Description
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. |
Additional Information
The most widely recognized markets for this item incorporate the accompanying nations. If you don’t mind ask with us if your nation or district isn’t recorded:
ASIA: Afghanistan, Israel, Jordan, Pakistan, Russia, Saudi Arabia, Singapore, Syria, Philippines, Turkey, Turkmenistan, Uzbekistan, Yemen, Vietnam, Indonesia, Malaysia, Iran, Tajikistan, and so forth.
AFRICA: South Africa, Uganda, Nigeria, Ghana, Kenya, Mauritius, Botswana, Egypt, Ethiopia, Libya, Sudan, Congo, Gambia, Ivory Coast , and so forth.
NORTH & SOUTH AMERICA: USA, Canada, Panama, Trinidad and Tobago, Costa Rica, Puerto Rico, Dominican Republic, Argentina, Guatemala, Guyana, Peru, Bolivia, Venezuela , Brazil, Bahamas, Ecuador, and so forth .
EUROPE: Austria , Azerbaijan, Belarus, Belgium, Cyprus, Czech Republic, Denmark, France, Georgia, Germany, Hungary, Ireland, Iceland, Netherlands, Norway, Poland, Spain, Sweden, Switzerland, Ukraine, United Kingdom (UK) , Latvia, and so forth.
OCEANIA: Australia, New Zealand, Fiji, and so forth.
