HPLC Method Standard
HPLC Method Standard
| item | specification |
|---|---|
| Identification | (1) infrared absorption <197K> (2) a solution containing 0.5 g in 10 ml of water meets the requirements of the test for sodium <191>. |
| Clarity and color of solution | Its absorbance is not greater than 0.35. |
| Specific rotation <781S> | -20 °~ -30.0 ° |
| Microbial enumeration <2021> | The total bacterial count does not exceed 1000 cfu / g, and the total combined molds and yeasts count does not exceed 100 cfu / g. It meets the requirements of the tests for absence of Salmonella species, and Escherichia coli. |
| pH <791> | 5.5 ~ 7.5 in a solution (1 in 100) |
| Loss on drying <731> | Not more than 10.0% |
| Residue on ignition <281> | 20.0% ~ 30.0% |
| Chloride <221> | Not more than 0.50% |
| Sulfate <221> | Not more than 0.24% |
| Heavy metals, Method II <231> | Not more than 0.002%. |
| Organic volatile impurities, Method I | Ethanol: not more than 0.5% |
| Electrophoretic purity <726> | Any individual impurity: not more than 2%. |
| Limit of protein | Not more than 6.0% |
| "Content of chondroitin sulfate sodium HPLC method" | 90.0%~105.0% |
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