Ceftiofur Hydrochloride 98

Test Items

Testing   Specifications

Testing Results

Appearance

Should be w hite or off-white crystalline powder

  O ff -w hite crystalline

powder

Specific rotation

Calculated on the anhydrous basis, the specific rotation should be -115° to -127°

C onform

ldentification

The retention time of the major peak of sample should correspond to that of reference standard .(HPLC)

C onform

The infrared absorption spectrum should be consistent with the spectrum of the reference standard.

C onform

Acidity

2.0-4.0

2. 35

Related

Substances

Ceftiofur oxime ethyl ester should not more than 0.5%

Absence

7-Aminocephalosporanic acid should not more than 0.5%

Absence

N-Deacyl ceftiofur should not more than 0.5%

Absence

Cefotaxime should not more than 0.5%

Absence

Ceftiofur delta-3 isomer should not more than 0.5%

0.11%

Ceftiofur E-isomer should not more than 3.6%

0.14%

Dihydrothiophenyl thioester should not more than 0.5%

Absence

Ceftiofur amide dimer should not more than 0.8%

Absence

N-Trityl ceftiofur Oxime should not more than 0.5%

Absence

Other single impurities should each not exceed 0.5%

C onform

Total impurities should not exceed 6.0%

0.92 %

Particle Size

D100 ≤ 10μm

C onform

Residue on ignition

≤ 0. 5 %

0. 1 1 %

Heavy metals

≤ 20ppm

C onform

Water

≤ 5.0%

2.04 %

Bacterial endotoxins

＜ 1. 0EU/mg.

C onform

Sterile

Should comply with the requirements

Co nform

Assay

Contain Ceftiofur HCl should not less than 91.0%

98.65 %

Conclusion

The above materials are done based on China pharmacopiea 2020 and all the testing data meet the established specifications.