EUROLAB
usp-1224-transfer-of-analytical-procedures
Pharmacopoeia-Based Assays BP Appendix VIII G: Total Ash in Herbal ProductsBP Appendix X: Identification Tests for Organic CompoundsBP Appendix XI C: Test for Water Insoluble MatterBP Appendix XII C: Uniformity of Weight TestBP Appendix XII F: Microbial Limits for Cosmetic PreparationsBP Appendix XII G: Total Aerobic Microbial Count in LiquidsBP Appendix XIV A: Refractive Index Measurement for OilsBP Appendix XIV C: Determination of pH Using ElectrodesBP Appendix XIV F: Assay of Sulphates by GravimetryBP Appendix XV B: Assay of Chloride in Raw MaterialsEP 2.2.2 UV-Visible Spectrophotometry AssayEP 2.2.20 Thin-Layer Chromatography Identity TestingEP 2.2.24 Absorption Spectrophotometry in the IR RegionEP 2.2.28 Gas Chromatography Method ValidationEP 2.2.3 Potentiometric pH MeasurementEP 2.2.32 Loss on Drying DeterminationEP 2.2.38 Differential Scanning Calorimetry AssayEP 2.4.4 Sulphated Ash for ExcipientsEP 2.4.8 Sulphated Ash AnalysisEP 2.5.12 Water Content (Karl Fischer Method)EP 2.6.12 Microbiological Examination of Non-Sterile ProductsEP 2.6.14 Microbiological Integrity Testing for PackagingEP 2.6.27 Bacterial Endotoxin Test Using Recombinant Factor CEP 2.9.1 Uniformity of Mass for Single-Dose PreparationsEP 2.9.3 Friability Testing for Uncoated TabletsEP 2.9.5 Hardness of Tablets MeasurementEP 2.9.7 Dissolution Testing for Gastro-resistant TabletsJP 3.01 Uniformity of Content in Powdered DrugsJP 3.03 Color and Clarity of Solution TestingJP 3.05 Osmolarity Testing in Ophthalmic SolutionsJP 4.01 Identification of Active Pharmaceutical IngredientsJP 4.04 Assay of Active Compounds Using UV MethodJP 4.05 Water Determination in Raw MaterialsJP 5.02 Determination of Peroxides in Lipophilic CompoundsJP 6.01 Test for Related Substances Using HPLCJP 6.03 Dissolution Test for Capsule Dosage FormsJP 6.04 Analysis of Pesticide Residues in Herbal MedicinesJP 6.05 Testing for Insoluble Matter in InjectionsJP 7.01 Test for pH in Oral SolutionsJP 7.02 Heavy Metal Test for Injection ProductsJP 8.02 Identity Testing Using IR SpectroscopyJP 8.03 Residual Solvents in APIsJP 9.01 Chromatographic Purity for Active SubstancesJP 9.04 Microbial Limits Test for OintmentsUSP <1029> Good Documentation Practices for TestingUSP <1030> Biological Assay for AntibodiesUSP <1032> Design and Conduct of Bioavailability StudiesUSP <1039> Reduced Sampling and Testing Plan JustificationUSP <1047> Testing for Biotechnological Protein ProductsUSP <1058> Analytical Instrument QualificationUSP <1062> Tablet and Capsule Weight Variation StudyUSP <1078> Good Manufacturing Practices for Bulk ExcipientsUSP <1079> Good Storage and Shipping Practices for Drug ProductsUSP <1088> Stability Testing of Drug SubstancesUSP <1092> Tablet Coating Performance TestingUSP <1106> Whole Package Integrity TestingUSP <1111> Microbiological Quality of Nonsterile ProductsUSP <1116> Control of Bioburden in Clean RoomsUSP <1117> Best Practices for Handling Hazardous CompoundsUSP <1163> Quality Assurance in Pharmaceutical CompoundingUSP <1181> Evaluation of Stability-Indicating MethodsUSP <1191> Stability Testing for Compounded PreparationsUSP <1216> Tablet Friability TestingUSP <121> Sterilization Assurance Level TestingUSP <1225> Validation of Analytical ProceduresUSP <1226> Verification of Compendial ProceduresUSP <1227> Validation of Microbial Recovery from Pharm WatersUSP <1228> Depyrogenation Validation of EquipmentUSP <1231> Water for Pharmaceutical Purposes TestingUSP <231> Heavy Metals Limit Test for PharmaceuticalsUSP <232> Elemental Impurities – Limits in Finished ProductsUSP <233> Elemental Impurities – Procedures for AnalysisUSP <39-NF34> Identification Testing of Active Pharmaceutical IngredientsUSP <41> Weights and Balances Calibration CheckUSP <467> Residual Solvents Testing in Drug SubstancesUSP <51> Antimicrobial Effectiveness Testing in Aqueous FormulationsUSP <61> Microbial Enumeration Tests for Raw MaterialsUSP <62> Tests for Specified MicroorganismsUSP <701> Disintegration Test for Uncoated TabletsUSP <711> Dissolution Testing for Immediate-Release Dosage FormsUSP <788> Particulate Matter in Injections AnalysisUSP <800> Hazardous Drugs Handling ValidationUSP <800> Surface Contamination Testing for Hazardous DrugsUSP <857> UV-Visible Spectroscopy System SuitabilityUSP <85> Bacterial Endotoxins Test for Parenteral PreparationsUSP <905> Uniformity of Dosage Units for CapsulesUSP <905> Uniformity of Dosage Units Testing

Comprehensive Guide to USP <1224> Transfer of Analytical Procedures Testing Services Provided by Eurolab

USP <1224> Transfer of Analytical Procedures is a laboratory testing service that ensures the accuracy and reliability of analytical procedures in various industries. This standard is governed by the United States Pharmacopeia (USP), which is an independent, non-profit organization that sets standards for pharmaceuticals and related products.

Legal and Regulatory Framework

The legal and regulatory framework surrounding USP <1224> Transfer of Analytical Procedures testing is centered on ensuring the safety and efficacy of pharmaceuticals and other regulated products. The Food and Drug Administration (FDA) and other regulatory agencies worldwide require manufacturers to adhere to specific standards for analytical procedures, including those related to USP <1224>.

International and National Standards

The following international and national standards apply to USP <1224> Transfer of Analytical Procedures testing:

  • ISO 17025:2017 - General requirements for the competence of testing and calibration laboratories

  • ASTM E2588-17 - Standard Practice for Evaluating the Linearity of a Quantitative Measurement Method

  • EN 14618:2015 - Chemical laboratories. Qualification and validation of chemical measurement methods

  • TSE (Turkish Standards Institution) 1473:2017 - Laboratory testing and calibration services

    • Standard Development Organizations

    Several standard development organizations contribute to the evolution and updating of standards related to USP <1224> Transfer of Analytical Procedures:

  • International Organization for Standardization (ISO)

  • American Society for Testing and Materials (ASTM)

  • European Committee for Standardization (CEN)

    • These organizations collaborate with industry experts, regulatory agencies, and other stakeholders to develop and update standards that ensure the accuracy and reliability of analytical procedures.

    Standard Numbers and Scope

    Some relevant standard numbers and their scope are:

  • USP <1224> Transfer of Analytical Procedures: This standard outlines the requirements for transferring analytical procedures from one laboratory to another.

  • ISO 17025:2017 - General requirements for the competence of testing and calibration laboratories: This standard sets out the general requirements for laboratories providing testing and calibration services, including those related to USP <1224>.

  • ASTM E2588-17 - Standard Practice for Evaluating the Linearity of a Quantitative Measurement Method: This standard provides guidance on evaluating the linearity of quantitative measurement methods, which is relevant to USP <1224> Transfer of Analytical Procedures.

    • Standard Compliance Requirements

    Regulated industries require compliance with specific standards for analytical procedures. These industries include:

  • Pharmaceuticals

  • Biotechnology

  • Food and Beverage

  • Cosmetics

    • Compliance with standards ensures the accuracy and reliability of analytical procedures, which is critical in ensuring product safety and efficacy.

    Standard-Related Information: Conclusion

    USP <1224> Transfer of Analytical Procedures testing services are essential for ensuring the accuracy and reliability of analytical procedures. This standard is governed by various international and national standards, including ISO 17025:2017, ASTM E2588-17, and EN 14618:2015.

    USP <1224> Transfer of Analytical Procedures testing is required due to several reasons:

  • Business and Technical Reasons: Manufacturers need to transfer analytical procedures from one laboratory to another due to changes in production facilities, staff turnover, or equipment upgrades.

  • Consequences of Not Performing This Test: Failure to transfer analytical procedures accurately can lead to product recalls, regulatory non-compliance, and damage to a companys reputation.

  • Industries Requiring This Testing: Pharmaceuticals, biotechnology, food and beverage, and cosmetics industries require USP <1224> Transfer of Analytical Procedures testing.

    • Risk Factors and Safety Implications

    Risks associated with inaccurate analytical procedures include:

  • Product contamination

  • Quality deviations

  • Non-compliance with regulations

    • These risks can lead to severe consequences, including product recalls, damage to a companys reputation, and even harm to consumers.

    Quality Assurance and Control Aspects

    USP <1224> Transfer of Analytical Procedures testing involves several quality assurance and control aspects:

  • Sample Preparation: Accurate sample preparation is critical for ensuring the accuracy of analytical procedures.

  • Testing Parameters: Laboratories must adhere to specific testing parameters, including temperature, humidity, pressure, and other environmental conditions.

    • Competitive Advantages

    Companies that undergo USP <1224> Transfer of Analytical Procedures testing can enjoy several competitive advantages:

  • Improved Product Quality: Accurate analytical procedures ensure product quality and reliability.

  • Increased Efficiency: Streamlined processes reduce costs and improve efficiency.

  • Enhanced Customer Confidence: Companies that adhere to regulatory standards demonstrate their commitment to customer safety.

    • Cost-Benefit Analysis

    The benefits of USP <1224> Transfer of Analytical Procedures testing far outweigh the costs:

  • Reduced Costs: Inaccurate analytical procedures can lead to costly product recalls, damage to reputation, and other financial losses.

  • Improved Efficiency: Streamlined processes reduce labor costs, equipment expenses, and other overheads.

    • Standard Requirements and Needs: Conclusion

    USP <1224> Transfer of Analytical Procedures testing is a critical aspect of ensuring the accuracy and reliability of analytical procedures. Companies that undergo this testing can enjoy several competitive advantages, including improved product quality, increased efficiency, and enhanced customer confidence.

    Please continue with the next section of the guide, which covers the laboratory process for USP <1224> Transfer of Analytical Procedures testing.

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