CEPHALEXIN MONOHYDRATE

COMPACTED POWDER

FOR ORAL ADMINISTRATION

MW: 365.41

-CAS – REGISTERED NO: 23325 – 78-2

MOLECULAR FORMULA: C₁₆ H₁₇ N₃ O₄ S, H₂Oıı

CHEMIDAL NAME:

(6R,7R)-7-[[(2R)-2-Amino-2-phenylacetyl]amino]-3-methyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid monohydrate.

CATEGORAY:

- Semi- synthetic broad spectrum cephalosporin

SPECIFICATION:

- Description: White to off-white crystalline powder.

- Odor: characteristic

- Specific optical rotation: +149˚ to +158˚

- pH: Between 4.0 and 5.5

- Water content (Karl Fischer Test) : Between 4.0 % and 8.0%

- Specific absorbance at 262 nm: Between 220 to 245

- Sulfated Ash: N.M.T. 1%

- Tapped density: N.L.T 0.7 g/ml

- Assay: N.L.T. 95.0% and N.M.T. 101.0% as anhydrous base

PACKAGING:

- 1*25 kg in double polyethylene bsgs in each carton box.

STORAGE:

Preserve in tight container store below 25ºC and dry place

SHELF LIFE: 48 months

PHARMACOPOEIAL QUALITY: USP / BP

REMARKS: N,N-Dimethyl anilline and dioxan are not used or generated during the process.

The referred material complies with BP, EP & USP.