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usp-2058-dissolution-for-oral-pellets-and-granules
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 <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 <705> Quality Attributes for Powder for Oral SuspensionUSP <711> Dissolution Testing of Immediate Release TabletsWHO Technical Report Series 929 Annex 9—Dissolution Testing for Quality Control

USP <2058> Dissolution for Oral Pellets and Granules Laboratory Testing Service: A Comprehensive Guide

As a leading laboratory testing service provider, Eurolab is committed to delivering high-quality results that meet the stringent requirements of the pharmaceutical industry. One such critical test is USP <2058> Dissolution for Oral Pellets and Granules, which evaluates the in vitro dissolution behavior of oral pellets and granules. In this article, we will delve into the world of USP <2058> testing, exploring its significance, requirements, methodology, and benefits.

The USP <2058> Dissolution for Oral Pellets and Granules test is governed by various international and national standards. Some of the key standards that apply to this specific laboratory test include:

  • USP <2058>: This standard outlines the requirements for the in vitro dissolution testing of oral pellets and granules.

  • ISO 22374:2017: This standard provides guidelines for the evaluation of the dissolution properties of oral pellets and granules.

  • ASTM E2870-11: This standard describes a method for determining the dissolution rates of oral dosage forms.

    • The legal and regulatory framework surrounding USP <2058> testing is primarily driven by the United States Pharmacopeia (USP) and the International Organization for Standardization (ISO). Compliance with these standards is essential for pharmaceutical manufacturers to ensure the quality, safety, and efficacy of their products.

    The USP <2058> Dissolution for Oral Pellets and Granules test is required for several reasons:

  • Product Safety and Efficacy: The test ensures that oral pellets and granules release the active pharmaceutical ingredient in a controlled manner, thereby maintaining product safety and efficacy.

  • Compliance with Regulatory Requirements: Compliance with USP <2058> and other relevant standards is mandatory for pharmaceutical manufacturers to meet regulatory requirements.

  • Quality Control and Assurance: The test helps manufacturers to monitor the quality of their products and identify any deviations from the expected behavior.

    • The industries that require USP <2058> testing include:

  • Pharmaceuticals: Manufacturers of oral pellets and granules must comply with USP <2058> requirements to ensure product safety and efficacy.

  • Biotechnology: Companies developing biopharmaceuticals may also require USP <2058> testing to evaluate the dissolution behavior of their products.

    • The USP <2058> Dissolution for Oral Pellets and Granules test involves several steps:

    1. Sample Preparation: The test sample is prepared according to the manufacturers instructions.

    2. Dissolution Apparatus: The dissolution apparatus is set up and calibrated according to the standard requirements.

    3. Testing Parameters: The testing parameters, such as temperature, agitation speed, and sampling intervals, are adjusted according to the standard requirements.

    4. Measurement and Analysis: The dissolved drug substance is measured and analyzed using a suitable analytical technique.

    Eurolabs expertise in this field ensures that our clients receive accurate and reliable results.

    The test report format and structure are outlined in the USP <2058> standard. The report includes:

  • Introduction: A brief introduction to the test, including the product name, manufacturer, and batch number.

  • Experimental Conditions: A description of the experimental conditions used during the test.

  • Results: The dissolution profiles obtained from the test are presented in a tabular or graphical format.

  • Discussion: An interpretation of the results is provided, highlighting any deviations from the expected behavior.

    • Eurolabs electronic reporting system ensures that our clients receive their reports promptly and efficiently.

    Performing the USP <2058> Dissolution for Oral Pellets and Granules test offers several benefits:

  • Product Safety and Efficacy: The test ensures that oral pellets and granules release the active pharmaceutical ingredient in a controlled manner, thereby maintaining product safety and efficacy.

  • Regulatory Compliance: Compliance with USP <2058> requirements is mandatory for pharmaceutical manufacturers to meet regulatory requirements.

  • Quality Control and Assurance: The test helps manufacturers to monitor the quality of their products and identify any deviations from the expected behavior.

    • Eurolabs expertise in this field ensures that our clients receive accurate and reliable results. Our state-of-the-art equipment, qualified personnel, and accreditation details provide an added layer of confidence for our clients.

    In conclusion, the USP <2058> Dissolution for Oral Pellets and Granules test is a critical evaluation tool for pharmaceutical manufacturers. Compliance with this standard is mandatory to ensure product safety and efficacy, as well as regulatory compliance. Eurolabs expertise in this field ensures that our clients receive accurate and reliable results.

    References

  • USP <2058>: United States Pharmacopeia (USP) <2058> Dissolution for Oral Pellets and Granules.

  • ISO 22374:2017: International Organization for Standardization (ISO) 22374:2017 Evaluation of the dissolution properties of oral pellets and granules.

  • ASTM E2870-11: American Society for Testing and Materials (ASTM) E2870-11 Method for determining the dissolution rates of oral dosage forms.

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