- E-mail : info@cixmechpharma.com
Tacrolimus is used together with other medicines to prevent the body from rejecting a transplanted organ (eg, kidney, liver, or heart). tacrolimus may be used with steroids, azathioprine , basiliximab, or mycophenolate mofetil . Tacrolimus belongs to a group of medicines known as immunosuppressive agents.
Specification:
|
TEST ITEMS |
STANDARDS |
OBSERVATION |
|
Description |
White to off white powder |
white powder |
|
Solubility |
Soluble in acetone, chloroform and ethylacetate. Insoluble in water. |
Soluble in acetone, chloroform and ethylacetate. Insoluble in water. |
|
Identification By IR
By HPLC |
The infrared spectrum of the test sample in KBr must be concordant with that of a similar preparation of Tacrolimus Monohydrate reference/working standard.
The retention time of the major peak in the chromatogram as obtained under assay rest. |
The infrared spectrum of the test sample is concordant with Tacrolimus Monohydrate working standard.
StandardRT:25.0min StandardRT:24.7min |
|
Water(by KF) |
NMT 3.0% w/w |
2.0% |
|
Specific Rotation(1.0% solution in chloroform,onanhydrous basis) |
Between -80℃ and -90℃ |
-83℃ |
|
Melting Range |
Between 123℃ and 130℃ |
123℃ - 127℃ |
|
Heavy metals |
NMT 0.002% |
Less than 0.002% |
|
Residue on lgnition |
NMT 0.20% w/w |
0.04% |
|
Chromatographic ourity% (By HPLC) |
||
|
Impurity A (Ascomycin) |
NMT 0.15% |
Below disregard limit |
|
Impurity B (Dihydro Tacrolimus) |
NMT 0.15% |
0.05% |
|
Impurity D (Detal Lactone) |
NMT 0.15% |
Below disregard limit |
|
Any individual unknown impurity |
NMT 0.10% |
0.05% |
|
Tatal impuritise (Excluding Tautomers) |
NMT 1.0% |
0.20% |
|
Content of Tautomers(By HPLC) (Imp.C) |
||
|
Tautomer I |
Report value |
0.30% |
|
Tautomer II |
Report value |
0.49% |
|
Tautomer I+II |
NMT 1.0% |
0.79% |
|
Assay |
98.0% to 102.0% |
99.0% |
Packaging details:
|
Packaging details: |
25kg/drum with double plastic bags inside; packed in a cardboard drum or fiber HDPE drum. |
|
Storage: |
Stored in a clean, cool, dry area; keep away from moisture and strong, direct light/heat |
|
Shelf Life: |
5 years if sealed and store away from direct sun light. |
