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usp-2057-dissolution-for-combination-drug-products
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 <1088> In Vitro Dissolution Profile Comparison for Generic DrugsUSP <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 <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 <2057> Dissolution for Combination Drug Products Laboratory Testing Service: A Comprehensive Guide

The USP <2057> Dissolution for Combination Drug Products laboratory testing service is governed by various international and national standards, including ISO 11133, ASTM E2308, EN 1408, TSE 2263, and others. These standards ensure the quality, safety, and efficacy of combination drug products.

International Standards

  • ISO 11133:2014 specifies the requirements for the testing of solid dosage forms.
  • ASTM E2308-16 sets forth the guidelines for dissolution testing of oral solid dosage forms.
  • EN 1408:2003A1:2009 outlines the requirements for the testing of tablets and capsules.
  • National Standards

  • TSE 2263 specifies the requirements for the testing of combination drug products in Turkey.
  • Other national standards, such as those in Japan (JP), China (GB), and India (IS), also govern dissolution testing.
  • Standard Development Organizations

    The International Organization for Standardization (ISO) is responsible for developing and publishing international standards. The American Society for Testing and Materials (ASTM) and the European Committee for Standardization (CEN) are other prominent standard development organizations.

    Evolution of Standards

    Standards evolve over time to reflect new scientific knowledge, technological advancements, and regulatory requirements. The revision process involves a comprehensive review of existing standards, consultation with experts, and approval by relevant governing bodies.

    Specific Standard Numbers and Scope

  • USP <2057> Dissolution for Combination Drug Products
  • ISO 11133:2014 Solid dosage forms - Dosage forms - Part 1: General information on the testing of solid dosage forms (includes dissolution testing)
  • ASTM E2308-16 Dissolution Testing of Oral Solid Dosage Forms
  • Standard Compliance Requirements

    Regulatory authorities worldwide require compliance with relevant standards for combination drug products. Companies must ensure their products meet these standards to avoid non-compliance, recalls, and reputational damage.

    The USP <2057> Dissolution for Combination Drug Products laboratory testing service ensures that combination drug products comply with international and national standards.

  • Compliance is essential for regulatory approval, market access, and customer confidence.
  • Non-compliance can result in costly recalls, reputational damage, and loss of business.
  • Companies must stay up-to-date with evolving standards to ensure ongoing compliance.
  • Standard-Related Information (conclusion)

    The USP <2057> Dissolution for Combination Drug Products laboratory testing service is governed by a complex array of international and national standards. Compliance with these standards is crucial for regulatory approval, market access, and customer confidence.

    Why is this specific test required?

  • Combination drug products pose unique challenges due to their multiple active ingredients.
  • Dissolution testing ensures that each component dissolves at the correct rate, ensuring optimal efficacy and safety.
  • Non-compliance can result in suboptimal product performance, reduced patient outcomes, or even harm.
  • Business and Technical Reasons for Conducting USP <2057> Dissolution Testing

    Conducting USP <2057> dissolution testing ensures:

  • Regulatory compliance with international and national standards
  • Optimal product performance and efficacy
  • Reduced risk of non-compliance, recalls, and reputational damage
  • Improved customer confidence and trust
  • Quality Assurance and Quality Control Aspects

    Dissolution testing contributes to product safety and reliability by ensuring:

  • Correct dissolution profiles for each component
  • Minimal variability in product performance
  • Optimal patient outcomes
  • Consequences of Not Performing this Test

    Non-compliance with USP <2057> Dissolution for Combination Drug Products testing can result in:

  • Regulatory non-compliance and potential recalls
  • Reduced customer confidence and trust
  • Suboptimal product performance, reduced efficacy, or harm to patients
  • Industries and Sectors Requiring this Testing

    Combination drug products are commonly used in the pharmaceutical industry. This test is particularly relevant for:

  • Pharmaceutical companies developing combination products
  • Regulatory agencies ensuring compliance with international and national standards
  • Quality control professionals responsible for product testing
  • Risk Factors and Safety Implications

    Dissolution testing helps mitigate risks associated with combination drug products, such as:

  • Variable dissolution profiles affecting product efficacy or safety
  • Non-compliance with regulatory requirements leading to recalls or reputational damage
  • Competitive Advantages of Having this Testing Performed

    Companies that conduct USP <2057> Dissolution for Combination Drug Products testing enjoy:

  • Regulatory compliance and reduced risk of non-compliance
  • Improved customer confidence and trust due to optimal product performance
  • Competitive market positioning through adherence to international and national standards
  • Standard Requirements and Needs (conclusion)

    The USP <2057> Dissolution for Combination Drug Products laboratory testing service ensures that combination drug products comply with international and national standards, ensuring optimal product performance, regulatory compliance, and customer confidence.

    The USP <2057> Dissolution for Combination Drug Products laboratory testing service provides a range of benefits, including:

  • Regulatory compliance with international and national standards
  • Optimal product performance and efficacy
  • Reduced risk of non-compliance, recalls, and reputational damage
  • Improved customer confidence and trust due to optimal product performance
  • Standard Requirements and Needs (conclusion)

    The USP <2057> Dissolution for Combination Drug Products laboratory testing service ensures that combination drug products meet international and national standards. Compliance with these standards is crucial for regulatory approval, market access, and customer confidence.

    The USP <2057> Dissolution for Combination Drug Products laboratory testing service provides a range of benefits, including:

  • Regulatory compliance with international and national standards
  • Optimal product performance and efficacy
  • Reduced risk of non-compliance, recalls, and reputational damage
  • Improved customer confidence and trust due to optimal product performance
  • Standard-Related Information (conclusion)

    The USP <2057> Dissolution for Combination Drug Products laboratory testing service ensures that combination drug products comply with international and national standards. Compliance with these standards is crucial for regulatory approval, market access, and customer confidence.

    ...

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