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usp-791-ph-determination-impact-on-impurity-solubility
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 <1151>: Pharmaceutical Dosage Forms and Impurity ConsiderationUSP <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 <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

USP <791>: pH Determination Impact on Impurity Solubility Laboratory Testing Service Provided by Eurolab

As a leading laboratory testing service provider, Eurolab is committed to delivering high-quality services that meet the stringent standards of regulatory bodies worldwide. One such critical testing service is USP <791>: pH Determination Impact on Impurity Solubility, which assesses the impact of pH on impurity solubility in pharmaceutical products. This comprehensive guide will delve into the world of USP <791> testing, exploring its relevance, importance, and Eurolabs capabilities in providing this service.

The United States Pharmacopeia (USP) is a non-profit organization that develops standards for pharmaceuticals, dietary supplements, and food ingredients. USP <791> is one such standard that outlines the requirements for determining the impact of pH on impurity solubility in pharmaceutical products.

Relevant Standards:

  • ISO 11095:2005 (Water quality - Determination of pH)

  • ASTM E2756-13 (Standard Guide for Determining Impurities in Pharmaceutical Compounds)

  • EN 12457-1:2012 (Wastewater treatment - Determination of the acid-base properties of aqueous solutions)

    • International and National Standards:

  • USP <791> is a national standard in the United States, while ISO 11095 and ASTM E2756 are international standards.

  • The European Union has adopted EU GMP (Good Manufacturing Practice) guidelines that mirror the requirements outlined in USP <791>.

    • Standard Development Organizations:

  • USP

  • International Organization for Standardization (ISO)

  • American Society for Testing and Materials (ASTM)

    • Evolution of Standards:

    Standards are regularly updated to reflect advances in technology, new scientific discoveries, or changes in regulatory requirements.

    Standard Numbers and Scope:

  • USP <791>: pH Determination Impact on Impurity Solubility

  • ISO 11095:2005: Water quality - Determination of pH

    • Industry-Specific Compliance Requirements:

  • Pharmaceutical manufacturers must comply with USP <791> to ensure product safety and efficacy.

  • Cosmetics and personal care products may require compliance with EN 12457-1.

    • Standard-Related Risks and Consequences:

    Failure to adhere to USP <791> standards can result in regulatory non-compliance, product recalls, or even market withdrawal.

    The pH determination impact on impurity solubility test is crucial for pharmaceutical manufacturers as it ensures that products meet the required specifications and are safe for human consumption. Impurities can be toxic or cause adverse reactions, which highlights the importance of this testing service.

    Business and Technical Reasons:

  • Ensuring product safety and efficacy

  • Maintaining regulatory compliance

  • Enhancing quality assurance and control

    • Industries Requiring This Testing Service:

  • Pharmaceutical manufacturers

  • Cosmetics and personal care products

  • Food and beverage industry

    • Quality Assurance and Control Aspects:

  • Regular monitoring of pH levels

  • Maintenance of accurate records

  • Continuous improvement of testing procedures

    • Benefits of Performing This Test:

  • Improved product safety and efficacy

  • Enhanced regulatory compliance

  • Competitive advantages through quality assurance and control

    • Cost-Benefit Analysis:

    The costs associated with performing this test are minimal compared to the benefits gained in terms of product safety, regulatory compliance, and market competitiveness.

    To conduct the USP <791> testing service, Eurolab follows a rigorous protocol that ensures accuracy and precision. The following steps outline the methodology:

    Testing Equipment and Instruments:

  • pH meter

  • Thermometer

  • Volumetric flasks

  • Pipettes

    • Testing Environment Requirements:

  • Temperature: 25C 0.1C

  • Humidity: 60 5

  • Pressure: 1013 mbar 10

    • Sample Preparation Procedures:

  • Weighting and preparation of samples

  • Mixing and homogenization of solutions

    • Testing Parameters and Conditions:

  • pH range: 4.0 to 9.0

  • Temperature range: 25C 0.1C

    • Measurement and Analysis Methods:

  • Titration methods (e.g., acid-base titration)

  • Spectrophotometric methods (e.g., UV-Vis)

    • Calibration and Validation Procedures:

  • Regular calibration of pH meters and other equipment

  • Validation of testing procedures through internal quality control and external audits

    • Quality Control Measures During Testing:

  • Regular monitoring of pH levels and temperature

  • Maintenance of accurate records and documentation

    • Data Collection and Recording Procedures:

  • Accurate recording of data and observations

  • Storage and retrieval of data in electronic format

    • Reporting Requirements:

  • Comprehensive report detailing the results of the test, including any deviations or discrepancies.

    • Eurolab is a reputable laboratory testing service provider with extensive experience in conducting USP <791> testing. Our team of experts ensures that each sample is handled with care and precision, providing accurate results that meet regulatory requirements.

    Benefits of Partnering with Eurolab:

  • High-quality testing services

  • Timely delivery of results

  • Expert analysis and interpretation of data

    • USP <791>: pH Determination Impact on Impurity Solubility is a critical testing service that ensures the safety and efficacy of pharmaceutical products. Eurolabs expertise in providing this service has earned us recognition as a leading laboratory testing service provider worldwide. Our team of experts is committed to delivering high-quality results, ensuring regulatory compliance, and maintaining product quality.

    References:

  • USP <791>: pH Determination Impact on Impurity Solubility

  • ISO 11095:2005 (Water quality - Determination of pH)

  • ASTM E2756-13 (Standard Guide for Determining Impurities in Pharmaceutical Compounds)

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

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