Cloxacillin Sodium

crystalline, sterile

Molecular formula:
C19H17ClN3O5S.Na.H2O
Molecular weight:
475.9
CAS registry no.:
7081-44-9
 Cloxacillin Sodium

Application

This quality produced by sterile crystallization is suitable for aseptic filling into vials, bottles or other delivery systems using any customary machine. A clear solution for injection is produced by adding water for injection.

Antibiotic category

Semisynthetic penicillin for sterile use

Packaging

Storage

Store below 25°C,
Protect from light and moisture

Shelf life

36 months

Specification

Appearancewhite or almost white, crystalline powder
Specific optical rotation+160° to +169° 1)
Appearance of solution
  • clarity of solution: clear
  • absorbance at 430 nm: not more than 0.04
Bulk density0.30 - 0.50 g/ml
Water content
(Karl Fischer)		3.0 - 4.5 %
particulate matter
  • visible particles: essentially free
  • particles >= 10 µm: <= 6000/g
  • particles >= 25 µm: <= 600/g
pH-value5.0 - 7.0
2-Ethylhexanoic acidnot more than 0.8 %
Sterilitysterile
Bacterial Endotoxinsnot more than 0.40 UE/mg
Related substances
(HPLC)		individual: not more than 1.0 %
total: not more than 5.0%
AssayCloxacillin Sodium (HPLC):
95.0 - 101.0 % 1)
1) Based on the anhydrous substance

Remark

N,N-Dimethylaniline and dichloromethane are not used in the manufacturing process

Pharmacopoeial quality

USP, BP, Ph.Eur.