CEFAZOLIN Na Sterile

Crystalline sterile powder

For Parenteral Administration

MW: 476.5

-CAS-REGISTRY No: 27164-46-1

- MOLECULAR FORMULA: C₁₄H₁₃N₈NaO₄S₃

- CHEMIDAL NAME:

Sodium (6R,7R)-3-[[(5-methyl-1,3,4-thiadiazol-2-yl)thio]methyl]-8-oxo-7-[(1H-tetrazol-1-ylacetyl)amino]-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid.

CATEGORAY:

SPECIFICATION:

- Description: White to off-white, practically odorless, crystalline powder, or white to off-white solid

- pH: Between 4.0 and 6.0

- Water content (Karl Fischer Test): N.M.T. 6.0% w/w

- 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. 0.15 E.U./ mg

- Related substance:

- Individual Impurity: N. M. T. 1.0%

-Total Impurity N. M. T. 3.5%

- Assay: N. L. T. 89.1% and N.M.T. 110.1%

PACKAGING: 1*10kg 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 Anilline and Benzene are not used or generated during the process.

The Referred Material Complies With BP, EP & USP.