Complaint
| Items | Specifications | Test Method |
| 1 Description | Clear, colorless slightly greenish-yellow, viscous, oily liquid. Ph.Eur /USP/FCC | Visual |
| 2 Identification | ||
| A optical rotation | -0.01°~ +0.01°, Ph.Eur | Ph.Eur 2.2.7 |
| B IR | To conform, Ph.Eur /USP/FCC | Ph.Eur 2.2.24 |
| B Color reaction | To conform, USP/FCC | USP |
| C Retention time, GC | To conform, USP/FCC | GC |
| 3 Related Substances | Ph.Eur 2.2.28 | |
| Impurity A | ≤ 0.5%, Ph.Eur | |
| Impurity B | ≤ 1.5%, Ph.Eur | |
| Impurity C | ≤ 0.5%, Ph.Eur | |
| Impurities D and E | ≤ 1.0%, Ph.Eur | |
| Any other impurity | ≤ 0.25%, Ph.Eur | |
| Total impurities | ≤ 2.5%, Ph.Eur | |
| 4 Acidity | ≤ 1.0ml, USP/FCC | USP/FCC |
5 Residual Solvents | To conform | Ph.Eur 2.4.24 USP <467> |
| 6 Heavy metals Pb | ≤ 2mg/kg, FCC | AA |
| 7 Arsenic | ≤ 1mg/kg (in-house) | ChP 0822 |
| 8 Copper | ≤ 25mg/kg (in-house) | ICP-MS |
| 9 Zinc | ≤ 25mg/kg (in-house) | |
| 10 Pd | ≤ 5mg/kg (in-house) | AA |
| 11 Assay | 96.5%~102.0% Ph.Eur 96.0%~102.0% USP/FCC | Ph.Eur 2.2.28 |
| 12 *Microbiological tests | ||
| Total aerobic microbial count | ≤1000cfu/g, Ph.Eur /USP | USP<61> Ph. Eur.2.6.12 |
| Total yeasts and moulds count | ≤100cfu/g, Ph.Eur /USP | |
| Escherichia coli | n.d./g, Ph.Eur /USP | USP<62> Ph. Eur.2.6.13 |
| Pseudomonas aeruginosa | n.d./g, Ph.Eur /USP | |
| Staphylococcus aureus | n.d./g, Ph.Eur /USP | |
| Enterobacteria | n.d./g, Ph.Eur /USP | |
| Salmonella | n.d./10g, Ph.Eur /USP |
