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Tacrolimus

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

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 common markets for this product include the following countries. Please inquire with us if your country or region is not listed:

Asia: Afghanistan, Israel, Jordan, Pakistan, Russia, Saudi Arabia, Singapore, Syria, Philippines, Turkey, Turkmenistan, Uzbekistan, Yemen, Vietnam, Indonesia, Malaysia, Iran, Tajikistan, etc.

Africa: South Africa, Uganda, Nigeria, Ghana, Kenya, Mauritius, Botswana, Egypt, Ethiopia, Libya, Sudan, Congo, Gambia, Ivory Coast , etc.

North & South America: USA, Canada, Panama, Trinidad and Tobago, Costa Rica, Puerto Rico, Dominican Republic, Argentina, Guatemala, Guyana, Peru, Bolivia, Venezuela , Brazil, Bahamas, Ecuador, etc .

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, etc.

OCEANIA: Australia, New Zealand, Fiji, etc.

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