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usp-1231-water-for-pharmaceutical-purposes-testing
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 <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

USP <1231> Water for Pharmaceutical Purposes Testing: Eurolabs Laboratory Testing Service

The United States Pharmacopeia (USP) <1231> is a comprehensive standard that outlines the requirements for testing water used in pharmaceutical manufacturing. This standard is essential for ensuring the quality and purity of water used in the production process, which is critical for maintaining product safety and efficacy.

Legal and Regulatory Framework

The USP <1231> standard is governed by regulatory agencies such as the FDA (Food and Drug Administration) in the United States and the EMA (European Medicines Agency) in Europe. These agencies enforce strict guidelines for pharmaceutical manufacturers to follow, which includes testing water for various parameters.

International and National Standards

The USP <1231> standard is based on international standards such as ISO 3696-1:2017, ASTM D1193-15, and EN 285:2004. These standards provide a framework for testing water used in pharmaceutical manufacturing and ensure that laboratories follow established protocols.

Standard Development Organizations

The International Organization for Standardization (ISO), the American Society for Testing and Materials (ASTM), and the European Committee for Standardization (CEN) are among the standard development organizations responsible for updating and revising standards related to USP <1231> Water for Pharmaceutical Purposes Testing.

Evolution of Standards

Standards evolve over time to reflect advances in technology, changes in regulatory requirements, or new scientific discoveries. For instance, the latest revision of the ISO 3696-1:2017 standard includes updated protocols for testing water for microbiological contaminants.

Standard Numbers and Scope

Some relevant standards related to USP <1231> Water for Pharmaceutical Purposes Testing include:

  • ISO 3696-1:2017: Water for analytical laboratory use Part 1: Specification and test methods

  • ASTM D1193-15: Standard Specification for Reagent Water

  • EN 285:2004: Sterilization Steam sterilizing installations

    • Compliance Requirements

    Manufacturers must comply with specific standards depending on their industry, location, or product type. For example:

  • Pharmaceutical manufacturers must follow USP <1231> guidelines.

  • Biotechnology companies may require compliance with ASTM D1193-15.

    • Standard Compliance for Different Industries

    Various industries have unique requirements for testing water used in pharmaceutical manufacturing. Some examples include:

  • Pharmaceutical: USP <1231>

  • Biotechnology: ASTM D1193-15

  • Cosmetics: ISO 3696-1:2017

    • Standard-Related Information Conclusion

    In summary, the USP <1231> standard is a critical component of testing water used in pharmaceutical manufacturing. This standard is governed by regulatory agencies and based on international standards such as ISO 3696-1:2017, ASTM D1193-15, and EN 285:2004.

    The USP <1231> Water for Pharmaceutical Purposes Testing testing service is essential for maintaining product safety and efficacy. This section will explain the business and technical reasons for conducting this test.

    Why is this Test Needed and Required?

    Pharmaceutical manufacturers require water with specific quality parameters to ensure product purity and stability. The USP <1231> standard outlines these requirements, which includes testing for various parameters such as conductivity, pH, and microbiological contaminants.

    Business and Technical Reasons for Conducting the Test

    Conducting the USP <1231> Water for Pharmaceutical Purposes Testing testing service has several business and technical reasons:

  • Ensures product safety and efficacy

  • Maintains regulatory compliance

  • Protects brand reputation and customer trust

  • Supports quality management systems (QMS)

  • Enhances competitiveness in the market

    • Consequences of Not Performing this Test

    Not conducting the USP <1231> Water for Pharmaceutical Purposes Testing testing service can have severe consequences, including:

  • Product contamination or adulteration

  • Loss of regulatory approval

  • Damage to brand reputation and customer trust

  • Increased costs due to product recalls or rework

    • Industries and Sectors that Require this Testing

    Various industries require the USP <1231> Water for Pharmaceutical Purposes Testing testing service, including:

  • Pharmaceutical manufacturing

  • Biotechnology companies

  • Cosmetics manufacturers

  • Food processing industry

    • Risk Factors and Safety Implications

    The risks associated with not conducting this test include contamination or adulteration of products, which can lead to adverse health effects in consumers.

    Quality Assurance and Quality Control Aspects

    Conducting the USP <1231> Water for Pharmaceutical Purposes Testing testing service is essential for maintaining quality assurance and quality control (QA/QC) standards.

    How this Test Contributes to Product Safety and Reliability

    This test contributes to product safety and reliability by ensuring that water used in pharmaceutical manufacturing meets specific quality parameters.

    Standard Requirements and Needs Conclusion

    In summary, the USP <1231> Water for Pharmaceutical Purposes Testing testing service is essential for maintaining product safety and efficacy. This standard outlines specific requirements for testing water used in pharmaceutical manufacturing, which ensures regulatory compliance and protects brand reputation.

    Standard-Related Information References:

  • ISO 3696-1:2017

  • ASTM D1193-15

  • EN 285:2004

  • USP <1231>

    • Standard Requirements and Needs References:

  • Pharmaceutical manufacturing

  • Biotechnology companies

  • Cosmetics manufacturers

  • Food processing industry

    • Please let me know if you want me to continue with the rest of the sections or if you have any questions so far.

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