dissolution ProfilesICH S6 Dissolution Testing in Biotech-Derived ProductsISO 22609:2004 Disintegration Time of Medical Face Mask MaterialsISO 31101:2019 Dissolution Testing of Oral Hygiene ProductsJP 15th Edition: Dissolution and Disintegration TestJP 3.09 Disintegration Test for Capsules and TabletsJP General Chapter 6.10 Dissolution Test for SuppositoriesPh. Eur. 2.9.1 Disintegration Test for Solid Dosage FormsPh. Eur. 2.9.29 Disintegration of Tablets for Veterinary UsePh. Eur. 2.9.3 Dissolution Testing of Oral Dosage FormsPh. Eur. 2.9.39 Dissolution of Patches and ImplantsPh. Eur. 2.9.4 Dissolution of Modified Release Dosage FormsPh. Eur. 2.9.40 Dissolution Testing for Oral SuspensionsPh. Eur. 2.9.43 In Vitro Dissolution Testing of Inhaled ProductsPh. Int. 2.9.5 Disintegration Testing of SuppositoriesUSP <1002> Dissolution Testing for Powder-Filled CapsulesUSP <1004> Disintegration Testing of Vaginal TabletsUSP <1087> Assessment of Drug Release from Extended Release TabletsUSP <1090> Assessment of Drug Release from Liposomal Dosage FormsUSP <1091> Assessment of Drug Release from MicrospheresUSP <1092> Dissolution Procedure Development and ValidationUSP <1094> Capsules—Dissolution and DisintegrationUSP <1097> Dissolution Testing for Transmucosal Drug Delivery SystemsUSP <2040> Dissolution Testing for Dietary SupplementsUSP <2041> Dissolution Testing of Oral Disintegrating TabletsUSP <2042> Disintegration and Dissolution of Buccal TabletsUSP <2043> Disintegration Testing of Chewable TabletsUSP <2044> Disintegration Testing for Orally Disintegrating TabletsUSP <2045> Dissolution of Transdermal PatchesUSP <2046> Disintegration of Medicated LozengesUSP <2047> Dissolution for Vaginal RingsUSP <2048> Dissolution for Oral Thin FilmsUSP <2049> Disintegration of Drug-Eluting StentsUSP <2050> Dissolution of Topical Creams and GelsUSP <2051> Dissolution Testing for Ion Exchange Resin-Based FormulationsUSP <2052> Disintegration of Controlled-Release TabletsUSP <2053> Dissolution Testing for Suppositories and PessariesUSP <2054> Disintegration Test for Extended-Release Film-Coated TabletsUSP <2055> Dissolution of Chewable GumsUSP <2056> In Vitro Drug Release for Implantable DevicesUSP <2057> Dissolution for Combination Drug ProductsUSP <2058> Dissolution for Oral Pellets and GranulesUSP <2059> Disintegration Testing of Oral Dispersible FilmsUSP <2060> In Vitro Release of Drug from Polymeric MicrospheresUSP <2061> Dissolution Testing of Nanocrystal FormulationsUSP <2062> Disintegration Testing for Multi-Layer TabletsUSP <2063> In Vitro Release Testing of Injectable SuspensionsUSP <2064> Dissolution of Non-Oral Dosage FormsUSP <2065> Disintegration Testing for Delayed Release CapsulesUSP <2066> Dissolution for MinitabletsUSP <2067> Dissolution of Coated Granules in SachetsUSP <2068> In Vitro Drug Release from Dermal SystemsUSP <2069> Disintegration Testing for Mucosal FilmsUSP <2070> Dissolution Testing for Sublingual TabletsUSP <2071> Drug Release Testing for Injectable GelsUSP <2072> Disintegration for Veterinary Bolus TabletsUSP <2073> Dissolution of Multi-Compartment CapsulesUSP <2074> Disintegration Testing of Gastro-Retentive TabletsUSP <2075> Dissolution Testing for Microemulsion SystemsUSP <2076> Dissolution Testing for Oral JelliesUSP <2077> Disintegration Testing for Modified-Release CapsulesUSP <2078> Dissolution of Floating TabletsUSP <2079> Disintegration Test for Multi-Unit Pellet SystemsUSP <2080> Drug Release from Drug-Eluting CoilsUSP <2081> In Vitro Drug Release Testing for Smart TabletsUSP <2082> Dissolution Testing of Effervescent GranulesUSP <2083> Disintegration Testing for Bilayer TabletsUSP <2084> Dissolution of Mucoadhesive TabletsUSP <2085> Disintegration of Matrix-Formed TabletsUSP <2086> Dissolution Testing of Suspended APIs in Liquid MediumUSP <2087> Disintegration Test for pH-Dependent Release CapsulesUSP <701> Disintegration of Effervescent TabletsUSP <701> Disintegration Testing of Uncoated TabletsUSP <705> Quality Attributes for Powder for Oral SuspensionUSP <711> Dissolution Testing of Immediate Release TabletsWHO Technical Report Series 929 Annex 9—Dissolution Testing for Quality Control

USP <1088> In Vitro Dissolution Profile Comparison for Generic Drugs: Laboratory Testing Services by Eurolab

The United States Pharmacopeia (USP) <1088> standard outlines the requirements for in vitro dissolution profile comparison testing for generic drugs. This laboratory test is critical for ensuring the quality and safety of generic medications, which account for approximately 90 of all prescription drugs dispensed in the United States.

Legal and Regulatory Framework

The USP <1088> standard is a consensus-based standard developed by the USP Expert Committee on Dissolution and Related Technologies. The standard is widely adopted by regulatory agencies globally, including the FDA, EMA, and WHO. Compliance with this standard is mandatory for generic drug manufacturers seeking to market their products in the United States.

International and National Standards

The USP <1088> standard harmonizes with international standards from organizations such as ISO (International Organization for Standardization), ASTM (American Society for Testing and Materials), EN (European Committee for Electrotechnical Standardization), TSE (Turkish Standards Institution), and others. National standards, including those from the FDA, EMA, and WHO, also support this standard.

Standard Development Organizations

Standard development organizations play a crucial role in creating and maintaining industry standards. Eurolab is an international organization that brings together laboratory testing experts to develop and harmonize standards for laboratory testing services. The USP <1088> standard was developed by the USP Expert Committee on Dissolution and Related Technologies, which includes representatives from various stakeholders, including regulatory agencies, industry professionals, and academia.

Standard Evolution and Updates

Standards evolve over time as technology advances and new scientific evidence emerges. Standards are updated to reflect changes in testing methodologies, equipment, and regulations. The USP <1088> standard is reviewed regularly by the USP Expert Committee on Dissolution and Related Technologies to ensure it remains relevant and effective.

Standard Compliance Requirements

Compliance with the USP <1088> standard requires laboratories to meet specific requirements for equipment, personnel, quality control, and data management. Laboratories must also demonstrate conformance to regulatory standards and guidelines from national and international authorities.

Industry-Specific Examples and Case Studies

Several industries rely on USP <1088> in vitro dissolution profile comparison testing services, including:

  • Pharmaceutical companies
  • Generic drug manufacturers
  • Biotechnology firms
  • Cosmetics and personal care product manufacturers
  • Examples of successful implementation of this standard include:

  • A generic manufacturer implemented USP <1088> testing to ensure their products met the required dissolution profiles for furosemide tablets.
  • A pharmaceutical company used USP <1088> testing to demonstrate bioequivalence between their brand-name and generic products.
  • Statistical Data and Research Findings

    Studies have shown that USP <1088> testing significantly improves product quality, reduces the risk of adverse reactions, and enhances patient safety. For instance, a study published in the Journal of Pharmaceutical Sciences found that implementing USP <1088> testing reduced the incidence of tablet failure by 23.

    Standard Numbers and Scope

    The following standard numbers and scopes apply to USP <1088> in vitro dissolution profile comparison testing:

  • USP <1088>: Dissolution Profile Comparison for Generic Drugs
  • ISO 14644-1: Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness
  • ASTM E2269: Standard Guide for Selecting and Testing the Performance of Automated In Vitro Release Test (IVRT) Instruments
  • The USP <1088> in vitro dissolution profile comparison testing service is essential for several reasons:

    Business and Technical Reasons for Conducting USP <1088> Testing

    Conducting USP <1088> testing provides several benefits, including:

  • Ensuring product quality and safety
  • Enhancing patient safety and well-being
  • Demonstrating regulatory compliance
  • Supporting business growth and market expansion
  • Improving supply chain efficiency
  • Consequences of Not Performing This Test

    Failing to conduct USP <1088> testing can lead to:

  • Poor product quality and safety
  • Regulatory non-compliance and penalties
  • Loss of customer trust and reputation damage
  • Reduced market share and revenue
  • Industries and Sectors that Require This Testing

    Several industries require USP <1088> in vitro dissolution profile comparison testing services, including:

  • Pharmaceutical companies
  • Generic drug manufacturers
  • Biotechnology firms
  • Cosmetics and personal care product manufacturers
  • Risk Factors and Safety Implications

    USP <1088> testing mitigates the following risks:

  • Poor product quality and safety
  • Regulatory non-compliance and penalties
  • Loss of customer trust and reputation damage
  • Reduced market share and revenue
  • Standard Requirements and Needs Conclusion

    The USP <1088> in vitro dissolution profile comparison testing service is a critical component of ensuring product quality, safety, and regulatory compliance. Laboratories must meet specific requirements for equipment, personnel, quality control, and data management to ensure conformance with this standard.

    Standard Numbers and Scope

    The following standard numbers and scopes apply to USP <1088> in vitro dissolution profile comparison testing:

  • USP <1088>: Dissolution Profile Comparison for Generic Drugs
  • ISO 14644-1: Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness
  • ASTM E2269: Standard Guide for Selecting and Testing the Performance of Automated In Vitro Release Test (IVRT) Instruments
  • Standard Requirements and Needs Conclusion

    The USP <1088> in vitro dissolution profile comparison testing service is a critical component of ensuring product quality, safety, and regulatory compliance. Laboratories must meet specific requirements for equipment, personnel, quality control, and data management to ensure conformance with this standard.

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