CEFTRIAXONE SODIUM (Sterile)

Crystalline sterile powder

For Parenteral Administration

MW: 661.61

-CAS-REGISTRY NO: 104376-79-6

MOLECULAR FORMULA_: C₁₈H₁₆N₈Na₂O₇S₃ , 3.½ H₂O

CHEMIDAL NAME:

(6R, 7R)-7-[[(2Z)-(2- Amino-4-thiazolyl) (methoxyimino)acetyl]amino]- 8-oxo-3-[[(1,2,5,6-tetrahydro-2-methyl-5,6-dioxo-1,2,4-triazin-3-yl)thio]methyl]-, 5-Thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid,

CATEGORAY:

-Semi-synthetic, long – acting, broad spectrum third generation cephalosporin.

SPECIFICATION:

- Description: White to yellowish-orange crystalline powder

- Specific optical rotation: Between -155º to -170º

- pH: Between 6.00 to 8.00

- Water content (Karl Fischer): Between 8.00 to 11.00

- Particulate Matter (visual): DAC Prob 5 SE<= 4.5

- Particulate Matter (HIAC): ³ 10mm N. M. T. 6000 Particles, ³ 25mm N. M. T. 600 Particles

- Sterility: Sterile

- Bacterial endotoxine: N.M.T 0.2 EU/mg

- Individual Impurity: N.M.T 1.0%

- Total Impurity: N.M.T 4.0%

- Assay: N.M.T 795µg/mg as Ceftriaxone anhydrous basis.

N.L.T 96% and N.M.T 102.0% of Ceftriaxone Na anhydrous.

PACKAGING:

1*10 kg in special aluminum can with type 1 rubber closure and aluminum seal in each carton.

STORAGE:

Preserve in tight container, store in cool (below 15ºC) and dry place, protect from light

SHELF LIFE: 24 months

PHARMACOPOEIAL QUALITY: USP, BP

REMARKS:

N-N-Dimethyl Aniline is not used or generated during the process.

The Referred Material Complies With BP, EP & USP.