Product Brief Introduction
Product name: Moxifloxacin HCL
CAS：186826-86-8
MF: C21H25ClFN3O4
MW: 437.892
Product Specification
|
Item |
Specification |
|
Appearance |
Light yellow or yellow powder or crystalline powder |
|
Identification |
IR: The infrared absorption spectrum of the sample complies with the reference standard. |
|
HPLC:The retention time of the major peak of the sample solution corresponds to that of the standard solution, as obtained in the assay. |
|
|
0.05g gives reaction(a) of chlorides |
|
|
Solubility |
Sparingly soluble in water, slightly soluble in ethanol(96 per cent), practically insoluble in acetone |
|
Appearance of Solution (50mg/ml Dilute Sodium Hydroxide Solution R) |
The solution is not more opalescent than reference suspension II and not more intensely coloured than GY2 |
|
PH |
3.9-4.6 (0.10g/50ml water) |
|
Moisture |
≤ 4.5% |
|
Sulfated Ash |
≤ 0.1% |
|
Enantiomeric Purity |
Impurity G≤ 0.15% |
|
Related Substances (HPLC) |
Impurity B≤ 0.15% |
|
Impurity E≤ 0.15% |
|
|
Impurity F≤ 0.15% |
|
|
Unspecified impurity ≤ 0.1% |
|
|
Total impurities ≤ 0.3% |
|
|
Residual Solvents (GC) |
Acetonitrile≤ 0.041% |
|
Methylene chloride≤ 0.06% |
|
|
Toluene≤ 0.089% |
|
|
N,N-dimethylformamide≤ 0.088% |
|
|
Triethylamine≤ 0.5% |
|
|
Total Plate Count |
≤ 1000cfu/g |
|
Yeasts&Molds |
≤ 100cfu/g |
|
Assay (HPLC) (on dried basis) |
98.0%-102.0% |
