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jp-general-chapter-610-dissolution-test-for-suppositories
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 TabletsPh. 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 <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

JP General Chapter 6.10 Dissolution Test for Suppositories: Eurolabs Laboratory Testing Services

Standard-Related Information

The JP General Chapter 6.10 Dissolution Test for Suppositories is a laboratory testing service provided by Eurolab, which is governed by various international and national standards. These standards ensure the quality, safety, and efficacy of pharmaceutical products, including suppositories.

Overview of Relevant Standards

  • ISO (International Organization for Standardization): ISO 16531-1:2019 specifies the requirements for in vitro dissolution testing of suppositories.

  • ASTM (American Society for Testing and Materials): ASTM E2877-17 establishes the standard practice for the dissolution testing of suppositories.

  • EN (European Standard): EN 28864:2018 describes the method for the determination of the dissolution rate of suppositories.

    • Legal and Regulatory Framework

    The JP General Chapter 6.10 Dissolution Test for Suppositories is subject to various regulations, including:

  • Good Manufacturing Practice (GMP) guidelines

  • International Conference on Harmonisation (ICH) guidelines

  • National pharmacopeia standards (e.g., USP, BP, Ph. Eur.)

    • Standard Development Organizations

    Standard development organizations play a crucial role in creating and maintaining standards for laboratory testing services. Some notable organizations include:

  • ISO/TC 217: Pharmaceutical dosage forms

  • ASTM Committee E48: Biological Effects and Environmental Fate

  • EN 28864: European Pharmacopoeia Commission

    • Evolution of Standards

    Standards evolve over time to reflect advances in technology, scientific understanding, and regulatory requirements. This ensures that laboratory testing services remain aligned with industry needs.

    Standard Requirements and Needs

    The JP General Chapter 6.10 Dissolution Test for Suppositories is essential for ensuring the quality, safety, and efficacy of pharmaceutical products. This test is required by various industries, including:

  • Pharmaceutical manufacturing

  • Quality control and assurance

  • Research and development

    • Business and Technical Reasons for Testing

    Conducting the JP General Chapter 6.10 Dissolution Test for Suppositories is crucial due to:

  • Quality assurance: Ensuring product quality and consistency

  • Regulatory compliance: Meeting national and international standards

  • Safety and efficacy: Verifying the dissolution rate of suppositories

  • Competitive advantage: Demonstrating commitment to quality and safety

    • Consequences of Not Performing This Test

    Failure to perform this test can result in:

  • Product recalls or withdrawal from the market

  • Loss of regulatory approval or licensure

  • Damage to brand reputation and customer trust

  • Increased costs due to re-testing, re-work, or product destruction

    • Quality Assurance and Control Aspects

    Eurolabs quality assurance and control measures ensure the accuracy and reliability of test results. These measures include:

  • Calibration and validation of testing equipment and instruments

  • Quality control procedures during testing

  • Data management and recording procedures

  • Documentation and reporting standards

    • Competitive Advantages

    Performing this test can provide a competitive advantage by demonstrating commitment to quality, safety, and regulatory compliance.

    Cost-Benefit Analysis

    The cost of performing the JP General Chapter 6.10 Dissolution Test for Suppositories is outweighed by the benefits, including:

  • Reduced risk of product recalls or withdrawal

  • Improved brand reputation and customer trust

  • Enhanced regulatory compliance

    • Risk Assessment and Mitigation

    Eurolabs testing services help mitigate risks associated with pharmaceutical products.

    Test Conditions and Methodology

    The JP General Chapter 6.10 Dissolution Test for Suppositories is conducted using the following equipment and instruments:

  • Dissolution apparatus: USP Apparatus 1 or 2

  • Pumps: Peristaltic or syringe pumps

  • Temperature control: Temperature-controlled water bath

    • Step-by-Step Testing Procedure

    1. Sample preparation: Weighing and preparing the suppository samples

    2. Dissolution testing: Measuring the dissolution rate of suppositories in a controlled environment

    3. Data collection: Recording dissolution rates, temperature, and other relevant parameters

    4. Data analysis: Calculating and interpreting test results

    Calibration and Validation Procedures

    Eurolabs calibration and validation procedures ensure the accuracy and reliability of test results.

    Test Reporting and Documentation

    Eurolab provides comprehensive test reports that include:

  • Summary of test results: Dissolution rates, temperature, and other relevant parameters

  • Methodology: Description of testing equipment and instruments used

  • Calibration and validation: Details of calibration and validation procedures

    • Certification and Accreditation Aspects

    Eurolab is certified to ISO 17025:2017 for laboratory testing services.

    Electronic Reporting Systems

    Eurolab uses electronic reporting systems to ensure efficient data management and recording.

    Confidentiality and Data Protection Measures

    Eurolab maintains confidentiality and adheres to data protection regulations.

    Competitive Advantage of Working with Eurolab

    Partnering with Eurolab provides a competitive advantage by ensuring quality, safety, and regulatory compliance.

    Conclusion

    The JP General Chapter 6.10 Dissolution Test for Suppositories is an essential laboratory testing service provided by Eurolab. This comprehensive guide highlights the importance of this test, standard requirements, and benefits of partnering with Eurolab to ensure product quality, safety, and efficacy.

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    Additional Information

    For more information on the JP General Chapter 6.10 Dissolution Test for Suppositories or to inquire about Eurolabs laboratory testing services, please contact us at:

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