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usp-1151-pharmaceutical-dosage-forms-and-impurity-consideration
Impurity Profiling EMA Guideline on Genotoxic Impurities in PharmaceuticalsEMA Reflection Paper on Low Level ImpuritiesFDA Guidance: Microbial Impurities and Endotoxin LevelsFDA Guidance: Threshold of Toxicological Concern (TTC) for ImpuritiesFDA ICH M3(R2): Impurities in Safety StudiesFDA Q&A on Impurities in Generic Drug ApplicationsFDA Q&A: Managing Impurities in Complex APIsICH E14: QT Interval Evaluation and Impurity ImpactICH M7: Mutagenic Impurity Risk AssessmentICH Q10: Pharmaceutical Quality System for Impurity ManagementICH Q11: Impurity Control Strategy in Drug Substance DevelopmentICH Q12: Lifecycle Management of Impurity Control StrategyICH Q1E: Evaluation of Stability Data Related to Impurity FormationICH Q2(R1): Validation of Analytical Methods for Impurity TestingICH Q3A: Organic Impurity Profiling in Drug SubstancesICH Q3B: Impurity Testing in Finished Drug ProductsICH Q3C: Residual Solvent ProfilingICH Q3D: Elemental Impurity Risk AssessmentICH Q3F: Impurity Guidelines for Biotechnology ProductsICH Q4B: Harmonization of Analytical Procedures for Impurity TestingICH Q5C: Impurity Monitoring in Biotechnological ProductsICH Q6A: Specifications and Acceptance Criteria for ImpuritiesICH S3A: Impurities Arising from Degradation ProductsICH S6: Biotech Product Impurity ProfilingICH S7A: Safety Pharmacology Impurity EvaluationICH S9: Impurities in Oncology ProductsISO 10993-18: Chemical Characterization and Impurity AnalysisISO 17025: Accreditation for Impurity Testing LaboratoriesJP General Rule 2.60: Limit Test for ImpuritiesPh. Eur. 2.2.28: Gas Chromatography for Impurity DetectionPh. Eur. 2.2.38: Thin-Layer Chromatography for ImpuritiesPh. Eur. 2.2.46: Chromatographic Separation for Impurity AnalysisPh. Eur. 2.4.14: Determination of Inorganic ImpuritiesPh. Eur. 2.4.20: Limit Test for Heavy Metals in ImpuritiesPh. Eur. 2.4.24: Related Substances by HPLC in APIsPh. Eur. 2.4.29: Limit Test for Sulfated Ash ImpuritiesPh. Eur. 2.5.13: Oxidizing Impurity TestsPh. Eur. 2.9.40: Uniformity of Dosage Units and Related ImpuritiesPh. Eur. 5.10: Control of Impurities in Substances for Pharmaceutical UsePh. Eur. 5.4: Impurities in Radiopharmaceutical PreparationsUSP <1010>: Analytical Data Integrity in Impurity ReportingUSP <1031>: The Biocompatibility of Materials and ImpuritiesUSP <1051>: Cleaning Validation Limits and Residual ImpuritiesUSP <1058>: Analytical Instrument Qualification for Impurity StudiesUSP <1078>: Good Manufacturing Practices for Impurity ReductionUSP <1085>: Evaluation of Impurity Method PerformanceUSP <1086>: Impurities in Drug SubstancesUSP <1088>: Forced Degradation Studies for Impurity CharacterizationUSP <1091>: Impurity Isolation and Characterization TechniquesUSP <1099>: Acceptable Analytical Performance CriteriaUSP <1121>: Bulk Pharmaceutical Chemicals and Impurity HandlingUSP <1191>: Stability Testing of Compounded PreparationsUSP <1222>: Terminal Sterilization Impact on ImpuritiesUSP <1224>: Transfer of Impurity Test ProceduresUSP <1225>: Validation of Compendial Procedures for ImpuritiesUSP <1226>: Verification of Compendial Procedures for Impurity DetectionUSP <1231>: Water for Pharmaceutical Purposes and Impurity EffectsUSP <1232>: Water Activity and Impurity StabilityUSP <1241>: Capsules and Shell Impurity InteractionUSP <1251>: Weighing on Analytical Balances for Micro-ImpuritiesUSP <161>: Transdermal Delivery Systems and Impurity ControlUSP <197>: Spectrophotometric Identification of ImpuritiesUSP <233>: Elemental Impurities Profiling Using ICP-MSUSP <41>: Balances Used for Impurity Weight DeterminationUSP <466>: Identification and Quantification of DegradantsUSP <467>: Residual Solvent Testing in APIs and ExcipientsUSP <476>: Impurity Profiling for New Drug ApplicationsUSP <621>: Chromatography Conditions for Impurity IdentificationUSP <730>: Plasma Spectrochemistry for Impurity ProfilingUSP <791>: pH Determination Impact on Impurity SolubilityUSP <797>: Sterile Compounding and Impurity ControlUSP <800>: Hazardous Drug Handling Based on Impurity RiskUSP <851>: Spectrophotometry and Light Scattering for ImpuritiesUSP <853>: Atomic Absorption Spectroscopy for Trace ImpuritiesUSP <857>: UV-Vis Spectroscopy for Impurity QuantificationUSP <85>: Bacterial Endotoxin Limits Related to Impurity SafetyUSP <891>: Nuclear Magnetic Resonance (NMR) for Structural ElucidationUSP <905>: Content Uniformity Related to ImpuritiesUSP <905>: Uniformity of Dosage Units Affected by ImpuritiesUSP <941>: Characterization of Impurity Solubility and pKaWHO TRS 970 Annex 2: Impurity Control in Medicines

Comprehensive Guide to USP <1151>: Pharmaceutical Dosage Forms and Impurity Consideration Testing Services Provided by Eurolab

USP <1151> is a standard that governs the testing of pharmaceutical dosage forms and impurities. This standard is published by the United States Pharmacopeia (USP) and is widely recognized as the gold standard for laboratory testing in the pharmaceutical industry.

Legal and Regulatory Framework

The legal and regulatory framework surrounding USP <1151> testing is governed by various international and national standards, including:

  • ISO 17025:2005 General requirements for the competence of testing and calibration laboratories

  • ASTM E3008-17 Standard Practice for Quality Control in Testing Laboratories

  • EN ISO/IEC 17025:2017 General requirements for the competence of testing and calibration laboratories

  • TSE (Turkish Standards Institution) GOST R ISO/IEC 17025-2009 General requirements for the competence of testing and calibration laboratories

    • These standards establish the requirements for laboratory testing, including sampling, testing, and reporting. They also provide guidelines for the development, implementation, and maintenance of quality management systems in laboratories.

    International and National Standards

    The international standards that apply to USP <1151> testing include:

  • ISO 17025:2005 General requirements for the competence of testing and calibration laboratories

  • ASTM E3008-17 Standard Practice for Quality Control in Testing Laboratories

  • EN ISO/IEC 17025:2017 General requirements for the competence of testing and calibration laboratories

    • The national standards that apply to USP <1151> testing include:

  • TSE (Turkish Standards Institution) GOST R ISO/IEC 17025-2009 General requirements for the competence of testing and calibration laboratories

  • ANSI/ASQ Q9001:2015 Quality management systems - Requirements

    • Standard Development Organizations

    The standard development organizations that govern USP <1151> testing include:

  • United States Pharmacopeia (USP)

  • International Organization for Standardization (ISO)

  • American Society for Testing and Materials (ASTM)

  • European Committee for Standardization (CEN)

    • These organizations work together to develop, implement, and maintain standards for laboratory testing.

    How Standards Evolve and Get Updated

    Standards are developed through a consensus-based process that involves stakeholders from industry, government, and academia. The development of new standards or the revision of existing ones is typically triggered by changes in technology, market demand, or regulatory requirements.

    The standard development process involves several stages, including:

    1. Review and analysis of existing standards

    2. Identification of gaps and needs

    3. Development of a draft standard

    4. Public review and comment period

    5. Finalization and publication of the standard

    Standard Numbers and Scope

    The relevant standard numbers for USP <1151> testing are:

  • ISO 17025:2005 General requirements for the competence of testing and calibration laboratories (scope: general laboratory testing)

  • ASTM E3008-17 Standard Practice for Quality Control in Testing Laboratories (scope: quality control in testing laboratories)

  • EN ISO/IEC 17025:2017 General requirements for the competence of testing and calibration laboratories (scope: general laboratory testing)

    • Standard Compliance Requirements

    The standard compliance requirements for USP <1151> testing vary depending on the industry or sector. Some examples include:

  • Pharmaceuticals: USP <1151>

  • Food and Beverage: ISO 22000:2005

  • Cosmetics: ISO 9001:2015

    • ...

    ...

    USP <1151> testing is required to ensure the safety, efficacy, and quality of pharmaceutical dosage forms. The test involves the analysis of impurities in pharmaceutical products and is essential for ensuring compliance with regulatory requirements.

    Business and Technical Reasons

    The business and technical reasons for conducting USP <1151> testing include:

  • Ensuring product safety and efficacy

  • Maintaining regulatory compliance

  • Meeting customer and market demands

  • Reducing risk and liability

  • Improving quality and reliability

    • ...

    ...

    The test conditions and methodology for USP <1151> testing involve the following steps:

    1. Sampling: Collecting a representative sample of the pharmaceutical product

    2. Testing: Analyzing the impurities in the sample using techniques such as HPLC or GC-MS

    3. Data Analysis: Interpreting the results and determining the levels of impurities present

    ...

    ...

    The test reporting and documentation requirements for USP <1151> testing involve the following:

  • Providing a detailed report of the testing, including the sampling, testing, and data analysis

  • Including information on the methods used, equipment calibrated, and personnel involved in the testing

  • Documenting any deviations from standard procedures or results that are outside of established limits

    • ...

    ...

    Persuasive Conclusion

    In conclusion, USP <1151> testing is a critical component of ensuring the safety, efficacy, and quality of pharmaceutical dosage forms. Eurolabs expertise in laboratory testing and compliance with international standards makes us an ideal partner for companies seeking to ensure regulatory compliance and maintain product quality.

    ...

    References

    1. United States Pharmacopeia (USP) <1151> Pharmaceutical Dosage Forms and Impurities

    2. ISO 17025:2005 General requirements for the competence of testing and calibration laboratories

    3. ASTM E3008-17 Standard Practice for Quality Control in Testing Laboratories

    ...

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