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usp-1251-weighing-on-analytical-balances-for-micro-impurities
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 <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

USP <1251>: Weighing on Analytical Balances for Micro-Impurities Testing Service Provided by Eurolab

The USP <1251> standard provides guidelines for the weighing of analytical balances for micro-impurities testing. This standard is part of the United States Pharmacopeia (USP) series, which is a widely recognized and accepted compendium of standards for pharmaceuticals.

Relevant Standards

  • ISO 8655:2002 - Analytical laboratory balances - Requirements for calibrating and validating

  • ASTM E2586-07 - Standard Practice for Evaluating the Linearity of a Quantitative Measurement Method

  • EN 13036-1:2014 - Calibration and verification of measuring instruments - Part 1: General principles and procedures

  • TSE ISO/IEC 17025:2017 - General requirements for competence in laboratory testing and calibration

    • Legal and Regulatory Framework

    The USP <1251> standard is governed by the United States Pharmacopeia Convention, which is accredited by the American National Standards Institute (ANSI). The standard is also recognized by the International Council on Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH).

    International and National Standards

    The following international and national standards apply to USP <1251> testing:

  • ISO/IEC 17025:2017 - General requirements for competence in laboratory testing and calibration

  • ASTM E2586-07 - Standard Practice for Evaluating the Linearity of a Quantitative Measurement Method

  • EN 13036-1:2014 - Calibration and verification of measuring instruments - Part 1: General principles and procedures

    • Standard Development Organizations

    The standard development organizations responsible for USP <1251> are:

  • United States Pharmacopeia (USP) Convention

  • American National Standards Institute (ANSI)

  • International Council on Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH)

    • Evolution and Updates

    Standards evolve over time to reflect new technologies, research findings, and industry practices. The USP <1251> standard is reviewed and updated periodically by the relevant standard development organizations.

    Standard Numbers and Scope

    The following are some standard numbers and their scope:

  • USP <1251>: Weighing on Analytical Balances for Micro-Impurities Testing

  • ISO 8655:2002 - Analytical laboratory balances - Requirements for calibrating and validating

    • Compliance Requirements

    Industry-specific compliance requirements for different sectors include:

  • Pharmaceutical industry: Comply with USP <1251> and FDA regulations (21 CFR Part 211)

  • Food industry: Comply with ISO/IEC 17025:2017 and FDA regulations (21 CFR Part 110)

    • ---

    The USP <1251> testing service is required to ensure the accuracy and reliability of analytical balances used in micro-impurities testing. The following are some reasons why this test is needed:

  • Business Reasons: Comply with regulatory requirements, reduce costs associated with non-compliance, and improve product safety

  • Technical Reasons: Ensure accurate weighing results, prevent equipment malfunctions, and maintain calibration records

    • Consequences of Non-Compliance

    Non-compliance with USP <1251> testing can lead to:

  • Product recalls and financial losses

  • Regulatory penalties and fines

  • Damage to reputation and customer trust

    • ---

    The following are the detailed step-by-step procedures for conducting USP <1251>: Weighing on Analytical Balances for Micro-Impurities testing:

    1. Equipment Selection: Select analytical balances that meet the requirements of USP <1251>

    2. Calibration and Validation: Calibrate and validate the selected analytical balance

    3. Sample Preparation: Prepare samples according to the standard procedures

    4. Testing Parameters: Measure and record the following parameters:

    Weighing accuracy

    Linearity

    Repeatability

    5. Data Analysis: Analyze data using statistical methods (e.g., regression analysis)

    Measurement and Analysis Methods

    The following are some measurement and analysis methods used in USP <1251> testing:

  • Weighing accuracy: Compare the measured weight to a reference standard

  • Linearity: Plot the measured weights against a known reference value

  • Repeatability: Measure multiple samples under identical conditions

    • Quality Control Measures

    The following are some quality control measures implemented during USP <1251> testing:

  • Regular calibration and validation of equipment

  • Use of certified reference materials (CRMs)

  • Implementation of statistical process control (SPC)

    • ---

    The following are the requirements for test reporting and documentation:

  • Test Report: Include a detailed report of the testing results, including:

    • Weighing accuracy

    Linearity

    Repeatability

  • Calibration Certificate: Include a calibration certificate for each analytical balance used in the testing

    • Continuing Education

    The following are some continuing education requirements:

  • Attend workshops and conferences on analytical balances and micro-impurities testing

  • Participate in online training programs and webinars

    • ---

    The following are some quality management system requirements for USP <1251> testing:

  • Policy: Develop a policy for quality management, including:

    • Quality objectives

    Responsibility assignments

  • Procedures: Establish procedures for quality control and assurance, including:

    • Calibration and validation of equipment

    Use of certified reference materials (CRMs)

  • Training: Provide training to personnel on quality management principles and practices

    • Corrective Action and Preventative Action (CAPA)

    The following are some corrective action and preventative action requirements:

  • Identify Non-Conforming Products: Identify products that do not meet the requirements of USP <1251>

  • Take Corrective Actions: Take corrective actions to prevent recurrence, including:

    • Implementing new procedures

    Re-training personnel

    ---

    The following are some complaint handling requirements for USP <1251> testing:

  • Identify and Investigate Complaints: Identify and investigate complaints related to analytical balances used in micro-impurities testing

  • Take Corrective Actions: Take corrective actions to prevent recurrence, including:

    • Implementing new procedures

    Re-training personnel

    ---

    The following are some regulatory compliance requirements for USP <1251> testing:

  • FDA Regulations: Comply with FDA regulations (21 CFR Part 211) for pharmaceutical industry and (21 CFR Part 110) for food industry

  • USP Convention: Comply with USP convention standards, including USP <1251>

    • Auditing and Certification

    The following are some auditing and certification requirements:

  • Internal Audit: Conduct internal audits to ensure compliance with regulatory requirements

  • Certification: Obtain certification from recognized third-party auditors

    • ---

    USP <1251> testing is a critical component of analytical balances used in micro-impurities testing. Compliance with this standard ensures accurate weighing results and maintains product safety.

    Recommendations

    The following are some recommendations:

  • Regular Calibration and Validation: Regularly calibrate and validate analytical balances to ensure accuracy and reliability

  • Continuing Education: Participate in continuing education programs to stay updated on the latest developments and technologies

    • ---

    The following is a list of terms used in this document:

  • USP <1251>: Weighing on Analytical Balances for Micro-Impurities Testing

  • Analytical Balance: A balance designed to measure small weights with high accuracy

  • Micro-Impurities Testing: A method of testing samples for impurities at the micro-level

    • The following are some appendices:

  • USP <1251> Standard: The full text of USP <1251> standard

  • Regulatory Requirements: A list of regulatory requirements for pharmaceutical and food industries

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