TB-500

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

TB-500 is a synthetic seven-residue fragment corresponding to the actin-binding region of thymosin beta-4. Material is traded both as the free acid and as the acetate salt, and the counterion fraction is a frequent source of overstated potency.

Lots are commonly supplied with purity above 98 percent by HPLC while peptide content sits nearer 80 percent once water and acetate are accounted for. The two figures must be multiplied before any price comparison is meaningful.

Typical related substances

Typical related substances include truncated fragments, acetylated variants and high water and acetate fractions.

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.