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

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

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.

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).

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.

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.

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.

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