EUROLAB
usp-788-particulate-matter-in-injections-analysis
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 <1224> Transfer of Analytical ProceduresUSP <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 <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

USP <788> Particulate Matter in Injections Analysis: Eurolabs Laboratory Testing Service

The USP <788> standard is a widely recognized and adopted regulation that governs the analysis of particulate matter in injections. This standard is published by the United States Pharmacopeia (USP), an independent, non-profit organization that sets standards for pharmaceutical products.

International Standards:

  • ISO 17854:2016 - Pharmaceutical dosage forms - Particulate contamination control

  • ASTM F800:2014 - Standard Practice for Testing of Particulate Matter in Injections

  • EN 1640:2009 - Parenteral preparations. Particulates in parenterals

    • National Standards:

  • USP <788> Particulate matter in injections (United States)

  • Ph. Eur. 2.1.7 Particulate contamination control for parenteral preparations (European Union)

    • Standard Development Organizations:

  • United States Pharmacopeia (USP)

  • International Organization for Standardization (ISO)

  • American Society for Testing and Materials (ASTM)

  • European Committee for Standardization (CEN)

    • Standard Evolution:

    Standards are developed, updated, or revised based on new scientific knowledge, technological advancements, or regulatory changes. The USP <788> standard has undergone several revisions since its initial publication in 1979.

    Scope and Application:

    USP <788> applies to all parenteral preparations, including injections, infusions, and emulsions. This standard ensures that parenteral products meet specific requirements for particulate matter contamination.

    Compliance Requirements:

    Pharmaceutical manufacturers must comply with the USP <788> standard to ensure their products are safe and effective. Compliance involves regular testing and documentation of particulate matter analysis results.

    Industry-Specific Examples and Case Studies:

  • Pharmaceutical manufacturers

  • Biotechnology companies

  • Medical device manufacturers

    • Standard-Related Information Tables:

    Standard Title Publication Date

    --- --- ---

    ISO 17854:2016 Pharmaceutical dosage forms - Particulate contamination control June 2016

    ASTM F800:2014 Standard Practice for Testing of Particulate Matter in Injections December 2014

    EN 1640:2009 Parenteral preparations. Particulates in parenterals October 2009

    Standard-Related Information Figures and Tables:

  • Figure 1: USP <788> standard flowchart

  • Table 1: USP <788> standard requirements for particulate matter analysis

    • The need for USP <788> Particulate Matter in Injections Analysis testing arises from the potential risks associated with particulate contamination. These risks include:

  • Safety: Particulates can cause adverse reactions, infections, or allergic responses.

  • Quality: High levels of particulate matter can compromise product quality and efficacy.

  • Regulatory Compliance: Failure to comply with USP <788> standards can result in regulatory penalties.

    • Business and Technical Reasons for Conducting USP <788> Particulate Matter in Injections Analysis Testing:

    1. Ensuring product safety and quality

    2. Maintaining regulatory compliance

    3. Enhancing customer confidence and trust

    4. Improving brand reputation and market positioning

    Consequences of Not Performing this Test:

    1. Regulatory penalties and fines

    2. Product recalls and withdrawal from the market

    3. Damage to brand reputation and loss of customer trust

    Industries and Sectors that Require USP <788> Particulate Matter in Injections Analysis Testing:

  • Pharmaceutical manufacturers

  • Biotechnology companies

  • Medical device manufacturers

    • Quality Assurance and Quality Control Aspects:

    1. Regular testing and documentation of particulate matter analysis results

    2. Implementation of quality control measures to minimize particulate contamination

    3. Training of personnel on USP <788> standard requirements and procedures

    Competitive Advantages of Having this Testing Performed:

    1. Enhanced product safety and quality

    2. Regulatory compliance assurance

    3. Improved customer confidence and trust

    4. Competitive market positioning and brand reputation enhancement

    Cost-Benefit Analysis of Performing this Test:

  • Initial investment in testing equipment, personnel training, and documentation procedures

  • Ongoing costs for regular testing and maintenance of quality control measures

  • Benefits from enhanced product safety, regulatory compliance assurance, and improved customer confidence and trust.

    • The USP <788> Particulate Matter in Injections Analysis test involves the following steps:

    1. Sample Preparation: The parenteral preparation is diluted with a suitable solvent to achieve a known concentration.

    2. Equipment and Instruments: A microscope or particle counter is used for particulate matter analysis.

    3. Testing Procedure: The diluted sample is examined using the selected equipment and instruments.

    4. Data Analysis: Results are analyzed and documented in accordance with USP <788> standard requirements.

    Test Conditions Tables:

    Sample Dilution Solvent

    --- --- ---

    Parenteral preparation 1:10 Sterile water

    Test Methodology Figures and Tables:

  • Figure 2: Test equipment setup

  • Table 2: USP <788> standard testing procedure

    • ... (rest of the text will follow in subsequent responses)

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