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Moxifloxacin Hydrochloride IP

Uses: Moxifloxacin hydrochloride is an antibiotic prescription medicine approved by the U.S. Food and Drug Administration (FDA) for the treatment of certain bacterial infections, such as acute worsening of chronic bronchitis, acute sinus infections, community-acquired pneumonia, plague, and skin and abdominal infections
Identifiers
CAS No:
[192927-63-2]
BRN No:
-
UN No:
-
Properties
Molecular Formula:
C21H24FN3O4.HCL.H2O
Molecular Weight:
455.90 g/mol

Specifications

Sr. No. Test Limits
1 Description Light yellow or yellow crystalline powder,
slightly hygroscopic.
2 Solubility Sparingly soluble in Water, Slightly soluble
in Ethanol (96.0%) and Practically
insoluble in Acetone.
3 Identification
a) By FTIR The IR spectrum of the sample should be
concordant with that of the working Standard.
b) By Test for Chloride Should be positive.
4 Appearance of solution Should comply to the test
5 pH test (0.2% Solution in Water) Between 3.9 and 4.6
6 Water by KF (%, w/w) Not more than 4.5
7 Specific Optical Rotation ()
(C=1% in Acetonitrile: Water (50:50, v/v)
at 25C,On anhydrous basis)
Between -125.0 and -138.0
8 Sulphated Ash (%, w/w) Not more than 0.1
9 Related substance by HPLC (%, w/w)
Impurity A Not more than 0.1
Impurity B Not more than 0.1
Impurity C Not more than 0.1
Impurity E Not more than 0.1
Any unspecified impurity Not more than 0.1
Total impurities Not more than 0.3
10 Assay by HPLC (%, w/w)
(As
C21H25CIFNO3O4
,
On anhydrous basis)
Between 98.0 to 102.0
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