Captisol® is supplied with a certificate of analysis (COA) of tests for physical, chemical and microbial quality attributes. For general raw material release CyDex suggests customers defer to their standard operating procedure and internal requirements. In lieu of that, CyDex recommends customers minimally perform physical appearance, infrared spectroscopy and Karl Fischer titration for moisture analysis. Dependent on the use of Captisol®, some customers may also prefer to perform an HPLC assay. CyDex provides this recommendation on the basis of the following: Captisol® is manufactured by a validated process; Captisol® is released by validated methods.
As there are no specific regulations for expiration dating of excipients, CyDex uses the following guidance from USP and IPEC Good Manufacturing Practices Guide for Bulk Pharmaceutical Excipients,
"If stability testing indicates a short re-evaluation interval under anticipated storage conditions (typically less than 2 years), the excipient should be labeled with an expiration or re-evaluation date. The expiration or re-evaluation date should be derived from appropriate stability testing, or from historical data if the excipient has been on the market for a long time. With few exceptions, expiration dates are not presently considered to be a general requirement for all Excipients provided that the stability of the excipient has been demonstrated. Thus, the absence of an expiration date is not objectionable".
A re-evaluation date allows for the re-analysis of the material and further use, if the material meets it quality attributes. An expiration date would render a material unusable after such date. As a result of its remarkable stability, Captisol® is assigned a recommended re-evaluation date (currently 5 years).
Captisol® standard is supplied as a current lot without further processing. CyDex recommends performing moisture analysis prior to use, as the material is hygroscopic. CyDex has assigned a retest date of two years for the Captisol® standard. This position is based on Captisol®'s 2 extreme stability when stored unopened and under the proper conditions of moisture protection.
When stored properly, on-going stability demonstrates Captisol® is stable 5 years.
Captisol® solutions have been shown to be stable under typical formulation conditions. For example a 40% w/w Captisol® solution in water was analyzed over a year and found to be stable. Cyclodextrins in general have been shown to degrade under extreme acidic conditions at elevated temperatures.
Captisol® should be stored at ambient temperature, protected from moisture.
View our easy-to-use PDF for more information on how to use Captisol®
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