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CAS NO.86483-48-9
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CERTIFICATE OF ANALYSIS
Name: Ciprofloxacin Hydrochloride
Batch Number: 20101012
Batch Size: 2000kg Packing Size: 25kg/drum
Certificate No.:20101012 Manu Date: October 12, 2010
Date of Release: October 14, 2010 Expiry Date: October 11, 2013
ANALYSIS AS PER USP 32
|
Items of Test |
Standard |
Result of Test |
|
Appearance |
White or light yellow crystalline powder |
conform |
|
Identification (a) IR
(b) TLC
(c) the reaction of chloride |
IR spectrum of sample corresponds to that of reference standard. The intensity and RF value of the principal band obtained from the test solution corresponds to that obtained from the standard solution. A solution of IIresponds to the tests of chloride |
Conform
Conform
Conform |
|
Related substances HPLC |
Chromatographic purity ≤ 0.2% Ciprofloxacin ethylenediamine analog ≤ 0.2% Unspecified impurity ≤ 0.50% Total impurities ≤ 0.5% |
0.15% <0.11% 0.40% |
|
Ph |
3.0-4.5 |
3.7 |
|
Heavy metals |
≤20ppm |
<20ppm |
|
Fluoroquinolonic acid |
≤0.2% |
Conform |
|
Sulphated ash |
≤0.04% |
<0.04% |
|
Water |
4.7%-6.7% |
5.90% |
|
Residue of ignition |
≤0.1% |
0.05% |
|
Residual solvent |
ethanol ≤ 5000ppm Isoamyl alcohol≤ 4000ppm |
560ppm Not found |
|
Assay (HPLC) |
98.0%-102% |
99.8% |
Conclusion: It meets the standard USP 32