TESTS |
SPECIFICATIONSCriterion |
| Characters |
Light yellow powder and little smell of meat |
| Identification |
HPLC : identical with RS |
| Peptide mapping: identical with RS |
| Species of origin |
Conform requirement |
| Visible impurities |
Not present |
| Valence |
≥ 26 U/mg |
| Endotoxins (LAL) |
≤ 10 EU/mg |
| High molecular mass proteins(SEC) |
≤ 1.0 % |
| Loss on drying(105degC/24hours) |
≤ 10.0 % |
| Nitrogen(dried substance) |
14.5 to 16.5 % |
| Proinsulin(EIA/dried substance) |
≤ 10 ppm |
| Purity (HPLC) |
≥94.0% |
| Related substances (HPLC) |
A-21 desamido: ≤3.0% |
| Total others: ≤3.0% |
| Solvent residue |
Ethanol: ≤7% |
| Specific absorption (276nm/dried substance) |
9.6 to 11.2 |
| Sulphated ash (residue on ignition/dried substance) |
≤2.5% |
| Viable count |
≤30 CFU/g |
| Zinc (AAS/dried substance) |
≤1.04% |
