LEVOFLOXACIN HEMIHYDRATE

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US $28-32 / Kilograms | 200 Kilogram/Kilograms (Min. Order)
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Overview
Quick Details
Function:
Antibacterial
Type:
Other
Place of Origin:
Zhejiang, China (Mainland)
Brand Name:
ZHECHEM
Model Number:
USP34
Dosage Form:
Powder
Product Name:
LEVOFLOXACIN HEMIHYDRATE
Appearance:
White or yellow light crystalline powder
Assay:
98.5~102.0%
Specification:
USP 34
Supply Ability
Supply Ability:
1000 Ton/Tons per Year
Packaging & Delivery
Packaging Details
25KGS/DRUM
Port
SHANGHAI
Lead Time :
Shipped in 30 days after payment

CERTIFICATE OF ANALYSIS

 

Product Name:    LEVOFLOXACIN HEMIHYDRATE                                                               

Packing:    1× 25KG                                                                                   

Batch No.: 20160522                                                                                          

Examined Basis:  USP34                                                                                 

Mfg. Date:      May 22,2016                                                                            

Exp. Date:      May 21,2020                                                                          

 

Tests

Acceptance Criteria

Results

Description

White or yellow light crystalline powder

Conform

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.

 

Conform

Water

2.1%2.7%

2.5%

Optical rotation

-92°~-106°

-97.20°

Residue on ignition

0.2%

0.07%

Heavy metals

10ppm

Conform

Individual impurity

 (N-Desmethyl levofloxacin)

0.3

0.06%

(Diamine derivative)

0.3

0.05%

 (Levofloxacin N-oxide)

0.3

0.04%

 (9-Desfluoro levofloxacin)

0.3

0.07%

(D-Isomer)

0.8

0.25%

 (Any unknown impurity)

0.1

Conform

Total impurity (Do not include D-Isomer )

0.5%

0.28%

Assay

98.5%~102.0%

99.25%

Conclusion                                                   Conforms to USP34 specification for levofloxacin

                                                      

 

 

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