| Customization: | Available |
|---|---|
| Certification: | ISO, FDA |
| Assay Method: | HPLC, UV, Gc |
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| Items | Specification | Result |
| Appearance | Yellow or Orange crystalline powder | Yellow crystalline powder |
| Odorless and no taste | Odorless and no taste | |
| Melting point about 48C | 49.1-50.9C | |
| Color reaction | Positive | Positive |
| Identification | Corresponds qualitatively to HPLC reference should be similar to IR that of the reference solutions (a) |
complies |
| Related substance | Any impurity: not more than 0.5% Total impurity: not more than 1.0% Impurity F: not more than 0.5% |
max 0.4% 1.0% Complies |
| Suplphated ash | Not more than 0.1% | 0.03% |
| Heavy metals | Not more than 0.002% | max0.002% |
| Assay | 97.0 percent to 103.0 percent | 99.65% |
| Arsenic | Not more than 2 ppm | max2ppm |
| Microbial limits | Total plate counts: not more than 1000cfu/g Yeast & molds: not more than 100cfu/g E.coli: negative |
max100cfu/g max10cfu/g negative |
| Residual solvents | Hexane: not more than 0.029% Ethyl acetate: not more than 0.5% Ethanol: not more than 0.5% |
complies complies complies |
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