Title

ceftazidime dihydrochloride

Formula

C₂₂H₂₂N₆O₇S₂ ×2HCl

 Structural formula:

Molecular weight 

619.53

IUPAC name

(6R,7R)-7-[[(Z)-2-(2-aminothiazol-4-yl)-2-[(1-carboxy-1-methylethoxy)imino]acetyl]amino]-8-oxo-3-[(1-pyridinio)methyl]-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate dihydro chloride

CAS number

N.A.

test

method

specification

ref. MeTH.

Description

Visual

White or almost white crystalline powder

Internal

Water content (200 mg)

Titrimetric (KF)

Not more than 5.0%

Internal

Color (1% w/v on water, Abs_420nm)

Spettrofotometric (UV)

Not more than 0.200 AU

Internal

Assay (on the anhydrous subst.)

HPLC

Not less than 80%

Internal

Impurities (area %):

C. Cefta-01

HPLC

Not more than 0.10%

Internal

G. Etanale

Not more than 0.2%

A. Δ-2-ceftazidime

Not more than 0.2%

B. E-ceftazidime

Not more than 0.2%

H. Impurity H

Not more than 0.10%

E. Cefta-02

Not more than 0.2%

   Total impurities

Not more than 2.0%

Residual solvents

GC

Complying to ICH limit

EP

Any Other Relevant Residual from synthesis

Not applicable

Complies*

Not applicable

Bacterial Endotoxins

LAL test (Gel clot)

Less than 0.025 EU/mg

Internal