Complaint
Name | Pidotimod |
Synonyms | (4R)-3-[[(2S)-5-Oxo-2-pyrrolidinyl]carbonyl]-4-Thiazolidinecarboxylic acid |
Brand | Salus |
Molecular Formula | C9H12N2O4S |
Molecular Weight | 244.27 |
CAS Registry Number | 121808-62-6 |
| Application | |
| Drug Indication | For use as immunostimulant therapy for treatment of cell-mediated immunosuppression with respiratory or urinary infections. Product Categories : Bioscience, Immunosuppressant Ingredients |
| Formulations/Preparations | Solution,Tablet |
| Product Name | Pidotimod | ||
| Batch Number | Z20180901 | ||
| Production Date | 2018.9. 3 | ||
| Batch Quantity | 24000G | ||
| Analysis Date | 2018.9. 4 | ||
| Expiry Date | 2020.9. 2 | ||
| Certificate Date | 2018.9. 15 | ||
| Item | Test Standard | Testing Result | |
| CBD | Not less than (NLT) 99.5% 99.9% | ||
| THC | Not detected | Undetected | |
| Assay | Method HPLC calculated on the anhydrous basis limit of quotation (LOQ) 0.8ppm | ||
| Appearance | White powder | White powder | |
| Identification | In the recorded chromatograms under the determination of the substance, retention time of the main peak of the solution should be consistent with the retention of time of the main peak of the reference solution | Complies | |
| Melting Point | 65~66ºC | 65.5ºC | |
| Loss on Drying | NMT 1.0% | 0.21% | |
| Residual solvents | Ethanol NMT 400ppm Heptane NMT 400ppm | 1.92ppm 256.0ppm | |
| Heavy Mental | NMT 20ppm | Complies | |
| Microbial Limite Test | Method: Plate Counting | ||
| Total aerobic bacteria count | NMT 1000cfu/g | Complies | |
| Combined molds and yeast | NMT 100cfu/g | Complies | |
| E. Coli | Not detacted per gram | Complies | |
| Salmanella | Not detacted per 10 gram | Complies | |
| Conclusion: Conform the testing result is qualified | |||
Storage: Closed container. Dry & cool. Keep away from moisture &strong light
Shelf life: 24 Months
