Analytical Testing

This study assesses cleaning procedures through drug swab recovery and quantitates drug residue on surfaces in compounding environments.

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.

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

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.

ARL Bio Pharma has extensive experience in analytical method development/validation for a variety of drug substances and products.

Our laboratory validates analytical methods based on ICH and USP guidelines and high-quality industry practices. Method parameters may include: precision, limit of detection, limit of quantitation, accuracy, linear range, specificity, robustness, system suitability, ruggedness and freeze-thaw.

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).

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).

Particulate matter tests for the presence of extraneous substances including: dust, glass, drug precipitates, rubber and other insoluble materials.

Photostability studies measure how a drug substance or product degrades when exposed to UV and visible light.

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.

This test measures the concentration of the active ingredient at a specific point in time. For a searchable list of our drugs available for testing, visit the Potency Drug List.

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

ARL Bio Pharma can provide characterization of a biological product (includes determination of physiochemical properties, biological activity, immunochemical properties, purity and impurities) by appropriate techniques as necessary to allow relevant specifications to be established.

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.

Temperature excursion studies are designed to evaluate how a compounded preparation responds when exposed to short-term temperature or humidity fluctuations outside its labeled storage range, such as 40°C ± 2°C / 75% RH ± 5% for 24 or 48 hours. After exposure to the higher temperature and humidity, the compounded preparations are then tested for stability using a stability-indicating method.

This test measures the amount of carbon in a water sample and is conducted based on USP 643 requirements. Swabs may also be tested for total organic carbon for cleaning validation and to monitor process control. A total organic carbon measurement is not a replacement test for endotoxin or microbiological control.

This test measures the level of hazardous drug surface residue to verify workplace safety.

Water activity refers to the water in a drug product freely available to participate in reactions such as hydrolysis or provide an environment that supports microbiological growth.

Water activity is measured by calculating the vapor pressure of water in the test sample relative to the vapor pressure of pure water at the same temperature. ARL’s water activity instrument uses a chilled dew point sensor to measure water activity with ± 0.003 accuracy.