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Tacrolimus monohydrate



Molecular Formula:C44H69NO12.H2O
Molecular Weight:822.0389
CAS Registry No: 109581-93-3
Systematic Name:
  • 15,19-Epoxy-3H-pyrido(2,1-c)(1,4)oxaazacyclotricosine- 1,7,20,21(4H,23H)-tetrone, 5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro- 5,19-dihydroxy-3-(2-(4-hydroxy-3-methoxycyclohexyl)-1- methylethenyl)-14,16-dimethoxy-4,10,12,18-tetramethyl-8-(2- propenyl)-, monohydrate, (3S- (3R*,(E(1S*,3S*,4S*)),4S*,5R*,8S*,9E,12R*,14R*,15S*,16R*,18S*,19S*,26aR*))-
StorageStore below 25C, protect from light and moisture
Shelf Life2 year(s)
Specification
Appearance white to off white powder
Solubility soluble in acetone, chloroform and ethyl acetate, insoluble in water
Identification a) Infrared spectrum of the sample in KBr must be concordant with that of a similar preparation of tacrolimus working standard
b) The retention time of the major peak in the chromatogram of sample corresponds to the standard as obtained under assay test
Water(KF)
not more than 0.3% w
w
Specific rotation-80C to -90C (1.0% solution in chloroform, on anhydrous basis)
Melting range123C to 130C
Heavy metalsnot more than 0.002%
Residue on ignition
not more than 0.2% w
w
Chromatographic purityimpurity A (accomycin): not more than 0.15%
impurity B (dihydro tacrolimus): not more than 0.15%
impurity D (delta lactose): not more than 0.15%
any other impurity: not more than 0.10%
total impurities (excluding tautomers): not more than 1.0%
Content of Tautomerstautomer I: not more than 0.5%
tautomer II: not more than 1.0%
tautomers (I+II): not more than 1.0%
Residual solvents acetone: not more than 1000ppm
di isopropyl ether: not more than 600ppm
ethyl acetate: not more than 2000ppm
acetonitrile: not more than 400ppm
toluene: not more than 250ppm
hexane: not more than 250ppm
Particle sized(0.9): not more than 100microns
Microbial tests
total aerobic microbial count : not more than 1000cfu
g
total mold and yeast count : not more than 100cfu
g
escherichia coli : should be absent
g
salmonella spp : should be absent
g
staphylococcus aureus : should be absent
g
pseudomonas aeruginosa : should be absent
g
Bacterial endotoxins
not more than 25EU
mg
Assay98.0% to 102.0%
1)1) by hplc, 2)by hplc 3)by hplc(%w/w on anhydrous basis, excluding tautomers)
RemarkNone
Pharmacopoeial QualityIn-House