Related substances of Doripenem in Sudopen Injection

Station 24M Date 28/10/2013

Condition 30°C/65% RH Analyst Bhawani
Packing Vial

Standard preparation
25.99 mg to mL 100
5 mL to mL 50

Sample preparation
1 Vial to mL 200
5 mL to mL 50

Potency (%w/w as is basis) 95.6

Claim (mg) 1000

Area count %
B. No
Highest impurity Total impurities Total Highest impurity Total impurities
BC(4773)007 25224 25224 20550839 0.123 0.123
BC(4773)008 32574 32574 21864260 0.149 0.149

Highest impurity (%) AT1/AT x 100

Total impurities (%) AT2/AT x 100

Prepared by: Checked by:

Date: Date:
 Organic Impurity of Cefepime for Injection_IP

Batch No. Date 5/09/2019

Analyst Anish

Standard Refrence B

7.47 mg to mL 5.0

1 mL to mL 10

2 mL to mL 100

Sample preparation

81.15 Vial to mL 50

Potency (%w/w as is basis) 82.3

Area of Ref.B 870709

N-Methyle Pyrrolidine 0.02

Area count Relative response Factor %

Related Compount A 0 1.00 0.000

Related Compount B 20060 1.00 0.003

All secondary peak(Unknown
Peak). 186634 1.00 0.032
Total Impurities(Including N-
Methyle pyrrolidine) 0.056

Any Individual Imp.% AT1/AS x DS/DT x P/100 x 100

Total impurities (%) AT1/AS x DS/DT x P/100 x 100

Prepared by: Checked by:

Date: Date: