General Information:
Type: Excipient| Items | Standard |
| Appearance |
White to slightly creamy white,
hygroscopic powder or flakes |
| Identification | A. An orange -yellow precipitate is formed |
| B.A pale blue precipitate is formed | |
| C.A deep red colour is produced | |
| PH(1 in 20) | 3.0~7.0 |
| Water | ≤5.0% |
| Residue on ignition | ≤0.1% |
| Lead | ≤ 10ppm |
| Aldehydes | ≤0.05% |
| Hydrazine | ≤ 1ppm |
| Vinylpyrrolidone | ≤0.2% |
| Peroxides | ≤400ppm |
| K-value | 27.0~32.4 |
| Assay(Nitrogen) | 11.5~12.8% |
| TAMC | ≤ 1000 cfu/g |
| TYMC | ≤ 100 cfu/g |
| Staphylococcus Aureus | Negative in 10g |
| Salmonella | Negative in 10g |
| Pseudomonas Aeruginosa | Negative in 10g |
| E.Coli | Negative in 10g |