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Levofloxacin hydrochloride

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Product Description:

Levofloxacin hemihydrate CAS 100986-85-4 is a kind of white or yellow light crystalline powder, and it is soluble in water. Levofloxacin hemihydrate has only USP grade. But we can also accept customized products if customer has special demand.


Specification:
USP Grade
Description                                                  White or yellow light crystalline powder
Identification (1)IR:                                    Conforms to the spectrum of Levofloxcain RS

(2)HPLC:                                                  The retention time of the major peak of the sample solution corresponds to that of 

                                                                 the standard solution,as obtained in the Assay.

Water                                                         2.1%~2.7%

Optical rotation                                            -92°~-106°

Residue on ignition                                      ≤0.2%

Heavy metals                                              ≤10ppm

Individual impurity N-Desmethyl levofloxacin     ≤0.3%
Diamine derivative  
                                      ≤0.3%

Levofloxacin N-oxide                                     ≤0.3%

9-Desfluoro levofloxacin                                 ≤0.3%

D-Isomer                                                     ≤0.8%

Any unknown impurity                                   ≤0.1

Total impurity(excluding D-Isomer)               ≤0.5%
*Residual solvents Ethanol 
                             ≤0.5%

Dimethyl Formamide                                      ≤0.088%
Toluene                                                      ≤0.089%
Dimethyl sulfoxide                                         0.5%
Assay                                                          98.5%~102.0%

Application:

Usual adult dose: The usual oral adult dose of ofloxacin is 200 to 400 mg every 12 hours.

Adverse effects: Adverse effects may include nausea, diarrhea, vomiting, mild abdominal or stomach pain, dizziness, headache, nervousness, drowsiness or insomnia, increased sensitivity of skin to sunlight, vaginitis, skin problems, and taste disturbances. Possible allergic reaction to material if inhaled, ingested or in contact with skin.

Overdose effects: There is limited information regarding overdose with ofloxacin, but symptoms may include drowsiness, nausea, dizziness, hot and cold flushed, facial swelling and numbness, slurred speech, and moderate disorientation.

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