Tacrolimus – Chemconpharma

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

- Description White to off white powder (Observation: white powder)
- Solubility Soluble in acetone, chloroform and ethylacetate, Insoluble in water (Observation: Soluble in acetone, chloroform and ethylacetate Insoluble in water)
- Identification
  - By IR The infrared spectrum of the test sample in KBr must be concordant with that of a similar preparation of Tacrolimus Monohydrate reference/working standard (Observation: The infrared spectrum of the test sample is concordant with Tacrolimus Monohydrate working standard StandardRT:25.0min)
  - By HPLC The retention time of the major peak in the chromatogram as obtained under assay rest (Observation: StandardRT:24.7min)
- Water(by KF) NMT 3.0% w/w (Observation: 2.0%)
- Specific Rotation(1.0% solution in chloroform,onanhydrous basis) Between -80℃ and -90℃ (Observation: -83℃)
- Melting Range Between 123℃ and 130℃ (Observation: 123℃ – 127℃)
- Heavy metals NMT 0.002% (Observation: Less than 0.002%)
- Residue on lgnition NMT 0.20% w/w (Observation: 0.04%)

Chromatographic ourity% (By HPLC)

- Impurity A (Ascomycin) NMT 0.15% (Observation: Below disregard limit)
- Impurity B (Dihydro Tacrolimus) NMT 0.15% (Observation: 0.05%)
- Impurity D (Detal Lactone) NMT 0.15% (Observation: Below disregard limit)
- Any individual unknown impurity NMT 0.10% (Observation: 0.05%)
- Tatal impuritise (Excluding Tautomers) NMT 1.0% (Observation: 0.20%)

Content of Tautomers(By HPLC) (Imp.C)

Tautomer I Report value (Observation: 0.30%)
Tautomer II Report value (Observation: 0.49%)
Tautomer I+II NMT 1.0% (Observation: 0.79%)
Assay 98.0% to 102.0% (Observation: 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: Saudi Arabia, Singapore, Syria, Philippines, Turkey, Turkmenistan, Afghanistan, Israel, Jordan, Pakistan, Russia, Uzbekistan, Yemen, Vietnam, Indonesia, Malaysia, Iran, Tajikistan, and so forth..

AFRICA: South Africa, Uganda, Ethiopia, Libya, Sudan, Congo, Gambia, Ivory Coast, Nigeria, Ghana, Kenya, Mauritius, Botswana, Egypt, and so forth.

NORTH & SOUTH AMERICA: Dominican Republic, Argentina, Guatemala, Guyana, Peru, Bolivia, Venezuela, USA, Canada, Panama, Trinidad and Tobago, Costa Rica, Puerto Rico, Brazil, Bahamas, Ecuador, and so forth .

EUROPE: France, Georgia, Germany, Hungary, Ireland, Iceland, Netherlands, Norway, Austria, Azerbaijan, Belarus, Belgium, Cyprus, Czech Republic, Denmark, Poland, Spain, Sweden, Switzerland, Ukraine, United Kingdom (UK) , Latvia, and so forth.

OCEANIA: Fiji, Australia, New Zealand, and so forth.