Pharmaceuticals

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).

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.

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Quality tests to ensure proper performance of the formulation, generally solid oral dose forms such as tablets and capsules.

This test identifies microorganisms isolated during different phases of manufacturing and quality testing to the genus/species level using DNA sequencing.

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 circulation.

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 dissolution/disintegration and quantitative tests of the active moiety in samples of drug substance or drug product or other selected component(s) in the drug product.

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

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

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

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

This test quantitates the total protein in pharmaceutical drug or therapeutic protein and products.

This test provides a direct measure of the effectiveness of the active ingredient.

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.

Osmolarity is a theoretical quantity that is calculated from the experimentally measured value of osmolality and the density of the solution. The units of osmolarity are osmole per liter of solution (Osmol/L) or milliosmole per liter of solution (mOsmol/L).

Osmolality measures the concentration of a solution expressed as the total number of solute particles per kilogram of water.  The units of osmolality are osmole per kilogram of water (Osmol/kg) or milliosmole per kilogram of water (mOsmol/kg).