99% up by HPLC Rifabutin LM427 72559-06-9

Product name

Rifabutin

CAS No.

72559-06-9

Molecular Formula

C46H62N4O11

Molecular Weight

847.00

Molecular Structure

Quality Standard

98.5% up by HPLC

Appearance

Reddish-violet amorphous powder

ITEMS

STANDARDS

RESULTS

Appearance

Reddish-violet amorphous powder

Reddish-violet amorphous powder

Identification

A.   The infrared absorption spectrum of test sample corresponds to that of rifabutin CRS.

Meet requirements

B.   The retention time of the major peak in the chromatogram of the assay preparation corresponds to that in the chromatogram of the Standard preparation obtained as directed in the assay.

Meet requirements

Solubility

It is soluble in chloroform and methanol, slightly soluble in ethanol, and very slightly soluble in water

Meet requirements

Water

≤2.5%

1.0%

Limit of N-isobutylpiperidone

No spot in the chromatogram of the test solution at an RF value corresponding to that of N-isobutylpiperidone is more intense than that of the principal spot observed in the chromatogram obtained from the Standard solution containing 0.05mg of N-isobutylpiperidone per mL(0.5%)

Meet requirements

Chromatographic purity

Any impurity peak detected at a retention time of about 0.5, 0.6, 0.8, or 1.4 relative to the retention time of the rifabutin peak does not exceed 1.0%

RRT0.5: 0.04%

RRT0.6: 0.1%

RRT0.8: 0.06%

RRT1.4: 0.1%

Not more than 0.5% of any other impurity is detected.

0.2%

The total of all impurity peaks is not more than 3.0%

0.9%

Residual solvents

Acetone≤5000ppm

N.D.

Pyridine≤200ppm

N.D.

Dichloromethane≤600ppm

111ppm

Ethanol≤5000ppm

127ppm

Dimethylformamide≤880ppm

N.D.

Ethylene glycol monomethyl ether≤50ppm

N.D.

Tetrahydrofuran≤720ppm

N.D.

Ethyl acetate≤5000ppm

N.D.

Cyclohexane≤3880ppm

91ppm

Benzene≤2ppm

N.D.

Microbial limits

TAMC≤103cfu/g

10cfu/g

TYMC≤102cfu/g

<1cfu/g

E.Coli(1g): Absent

N.D.

Assay

950ug/mg~1020ug/mg

(calculated on the anhydrous basis)

998ug/mg

Conclusion

Conforms to USP42