Product Category

Tacrolimus

  • Product Name : Tacrolimus
  • Grade : IP / BP / USP
  • Therapeutic Category : Immune Suppressant
  • CAS No : 104987-11-3
  • COA : Available
  • MSDS : Available
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Description

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.