Specification
The Sunshine Standard
The complete specification a lot must meet before it is released.
Release panel, every lot
| Test | Method | Specification |
|---|---|---|
| Purity | RP-HPLC, UV detection at 214 nm | Greater than 98% |
| Identity | HPLC retention time against a certified reference standard | Matches |
| Quantity | HPLC-UV | Label claim within the stated tolerance |
| Bacterial endotoxin | Kinetic LAL, USP <85> | Within the limit on the certificate, in EU/mg |
| Chromatogram | Full HPLC trace | Printed on the certificate |
Extended screens, published when run
| Test | Method | Specification |
|---|---|---|
| Sterility | USP <71> | No growth |
| Heavy metals | ICP-MS for As, Cd, Pb and Hg | Not detected |
| Residual solvents | GC-MS, USP <467> | Within limits |
| Trifluoroacetic acid | Ion chromatography | Reported |
Manufacturing and handling
| Control | Method | Specification |
|---|---|---|
| Batch records | cGMP documentation practice | Retained per lot |
| Quality system | ISO 9001:2015 | Certified facility |
| Appearance | Visual vial inspection | Intact seal, uniform cake |
| Cold chain | Insulated liner and cold pack | 2 to 8 degrees Celsius, every order |