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 |