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99% up by HPLC Rifabutin LM427 72559-06-9 CAS NO.72559-06-9
- Min.Order: 0 Metric Ton
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- Product Details
Keywords
- Rifabutin
- Rifabutin powder
- LM427
Quick Details
- ProName: 99% up by HPLC Rifabutin LM427 72559-0...
- CasNo: 72559-06-9
- Molecular Formula: C46H62N4O11
- Application: API
- ProductionCapacity: Metric Ton/Day
- Purity: 99% up by HPLC
- LimitNum: 0 Metric Ton
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Details
|
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 |
|
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.
