21 C.F.R. § 73.2120
(b) Specifications. Disodium EDTA-copper shall conform to the following specifications and shall be free from impurities other than those named to the extent that such impurities may be avoided by good manufacturing practice:
Total copper, not less than 13.5 percent. Total (ethylene-dinitrilo) tetracetic acid, not less than 62.5 percent. Free copper, not more than 100 parts per million. Free disodium salt of (ethylene-dinitrilo) tetraacetic acid, not more than 1.0 percent. Moisture, not more than 15 percent. Water insoluble matter, not more than 0.2 percent. Lead (as Pb), not more than 20 parts per million. Arsenic (as As), not more than 3 parts per million.