The Pure ChainCJC-1295 w/ DAC
Regulatory status
Placed in Category 2 of FDA's 503A bulk drug substances list — significant safety risks identified. Not eligible for 503A compounding. Available to verified facilities for research and manufacturing use.
Summary
CJC-1295 with drug affinity complex carries a maleimidopropionic acid group intended to bind serum albumin. The conjugation step adds cost and adds a characteristic set of related substances not present in the non-DAC form.
Purchasing staff should confirm on the certificate of analysis that the DAC group is present and quantified, since mislabelled non-DAC material is the most common substitution we see in this line.
Typical related substances
Typical related substances include unconjugated CJC-1295, hydrolysed maleimide adducts and succinimide ring-opened variants.
Regulatory note
Category 2 of the FDA 503A bulk drug substances list. Not eligible for 503A compounding.
Regulatory status shown is our current understanding and is not legal advice. Each facility is responsible for confirming eligibility for its own licence type before purchase.