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Stability and Solubility Studies

Chemical and physical stability

The stability study intends to evaluate the API's chemical and physical stability in solution and solid-state. The solid-state evaluation will probe the propensity of form change, crystallization (for amorphous), and deliquescence (for salts). The chemical stability testing will screen the set of conditions in which the API is unstable and could cause difficulties in development.

 

Our chemical and physical stability services include a range of monitored temperature, humidity, and light stability storage cabinets which comply with ICH Guidelines.

 

Solubility

Crystal Pharmatech also can measure the solubility of compounds under a variety of conditions. The data obtained from these studies are necessary for obtaining outputs such as preclinical dose number, DCS evaluation, and preclinical decision tree.

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bd_global@crystalpharmatech.com +1-609-604-8303
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6800 Kitimat Rd, Unit 1, Mississauga, Ontario, Canada L5N 5M1
China
Suite B4-101, Biobay, 218 Xinghu Street, Suzhou Industrial Park, Suzhou, China, 215123
Suite 500-B, 3000 Eastpark Blvd, Cranbury, New Jersey 08512, USA
bd_global@crystalpharmatech.com +1-609-604-8303