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C17H18FN3O3•HCl•H2O
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Description Back to Top
Ciprofloxacin Hydrochloride, USP is used as an antibiotic and in the treatment of bacterial infections. All Spectrum Chemical USP grade products are manufactured, packaged and stored under current Good Manufacturing Practices (cGMP) per 21CFR part 211 in FDA registered and inspected facilities.
1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-monohydrochloride, monohydrate;
Specifications Back to Top
Test | Specification | |
---|---|---|
Min | Max | |
ASSAY (ANHYDROUS BASIS) | 98.0 | 102.0 % |
pH OF A 1 IN 40 SOLUTION | 3.0 | 4.5 |
WATER DETERMINATION | 4.7 | 6.7 % |
RESIDUE ON IGNITION | 0.1 % | |
ELEMENTAL IMPURITIES | AS REPORTED | |
ORGANIC IMPURITIES | ||
CIPROFLOXACIN ETHYLENDIAMINE ANALOG | 0.2 % | |
FLUOROQUINOLONIC ACID | 0.2 % | |
ANY INDIVIDUAL, UNSPECIFIED IMPURITY | 0.2 % | |
TOTAL IMPURITIES | 0.5 % | |
IDENTIFICATION A (FTIR) | SPECTRUM MATCHES REFERENCE | |
IDENTIFICATION (B) | RETENTION TIME CORRESPONDS TO STANDARD | |
IDENTIFICATION (C) | POSITIVE FOR CHLORIDE | |
DATE OF MANUFACTURE | ||
EXPIRATION DATE | ||
APPEARANCE | ||
RESIDUAL SOLVENTS | AS REPORTED |
Regulatory Documents Back to Top
Shipping & Storage Back to Top