Stability Studies

Stability Studies
Product Description

A stability study measures the extent to which a product retains, within specified limits, and throughout its period of storage and use, the same properties and characteristics that it possessed at the time of compounding.

A study commonly includes: a stability indicating method assay, sterility (for sterile preparations), endotoxin (for most sterile preparations), pH, visual inspection, particulate matter, preservative effectiveness, preservative quantification, microbial limits (for non-sterile preparations), and the absence of specified organisms (for non-sterile preparations).

ARL Bio Pharma

  • US
  • 2019
    On CPHI since
  • 3
    Certificates
  • 100 - 249
    Employees
Company types
Contract Service

ARL Bio Pharma

  • US
  • 2019
    On CPHI since
  • 3
    Certificates
  • 100 - 249
    Employees
Company types
Contract Service

More Products from ARL Bio Pharma (14)

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    A PK/PD study analyzes the rate and extent of absorption of the active ingredient or moiety and emphasizes the use of pharmacokinetic endpoints in an accessible biological matrix, such as blood, plasma, and/or serum, to indicate release of the drug substance from the drug product into the systemic circulat...
  • Pre-Clinical and Clinical Analytical Testing

    Product Pre-Clinical and Clinical Analytical Testing

    ARL Bio Pharma has extensive experience with chemical, manufacturing and controls testing for original and abbreviated new drug applications. This testing includes: identification tests, quantitative tests for impurities content, limit tests for the control of impurities, performance tests such as dissolut...
  • Protein Aggregation

    Product Protein Aggregation

    This test detects and quantifies impurity particles in a drug or therapeutic protein.
  • Protein Content

    Product Protein Content

    This test quantitates the total protein in pharmaceutical drug or therapeutic protein and products.
  • Raw Material Testing

    Product Raw Material Testing

    ARL Bio Pharma qualifies drug substances, excipients, and drug products to meet pharmacopeia specifications.

    USP / NF (United States Pharmacopeia) testingEP (European Pharmacopeia) testing
    JP (Japanese Pharmacopeia) testing

    ...
  • Residual Protein A

    Product Residual Protein A

    ELISA methods are used to test for the presence of residual proteins left in a drug or therapeutic protein following purification.
  • Biological Activity

    Product Biological Activity

    This test provides a direct measure of the effectiveness of the active ingredient.
  • Chinese Hamster Ovary Host Cell Protein Testing

    Product Chinese Hamster Ovary Host Cell Protein Testing

    ELISA methods are used to test for the presence of residual host cell proteins left in a drug or therapeutic protein following purification.
  • Compatibility Studies

    Product Compatibility Studies

    Also known as y-site studies, compatibility testing is performed to ensure that the mixing of two different formulations does not impact the physical or chemical properties of the drugs.
  • Dissolution Testing

    Product Dissolution Testing

    Quality tests to ensure proper performance of the formulation, generally solid oral dose forms such as tablets and capsules.
  • E. Coli Host Cell Proteins

    Product E. Coli Host Cell Proteins

    ELISA methods are used to test for the presence of residual host cell proteins left in a drug or therapeutic protein following purification. 
  • Extractable Volume

    Product Extractable Volume

    Each container of an injection contains sufficient excess to allow withdrawal of the labeled quantity of drug.  This test allows measurement to verify withdrawal and administration of the labeled volumes.