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usp-1092-dissolution-procedure-development-and-validation
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 <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 <1092> Dissolution Procedure Development and Validation Laboratory Testing Service: A Comprehensive Guide

The United States Pharmacopeia (USP) <1092> dissolution procedure development and validation is a critical laboratory testing service that ensures the quality and efficacy of pharmaceutical products. This service is governed by various international and national standards, including ISO 14644-1:2015 (Cleanrooms and associated controlled environments), ASTM E1169-18 (Standard Practice for Conducting Ruggedness Tests), EN ISO 14698-1:2004 (Cleanrooms - Part 1: Classification of air cleanliness), TSE 1472-2006 (Pharmaceutical products - Dissolution testing), and others.

The legal and regulatory framework surrounding this testing service is governed by various laws, regulations, and guidelines, including the USP <1092> general chapter, the European Pharmacopoeia (Ph. Eur.), and national regulations such as the FDAs Guidance on Dissolution Testing of Immediate Release Solid Oral Dosage Forms (2000). These standards and regulations specify the requirements for dissolution testing, including equipment, procedures, and data analysis.

The International Organization for Standardization (ISO) is responsible for developing international standards for cleanrooms and associated controlled environments. The European Committee for Standardization (CEN) and the Turkish Standards Institution (TSE) are also involved in standard development and publication. These organizations work together to ensure that standards evolve and get updated as needed.

The scope of these standards includes:

  • ISO 14644-1:2015 - Cleanrooms and associated controlled environments

  • ASTM E1169-18 - Standard Practice for Conducting Ruggedness Tests

  • EN ISO 14698-1:2004 - Cleanrooms - Part 1: Classification of air cleanliness

  • TSE 1472-2006 - Pharmaceutical products - Dissolution testing

    • These standards specify the requirements for dissolution testing, including equipment, procedures, and data analysis. Compliance with these standards is mandatory for industries such as pharmaceuticals, biotechnology, and cosmetics.

    The USP <1092> dissolution procedure development and validation is a critical laboratory testing service that ensures the quality and efficacy of pharmaceutical products. The business and technical reasons for conducting this test include:

  • Ensuring product safety and efficacy

  • Compliance with regulatory requirements

  • Quality control and assurance

  • Risk assessment and mitigation

  • Cost savings and efficiency improvements

    • The consequences of not performing this test can be severe, including:

  • Product recalls

  • Regulatory non-compliance

  • Financial losses

  • Damage to reputation and brand image

    • This testing is required by various industries, including pharmaceuticals, biotechnology, and cosmetics. The risk factors associated with this testing include:

  • Inadequate equipment or procedures

  • Insufficient training or expertise

  • Lack of quality control measures

    • The quality assurance and quality control aspects of this testing include:

  • Use of validated equipment and procedures

  • Training and certification of personnel

  • Implementation of quality control measures

  • Regular calibration and maintenance of equipment

    • This test contributes to product safety and reliability by ensuring that products meet the required standards. The competitive advantages of having this testing performed include:

  • Improved product quality and efficacy

  • Enhanced reputation and brand image

  • Increased customer confidence and trust

  • Compliance with regulatory requirements

    • The cost-benefit analysis of performing this test includes:

  • Cost savings through reduced product recalls and regulatory non-compliance

  • Efficiency improvements through optimized product development and manufacturing processes

  • Financial benefits through increased revenue and market share

    • The USP <1092> dissolution procedure development and validation is a laboratory testing service that involves the following steps:

    1. Equipment calibration and maintenance

    2. Sample preparation and dosing

    3. Dissolution testing using validated equipment and procedures

    4. Data analysis and interpretation

    5. Reporting and documentation of results

    The testing equipment used includes:

  • Dissolution testing apparatus (e.g., paddle, basket, or flow-through cells)

  • pH meters and temperature control systems

  • UV-Vis spectrophotometers for dissolved substance measurement

    • The testing environment requirements include:

  • Cleanrooms and associated controlled environments

  • Temperature and humidity control systems

  • Air cleanliness classification according to ISO 14698-1:2004

    • The sample preparation procedures involve:

  • Weighing and dosing of samples

  • Mixing and homogenization of samples

  • Calibration of equipment used for sample preparation

    • The testing parameters and conditions include:

  • Dissolution media (e.g., water, buffer solutions)

  • Agitation speed and duration

  • Temperature and pH control systems

  • Sampling intervals and frequency

    • The measurement and analysis methods involve:

  • UV-Vis spectrophotometry for dissolved substance measurement

  • pH measurement using pH meters

  • Temperature measurement using thermocouples or thermistors

    • The reporting and documentation of the USP <1092> dissolution procedure development and validation include:

  • A summary of the testing procedures used

  • Results of equipment calibration and maintenance

  • Data analysis and interpretation

  • Reporting of results in accordance with regulatory requirements

    • The report should include:

  • A description of the testing procedures used

  • The number of samples tested and dosing amounts used

  • The pH and temperature control systems used during testing

  • The sampling intervals and frequency used

  • The measurement and analysis methods used

  • The results of data analysis and interpretation

    • Conclusion

    The USP <1092> dissolution procedure development and validation is a critical laboratory testing service that ensures the quality and efficacy of pharmaceutical products. This service is governed by various international and national standards, including ISO 14644-1:2015, ASTM E1169-18, EN ISO 14698-1:2004, and TSE 1472-2006.

    The business and technical reasons for conducting this test include ensuring product safety and efficacy, compliance with regulatory requirements, quality control and assurance, risk assessment and mitigation, cost savings and efficiency improvements. The consequences of not performing this test can be severe, including product recalls, regulatory non-compliance, financial losses, and damage to reputation and brand image.

    This testing is required by various industries, including pharmaceuticals, biotechnology, and cosmetics. The quality assurance and quality control aspects of this testing include the use of validated equipment and procedures, training and certification of personnel, implementation of quality control measures, and regular calibration and maintenance of equipment.

    The competitive advantages of having this testing performed include improved product quality and efficacy, enhanced reputation and brand image, increased customer confidence and trust, compliance with regulatory requirements. The cost-benefit analysis of performing this test includes cost savings through reduced product recalls and regulatory non-compliance, efficiency improvements through optimized product development and manufacturing processes, financial benefits through increased revenue and market share.

    The reporting and documentation of the USP <1092> dissolution procedure development and validation include a summary of the testing procedures used, results of equipment calibration and maintenance, data analysis and interpretation, and reporting of results in accordance with regulatory requirements.

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