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

) Ltd
ISO CERTIFIED
Standard Analytical Testing Method

SUBJECT / TITLE : CEFAST INJECTION 500mg IM Page 1 of 5.

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

QC-STM-PI-005-02 April-2018 April-2016 April-2020 Specification: USP

FINISHED PRODUCT SPECIFICATION

S.
Test Specification
#
1. Appearance White to off-white crystalline powder filled in clear glass vial.
The retention time for the Ceftriaxone peak in the chromatogram
2. Identification of the assay preparation corresponds to that in the chromatogram
of the standard preparation as obtained in the assay.
3. Uniformity of weight 625mg ± 10% (563mg-688mg)

4. pH (100mg/ml) 4.5 to 6.5

Loss on Drying
5. (Dry at 1000C 1050C for 3hrs.) NMT 3.0%

6. Sterility Must comply

7. Bacterial Endotoxin It contains NMT 0.2 Endotoxin Unit /mg of Ceftriaxone Sodium

Clarity of reconstituted Clear light yellow to yellow solution after reconstitution with
8. solution recommended diluent.
(1vial+2ml of Lidocaine)

9. Assay (Ceftriaxone) 90.0%-115.0% of the labeled amount

10. Specification USP

11. Shelf life 2 Years

12. Label claim Ceftriaxone Sodium equivalent to Ceftriaxone……….500mg

Standard Analytical Testing Method (By HPLC)

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 : CEFAST INJECTION 500mg IM Page 2 of 5.

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

QC-STM-PI-005-02 April-2018 April-2016 April-2020 Specification: USP

Assay (Ceftriaxone):

Chromatographic Condition

Equipment : High Performance Liquid Chromatographic System

Column : 4mm x 150 cm, 5µm
Wavelength : 270 nm
Flow Rate : 2 ml/mins
Injection Volume : 20.µl
Column Temperature : Ambient

pH 7.0 Buffer:

Dissolve 13.6 g of dipotassium hydrogen phosphate and 4.0 g of potassium dihydrogen phosphate in
water to obtain 1000 ml of solution. Adjust this solution with phosphoric acid or 10 N potassium
hydroxide to a pH of 7.0 ± 0.1.

pH 5.0 buffer:

Dissolve 25.8 g of sodium citrate in 500 ml of water, adjust with citric acid solution (1 in 5 ) to
a pH of 5.0±0.1, and dilute with water to a volume of 1000 ml.

Mobile Phase:

Dissolve 3.2 g of tetraheptylammonium bromide in 400 ml of acetonitrile, add 44 ml of pH 7.0

buffer and 4 ml of pH 5.0 buffer, and add water to make 1000 ml. Filter through a 0.45 µm
membrane filter and degas. Make adjustments if necessary.

Standard Preparation:

weigh accurately 50 mg of Ceftriaxone sodium and transfer into a 50 ml volumetric flask. Dissolve
in and dilute to mark with mobile phase. Take 5 ml of the resulting solution into 25 ml volumetric
flask. Dissolve in and dilute to mark with the same solvent.

Sample preparation:

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 : CEFAST INJECTION 500mg IM Page 3 of 5.

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

QC-STM-PI-005-02 April-2018 April-2016 April-2020 Specification: USP

weigh accurately 50 mg of Ceftriaxone sodium and transfer into a 50 ml volumetric flask. Dissolve
in and dilute to mark with mobile phase. Take 5 ml of the resulting solution into 25 ml volumetric
flask. Dissolve in and dilute to mark with the same solvent.

Procedure:

Separately inject equal volumes (about 20µL) of the standard preparation and the assay preparation
into the chromatograms and measure the responses into the chromatograms for major peaks.

Calculation:

Avg. peak area of sps. Wt of std 5 50 50 Purity of std

mg/vial = x X x x X x. Avg. Wt
Avg. peak area of sps. 50 25 Wt. of sp 5 100

% Result = Found x 100

Labelled claim

Alternet Analytical Testing Method(By UV)

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 : CEFAST INJECTION 500mg IM Page 4 of 5.

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

QC-STM-PI-005-02 April-2018 April-2016 April-2020 Specification: USP

Assay(Ceftriaxone)
Diluent:DI water.

Standard Preparation:
Weigh accurately about 25mg of Ceftriaxone working standard and transfer into a 100ml volumetric
flask, add DI water, mix to dissolve (sonicate if necessary) cool to room temperature and make up
the volume to the mark with DI water.
Shake and pipette out 3ml of the resulting solution into a 50ml volumetric flask and make up the
volume with DI water to the mark.

Sample Preparation:
Weigh accurately and transfer about 625mg of Cefast Injection (equivalent to 500mg of
Ceftriaxone) into a 500ml volumetric flask, add 250ml of DI water, mix to dissolve (sonicate if
necessary), cool to room temperature and make up the volume to the mark with DI water.
Shake and pipette out 3ml of the resulting solution into a 200ml volumetric flask and make up the
volume with DI water to the mark.

Measurements:
Measure the absorbance of standard and sample at the maximum 254 nm using DI water as blank.

Calculation:
mg/vial = Average Absorbance of sp. x wt. of std. x 3 x 500 x 200 x Purity of std x Avg. wt.
Average Absorbance of std. x 100 x 50 x wt. of sp. x3 100

% Result = Found x 100

Labelled claim

History:
Finished Product Specification
Prepared By(Name):……………..
Preparation Date : Jan-2018
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 : CEFAST INJECTION 500mg IM Page 5 of 5.

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

QC-STM-PI-005-02 April-2018 April-2016 April-2020 Specification: USP

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