Fengchen Group Co., Ltd. (Qingdao Fengchen Technology and Trade Co., Ltd.)

Testing Item

Standard

Result

Appearance  

White   or yellowish-white crystalline powder

Complies

Crystallinity

the particles show birefringence (interference colors) and   extinction positions when the microscope stage is revolved.

Complies

Identification

Infrared-spectrometry: The spectrum of the substance to be   examined and of a qualified reference standard are comparable to the position   of the absorption bands

Complies

HPLC: The retention time of major peak in the chromatogram of   test solution correspond to this of standard solution

Complies

Test for solution: It responds to the reaction of sodium

Complies

Visible foreign matter

Essential free

Absent

pH

6.0 ~ 8.0

7.06

Absorbance(430nm)

<0.1

0.05

Related Substances

Deacetylcefotaxime lactone: ≤ 0.5%;
  7-aminocephalosporanic acid: ≤ 0.5%;
  Ceftriazone triazine analog: ≤ 1.0%;
  Ceftriazone benzothiazolyl oxime: ≤ 0.2%;
  Deacyl ceftriaxone: ≤ 0.5%;
  Ceftriaxone 3-ene isomer: ≤ 0.3%
  Ceftriaone E-isomer: ≤ 0.5%;
  Any individual unspecified impurity: ≤ 0.2%;

Total impurities: ≤ 2.5%

0.008%
  Absent
  0.02%
  Absent
  0.007%
  Absent
  Absent
  0.006%
  0.05%

Water

8.0%   ~ 11.0%

9.46%

Residual Solvents

Triethylamine ≤ 0.02%

N,N-dimethylaniline ≤ 0.002%

2-ethylhexanoic acid ≤ 0.8%

Isoproranol ≤ 0.5%

Methanol ≤ 0.3%

Acetone ≤ 0.5%

Methylene chloride ≤ 0.06%

Ethyl acetate ≤ 0.5%

Ethanol ≤ 0.5%

Absent

Absent

Absent

0.005%

Absent

0.002%

None

0.0003%

0.001%

Bulk   Density

>   0.5g/ml

0.56   g/ml

Bacterial   Endotoxins

≤   0.20 USP Endotoxin Unit/mg of Ceftriaxone

Complies

Pyrogens

Non-Pyrogenic

Non-Pyrogenic

Sterility   test

Should   be sterile

Sterile

Assay

(Ceftriaxone   Sodium)

≥   795ug/mg of Ceftriaxone (Dried basis)

925.6ug/mg