Customization: | Available |
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Function: | Pharmaceutical Medicine |
Certification: | GMP, FDA, ISO |
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Items | Standard | Results |
Appearance | White or off-white crystalline powder | White crystalline powder |
Identification | By IR: Conforms to Ref. Standard | Complies |
By Chlorides: It gives reaction of chloride | Complies | |
Water Content | ≤ 0.50% | 0.03% |
pH | 4.5~6.5 | 5.99 |
Heavy Metals | ≤ 20ppm | Complies |
Residual on Ignition | ≤ 0.10% | 0.02% |
Solution in Methanol | Clear and colorless | Complies |
Related Substances |
|
0.01% |
|
0.02 % | |
N-Methyl-3-phenyl-3-[3-(trifluoromethyl)phenoxy]propan-1-amine: ≤ 0.15% | 0.03% | |
Other single impurity: ≤ 0.10% | 0.02% | |
Total Impurities: ≤ 0.50% | 0.09% | |
Assay | 98.0%~102.0% | 99.87% |
Reference Standard | USP37/EP8.0 Standard | |
Conclusion | The product complied to USP37/EP8.0 standard. | |
Storage | Preserve in tight,light-resistant containers in a cool place |