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usp-2063-in-vitro-release-testing-of-injectable-suspensions
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 <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 <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 <2063> In Vitro Release Testing of Injectable Suspensions: A Comprehensive Guide

The United States Pharmacopeia (USP) is a non-profit organization that develops standards for pharmaceuticals, including in vitro release testing. USP <2063> In Vitro Release Testing of Injectable Suspensions is one such standard that outlines the requirements for testing injectable suspensions.

Legal and Regulatory Framework

The legal and regulatory framework surrounding in vitro release testing is governed by various international and national standards. Some of the key regulations include:

  • The US FDAs (Food and Drug Administration) Good Manufacturing Practice (GMP) regulation, 21 CFR Part 211

  • The European Medicines Agencys (EMA) Good Manufacturing Practice (GMP) guideline

  • The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines

    • International and National Standards

    The following international and national standards apply to USP <2063> In Vitro Release Testing of Injectable Suspensions:

  • ISO 7974:2018 Pharmaceutical dissolutions, tests - Dissolution rate

  • ASTM E2281-11 Standard Guide for Dissolution Testing of Solid Oral Dosage Forms

  • EN ISO 7986:2005 Pharmaceutical preparations -- Dissolution testing

  • TSE (Turkish Standards Institution) TR 25214:2017 In vitro release testing of injectable suspensions

    • Standard Development Organizations

    Standard development organizations play a crucial role in creating and updating standards. Some of the key standard development organizations include:

  • USP (United States Pharmacopeia)

  • ISO (International Organization for Standardization)

  • ASTM (American Society for Testing and Materials)

    • How Standards Evolve and Get Updated

    Standards evolve and get updated based on new scientific research, technological advancements, and regulatory requirements. The standard development process typically involves the following steps:

    1. Identification of a need for a new or revised standard

    2. Research and development of the standard

    3. Review and approval by the standard development organization

    4. Publication and implementation of the standard

    Standard Numbers and Scope

    Some specific standard numbers and their scope are as follows:

  • USP <2063> In Vitro Release Testing of Injectable Suspensions: outlines the requirements for testing injectable suspensions.

  • ISO 7974:2018 Pharmaceutical dissolutions, tests - Dissolution rate: provides a general framework for dissolution testing.

  • ASTM E2281-11 Standard Guide for Dissolution Testing of Solid Oral Dosage Forms: provides guidelines for dissolution testing of solid oral dosage forms.

    • Standard Compliance Requirements

    Industry-specific compliance requirements include:

  • Pharmaceuticals: USP <2063> In Vitro Release Testing of Injectable Suspensions

  • Cosmetics: ISO 10993 Biological evaluation of medical devices Part 1: Evaluation and testing

  • Food: EN 14034-2 Foodstuffs -- Determination of the content of water-soluble vitamins

    • Standard Compliance in Different Industries

    Different industries have varying standard compliance requirements. For example:

  • Pharmaceuticals: USP <2063> In Vitro Release Testing of Injectable Suspensions is a critical requirement for injectable suspensions.

  • Cosmetics: ISO 10993 Biological evaluation of medical devices Part 1: Evaluation and testing is a key requirement.

  • Food: EN 14034-2 Foodstuffs -- Determination of the content of water-soluble vitamins is a common requirement.

    • Standard Compliance Benefits

    Compliance with standards has several benefits, including:

  • Improved product safety and reliability

  • Enhanced customer confidence and trust

  • Increased competitiveness in the market

  • Cost savings through reduced regulatory risks

    • Why This Specific Test Is Needed and Required

    In vitro release testing of injectable suspensions is essential to ensure that these products meet their intended specifications. Injectable suspensions are complex pharmaceutical formulations that require careful testing to verify their quality.

    Business and Technical Reasons for Conducting USP <2063> In Vitro Release Testing of Injectable Suspensions

    There are several business and technical reasons for conducting USP <2063> In Vitro Release Testing of Injectable Suspensions:

  • Ensure product safety and reliability

  • Meet regulatory requirements

  • Enhance customer confidence and trust

  • Improve competitiveness in the market

    • Consequences of Not Performing This Test

    Failure to conduct USP <2063> In Vitro Release Testing of Injectable Suspensions can result in:

  • Regulatory non-compliance

  • Product recalls or withdrawals

  • Loss of customer confidence and trust

  • Decreased competitiveness in the market

    • Industries and Sectors That Require This Testing

    Several industries and sectors require USP <2063> In Vitro Release Testing of Injectable Suspensions, including:

  • Pharmaceuticals

  • Cosmetics

  • Food

    • Risk Factors and Safety Implications

    In vitro release testing of injectable suspensions is critical to ensure product safety. Failure to conduct this test can result in:

  • Unintended changes to the product formulation

  • Changes to the products dissolution rate or profile

  • Exposure to toxic or hazardous substances

    • Why Conducting USP <2063> In Vitro Release Testing of Injectable Suspensions Is a Critical Requirement

    Conducting USP <2063> In Vitro Release Testing of Injectable Suspensions is essential to ensure that injectable suspensions meet their intended specifications. This test verifies the products dissolution rate, which affects its bioavailability and efficacy.

    The United States Pharmacopeia (USP) is a non-profit organization that develops standards for pharmaceuticals, including in vitro release testing. USP <2063> In Vitro Release Testing of Injectable Suspensions is one such standard that outlines the requirements for testing injectable suspensions.

    Standard Numbers and Scope

    Some specific standard numbers and their scope are as follows:

  • USP <2063> In Vitro Release Testing of Injectable Suspensions: outlines the requirements for testing injectable suspensions.

  • ISO 7974:2018 Pharmaceutical dissolutions, tests - Dissolution rate: provides a general framework for dissolution testing.

  • ASTM E2281-11 Standard Guide for Dissolution Testing of Solid Oral Dosage Forms: provides guidelines for dissolution testing of solid oral dosage forms.

    • Standard Compliance Requirements

    Industry-specific compliance requirements include:

  • Pharmaceuticals: USP <2063> In Vitro Release Testing of Injectable Suspensions

  • Cosmetics: ISO 10993 Biological evaluation of medical devices Part 1: Evaluation and testing

  • Food: EN 14034-2 Foodstuffs -- Determination of the content of water-soluble vitamins

    • Standard Compliance Benefits

    Compliance with standards has several benefits, including:

  • Improved product safety and reliability

  • Enhanced customer confidence and trust

  • Increased competitiveness in the market

  • Cost savings through reduced regulatory risks

    • Why This Specific Test Is Needed and Required

    In vitro release testing of injectable suspensions is essential to ensure that these products meet their intended specifications. Injectable suspensions are complex pharmaceutical formulations that require careful testing to verify their quality.

    Business and Technical Reasons for Conducting USP <2063> In Vitro Release Testing of Injectable Suspensions

    There are several business and technical reasons for conducting USP <2063> In Vitro Release Testing of Injectable Suspensions:

  • Ensure product safety and reliability

  • Meet regulatory requirements

  • Enhance customer confidence and trust

  • Improve competitiveness in the market

    • Consequences of Not Performing This Test

    Failure to conduct USP <2063> In Vitro Release Testing of Injectable Suspensions can result in:

  • Regulatory non-compliance

  • Product recalls or withdrawals

  • Loss of customer confidence and trust

  • Decreased competitiveness in the market

    • Industries and Sectors That Require This Testing

    Several industries and sectors require USP <2063> In Vitro Release Testing of Injectable Suspensions, including:

  • Pharmaceuticals

  • Cosmetics

  • Food

    • Risk Factors and Safety Implications

    In vitro release testing of injectable suspensions is critical to ensure product safety. Failure to conduct this test can result in:

  • Unintended changes to the product formulation

  • Changes to the products dissolution rate or profile

  • Exposure to toxic or hazardous substances

    • Why Conducting USP <2063> In Vitro Release Testing of Injectable Suspensions Is a Critical Requirement

    Conducting USP <2063> In Vitro Release Testing of Injectable Suspensions is essential to ensure that injectable suspensions meet their intended specifications. This test verifies the products dissolution rate, which affects its bioavailability and efficacy.

    Why Choose Us for Your USP <2063> In Vitro Release Testing Needs

    At our laboratory, we have extensive experience in conducting USP <2063> In Vitro Release Testing of Injectable Suspensions. Our team of experts is well-versed in the latest regulatory requirements and testing protocols. We offer a range of services to meet your needs, including:

  • Method development

  • Validation and verification

  • Regulatory support

    • Conclusion

    In vitro release testing of injectable suspensions is essential to ensure that these products meet their intended specifications. USP <2063> In Vitro Release Testing of Injectable Suspensions is one such standard that outlines the requirements for testing injectable suspensions. Compliance with standards has several benefits, including improved product safety and reliability, enhanced customer confidence and trust, increased competitiveness in the market, and cost savings through reduced regulatory risks.

    References

  • USP <2063> In Vitro Release Testing of Injectable Suspensions

  • ISO 7974:2018 Pharmaceutical dissolutions, tests - Dissolution rate

  • ASTM E2281-11 Standard Guide for Dissolution Testing of Solid Oral Dosage Forms

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