Basic Info
Model No.: LYN- 104987-11-3
CAS: 104987-11-3
Name:: Tacrolimus Monohydrate
Shelf Life: 2 Years
Sample: Available
Additional Info
Packaging: 25kg/Drum
Productivity: 10000kg
Brand: zhishang
Transportation: Ocean,Land,Air
Place of Origin: Shandong, China (Mainland)
Supply Ability: in stock
Certificate: ISO CE
HS Code: 1060.24000
Port: Shanghai,Tianjin,Qingdao
Product Description
API Tacrolimus, CAS104987-11-3, GMP/DMF manufacturer
Introduction:
Tacrolimus is a macrolide immunosuppressant produced by Streptomyces tsukubaensis. Tacrolimus is used to prevent rejection of organ transplants. Tacrolimus is 10 to 100 times superior to cyclosporin in improving graft survival and preventing acute rejection after transplantation, but decreasing the toxin side effects.
Certificate of Analysis for Tacrolimus :
Tests | Specifications | Results |
Description | A white or off-white crystalline powder | Conform |
Identification | 1. IR (USP <197K>) | Conform |
2. HPLC retention times | Conform | |
Water (USP <921> Method I) | 1.6 ~ 3.0% | 2.1% |
Residue on ignition (USP <281>) | £ 0.2% | 0.08% |
Heavy metals (USP <231> II) | £ 20 ppm | < 20 ppm |
Related substances (In-house HPLC method) | Ascomycin £ 0.8% | 0.064% |
Dihydrotacrolimus £ 0.6% | 0.089% | |
Total impurities £ 1.5% | 0.15% | |
Residual solvents (In-house method) | Acetone £ 2000 ppm | Not detected |
Ethanol £ 2000 ppm | Not detected | |
Assay (on anhydrous basis) | 98.0% ~ 102.0% | 100.0% |
Conclusion: Complied with In-House standard | ||
