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usp-1049-excipient-stability-and-shelf-life-evaluation
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for Expiration Dating and Stability StudiesFDA Container Closure Stability Evaluation for Ophthalmic ProductsFDA Draft Guidance for Stability of Inhaled Cannabis ProductsFDA Draft Guidance on Cannabis Stability Testing in Drug DevelopmentFDA Guidance for Allergenic Products Stability AssessmentFDA Guidance for Industry: Stability Testing for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 <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 <1168> Stability Testing for RadiopharmaceuticalsUSP <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 <1049> Excipient Stability and Shelf-Life Evaluation Laboratory Testing Service: A Comprehensive Guide

The United States Pharmacopeia (USP) <1049> Excipient Stability and Shelf-Life Evaluation is a comprehensive standard that outlines the guidelines for evaluating the stability of excipients in pharmaceutical products. This standard is essential for ensuring the quality, safety, and efficacy of pharmaceuticals.

Relevant Standards:

  • ISO 10993-1:2018 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process

  • ASTM E2557-08 Standard Practice for Evaluating Stability of Pharmaceutical Excipients

  • EN ISO 14644-1:2015 Cleanrooms and associated controlled environments Part 1: Classification of air cleanliness

  • TSE (Turkish Standards Institution) ISO 11607-2:2006 Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing, and testing sterilization wrap pouches.

  • USP <1049> Excipient Stability and Shelf-Life Evaluation

    • Legal and Regulatory Framework:

    The legal and regulatory framework surrounding this testing service is governed by various national and international standards. The primary goal of these regulations is to ensure the quality, safety, and efficacy of pharmaceuticals.

    Standard Development Organizations:

  • International Organization for Standardization (ISO)

  • American Society for Testing and Materials (ASTM)

  • European Committee for Standardization (CEN)

  • Turkish Standards Institution (TSE)

    • International and National Standards:

    The international standards that govern USP <1049> Excipient Stability and Shelf-Life Evaluation testing include ISO 10993-1, ASTM E2557-08, and EN ISO 14644-1. The national standards that apply to this specific laboratory test include TSE (Turkish Standards Institution) ISO 11607-2.

    Standard Compliance Requirements:

    The standard compliance requirements for different industries vary depending on the country of operation. For example:

  • In the United States, pharmaceutical manufacturers must comply with USP <1049> Excipient Stability and Shelf-Life Evaluation.

  • In Europe, pharmaceutical manufacturers must comply with EN ISO 14644-1.

  • In Turkey, pharmaceutical manufacturers must comply with TSE (Turkish Standards Institution) ISO 11607-2.

    • Standard Evolution and Update:

    Standards evolve over time to reflect advances in technology, changes in regulations, or new research findings. The standards development organizations continually review and update their standards to ensure they remain relevant and effective.

    Standard Numbers and Scope:

    The standard numbers and scope for USP <1049> Excipient Stability and Shelf-Life Evaluation testing are as follows:

  • ISO 10993-1:2018 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process

  • ASTM E2557-08 Standard Practice for Evaluating Stability of Pharmaceutical Excipients

  • EN ISO 14644-1:2015 Cleanrooms and associated controlled environments Part 1: Classification of air cleanliness

    • Standard Compliance Requirements by Industry:

    The standard compliance requirements vary depending on the industry. For example:

  • Pharmaceutical manufacturers must comply with USP <1049> Excipient Stability and Shelf-Life Evaluation.

  • Medical device manufacturers must comply with ISO 10993-1.

    • Why This Test is Needed and Required:

    USP <1049> Excipient Stability and Shelf-Life Evaluation testing is essential for ensuring the quality, safety, and efficacy of pharmaceuticals. The consequences of not performing this test can be severe, including product recalls, loss of market share, and damage to reputation.

    Business and Technical Reasons for Conducting USP <1049> Excipient Stability and Shelf-Life Evaluation Testing:

    The business and technical reasons for conducting USP <1049> Excipient Stability and Shelf-Life Evaluation testing include:

  • Ensuring the quality and safety of pharmaceuticals

  • Complying with regulatory requirements

  • Maintaining market share and reputation

  • Reducing costs associated with product recalls and rework

    • Consequences of Not Performing This Test:

    The consequences of not performing USP <1049> Excipient Stability and Shelf-Life Evaluation testing can be severe, including:

  • Product recalls

  • Loss of market share

  • Damage to reputation

  • Reduced customer confidence and trust

    • Industries and Sectors that Require This Testing:

    The industries and sectors that require USP <1049> Excipient Stability and Shelf-Life Evaluation testing include:

  • Pharmaceutical manufacturers

  • Medical device manufacturers

  • Biotechnology companies

  • Contract research organizations (CROs)

  • Contract manufacturing organizations (CMOs)

    • Risk Factors and Safety Implications:

    The risk factors and safety implications of not performing USP <1049> Excipient Stability and Shelf-Life Evaluation testing include:

  • Product contamination

  • Product failure

  • Patient harm

    • Why This Test is Essential for Pharmaceutical Manufacturers:

    USP <1049> Excipient Stability and Shelf-Life Evaluation testing is essential for pharmaceutical manufacturers because it ensures the quality, safety, and efficacy of their products. The consequences of not performing this test can be severe, including product recalls, loss of market share, and damage to reputation.

    Why This Test is Essential for Medical Device Manufacturers:

    USP <1049> Excipient Stability and Shelf-Life Evaluation testing is essential for medical device manufacturers because it ensures the quality, safety, and efficacy of their products. The consequences of not performing this test can be severe, including product recalls, loss of market share, and damage to reputation.

    Conclusion:

    In conclusion, USP <1049> Excipient Stability and Shelf-Life Evaluation testing is essential for ensuring the quality, safety, and efficacy of pharmaceuticals. The consequences of not performing this test can be severe, including product recalls, loss of market share, and damage to reputation.

    ---

    Standards and Regulations:

    The standards and regulations that govern USP <1049> Excipient Stability and Shelf-Life Evaluation testing include:

  • ISO 10993-1:2018 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process

  • ASTM E2557-08 Standard Practice for Evaluating Stability of Pharmaceutical Excipients

  • EN ISO 14644-1:2015 Cleanrooms and associated controlled environments Part 1: Classification of air cleanliness

    • Why This Test is Essential for Compliance with Regulations:

    USP <1049> Excipient Stability and Shelf-Life Evaluation testing is essential for compliance with regulations because it ensures the quality, safety, and efficacy of pharmaceuticals. The consequences of not performing this test can be severe, including product recalls, loss of market share, and damage to reputation.

    Industry-Specific Standards and Regulations:

    The industry-specific standards and regulations that govern USP <1049> Excipient Stability and Shelf-Life Evaluation testing include:

  • Pharmaceutical manufacturers must comply with USP <1049> Excipient Stability and Shelf-Life Evaluation.

  • Medical device manufacturers must comply with ISO 10993-1.

    • Conclusion:

    In conclusion, USP <1049> Excipient Stability and Shelf-Life Evaluation testing is essential for ensuring the quality, safety, and efficacy of pharmaceuticals. The consequences of not performing this test can be severe, including product recalls, loss of market share, and damage to reputation.

    ---

    Laboratory Testing Requirements:

    The laboratory testing requirements for USP <1049> Excipient Stability and Shelf-Life Evaluation testing include:

  • ISO 10993-1:2018 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process

  • ASTM E2557-08 Standard Practice for Evaluating Stability of Pharmaceutical Excipients

  • EN ISO 14644-1:2015 Cleanrooms and associated controlled environments Part 1: Classification of air cleanliness

    • Why This Test is Essential for Laboratory Testing Requirements:

    USP <1049> Excipient Stability and Shelf-Life Evaluation testing is essential for laboratory testing requirements because it ensures the quality, safety, and efficacy of pharmaceuticals. The consequences of not performing this test can be severe, including product recalls, loss of market share, and damage to reputation.

    Industry-Specific Laboratory Testing Requirements:

    The industry-specific laboratory testing requirements that govern USP <1049> Excipient Stability and Shelf-Life Evaluation testing include:

  • Pharmaceutical manufacturers must comply with USP <1049> Excipient Stability and Shelf-Life Evaluation.

  • Medical device manufacturers must comply with ISO 10993-1.

    • Conclusion:

    In conclusion, USP <1049> Excipient Stability and Shelf-Life Evaluation testing is essential for ensuring the quality, safety, and efficacy of pharmaceuticals. The consequences of not performing this test can be severe, including product recalls, loss of market share, and damage to reputation.

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