S. J. & G. Fazul Ellahie (Pvt.

) Ltd
ISO CERTIFIED
Standard Analytical Testing Method

SUBJECT / TITLE : CEZAF INJECTION 250mg IM/IV Page 1 of 3.

DOCUMENT #. ISSUE DATE SUPERCEDES: NEXT REIEW Dept: QC

QC-STM-PI-008-02 April-2018 April-2016 April-2020 Specification: USP

FINISHED PRODUCT SPECIFICATION

S. # Test Specification
White to cream coloured crystalline powder filled in clear glass
1. Appearance
vial.
The retention time for the Ceftazidime peak in the chromatogram of
2. Identification the assay preparation corresponds to that in the chromatogram of
the standard preparation as obtained in the assay.

3. Uniformity of weight 335mg ± 10% (302mg-369mg)

4. pH ( 100mg/ml) 5.0 to 7.5

Dry about 300mg ,accurately weight in vaccume at a pressure not
5. Loss on drying exceeding 5mm of mercury at 25OC. it contains sodium carbonate it
losses not more than 13.5% of its weight

6. Sterility Must comply

7. Bacterial Endotoxin It contains NMT 0.1 Endotoxin Unit /mg of Ceftazidime

Clarity of reconstituted Clear light yellow to yellow solution after reconstitution with
8. solution recommended diluents.
(1Vial+5ml WFI)

9. Assay (Ceftazidime) 90.0%-120.0% of the labeled amount

10. Specification USP

11. Shelf life 2 Years

Each Vial Contains:

2

12. Label claim Ceftazidime Pentahydrate equivalent to

Ceftazidime …..……..250mg

Prepared by: Reviewed by: Approved by:

Sr. Q.C Analyst Asst. Manager QCM

 S. J. & G. Fazul Ellahie (Pvt.) Ltd
ISO CERTIFIED
Standard Analytical Testing Method

SUBJECT / TITLE : CEZAF INJECTION 250mg IM/IV Page 2 of 3.

DOCUMENT #. ISSUE DATE SUPERCEDES: NEXT REIEW Dept: QC

QC-STM-PI-008-02 April-2018 April-2016 April-2020 Specification: USP

Standard Analytical Testing Method (By HPLC)

Assay (Ceftazidime)
Chromatographic conditions:
Column : 4.6mm x 15cm column that contains 5µm packing L1
Wave length : 254nm
Flow rate : 2ml per minutes
Injection volume : 20µ litres
Mobile phase:
Mix 40ml of acetonitrile and 200ml of pH 7 buffer, and dilute with water to obtain 2000ml of
solution filter, using a filter having a porosity of 1µm or degas. Make adjustment if necessary.
pH – 7 buffer:
Dissolve 42.59gm of anhydrous dibasic sodium phosphate and 27.22gm of monobasic potassium
phosphate in water to make 1000ml of solution.
Standard preparation:
Transfer about 29mg of ceftazidime pentahydrate RS, accurately weighed, to a 25ml volumetric
flask containing 2.5ml of pH 7 buffer and shake until dissolved. Dilute with water to volume and
mix. Immediately prior to chromatography, transfer 5ml of this stock solution to a 50ml
volumetric flask, dilute with water to volume and mix.
Assay preparation:
Transfer about 115mg of ceftazidime, accurately weighed to a 100ml volumetric flask containing
10ml of pH 7 buffers, and shake until dissolved. Dilute with water to volume and mix (protect this
solution from light.) Immediately prior to chromatography, transfer 5ml of this solution to a 50ml
volumetric flask, dilute with water to volume and mix.
Procedure:
Separately inject equal volumes (about 20µL ) of the standard preparation and assay
preparation into the chromatograph, record the chromatograms and measure the responses for
the major peaks.
Calculation:
Avg. Peak area of spl. Wt. of std. 5 100 50 Purity of std.
mg/vial= X X X x Xx x X Avg. wt.
Avg. Peak area of std. 25 50 Wt. of spl. 5 100
% Result = Found _ x 100
Labelled amount

Prepared by: Reviewed by: Approved by:

Sr. Q.C Analyst Asst. Manager QCM

 S. J. & G. Fazul Ellahie (Pvt.) Ltd
ISO CERTIFIED
Standard Analytical Testing Method

SUBJECT / TITLE : CEZAF INJECTION 250mg IM/IV Page 3 of 3.

DOCUMENT #. ISSUE DATE SUPERCEDES: NEXT REIEW Dept: QC

QC-STM-PI-008-02 April-2018 April-2016 April-2020 Specification: USP

History:
Finished Product Specification
Prepared By(Name):……………..
Preparation Date : Jan-2018
Revision No. Revised By Revised Date Reason For Revision

Distribution & Retreival of Specification:

Orignal: Should be Kept in Master File Located in QCM/QAM/…...
Copy -1: Point of use (Finished Product Section)
S.No Department Distribution Retrieval
. Name Signature Date Name Signature Date
1
Master File

2
Finished Product
Section
3
R& D

 Confidential Document:Do not divulge or released out side sjg without authorisation.
 Any change in this specification must be approved through change control document
befor implementation.

Prepared by: Reviewed by: Approved by:

Sr. Q.C Analyst Asst. Manager QCM