Certification: | GMP, FDA, ISO |
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Grade Standard: | Medicine Grade |
Type: | Chemicals |
State: | Solid |
Volatile: | Not Volatile |
Appearance: | Practically White Crystals or Crystalline Powder |
Customization: |
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Items | Standards | Results |
Appearance | Practically white crystals or crystalline powder, having a faint odor | Complies |
Identification | A)By IR | Complies |
B)Levomethorphan content by HPLC: ≤ 0.10% | ND | |
Solubility | Freely soluble in alcohol and in chloroform, sparingly soluble in water, insoluble in ether | Complies |
Melting Point | About 126.0ºC | 127ºC |
pH(1% w/v solution) | 5.2~6.5 | 5.6 |
Water Content(KF) | 3.5%~5.5% | 5.1% |
Residue on Ignition | ≤ 0.10% | Complies |
Limit of Phenolic compounds | No blue-green color develops | Complies |
Limit of N,N-Dimethylaniline | ≤ 0.001% | < 0.001% |
Residual Solvent (by GCHS) |
Methanol: ≤ 3000ppm | ND |
Acetone: ≤ 5000ppm | ND | |
Toluene: ≤ 890ppm | ND | |
Residual Solvent (by HPLC) |
Formic Acid: ≤ 5000ppm | ND |
Acetic Acid: ≤ 5000ppm | ND | |
Assay by HPLC (On anhydrous basis) |
98.0%~102.0% | 100.70% |
Reference Standard | USP41 Standard | |
Conclusion | The product complied to USP41 standard. | |
Storage | Preserve in tight,light-resistant containers, protect from moisture and store around 25ºC. |
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