EUROLAB
ep-2512-water-content-karl-fischer-method
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 2.6.12 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 <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 EP 2.5.12 Water Content (Karl Fischer Method) Laboratory Testing Service

Provided by Eurolab

Standard-Related Information

EP 2.5.12 Water Content (Karl Fischer Method) testing is governed by various international and national standards, which are essential for ensuring the accuracy, reliability, and comparability of test results.

Relevant Standards

  • ISO 165:2009 - Determination of moisture content in rubber and other elastomers using the Karl-Fischer method

  • ASTM D1533-09 - Standard Test Method for Specific Gravity of Water (and Other Liquids)

  • EN ISO 3696-1:2015 - Water for analytical laboratory use. Specification and test methods

  • TSE 547:2008 - Determination of moisture content in rubber using the Karl-Fischer method

    • These standards outline the requirements for equipment, reagents, sample preparation, and testing procedures to ensure accurate and reliable results.

    Legal and Regulatory Framework

    The legal and regulatory framework surrounding EP 2.5.12 Water Content (Karl Fischer Method) testing is primarily based on national and international regulations related to product safety, quality control, and standardization.

  • In the European Union, the EUs directives and regulations, such as the Machinery Directive (2006/42/EC) and the Low Voltage Directive (2014/35/EU), mandate the use of standardized testing procedures for ensuring product safety.

  • In the United States, the Federal Trade Commission (FTC) regulates the accuracy and reliability of test results through guidelines on labeling and advertising.

    • Standard Development Organizations

    Standard development organizations play a crucial role in developing, revising, and maintaining standards related to EP 2.5.12 Water Content (Karl Fischer Method) testing.

  • The International Organization for Standardization (ISO)

  • The American Society for Testing and Materials (ASTM)

  • The European Committee for Standardization (CEN)

    • These organizations ensure that standards are developed, reviewed, and updated regularly to reflect the latest scientific knowledge and technological advancements.

    Evolution of Standards

    Standards related to EP 2.5.12 Water Content (Karl Fischer Method) testing evolve over time as new technologies, techniques, and research findings become available.

  • New standards may be developed in response to emerging trends or changes in regulations.

  • Existing standards may be revised or updated to reflect the latest scientific knowledge or technological advancements.

    • Specific Standard Numbers and Scope

    Some relevant standard numbers and their scope are:

    Standard Number Title

    --- ---

    ISO 165:2009 Determination of moisture content in rubber and other elastomers using the Karl-Fischer method

    ASTM D1533-09 Standard Test Method for Specific Gravity of Water (and Other Liquids)

    Compliance Requirements

    Compliance with standards related to EP 2.5.12 Water Content (Karl Fischer Method) testing is essential for industries that require accurate and reliable test results.

  • Compliance with international and national standards ensures the accuracy, reliability, and comparability of test results.

  • Failure to comply with standards can result in product recalls, fines, or even lawsuits.

    • Industry-Specific Requirements

    EP 2.5.12 Water Content (Karl Fischer Method) testing is required for various industries that need accurate and reliable moisture content analysis.

  • Rubber and plastics manufacturing

  • Textile and leather industry

  • Pharmaceutical and biotechnology

  • Food and beverage processing

    • Standard Requirements and Needs

    EP 2.5.12 Water Content (Karl Fischer Method) testing is essential for ensuring product safety, quality control, and regulatory compliance.

    Consequences of Not Performing This Test

    Failure to perform EP 2.5.12 Water Content (Karl Fischer Method) testing can result in:

  • Product recalls

  • Fines or lawsuits due to non-compliance with regulations

  • Loss of customer confidence and trust

  • Decreased product quality and performance

    • Risk Factors and Safety Implications

    EP 2.5.12 Water Content (Karl Fischer Method) testing is critical for ensuring product safety and reliability.

  • Inaccurate or unreliable test results can lead to product failures, recalls, or even accidents.

  • Compliance with standards ensures the accuracy, reliability, and comparability of test results.

    • Quality Assurance and Quality Control Aspects

    EP 2.5.12 Water Content (Karl Fischer Method) testing is subject to quality assurance and quality control procedures to ensure accurate and reliable results.

  • Equipment calibration and maintenance

  • Reagent preparation and storage

  • Sample handling and preparation

  • Testing procedures and protocols

    • Competitive Advantages

    EP 2.5.12 Water Content (Karl Fischer Method) testing provides several competitive advantages for industries that require accurate and reliable moisture content analysis.

  • Improved product quality and performance

  • Enhanced customer confidence and trust

  • Compliance with regulations and standards

  • Cost savings through reduced product failures and recalls

    • Industry-Specific Requirements

    EP 2.5.12 Water Content (Karl Fischer Method) testing is required for various industries that need accurate and reliable moisture content analysis.

  • Rubber and plastics manufacturing

  • Textile and leather industry

  • Pharmaceutical and biotechnology

  • Food and beverage processing

    • Standard Development Organizations

    Standard development organizations play a crucial role in developing, revising, and maintaining standards related to EP 2.5.12 Water Content (Karl Fischer Method) testing.

    Relevant Standard Numbers and Scope

    Some relevant standard numbers and their scope are:

    Standard Number Title

    --- ---

    ISO 165:2009 Determination of moisture content in rubber and other elastomers using the Karl-Fischer method

    ASTM D1533-09 Standard Test Method for Specific Gravity of Water (and Other Liquids)

    Compliance Requirements

    Compliance with standards related to EP 2.5.12 Water Content (Karl Fischer Method) testing is essential for industries that require accurate and reliable test results.

  • Compliance with international and national standards ensures the accuracy, reliability, and comparability of test results.

  • Failure to comply with standards can result in product recalls, fines, or even lawsuits.

    • Industry-Specific Requirements

    EP 2.5.12 Water Content (Karl Fischer Method) testing is required for various industries that need accurate and reliable moisture content analysis.

  • Rubber and plastics manufacturing

  • Textile and leather industry

  • Pharmaceutical and biotechnology

  • Food and beverage processing

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

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