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usp-1223-water-activity-determination-in-drug-products
Pharmaceutical Microbiology Testing ICH Q10 Pharmaceutical Quality System and Microbial ControlsICH Q6A Testing for Microbiological Attributes of Drug SubstancesICH Q7 GMP Guidelines for Microbial Control in APIsICH Q9 Risk-Based Approach to Microbial ContaminationISO 11737-1 Bioburden Testing for Medical Devices and Pharmaceutical PackagingISO 11737-2 Sterility Assurance and Validation for Pharmaceutical ComponentsISO 11930 Preservation Efficacy Testing for Topical PharmaceuticalsISO 14644-1 Cleanroom Classification for Pharmaceutical ManufacturingISO 14698-1 Biocontamination Control in CleanroomsISO 16212 Yeast and Mold Testing in Pharmaceutical Raw MaterialsISO 18415 Detection of Pathogenic Microorganisms in Non-Sterile ProductsISO 21149 Enumeration of Aerobic Mesophilic Bacteria in Cosmetic and PharmaJP XVII Bacterial Endotoxin Test for Injectable PharmaceuticalsJP XVII Microbial Limit Tests for Oral PreparationsJP XVII Sterility Test for Pharmaceutical ProductsPh. Eur. 2.6.1 Sterility Testing for Finished Pharmaceutical ProductsPh. Eur. 2.6.11 Detection of Pathogens in Veterinary PharmaceuticalsPh. Eur. 2.6.12 Microbial Contamination Testing of Non-Sterile ProductsPh. Eur. 2.6.13 Detection of Clostridia in Parenteral SolutionsPh. Eur. 2.6.14 Bacterial Endotoxins – Gel Clot MethodPh. Eur. 2.6.15 Test for Pseudomonas aeruginosa in Topical DrugsPh. Eur. 2.6.16 Test for Staphylococcus aureus in Creams and GelsPh. Eur. 2.6.2 Mycoplasma Detection in Cell-Based PharmaceuticalsPh. Eur. 2.6.25 Testing for Anaerobic Bacteria in Sterile ProductsPh. Eur. 2.6.27 Bacterial Endotoxin Testing in Parenteral DrugsPh. Eur. 2.6.30 Monitoring of Controlled EnvironmentsPh. Eur. 2.6.32 Control of Bacterial Contamination in Ophthalmic DrugsPh. Eur. 2.6.7 Mycobacteria Detection in BiopharmaceuticalsPh. Eur. 2.6.9 Test for Escherichia coli in Non-Sterile PharmaPh. Eur. 5.1.4 Microbiological Quality of Pharmaceutical PreparationsPh. Eur. 5.1.6 Alternative Methods for Microbiological Quality ControlPh. Eur. 5.1.8 Bioburden Limits in Parenteral ManufacturingUSP <1072> Disinfectants and Antiseptics Microbial Efficacy TestUSP <1111> Microbiological Examination of Non-Sterile ProductsUSP <1115> Bioburden Control of Non-Sterile Drug SubstancesUSP <1116> Microbiological Control of Clean Rooms and Controlled EnvironmentsUSP <1117> Microbial Best Practices for Pharmaceutical Lab PersonnelUSP <1207> Package Integrity Evaluation – Microbial Ingress TestUSP <1208> Integrity Testing for Sterile Barrier SystemsUSP <1227> Validation of Microbial Recovery MethodsUSP <1229> Microbial Quality of Compendial Water SystemsUSP <1231> Water for Pharmaceutical Purposes – Microbiological TestingUSP <39> Bioburden Limit Testing for Bulk Active IngredientsUSP <39> Microbiological Quality of Compounding PharmaciesUSP <51> Preservative Effectiveness Testing of Multi-Dose PharmaceuticalsUSP <55> Biological Indicators for Sterilization ValidationUSP <61> Microbial Enumeration Tests for Raw Pharmaceutical MaterialsUSP <61>/<62> Microbial Limit Tests for Tablet and Capsule FormsUSP <62> Tests for Specified Microorganisms in Non-Sterile ProductsUSP <71> Sterility Testing of Injectable Pharmaceutical Products

Comprehensive Guide to USP <1223> Water Activity Determination in Drug Products Testing Services Provided by Eurolab

USP <1223> Water Activity Determination in Drug Products is a critical laboratory testing service that ensures the quality and safety of pharmaceutical products. This standard is governed by various international and national standards, including ISO 11133, ASTM E2424, EN 13726, and TSE 2435.

Legal and Regulatory Framework

The legal and regulatory framework surrounding USP <1223> Water Activity Determination in Drug Products testing is established by governing bodies such as the United States Pharmacopeia (USP), the International Organization for Standardization (ISO), and national regulatory agencies. These standards ensure that pharmaceutical products meet specific requirements for water activity, which is a critical factor in ensuring product stability and safety.

International and National Standards

International standards relevant to USP <1223> Water Activity Determination in Drug Products include:

  • ISO 11133:2009 (Water Activity Measurement - Guidelines for Measuring the Water Activity of Moisture-Sensitive Substances)

  • ASTM E2424-10 (Standard Practice for Measuring Water Activity Using Dew Point Hygrometry)

    • National standards relevant to USP <1223> Water Activity Determination in Drug Products include:

  • EN 13726:2002 (Water Activity Measurement - Guidelines for Measuring the Water Activity of Moisture-Sensitive Substances)

  • TSE 2435:2017 (Water Activity Measurement - Guidelines for Measuring the Water Activity of Moisture-Sensitive Substances)

    • Standard Development Organizations

    Standard development organizations play a crucial role in establishing and maintaining standards related to USP <1223> Water Activity Determination in Drug Products. These organizations include:

  • United States Pharmacopeia (USP)

  • International Organization for Standardization (ISO)

  • American Society for Testing and Materials (ASTM)

    • Evolution of Standards

    Standards evolve over time as new technologies and techniques emerge, or when there are changes in regulatory requirements. Eurolab stays up-to-date with the latest standards and updates to ensure compliance and accuracy in USP <1223> Water Activity Determination in Drug Products testing.

    Why This Specific Test is Needed and Required

    USP <1223> Water Activity Determination in Drug Products testing is essential for ensuring the quality, safety, and stability of pharmaceutical products. The water activity of a product can affect its shelf life, efficacy, and overall performance.

    Business and Technical Reasons for Conducting USP <1223> Water Activity Determination in Drug Products Testing

    Conducting USP <1223> Water Activity Determination in Drug Products testing is necessary for several reasons:

  • Ensures compliance with regulatory requirements

  • Ensures product stability and safety

  • Supports quality assurance and control initiatives

  • Enhances customer confidence and trust

  • Facilitates international market access and trade

    • Consequences of Not Performing This Test

    Not performing USP <1223> Water Activity Determination in Drug Products testing can have serious consequences, including:

  • Regulatory non-compliance

  • Product instability or degradation

  • Safety risks to consumers

  • Damage to brand reputation

    • Step-by-Step Explanation of How the Test is Conducted

    The USP <1223> Water Activity Determination in Drug Products testing process involves several steps:

    1. Sample preparation: Collecting and preparing a representative sample of the pharmaceutical product.

    2. Instrument calibration: Calibrating the water activity measuring instrument according to the manufacturers instructions.

    3. Measurement: Measuring the water activity of the sample using the calibrated instrument.

    4. Analysis: Analyzing the measured data to determine the water activity value.

    Testing Equipment and Instruments Used

    Eurolab uses state-of-the-art equipment, including:

  • Water activity measuring instruments (e.g., DewPoint Hygrometer)

  • Temperature-controlled environments

  • Humidity-controlled environments

    • Test Results Documentation and Reporting

    USP <1223> Water Activity Determination in Drug Products test results are documented and reported according to the following guidelines:

  • Report format: USP <1223> compliant report format

  • Data interpretation: Interpretation of test data according to regulatory requirements

  • Certification and accreditation: Compliance with relevant certification and accreditation standards

    • Comprehensive Explanation of Benefits and Advantages

    Performing USP <1223> Water Activity Determination in Drug Products testing offers numerous benefits, including:

  • Ensures product quality and safety

  • Supports regulatory compliance

  • Enhances customer confidence and trust

  • Facilitates international market access and trade

  • Supports innovation and research development

    • Why Eurolab Should Be Your Partner (Commercial Appeal)

    Eurolab is the ideal partner for USP <1223> Water Activity Determination in Drug Products testing due to its:

  • Expertise and experience in pharmaceutical testing

  • State-of-the-art equipment and facilities

  • Compliance with relevant regulatory requirements

  • Commitment to quality and customer satisfaction

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

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