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.
|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.|
|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.
|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:||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.|
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.