Rifabutin 72559-06-9

998ug/mg, USP42

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Product Information

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

COA of Rifabutin

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
Identification	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

Usage

Rifabutin (LM427) is a rifamycin derivative containing a spiropiperazine group with broad-spectrum antibacterial activity. Its mechanism of action is the same as that of rifampicin, which can form a stable combination with the β subunit of the DNA-dependent RNA polymerase of microorganisms, inhibit the activity of this enzyme, and thereby inhibit the synthesis of bacterial RNA. It has been approved in foreign countries for the prevention and treatment of HIV-infected patients with Mycobacterium avium-Mycobacterium intracellulare complex (MAC) widely disseminated infection, and also for the treatment of multidrug-resistant tuberculosis.

*Products under the patent are only for R&D use