CAS number： 104987-11-3
Molecular formula： C44H69NO12
molecular weight： 804.031
Chemical structure：
| Sr No. | Test | Specification | Result | |||
| 1 | Description | White crystals or white crystalline powder | White crystalline powder | |||
| 2 | Solubility | Very soluble in Methanol, Freely soluble in N,N-Dimethylformamide and in Alcohol, practically insoluble in water | Very soluble in Methanol, Freely soluble in N,N-Dimethylformamide and in Alcohol, practically insoluble in water | |||
| 3 | Identification BY IR | Compare the IR absorption spectrum of test sample with that obtained of a similar preparation of the corresponding refence spectrum of Tacrolimus. | The IR absorption spectrum of the test sample with that obtained of a similar preparation of the corresponding working standard | |||
| Identification By HPLC | The retention time of the major peak of the sample solution corresponds to that of the reference solution (a) as obtained in the assay test | Standard RT: 26.1 minutes Standard RT: 26.3 minutes Complies | ||||
| 4 | Water (by KF) | NMT 4.0% | 2.10% | |||
| 5 | Specific optical rotation 1% w/v solution in Dimethylformamide on an As is basis | -110.00 to -115.00 | -1120 | |||
| 6 | Heavy metals | NMT 10 ppm | Less than 10 ppm | |||
| 7 | Sulphated ash | NMT 0.1 % | 0.04% | |||
| Related substances (By HPLC) Method B | ||||||
| Ascomycin 19-epimer | NMT 0.1% | Not detected | ||||
| Ascomycin | NMT 0.5% | Below disregard limit | ||||
| 8 | Desmethyl tacrolimus | NMT 0.1% | Below disregard limit | |||
| 8 | Tacrolimus 8-epimer | NMT 0.1% | Not detected | |||
| Tacrolimus 8-propyl analog | NMT 0.15% | Below disregard limit | ||||
| Any individual unspecified impurity | NMT 0.10 % | Below disregard limit | ||||
| Total impurities (Excluding Tacrolimus open ring and Tacrolimus 19-epimer) | NMT 1.0 % | Nil | ||||
| 9 | Assay ( By HPLC) | NLT 98.0 % and NMT 102.0 % of C44H69NO12 , calculated on the anhydrous and solvent free basis | 98.80% | |||
| Residual solvents (By GC Headspace) | ||||||
| Acetone | NMT 1000 ppm | Below detection limit | ||||
| Di isopropyl Ether | NMT 100 ppm | 4 ppm | ||||
| 10 | Ethyl acetate | NMT 2000 ppm | Below detection limit | |||
| Acetonitrile | NMT 400 ppm | Below detection limit | ||||
| Toluene | NMT 250 ppm | Below detection limit | ||||
| Hexane | NMT 250 ppm | Below detection limit | ||||
| 11 | Particle size distribution | For information | d(0.1):9 µm | |||
| d (0.5):31 µm | ||||||
| d(0.9):89 µm | ||||||
| Microbial limit Tests | ||||||
| 12 | Total viable aerobic count | NMT 1000 cfu/g | Less than 10 cfu/g | |||
| Total mold and yeast count | NMT 1000 cfu/g | Less than 10 cfu/g | ||||
| Test for specified microorganism | Should be Absent/g | Absent /g | ||||
| E.coli | Should be Absent/10 g | Absent/10 g | ||||
| Salmonella spp | Should be Absent/g | Absent /g | ||||
| S.aureus | Should be Absent/g | Absent /g | ||||
| Pseudomonas aeruginosa | Should be Absent/g | Absent /g | ||||
| Candida albicans | Should be Absent/g | Absent /g | ||||
| Clostridium sporogeneses | Should be Absent/g | Absent /g | ||||
| Bile tolerant gram negative bacteria | Should be Absent/g | Absent /g | ||||
