Chemical grade:
| ITEMS | SPECIFICATION |
| Description | Should be white crystals or white crystal powder with a slight characteristic odor. Hygroscopic. |
| Dissolution | Readily soluble in water,moderately soluble in 95% alcohol,practically insoluble in chloroform and ether. |
| Indentification | (1) Should be positive respond (2) IR grahs should be conforms to the reference standard |
| pH | 7.5~9.0 |
| Clarity | Should be clear |
| Color | Should be colorless |
| Water | 19~21% |
| Assay | No less than 99.0% and not more than 101.0% of C6H14N2O2·2H2O |
Oral grade:
| ITEMS | SPECIFICATION |
| Description | Should be white crystals or white crystal powder with a slight characteristic odor. Hygroscopic. |
| Dissolution | Dissolve 0.200 g in 20 ml of water . The solution is not more opalescent than reference suspension I (EP2.2.1) and colorless (EP2.2.2). |
| Indentification | (1) Should be positive respond (2) IR grahs should be conforms to the reference standard |
| Clarity | Should be clear |
| Color | Should be colorless |
| pH | 7.5 - 9.0 |
| Chlorides | Nmt 0.01% |
| Any detectable impurity | Nmt0.10% |
| Sum of impurities | Nmt1.0% |
| Water | 19~21% |
| Imp a | Nmt0.10% |
| Sulfates | Nmt 0.05% |
| Sulphated ash | Nmt 0.1% |
| Heavy metal | Nmt0.001% |
| Methanol | Nmt3000ppm |
| Ethanol | Nmt5000ppm |
| Isopropanol | Nmt5000ppm |
| toluene | Nmt890ppm |
| Phenylethylene | Nmt20ppm |
| Assay | No less than 99.0% and not more than 101.0% of C6H14N2O2·2H2O |
Injection grade:
| ITEMS | SPECIFICATION |
| Description | Should be white crystals or white crystal powder with a slight characteristic odor. Hygroscopic. |
| Dissolution | Dissolve 0.200 g in 20 ml of water . The solution is not more opalescent than reference suspension I (EP2.2.1) and colorless (EP2.2.2). |
| Indentification | (1) Should be positive respond (2) IR grahs should be conforms to the reference standard |
| Clarity | Should be clear |
| Color | Should be colorless |
| pH | 7.5 -9.0 |
| Chlorides | Nmt 0.01% |
| Any detectable impurity | Nmt0.10% |
| Sum of impurities | Nmt0.50% |
| Water | 19.7~21% |
| Sulphated ash | Nmt 0.05% |
| Heavy metal | Nmt0.001% |
| Methanol | Nmt3000ppm |
| Ethanol | Nmt5000ppm |
| Isopropanol | Nmt5000ppm |
| toluene | Nmt890ppm |
| Phenylethylene | Nmt20ppm |
| Bacterial Endotoxins | Nmt0.35Eu/mg |
| Assay | No less than 99.0% and not more than 101.0% of C6H14N2O2·2H2O |
| TAMC | Nmt100/g |
| TYMC | Nmt100/g |
| Pseudomonns acruginosa | ND |
| Escherichla coll | ND |
| Staphylococcus aurcus | ND |