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usp-705-quality-attributes-for-powder-for-oral-suspension
Dissolution and Disintegration Testing EMA Guideline on the Investigation of Bioequivalence—Dissolution CriteriaFDA Guidance for Industry: Dissolution Testing of Immediate Release Solid Oral Dosage FormsFDA QbD Dissolution Modeling for PAT IntegrationICH M9 Biopharmaceutics Classification System-based BiowaiversICH Q1A(R2) Stability Testing Impacting Dissolution RateICH Q3C (R8) Residual Solvent Impact on DissolutionICH Q6A Dissolution Testing as Part of SpecificationsICH Q8(R2) Design Space and Dissolution ProfilesICH S6 Dissolution Testing in Biotech-Derived ProductsISO 22609:2004 Disintegration Time of Medical Face Mask MaterialsISO 31101:2019 Dissolution Testing of Oral Hygiene ProductsJP 15th Edition: Dissolution and Disintegration TestJP 3.09 Disintegration Test for Capsules and TabletsJP General Chapter 6.10 Dissolution Test for SuppositoriesPh. Eur. 2.9.1 Disintegration Test for Solid Dosage FormsPh. Eur. 2.9.29 Disintegration of Tablets for Veterinary UsePh. Eur. 2.9.3 Dissolution Testing of Oral Dosage FormsPh. Eur. 2.9.39 Dissolution of Patches and ImplantsPh. Eur. 2.9.4 Dissolution of Modified Release Dosage FormsPh. Eur. 2.9.40 Dissolution Testing for Oral SuspensionsPh. Eur. 2.9.43 In Vitro Dissolution Testing of Inhaled ProductsPh. Int. 2.9.5 Disintegration Testing of SuppositoriesUSP <1002> Dissolution Testing for Powder-Filled CapsulesUSP <1004> Disintegration Testing of Vaginal TabletsUSP <1087> Assessment of Drug Release from Extended Release TabletsUSP <1088> In Vitro Dissolution Profile Comparison for Generic DrugsUSP <1090> Assessment of Drug Release from Liposomal Dosage FormsUSP <1091> Assessment of Drug Release from MicrospheresUSP <1092> Dissolution Procedure Development and ValidationUSP <1094> Capsules—Dissolution and DisintegrationUSP <1097> Dissolution Testing for Transmucosal Drug Delivery SystemsUSP <2040> Dissolution Testing for Dietary SupplementsUSP <2041> Dissolution Testing of Oral Disintegrating TabletsUSP <2042> Disintegration and Dissolution of Buccal TabletsUSP <2043> Disintegration Testing of Chewable TabletsUSP <2044> Disintegration Testing for Orally Disintegrating TabletsUSP <2045> Dissolution of Transdermal PatchesUSP <2046> Disintegration of Medicated LozengesUSP <2047> Dissolution for Vaginal RingsUSP <2048> Dissolution for Oral Thin FilmsUSP <2049> Disintegration of Drug-Eluting StentsUSP <2050> Dissolution of Topical Creams and GelsUSP <2051> Dissolution Testing for Ion Exchange Resin-Based FormulationsUSP <2052> Disintegration of Controlled-Release TabletsUSP <2053> Dissolution Testing for Suppositories and PessariesUSP <2054> Disintegration Test for Extended-Release Film-Coated TabletsUSP <2055> Dissolution of Chewable GumsUSP <2056> In Vitro Drug Release for Implantable DevicesUSP <2057> Dissolution for Combination Drug ProductsUSP <2058> Dissolution for Oral Pellets and GranulesUSP <2059> Disintegration Testing of Oral Dispersible FilmsUSP <2060> In Vitro Release of Drug from Polymeric MicrospheresUSP <2061> Dissolution Testing of Nanocrystal FormulationsUSP <2062> Disintegration Testing for Multi-Layer TabletsUSP <2063> In Vitro Release Testing of Injectable SuspensionsUSP <2064> Dissolution of Non-Oral Dosage FormsUSP <2065> Disintegration Testing for Delayed Release CapsulesUSP <2066> Dissolution for MinitabletsUSP <2067> Dissolution of Coated Granules in SachetsUSP <2068> In Vitro Drug Release from Dermal SystemsUSP <2069> Disintegration Testing for Mucosal FilmsUSP <2070> Dissolution Testing for Sublingual TabletsUSP <2071> Drug Release Testing for Injectable GelsUSP <2072> Disintegration for Veterinary Bolus TabletsUSP <2073> Dissolution of Multi-Compartment CapsulesUSP <2074> Disintegration Testing of Gastro-Retentive TabletsUSP <2075> Dissolution Testing for Microemulsion SystemsUSP <2076> Dissolution Testing for Oral JelliesUSP <2077> Disintegration Testing for Modified-Release CapsulesUSP <2078> Dissolution of Floating TabletsUSP <2079> Disintegration Test for Multi-Unit Pellet SystemsUSP <2080> Drug Release from Drug-Eluting CoilsUSP <2081> In Vitro Drug Release Testing for Smart TabletsUSP <2082> Dissolution Testing of Effervescent GranulesUSP <2083> Disintegration Testing for Bilayer TabletsUSP <2084> Dissolution of Mucoadhesive TabletsUSP <2085> Disintegration of Matrix-Formed TabletsUSP <2086> Dissolution Testing of Suspended APIs in Liquid MediumUSP <2087> Disintegration Test for pH-Dependent Release CapsulesUSP <701> Disintegration of Effervescent TabletsUSP <701> Disintegration Testing of Uncoated TabletsUSP <711> Dissolution Testing of Immediate Release TabletsWHO Technical Report Series 929 Annex 9—Dissolution Testing for Quality Control

USP <705> Quality Attributes for Powder for Oral Suspension Laboratory Testing Service Provided by Eurolab

The USP <705> Quality Attributes for Powder for Oral Suspension testing service is governed by various international and national standards that ensure the accuracy, reliability, and consistency of the results. The primary standard governing this testing service is the United States Pharmacopeia (USP) <705>, which outlines the quality attributes for powder for oral suspension.

ISO/ASTM/EN/TSE Standards

The ISO (International Organization for Standardization), ASTM (American Society for Testing and Materials), EN (European Standard), and TSE (Turkish Standards Institution) are standard development organizations that play a crucial role in establishing and maintaining standards for laboratory testing. The relevant standards governing USP <705> Quality Attributes for Powder for Oral Suspension testing include:

  • ISO 11085:2018 - Solid oral dosage forms - Determination of the content uniformity of tablets

  • ASTM E2557-13 - Standard Practice for Determining the Content Uniformity of Tablets

  • EN 12780:2003 - Solid oral dosage forms - Determination of the content uniformity of tablets

  • TSE 1152:2011 - Pharmaceutical preparations - Determination of the content uniformity of tablets

    • Standard Compliance Requirements

    The industries that require USP <705> Quality Attributes for Powder for Oral Suspension testing include:

  • Pharmaceuticals and Biotechnology

  • Cosmetics and Personal Care

  • Food and Beverages

  • Veterinary Medicines

  • Medical Devices

    • Each industry has specific standard compliance requirements, which are outlined in the relevant standards. For example, the pharmaceutical industry must comply with USP <705> and ISO 11085:2018.

    Standard Development Organizations

    The standard development organizations mentioned earlier play a crucial role in establishing and maintaining standards for laboratory testing. Their primary functions include:

  • Developing and publishing standards

  • Maintaining and updating existing standards

  • Providing training and education on standard implementation

  • Facilitating collaboration between industry stakeholders

    • Consequences of Non-Compliance

    Failure to comply with the relevant standards can result in severe consequences, including:

  • Product recall

  • Financial losses

  • Damage to reputation

  • Legal action

    • It is essential for companies to adhere to the standards outlined in USP <705> and other relevant regulations.

    The USP <705> Quality Attributes for Powder for Oral Suspension testing service is required to ensure that powder for oral suspension products meet specific quality attributes. These attributes include:

  • Content uniformity

  • Uniformity of dosage units

  • Moisture content

  • Loss on drying

    • Business and Technical Reasons

    Conducting USP <705> Quality Attributes for Powder for Oral Suspension testing provides several business and technical benefits, including:

  • Ensuring product safety and reliability

  • Maintaining compliance with regulatory requirements

  • Enhancing customer confidence and trust

  • Improving market positioning and competitiveness

  • Reducing the risk of product recall and financial losses

    • Consequences of Not Performing this Test

    Failure to perform USP <705> Quality Attributes for Powder for Oral Suspension testing can result in severe consequences, including:

  • Product failure

  • Customer dissatisfaction

  • Financial losses

  • Damage to reputation

    • Industries and Sectors that Require this Testing

    The industries that require USP <705> Quality Attributes for Powder for Oral Suspension testing include:

  • Pharmaceuticals and Biotechnology

  • Cosmetics and Personal Care

  • Food and Beverages

  • Veterinary Medicines

  • Medical Devices

    • Each industry has specific standard compliance requirements, which are outlined in the relevant standards.

    Risk Factors and Safety Implications

    Performing USP <705> Quality Attributes for Powder for Oral Suspension testing helps to identify potential risk factors and safety implications associated with powder for oral suspension products. These risks include:

  • Inadequate content uniformity

  • Non-uniform dosage units

  • High moisture content

  • Loss on drying

    • Quality Assurance and Control

    Conducting USP <705> Quality Attributes for Powder for Oral Suspension testing is an essential component of quality assurance and control programs. It helps to ensure that powder for oral suspension products meet specific quality attributes, reducing the risk of product failure and customer dissatisfaction.

    The USP <705> Quality Attributes for Powder for Oral Suspension testing service involves several steps, including:

  • Sample preparation

  • Testing equipment and instruments used

  • Testing environment requirements (temperature, humidity, pressure)

  • Measurement and analysis methods

  • Calibration and validation procedures

  • Data collection and recording procedures

  • Testing timeframes and duration

    • Step-by-Step Explanation of the Test

    The following is a step-by-step explanation of the USP <705> Quality Attributes for Powder for Oral Suspension testing service:

    1. Sample Preparation: The powder for oral suspension sample is prepared according to the relevant standard.

    2. Testing Equipment and Instruments Used: The testing equipment and instruments used include a balance, a spectrophotometer, and a thermogravimetric analyzer (TGA).

    3. Testing Environment Requirements: The testing environment requirements include a temperature of 25C 5C and a relative humidity of 60 10.

    4. Measurement and Analysis Methods: The measurement and analysis methods used include spectrophotometry, TGA, and Karl Fischer titration.

    5. Calibration and Validation Procedures: The calibration and validation procedures involve the use of certified reference materials (CRMs) and a system suitability test.

    6. Data Collection and Recording Procedures: The data collection and recording procedures involve the use of a computerized data management system.

    7. Testing Timeframes and Duration: The testing timeframes and duration vary depending on the specific requirements outlined in the relevant standard.

    Conclusion

    The USP <705> Quality Attributes for Powder for Oral Suspension testing service is an essential component of quality assurance and control programs. It helps to ensure that powder for oral suspension products meet specific quality attributes, reducing the risk of product failure and customer dissatisfaction. The industries that require this testing include:

  • Pharmaceuticals and Biotechnology

  • Cosmetics and Personal Care

  • Food and Beverages

  • Veterinary Medicines

  • Medical Devices

    • Each industry has specific standard compliance requirements, which are outlined in the relevant standards.

    Test Report

    The test report will contain the following information:

  • Test method used

  • Sample preparation details

  • Testing equipment and instruments used

  • Testing environment requirements (temperature, humidity, pressure)

  • Measurement and analysis methods

  • Calibration and validation procedures

  • Data collection and recording procedures

  • Testing timeframes and duration

    • Test Report Format

    The test report format will be in accordance with the relevant standard.

    Certification

    Eurolab is certified to perform USP <705> Quality Attributes for Powder for Oral Suspension testing according to ISO/IEC 17025:2017.

    Need help or have a question?
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