EUROLAB
jp-405-water-determination-in-raw-materials
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 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

JP 4.05 Water Determination in Raw Materials Laboratory Testing Service: A Comprehensive Guide

JP 4.05 Water Determination in Raw Materials testing is governed by various international and national standards, which are developed and maintained by standard development organizations such as the International Organization for Standardization (ISO), American Society for Testing and Materials (ASTM), European Committee for Standardization (CEN), Turkish Standards Institution (TSE), and others.

Legal and Regulatory Framework

The legal and regulatory framework surrounding JP 4.05 Water Determination in Raw Materials testing is complex and multifaceted. The relevant standards are based on the principles of quality management, product safety, and environmental protection. Regulatory bodies such as government agencies, industry associations, and certifying organizations play a crucial role in enforcing these standards.

International and National Standards

The following international and national standards apply to JP 4.05 Water Determination in Raw Materials testing:

  • ISO 3696:1987 Water for analytical laboratory use - Specification and test methods

  • ASTM D6304-22 Standard Test Method for Determination of Moisture Content of Any Solid Material by the Owens Corning Desiccator Method

  • EN 1262:2009A1:2014 Water quality - Determination of the water content of solid materials using a desiccator method

  • TSE EN 1262:2007A1:2013 Su kalitesi - Çimento ve çimentonun hazırlanması için kullanılan suyun sınıflandırılması

    • These standards specify the requirements for the testing equipment, sample preparation, and measurement methods.

    Standard Development Organizations

    The standard development organizations responsible for JP 4.05 Water Determination in Raw Materials testing are:

  • International Organization for Standardization (ISO)

  • American Society for Testing and Materials (ASTM)

  • European Committee for Standardization (CEN)

  • Turkish Standards Institution (TSE)

    • These organizations develop, maintain, and publish standards based on the consensus of experts from various industries.

    Evolution of Standards

    Standards evolve over time to reflect changes in technology, industry practices, and regulatory requirements. Updates to standards ensure that they remain relevant and effective in ensuring product safety and quality.

    Standard Compliance Requirements

    Compliance with these standards is mandatory for industries such as:

  • Construction

  • Cement production

  • Chemical manufacturing

  • Food processing

    • Non-compliance can result in penalties, fines, and damage to reputation.

    JP 4.05 Water Determination in Raw Materials testing is governed by various international and national standards, which are developed and maintained by standard development organizations such as the International Organization for Standardization (ISO), American Society for Testing and Materials (ASTM), European Committee for Standardization (CEN), Turkish Standards Institution (TSE), and others.

    Legal and Regulatory Framework

    The legal and regulatory framework surrounding JP 4.05 Water Determination in Raw Materials testing is complex and multifaceted. The relevant standards are based on the principles of quality management, product safety, and environmental protection. Regulatory bodies such as government agencies, industry associations, and certifying organizations play a crucial role in enforcing these standards.

    International and National Standards

    The following international and national standards apply to JP 4.05 Water Determination in Raw Materials testing:

  • ISO 3696:1987 Water for analytical laboratory use - Specification and test methods

  • ASTM D6304-22 Standard Test Method for Determination of Moisture Content of Any Solid Material by the Owens Corning Desiccator Method

  • EN 1262:2009A1:2014 Water quality - Determination of the water content of solid materials using a desiccator method

  • TSE EN 1262:2007A1:2013 Su kalitesi - Çimento ve çimentonun hazırlanması için kullanılan suyun sınıflandırılması

    • These standards specify the requirements for the testing equipment, sample preparation, and measurement methods.

    Standard Development Organizations

    The standard development organizations responsible for JP 4.05 Water Determination in Raw Materials testing are:

  • International Organization for Standardization (ISO)

  • American Society for Testing and Materials (ASTM)

  • European Committee for Standardization (CEN)

  • Turkish Standards Institution (TSE)

    • These organizations develop, maintain, and publish standards based on the consensus of experts from various industries.

    Evolution of Standards

    Standards evolve over time to reflect changes in technology, industry practices, and regulatory requirements. Updates to standards ensure that they remain relevant and effective in ensuring product safety and quality.

    Standard Compliance Requirements

    Compliance with these standards is mandatory for industries such as:

  • Construction

  • Cement production

  • Chemical manufacturing

  • Food processing

    • Non-compliance can result in penalties, fines, and damage to reputation.

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