Drug Development

Stability Studies

CBI routinely performs stability studies of protein, peptide, and organic pharmacophores. While each stability study is somewhat different, in general, CBI will maintain a sufficient number of vialed test aliquots under each of four different environmental conditions (following prescribed FDA and ICH guidelines)

• Room temperature, ambient humidity
• 4°C, ambient humidity
• 40°C, 75% relative humidity
• -20°C, ambient humidity

At each time point, up to one year in some cases, a certain number of vials are removed from each test condition and subjected to a series of analyses, which might include:

• Physical inspection
• Identification by RP HPLC
• Determination or purity by RP HPLC
• Dissolution profile
• Assessment of disintegration products by LC/ES/MS or MALDI-TOF/MS
• Determination of water content by the Karl Fisher technique

Typical time points for analysis are 0, 7 days, 14 days, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 9 months, 12, 15 18, 21, 24, 30 and 36 months.



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Commonwealth Biotechnologies, Inc. 601 Biotech Drive, Richmond, VA 23235 800-735-9224 (800-RELY-CBI) FAX: 804-648-2641 email: [email protected]