Tacrolimus

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:

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.