STANDARD TEST METHOD

MEDICRAFT PHARMA (PVT) LTD. PESHAWAR

Department: Quality Control Section: Bulk Product / Finished product

Subject: Specification and Testing Method for ISO SOP No. DS/STM/003
Cefpomed Dry Suspension Supersedes date: May 2009
SOP No.: QCD /3/265
Issue date To be revised on: Revision no. New
20-06-2013 20-06-2018 03 Page 1 of 3
Prepared by: Reviewed by: Checked by: Approved by:

Sign. Sign. Sign. Sign.

Name Sunya Name Riaz Ahmad Name Kashif Khattak Name Nasr Ullah Khan

Desig Analyst Desig Analyst Desig. AQCM Desig QCM

.

Product Specification:

a) Description: White to off white suspension after

Reconstitution with water
Have mix fruit Flavor.

b) pH: 4.0 to 5.5

c) Identification: Cefpodoxime Proxetil

 STANDARD TEST METHOD
MEDICRAFT PHARMA (PVT) LTD. PESHAWAR

Department: Quality Control Section: Bulk Product / Finished product

Subject: Specification and Testing Method for ISO SOP No. DS/STM-003
Cefpomed Dry Suspension Supersedes date: May 2009
SOP No.: QCD /3/265
Issue date To be revised on: Revision no. New
20-06-2013 20-06-2018 03 Page 2 of 3
d) Assay:

Cefpodoxime: 40 mg / 5ml
90 – 110 %

Test Methods:

Description: Examine the sample for color, clarity, taste and odour.

pH: Determine the pH on a calibrated pH meter at 25º C.

Assay(Cefpodoxime):

Mobile Phase:
Prepare a filtered and degassed mixture of 0.02M
Ammonium acetate and acetonitrile(6:4)

Diluent:
Prepare a degassed mixture of water and acetonitrile (6:4)
 STANDARD TEST METHOD
MEDICRAFT PHARMA (PVT) LTD. PESHAWAR

Department: Quality Control Section: Bulk Product / Finished product

Subject: Specification and Testing Method for ISO SOP No. DS/STM-003
Cefpomed Dry Suspension Supersedes date: May 2009
SOP No.: QCD /3/265
Issue date To be revised on: Revision no. New
20-06-2013 20-06-2018 03 Page 3 of 3

Standard Solution:

Take standard Cefpodoxime proxetil equivalent to about 40

mg cefpodoxime and dissolve in 10ml of methanol and then
dilute to 100ml with diluent. Further dilute 2ml of this solution
to 50ml with diluent, mix and filter.

Sample Solution:

Take 5ml of the sample solution equivalent to 40 mg of

Cefpodoxime and add 10ml of distilled water to disperse,
then add 20ml of acetonitrile and sonicate for 15 minutes.
Cool to room temperature, dilute with diluent to 100ml.

further dilute 2ml of this solution to 50ml with diluent.

sonicate and filter.

Chromatographic conditions:

Flow rate: 1.5 ml /min

Column : L1 (4.6mm x 25cm) C18
max   235nm
Temperature: 30°C
 STANDARD TEST METHOD
MEDICRAFT PHARMA (PVT) LTD. PESHAWAR

Department: Quality Control Section: Bulk Product / Finished product

Subject: Specification and Testing Method for ISO SOP No. DS/STM-003
Cefpomed Dry Suspension Supersedes date: May 2009
SOP No.: QCD /3/265
Issue date To be revised on: Revision no. New
20-06-2013 20-06-2018 03 Page 4 of 3
Procedure:

Separately inject equal volume of the standard solution and

sample solution into the chromatograph, record the
chromatograms and measure the peak responses for the
major peaks. Calculates the percentages of Cefpodoxime in
the sample using the following formula:

%age = Area of the sample x Potency of the reference

Area of the reference