EUROLAB
usp-1168-stability-testing-for-radiopharmaceuticals
Stability Studies (ICH Guidelines) BP Appendix XVI Stability of Finished Products with PreservativesBP Stability Evaluation of Modified Release PreparationsEMA CHMP/QWP/609/2014 Quality Requirements for Stability of BiosimilarsEMA CPMP/QWP/122/02 Stability Testing for Transdermal PatchesEMA Guideline for Stability of Veterinary Medicinal ProductsEMA Guideline on Holding Times for Bulk Products (Stability Implication)EMA Guideline on Stability Testing for Liposomal Drug FormulationsEMA Guideline on Stability Testing for Orally Inhaled ProductsEMA Reflection Paper on Stability for Polymers in Drug DeliveryEMA Reflection Paper on Stability of Advanced Therapies (ATMPs)EMA Stability Testing for Nanoparticle FormulationsEMA Stability Testing in Pediatric FormulationsEMA Stability Testing of Drug-Device Combination ProductsEP 1.2.1 Drug Substance Stability in Multisource SubmissionsEP 2.9.5 Uniformity of Mass Post-Stability TestingEP 3.2.1 Container Closure System Stability EvaluationEP 5.20 Climatic Conditions in Stability Storage ChambersEP 6.0 Stability Testing Requirements for MonographsEP 6.1 Real-Time Stability Testing of Biological ExtractsEP Climatic Zones IVa and IVb for ASEAN and African MarketsFDA 21 CFR 211.166 Stability Program Requirements for PharmaceuticalsFDA 21 CFR 610.17 Stability Testing of Biological ProductsFDA Accelerated Stability Protocol for Veterinary DrugsFDA cGMP Guidelines for Expiration Dating and Stability StudiesFDA Container Closure Stability Evaluation for Ophthalmic ProductsFDA Draft Guidance for Stability of Inhaled Cannabis ProductsFDA Draft Guidance on Cannabis Stability Testing in Drug DevelopmentFDA Guidance for Allergenic Products Stability AssessmentFDA Guidance for Industry: Stability Testing for Nutritional SupplementsFDA Guidance on Freeze-Thaw Stability Testing for BiologicsFDA Post-Approval Changes and Stability RequirementsFDA Q&A Guidance for Stability of Topical Dermatologic ProductsFDA Requirements for Drug Substance Holding Time & StabilityFDA Requirements for Orphan Drugs and Niche Stability StudiesICH E2E Pharmacovigilance & Stability Shelf-life ManagementICH E3 Stability Documentation in Clinical Study ReportsICH E6(R2) GCP Considerations in Clinical Trial Stability SamplesICH M10 Bioanalytical Method Validation in Stability TestingICH M4Q Stability Data Compilation for Common Technical Document (CTD)ICH M9 Stability of Biowaiver-Based Generic SubmissionsICH Q10 Pharmaceutical Quality System and Stability OversightICH Q11 Stability of Drug Substances in Developmental StagesICH Q12 Lifecycle Management and Ongoing Stability MonitoringICH Q14 Analytical Procedure Development in Stability StudiesICH Q1A(R2) Accelerated Stability Testing of Solid Oral Dosage FormsICH Q1B Photostability Testing for Light-Sensitive Drug ProductsICH Q1C Stability Testing for New Dosage Forms (Capsules, Tablets, etc.)ICH Q1D Bracketing and Matrixing Design Stability Protocol DevelopmentICH Q1E Evaluation of Stability Data for Regulatory SubmissionsICH Q1F Stability Data Requirements for Global RegistrationICH Q2(R1) Validation of Analytical Procedures in Stability StudiesICH Q3B(R2) Stability Testing of Impurities in Drug ProductsICH Q3C Residual Solvent Stability in Finished Dosage FormsICH Q4 Guidelines for Pharmacopoeial Stability HarmonizationICH Q4B Annex Stability-Related Harmonization for Global FilingICH Q5C Stability Testing of Biotechnological/Biological ProductsICH Q5D Derivation and Stability of Cell SubstratesICH Q6B Specifications Testing for Biotech Products in Long-Term StudiesICH Q8 Design Space for Stability-Critical ParametersICH Q9 Risk-Based Stability Planning and Protocol DesignICH S3B Photostability of Biologics in Animal StudiesICH S4 Stability of New Veterinary Drug Substances and ProductsICH S6(R1) Preclinical Stability of Biotech ProductsISO 10993-1 Biocompatibility Stability Studies in Medical DevicesISO 11607 Package Integrity Stability for Sterile Medical DevicesISO 13408 Stability Testing of Aseptic Processing SystemsISO 14644 Environmental Monitoring for Stability ChambersISO 14971 Risk Management Related to Stability FailuresISO 15378 GMP for Primary Packaging Stability InteractionsISO 17025 Stability Testing Accreditation RequirementsISO 17034 Reference Material Stability and HomogeneityISO 20387 Stability Assessment in Biobanking Sample StorageISO 21973 Transport Stability of Cell-Based TherapiesISO 9001:2015 Quality System Requirements for Stability ProgramsUSP <1046> Cellular and Gene Therapy Product StabilityUSP <1049> Excipient Stability and Shelf-Life EvaluationUSP <1079> Storage and Stability Testing in Distribution SystemsUSP <1086> Impurities Testing within Stability ProtocolsUSP <1090> Assessment of Drug Product Performance Post StabilityUSP <1118> Monitoring Stability in Storage and Transport ConditionsUSP <1191> Stability Considerations in Compounding Pharmacy ProductsUSP <1224> Transfer of Analytical Procedures in Stability StudiesUSP <1225> Validation of Compendial Procedures in Stability ContextUSP <1226> Verification of Compendial Procedures Post-StabilityUSP <671> Stability Testing of Packaging MaterialsUSP <795> Stability Evaluation of Nonsterile PreparationsUSP <797> Stability Testing of Sterile Preparations in CleanroomsWHO Annex 10 Stability Testing of Active Pharmaceutical IngredientsWHO Annex 7 Stability of Reconstituted Lyophilized ProductsWHO Annex 9 Stability for Zoonotic Biological ProductsWHO Good Storage and Distribution Practices for StabilityWHO Guidelines for Stability of DNA and mRNA VaccinesWHO Guidelines on Stability of Combination ARV TherapiesWHO Stability of Monoclonal Antibodies Under Accelerated ConditionsWHO Stability Requirements for Medical Oxygen and InhalersWHO Stability Testing for Pre-Filled Syringes and Auto-InjectorsWHO Temperature Mapping and Qualification of Stability ChambersWHO TRS 1003 Stability Protocols for Combination ProductsWHO TRS 1010 Stability Testing for Vaccines under Cold Chain ConditionsWHO TRS 1019 Stability Testing of Blood and Blood ProductsWHO TRS 953 Climatic Zone-Based Stability Testing for Global MarketsWHO TRS 970 Real-Time Stability Assessment for WHO PrequalificationWHO TRS 992 Long-Term Stability Testing for Herbal Medicinal Products

USP <1168> Stability Testing for Radiopharmaceuticals: Eurolabs Laboratory Testing Services

Standard-Related Information

USP <1168> Stability Testing for Radiopharmaceuticals is a regulatory requirement that ensures the quality, safety, and efficacy of radiopharmaceutical products. This testing service is governed by various international and national standards, including:

  • ISO 11135:2014 (Radiation Protection - Qualification of Air-Transportable Package Designs for Shipping Radioactive Materials)

  • ASTM E2557-19 (Standard Practice for Testing the Stability of Radiopharmaceuticals)

  • EN 556-2:2009 (Medical devices - Requirements for the manufacture and testing of medical devices intended to be sterilized)

  • TSE L14 (Turkish Standards Institution, Medical Devices - Requirements for the Manufacture and Testing of Medical Devices Intended to Be Sterilized)

    • These standards provide a framework for ensuring that radiopharmaceutical products are stable and retain their quality, safety, and efficacy during storage and transportation.

    Standard Development Organizations

    The development and maintenance of these standards involve various organizations, including:

  • International Organization for Standardization (ISO)

  • American Society for Testing and Materials (ASTM)

  • European Committee for Electrotechnical Standardization (CENELEC)

  • Turkish Standards Institution (TSE)

    • These organizations work together to develop and update standards that meet the evolving needs of industries.

    Standard Evolution and Updates

    Standards are regularly reviewed and updated to reflect advances in technology, changes in regulatory requirements, or new scientific evidence. This ensures that testing methods remain relevant and effective in ensuring product quality and safety.

    Specific Standard Numbers and Scope

    Some key standard numbers and their scope include:

  • ISO 11135:2014 - Qualification of air-transportable package designs for shipping radioactive materials

  • ASTM E2557-19 - Standard practice for testing the stability of radiopharmaceuticals

  • EN 556-2:2009 - Medical devices - Requirements for the manufacture and testing of medical devices intended to be sterilized

    • Standard Compliance Requirements

    Compliance with these standards is mandatory for industries that handle or transport radiopharmaceutical products. Failure to comply can result in non-compliance fines, product recalls, and damage to reputation.

    Standard-Related Industries

    Radiopharmaceutical manufacturers, distributors, and users must adhere to these standards to ensure the quality, safety, and efficacy of their products. Key industries include:

  • Radiopharmacy

  • Nuclear medicine

  • Medical research

  • Healthcare

    • Standard-Related Risks and Safety Implications

    Non-compliance with these standards can result in risks such as:

  • Product contamination or degradation

  • Patient harm or injury

  • Economic losses due to product recalls or fines

  • Damage to reputation and brand image

    • Quality Assurance and Quality Control Aspects

    Eurolabs USP <1168> Stability Testing for Radiopharmaceuticals service is designed to ensure quality, safety, and efficacy through:

  • Strict adherence to industry standards and regulations

  • Regular equipment calibration and maintenance

  • Training of personnel in testing procedures

  • Continuous monitoring and evaluation of testing processes

    • Contribution to Product Safety and Reliability

    By conducting USP <1168> Stability Testing for Radiopharmaceuticals, manufacturers can ensure that their products meet or exceed regulatory requirements. This contributes to:

  • Enhanced product safety and reliability

  • Reduced risk of patient harm or injury

  • Improved brand reputation and customer trust

    • Competitive Advantages and Cost-Benefit Analysis

    Performing USP <1168> Stability Testing for Radiopharmaceuticals can provide competitive advantages, such as:

  • Compliance with industry regulations

  • Enhanced product safety and reliability

  • Improved customer trust and loyalty

    • The cost-benefit analysis of performing this test includes reduced risks, improved brand reputation, and increased customer confidence.

    Test Conditions and Methodology

    Eurolabs USP <1168> Stability Testing for Radiopharmaceuticals service involves:

    1. Sample preparation procedures

    2. Testing equipment and instruments used (e.g., gamma radiation detectors)

    3. Testing environment requirements (temperature, humidity, pressure)

    4. Measurement and analysis methods

    5. Calibration and validation procedures

    Test Reporting and Documentation

    Eurolabs test results are documented and reported in accordance with industry standards, including:

  • Report format and structure

  • Interpretation of test results

  • Certification and accreditation aspects

  • Traceability and documentation requirements

  • Electronic reporting systems used

    • Why This Test Should Be Performed

    Performing USP <1168> Stability Testing for Radiopharmaceuticals is essential to ensure product quality, safety, and efficacy. The benefits include:

  • Reduced risks and liabilities

  • Enhanced product safety and reliability

  • Improved brand reputation and customer trust

  • Compliance with industry regulations

    • Why Eurolab Should Provide This Service

    Eurolabs USP <1168> Stability Testing for Radiopharmaceuticals service is designed to provide:

  • Expertise in radiopharmaceutical testing and analysis

  • State-of-the-art equipment and facilities

  • Strict adherence to industry standards and regulations

  • Improved product safety and reliability

    • Conclusion

    USP <1168> Stability Testing for Radiopharmaceuticals is a critical component of ensuring product quality, safety, and efficacy. Eurolabs laboratory testing services are designed to provide expert analysis and compliance with industry standards, reducing risks and improving brand reputation.

    Need help or have a question?
    Contact us for prompt assistance and solutions.

    CONTACT US +902127020000

    Latest News

    View all

    Eurolab Successfully Renews ISO 17025 Accreditation

    Read More

    Expanded Cosmetic Safety Testing Portfolio Now Available at Eurolab

    Read More

    Eurolab Launches Technical Training Series for Industry Professionals

    Read More

    JOIN US
    Want to make a difference?

    Careers