BP/USP/EP
Antibiotic and Antimicrobial Agents
GMP
Medicine Grade
Chemical Reagent
Solid
Not Volatile
SINOAH
25kg/Drum
USP/BP
China
3004101110
Product Description
veterinary medicines with GMP Tilmicosin Phosphate
Specification:
Specification:
| Product Name | Tilmicosin Phosphate | Batch No. | 201903061 | |||
| Quantity | 1500KG | MFG. Date | MAR.10, 2019 | |||
| Date of analysis | MAR.14, 2019 | EXP. Date | MAR.09, 2021 | |||
| Analysis Item | Standard | Test results | Items Conclusion | |||
| Appearance | Type white to yellow powder | Pale yellow powder | Conforms | |||
| Solubility | Soluble in water, no visible evidence of contamination of foreign matter | Conforms | Conforms | |||
| Identification | IR spectra is consistent with CRS. | Conforms | Conforms | |||
| The retention time of the major peak of the assay preparation corresponds to that of the standard preparation, as obtained in the assay. | Conforms | Conforms | ||||
| Positive in phosphate test | Conforms | Conforms | ||||
| PH | 5.0~8.0 | 7.6 | Conforms | |||
| Water | ≤5.0% | 1.2% | Conforms | |||
| Cis-Isomer | 82.0%~88.0% | 86.1% | Conforms | |||
| Trans-Isomer | 12.0%~18.0% | 13.9% | Conforms | |||
| Residue on Ignition | ≤5.0% | 2.0% | Conforms | |||
| Heavy Metal | ≤30PPM | Conforms | Conforms | |||
| Assay | ≥75.0% (Tilmicosin assay dried) | 77.5% | Conforms | |||
| Conclusion | Complies with the requirements of Enterprise Standard. | |||||
