Central Pharmaceuticals Ltd.

2A/1 South West Darus Salam Road, Mirpur, Section-01, Dhaka-1216

QUALITY CONTROL DEPARTMENT

Standard Test Procedure for

NEOFLOX TABLET
Ciprofloxacin 500 mg as Ciprofloxacin Hydrochloride USP

Document No. : QC-STP-TAB-118 COPY NO:

Revision No. : 01
Issue Date: 01.09.2018
Effective Date: 08.09.2018
Review Date: 07.09.2021
Replace Issue: 01.06.2013

REVISION HISTORY
Date Revision Reason of Change
01.09.2018 00 New
08.09.2018 01 Update of format & information

DISTRIBUTION
No. Copy Distributed to
01. Master copy Quality Assurance Manager
02. Control copy Working Reference in quality control department

Prepared by: Checked By: Approved By: Authorized By:

QC Officer Asst. Manager QC QA Manager Plant Manager

 Central Pharmaceuticals Ltd.
2A/1 South West Darus Salam Road, Mirpur, Section-01, Dhaka-1216
QUALITY CONTROL DEPARTMENT
Standard Test Procedure for
NEOFLOX TABLET
Ciprofloxacin 500 mg as Ciprofloxacin Hydrochloride USP
Document No. : QC-STP-TAB-118 Revision No. 01 Issue Date: 01.09.2018
Effective Date: 08.09.2018 Review Date: 07.09.2021 Replace Issue: 01.06.2013
Prepared by: Checked By: Approved By: Authorized By:

QC Officer Asst. Manager QC QA Manager Plant Manager

Stage 1: Blend/Bulk

S/L TESTS SPECIFICATIONS REFERENCES

1.1 LOD Not more than 2.5 % at 1050C. In-house
1.2 Identificatio Must be positive of Ciprofloxacin HCl USP USP
n
1.3 Assay Ciprofloxacin 54.5 ± 5% w/w. In-house

Page 2 of 11
 Central Pharmaceuticals Ltd.
2A/1 South West Darus Salam Road, Mirpur, Section-01, Dhaka-1216
QUALITY CONTROL DEPARTMENT
Standard Test Procedure for
NEOFLOX TABLET
Ciprofloxacin 500 mg as Ciprofloxacin Hydrochloride USP
Document No. : QC-STP-TAB-118 Revision No. 01 Issue Date: 01.09.2018
Effective Date: 08.09.2018 Review Date: 07.09.2021 Replace Issue: 01.06.2013
Prepared by: Checked By: Approved By: Authorized By:

QC Officer Asst. Manager QC QA Manager Plant Manager

1.1 LOSS ON DRYING

Adjust the temperature of the moisture analysis balance at 105 0C. Warm up the instrument for about 3 to 5
minutes. Again tare the instrument. Place about 1 gm blend uniformly on the tray of the instrument and allow
the sample to dry. After drying is completed note the value of loss of moisture displayed on the screen of the
apparatus.

Requirement: Loss on drying of the sample must not be more than 2.5 % at 1050C.

1.2. IDENTIFICATION
a) By HPLC: Follow the procedure as per assay of in test sample. Record the HPLC chromatogram of test
sample as well as reference standard of Ciprofloxacin Hydrochloride.

Requirement: Retention time of the major peak in test sample must comply with that of standard Ciprofloxacin
Hydrochloride and must not vary more than 2%.

b) By UV: Follow the procedure as per assay of in test sample. Record the UV spectrum of test sample as well
as reference standard of Ciprofloxacin Hydrochloride.
1.3. ASSAY(By HPLC)

Preparation of buffer solution: Dissolve 2.88 gm Ortho phosphoric acid H 3PO4 (85%) in 1000 ml water and
adjust pH to 3.0 with 10% V/V solution of triethyl amine.
Mobile phase: Mix Acetonitrile and buffer solution at a ratio20:80. Filter through 0.20 mm filter paper. Finally
degas the mixture in an ultrasonic bath. This is mobile phase.
Crush about 5 gm blend to fine powder. Take about 40 mg test sample in a 50 ml volumetric flask and add 12
ml of Mobile phase. Sonicate to dissolve the substance and adjust the volume q. s to 50 ml with mobile phase.
Filter through 0.20 mm filter paper. This is sample solution.
Take about 25.0 mg Ciprofloxacin Hydrochloride in a 50 ml volumetric flask and add 12 ml Mobile phase.
Sonicate and make the final volume q. s. to 50 ml with mobile phase. Filter through 0.20 mm filter paper. This is
standard solution.
Chromatographic condition:
Column : Luna, C18, 250 mm x 4.6 mm.
Detector : 278 nm
Column Oven Temp.: 400C
Injection volume : 25 ml
Flow rate : 1 ml per minute
Run time : 15 minutes
Equilibrate the column at initial flow rate for about 60 minutes. Inject 25 ml of sample solution and then
respective standard solutions. Record the chromatogram. Calculate the quantity of active present in blend by
using the following equation:
Calculation: Potency of bulk ( % of Ciprofloxacin W/W)

As Wst 50 P 500
× × × × ×100
Ast 50 Vs 100 582.21

Page 3 of 11
 Central Pharmaceuticals Ltd.
2A/1 South West Darus Salam Road, Mirpur, Section-01, Dhaka-1216
QUALITY CONTROL DEPARTMENT
Standard Test Procedure for
NEOFLOX TABLET
Ciprofloxacin 500 mg as Ciprofloxacin Hydrochloride USP
Document No. : QC-STP-TAB-118 Revision No. 01 Issue Date: 01.09.2018
Effective Date: 08.09.2018 Review Date: 07.09.2021 Replace Issue: 01.06.2013
Prepared by: Checked By: Approved By: Authorized By:

QC Officer Asst. Manager QC QA Manager Plant Manager

where, As = peak area of sample solution.

Ast = peak area of respective standard solution.
Vs = weight of sample taken.
Wst = weight of standard.
P = potency of standard (as Ciprofloxacin Hydrochloride)
ASSAY(By UV)

Grind 5 gm blend into fine powder. Take 47.5 mg powder in a 100 ml volumetric flask, add 60 ml 0.01 N
Hydrochloric acid and sonicate for 15 minutes. Filter, transfer 2 ml filtrate in a 100 ml volumetric flask and add
0.01N Hydrochloric acid q. s. to 100 ml. This is sample solution.

Take 30 mg Ciprofloxacin Hydrochloride in a 100 ml volumetric flask, add 60 ml 0.01 Hydrochloric acid and
shake to dissolve. Add 0.01N Hydrochloric acid q. s. to 100 ml and mix. Transfer 2 ml of this solution in a 100
ml volumetric flask and dilute to 100 ml with 0.01N Hydrochloric acid. This is standard solution.

Measure the absorbance of sample and standard solution at 276 nm in an ultraviolet spectrophotometer using
0.01 Hydrochloric acid as blank. Calculate the amount of active substance in tablet by using the following
equation:

Calculation: Potency of bulk ( % of Ciprofloxacin W/W)

As Ws 2 100 100 P 500
× × × × × × × 100
Ast 100 100 Wst 2 100 582.2
As Ws 2 100 100 P 500
× × × × × × × 100
Ast 100 100 Wst 2 100 582.2
Where, As = absorbance of sample solution.
Ast = absorbance of standard solution.
Wst = weight of sample taken for sample solution.
Ws = weight of standard
P = potency of standard (as Ciprofloxacin HCl)

Page 4 of 11
 Central Pharmaceuticals Ltd.
2A/1 South West Darus Salam Road, Mirpur, Section-01, Dhaka-1216
QUALITY CONTROL DEPARTMENT
Standard Test Procedure for
NEOFLOX TABLET
Ciprofloxacin 500 mg as Ciprofloxacin Hydrochloride USP
Document No. : QC-STP-TAB-118 Revision No. 01 Issue Date: 01.09.2018
Effective Date: 08.09.2018 Review Date: 07.09.2021 Replace Issue: 01.06.2013
Prepared by: Checked By: Approved By: Authorized By:

QC Officer Asst. Manager QC QA Manager Plant Manager

Stage 2: Core Tablet

S/N TEST SPECIFICATION REFERENCE

2.1 Description 19.1 x 9.1 mm Caplet shaped off white core tablet with a bisect line In-house
on one side.
2.2 Identification Must be positive of Ciprofloxacin HCl USP USP
2.3 Average weight 920mg ±2% In-house
2.4 Disintegration time Not more than 15 minutes. USP
2.5 Assay Each tablet must contain Ciprofloxacin 450 mg to 550 mg. USP

Page 5 of 11
 Central Pharmaceuticals Ltd.
2A/1 South West Darus Salam Road, Mirpur, Section-01, Dhaka-1216
QUALITY CONTROL DEPARTMENT
Standard Test Procedure for
NEOFLOX TABLET
Ciprofloxacin 500 mg as Ciprofloxacin Hydrochloride USP
Document No. : QC-STP-TAB-118 Revision No. 01 Issue Date: 01.09.2018
Effective Date: 08.09.2018 Review Date: 07.09.2021 Replace Issue: 01.06.2013
Prepared by: Checked By: Approved By: Authorized By:

QC Officer Asst. Manager QC QA Manager Plant Manager

2.1. DESCRIPTION

Take 10 tablets in a watch glass and observe visually against white background.

Requirement: It should be 19.1 x 9.1 mm Caplet shaped off white core tablet with a bisect line on one side.
2.2. IDENTIFICATION

a) By HPLC: Follow the procedure as per assay of in test sample. Record the HPLC chromatogram of test
sample as well as reference standard of Ciprofloxacin Hydrochloride.

Requirement: Retention time of the major peak in test sample must comply with that of standard Ciprofloxacin
Hydrochloride and must not vary more than 2%.

b) By UV: Follow the procedure as per assay of in test sample. Record the UV spectrum of test sample as well
as reference standard of Ciprofloxacin Hydrochloride.

2.3. AVERAGE WEIGHT

Weigh individually twenty tablets at random and determine the average weight. Not more than two of the
individual weights deviate from the average weight by more than 2% and none deviates by more than twice of
this percentage.

Requirement: Each tablet must have weight within 901.6 mg to 938.4 mg. Only two tablets, out of twenty, may
deviate this range but must be within 901.6 mg to 938.4 mg.

2.4. DISINTEGRATION
Check the water bath, if necessary, add water to maintain desired water level. Take 600 ml water in a 1000 ml
beaker; place the beaker in its position in the disintegration tester. Adjust the thermostat at 37.8ºC. After
attaining this temperature introduce one tablet in each of the six tubes of the basket. Suspend the assembly in the
beaker and operate the apparatus until disintegration is completed. Disintegration is considered to be achieved
when no residue remains on the screen of the test apparatus. Record the time taken for disintegration.

Requirement: All the six tablets must disintegrate within 15 minutes.

2.5. ASSAY(By HPLC)

Preparation of buffer solution: Dissolve 2.88 gm Ortho phosphoric acid H 3PO4 (85%) in 1000 ml water and
adjust pH to 3.0 with 10% V/V solution of triethyl amine.
Mobile phase: Mix Acetonitrile and buffer solution at a ratio20:80. Filter through 0.20 mm filter paper. Finally
degas the mixture in an ultrasonic bath. This is mobile phase.
Crush about 5 gm blend to fine powder. Take about 40 mg test sample in a 50 ml volumetric flask and add 12
ml of Mobile phase. Sonicate to dissolve the substance and adjust the volume q. s to 50 ml with mobile phase.
Filter through 0.20 mm filter paper. This is sample solution.

Page 6 of 11
 Central Pharmaceuticals Ltd.
2A/1 South West Darus Salam Road, Mirpur, Section-01, Dhaka-1216
QUALITY CONTROL DEPARTMENT
Standard Test Procedure for
NEOFLOX TABLET
Ciprofloxacin 500 mg as Ciprofloxacin Hydrochloride USP
Document No. : QC-STP-TAB-118 Revision No. 01 Issue Date: 01.09.2018
Effective Date: 08.09.2018 Review Date: 07.09.2021 Replace Issue: 01.06.2013
Prepared by: Checked By: Approved By: Authorized By:

QC Officer Asst. Manager QC QA Manager Plant Manager

Take about 25.0 mg Ciprofloxacin Hydrochloride in a 50 ml volumetric flask and add 12 ml Mobile phase.
Sonicate and make the final volume q. s. to 50 ml with mobile phase. Filter through 0.20 mm filter paper. This is
standard solution.
Chromatographic condition:
Column : Luna, C18, 250 mm x 4.6 mm.
Detector : 278 nm
Column Oven Temp.: 400C
Injection volume : 25 ml
Flow rate : 1 ml per minute
Run time : 15 minutes

Equilibrate the column at initial flow rate for about 60 minutes. Inject 25 ml of sample solution and then
respective standard solutions. Record the chromatogram. Calculate the quantity of active present in blend by
using the following equation:
Calculation: Potency of bulk ( % of Ciprofloxacin W/W)

As Wst Vs P 500
× × × × ×W mg/Tablet
Ast 50 50 100 582.21
where, As = peak area of sample solution.
Ast = peak area of respective standard solution.
Vs = weight of sample taken.
Wst = weight of standard.
P = potency of standard (as Ciprofloxacin Hydrochloride)
W = Average weight of talet

ASSAY(By UV)

Grind 5 gm blend into fine powder. Take 47.5 mg powder in a 100 ml volumetric flask, add 60 ml 0.01 N
Hydrochloric acid and sonicate for 15 minutes. Filter, transfer 2 ml filtrate in a 100 ml volumetric flask and add
0.01N Hydrochloric acid q. s. to 100 ml. This is sample solution.

Take 30 mg Ciprofloxacin Hydrochloride in a 100 ml volumetric flask, add 60 ml 0.01 Hydrochloric acid and
shake to dissolve. Add 0.01N Hydrochloric acid q. s. to 100 ml and mix. Transfer 2 ml of this solution in a 100
ml volumetric flask and dilute to 100 ml with 0.01N Hydrochloric acid. This is standard solution.

Measure the absorbance of sample and standard solution at 276 nm in an ultraviolet spectrophotometer using
0.01 Hydrochloric acid as blank. Calculate the amount of active substance in tablet by using the following
equation:

Calculation: Potency of bulk ( % of Ciprofloxacin W/W)

As Ws 2 100 100 P 500
× × × × × × × 100
Ast 100 100 Wst 2 100 582.2
As Ws 2 100 100 P 500
× × × × × × × W mg/Tablet
Ast 100 100 Wst 2 100 582.2

Page 7 of 11
 Central Pharmaceuticals Ltd.
2A/1 South West Darus Salam Road, Mirpur, Section-01, Dhaka-1216
QUALITY CONTROL DEPARTMENT
Standard Test Procedure for
NEOFLOX TABLET
Ciprofloxacin 500 mg as Ciprofloxacin Hydrochloride USP
Document No. : QC-STP-TAB-118 Revision No. 01 Issue Date: 01.09.2018
Effective Date: 08.09.2018 Review Date: 07.09.2021 Replace Issue: 01.06.2013
Prepared by: Checked By: Approved By: Authorized By:

QC Officer Asst. Manager QC QA Manager Plant Manager

Where, As = absorbance of sample solution.

Ast = absorbance of standard solution.
Ws t = weight of sample taken for sample solution.
Ws = weight of standard
W = Average weight of tablet
P = potency of standard (as Ciprofloxacin HCl)

Note: 385.8 mg Ciprofloxacin hydrochloride monohydrate is equivalent to 331.4 mg Ciprofloxacin.

Requirement: Each tablet must contain Ciprofloxacin 450 mg to 550 mg.

Stage 3: Coated Tablet

S/N TEST SPECIFICATION REFERENCE
3.1 Description 19.1 x 9.1 mm Caplet shaped off white core tablet with a bisect line In-house
on one side.
3.1 Identification Must be positive of Ciprofloxacin HCl USP USP
3.3 Average weight 920mg ±2% In-house
3.4 Disintegration Not more than 15 minutes. USP
time
3.5 Dissolution Rate Not less than 80% of the labeled amount of Ciprofloxacin in 30
minutes.
3.6 Assay Each tablet must contain Ciprofloxacin 450 mg to 550 mg. USP

3.1. DESCRIPTION

Take 10 tablets in a watch glass and observe visually against white background.

Requirement: It should be 19.1 x 9.1 mm Caplet shaped off white core tablet with a bisect line on one side.

3.2. IDENTIFICATION

a) By HPLC: Follow the procedure as per assay of in test sample. Record the HPLC chromatogram of test
sample as well as reference standard of Ciprofloxacin Hydrochloride.

Requirement: Retention time of the major peak in test sample must comply with that of standard Ciprofloxacin
Hydrochloride and must not vary more than 2%.

b) By UV: Follow the procedure as per assay of in test sample. Record the UV spectrum of test sample as well
as reference standard of Ciprofloxacin Hydrochloride.

3.3. AVERAGE WEIGHT

Weigh individually twenty tablets at random and determine the average weight. Not more than two of the
individual weights deviate from the average weight by more than 2% and none deviates by more than twice of
this percentage.

Page 8 of 11
 Central Pharmaceuticals Ltd.
2A/1 South West Darus Salam Road, Mirpur, Section-01, Dhaka-1216
QUALITY CONTROL DEPARTMENT
Standard Test Procedure for
NEOFLOX TABLET
Ciprofloxacin 500 mg as Ciprofloxacin Hydrochloride USP
Document No. : QC-STP-TAB-118 Revision No. 01 Issue Date: 01.09.2018
Effective Date: 08.09.2018 Review Date: 07.09.2021 Replace Issue: 01.06.2013
Prepared by: Checked By: Approved By: Authorized By:

QC Officer Asst. Manager QC QA Manager Plant Manager

Requirement: Each tablet must have weight within 901.6 mg to 938.4 mg. Only two tablets, out of twenty, may
deviate this range but must be within 901.6 mg to 938.4 mg.

3.4. DISINTEGRATION

Check the water bath, if necessary, add water to maintain desired water level. Take 600 ml water in a 1000 ml
beaker; place the beaker in its position in the disintegration tester. Adjust the thermostat at 37.8ºC. After
attaining this temperature introduce one tablet in each of the six tubes of the basket. Suspend the assembly in the
beaker and operate the apparatus until disintegration is completed. Disintegration is considered to be achieved
when no residue remains on the screen of the test apparatus. Record the time taken for disintegration.

Requirement: All the six tablets must disintegrate within 30 minutes.

3.5. DISSOLUTION

Dissolution medium: 0.01N Hydrochloric acid, 900 ml.

Apparatus # 2 ( paddle )
Rpm : 50
Run time : 30 minutes.

Check the water bath, if necessary, add water to maintain desired water level. Take 900 ml 0.01N Hydrochloric
acid into each of the six vessels of the apparatus. Adjust the thermostat at 37.8ºC. After attaining this
temperature adjust the rotation at 100 rpm. Place one tablet in each of the six vessels. Operate the apparatus for
30 minutes. After rotation is completed, withdraw about 50 ml of samples from each of the vessels. Filter and
collect the filtrate. Transfer 1 ml of these solutions in a 100 ml volumetric flask and dilute to 100 ml with 0.01N
Hydrochloric acid. These are sample solutions.

Take 33.0 mg Ciprofloxacin hydrochloride in a 50 ml volumetric flask and add 0.01N Hydrochloric acid q. s. to
50 ml and mix. Transfer 1 ml of this solution in a 100 ml volumetric flask and dilute to 100 ml with 0.01N
Hydrochloric acid. This is standard solution.

Measure the absorbance of sample and standard solution at 276 nm in an ultraviolet spectrophotometer using
0.01N Hydrochloric acid as blank. Calculate the % dissolution by using the following equation:

% of Dissolution of Ciprofloxacin=

As Wst 1 900 100 P 500

× × × × × ×100 ×
Ast 50 100 Ws 1 100 582.2
Where, As = absorbance of sample solution.
Ast = absorbance of standard solution.
Ws = labeled amount of active per tablet.
Wst = weight of standard.
P = potency of standard (as CiprofloxacinHCl)

Note: 385.8 mg Ciprofloxacin hydrochloride monohydrate is equivalent to 331.4 mg Ciprofloxacin.

Page 9 of 11
 Central Pharmaceuticals Ltd.
2A/1 South West Darus Salam Road, Mirpur, Section-01, Dhaka-1216
QUALITY CONTROL DEPARTMENT
Standard Test Procedure for
NEOFLOX TABLET
Ciprofloxacin 500 mg as Ciprofloxacin Hydrochloride USP
Document No. : QC-STP-TAB-118 Revision No. 01 Issue Date: 01.09.2018
Effective Date: 08.09.2018 Review Date: 07.09.2021 Replace Issue: 01.06.2013
Prepared by: Checked By: Approved By: Authorized By:

QC Officer Asst. Manager QC QA Manager Plant Manager

Requirement: Dissolution must not less than 80% of the labeled amount of Ciprofloxacin in 30 minutes.

3.6. ASSAY(By HPLC)

Preparation of buffer solution: Dissolve 2.88 gm Ortho phosphoric acid H 3PO4 (85%) in 1000 ml water and
adjust pH to 3.0 with 10% V/V solution of triethyl amine.
Mobile phase: Mix Acetonitrile and buffer solution at a ratio20:80. Filter through 0.20 mm filter paper. Finally
degas the mixture in an ultrasonic bath. This is mobile phase.
Crush about 5 gm blend to fine powder. Take about 40 mg test sample in a 50 ml volumetric flask and add 12
ml of Mobile phase. Sonicate to dissolve the substance and adjust the volume q. s to 50 ml with mobile phase.
Filter through 0.20 mm filter paper. This is sample solution.
Take about 25.0 mg Ciprofloxacin Hydrochloride in a 50 ml volumetric flask and add 12 ml Mobile phase.
Sonicate and make the final volume q. s. to 50 ml with mobile phase. Filter through 0.20 mm filter paper. This is
standard solution.
Chromatographic condition:
Column : Luna, C18, 250 mm x 4.6 mm.
Detector : 278 nm
Column Oven Temp.: 400C
Injection volume : 25 ml
Flow rate : 1 ml per minute
Run time : 15 minutes

Equilibrate the column at initial flow rate for about 60 minutes. Inject 25 ml of sample solution and then
respective standard solutions. Record the chromatogram. Calculate the quantity of active present in blend by
using the following equation:
Calculation: Potency of bulk ( % of Ciprofloxacin W/W)

As Wst Vs P 500
× × × × ×W mg/Tablet
Ast 50 50 100 582.21
where, As = peak area of sample solution.
Ast = peak area of respective standard solution.
Vs = weight of sample taken.
Wst = weight of standard.
P = potency of standard (as Ciprofloxacin Hydrochloride)
W = Average weight of talet

ASSAY(By UV)

Page 10 of 11
 Central Pharmaceuticals Ltd.
2A/1 South West Darus Salam Road, Mirpur, Section-01, Dhaka-1216
QUALITY CONTROL DEPARTMENT
Standard Test Procedure for
NEOFLOX TABLET
Ciprofloxacin 500 mg as Ciprofloxacin Hydrochloride USP
Document No. : QC-STP-TAB-118 Revision No. 01 Issue Date: 01.09.2018
Effective Date: 08.09.2018 Review Date: 07.09.2021 Replace Issue: 01.06.2013
Prepared by: Checked By: Approved By: Authorized By:

QC Officer Asst. Manager QC QA Manager Plant Manager

Grind 5 gm blend into fine powder. Take 47.5 mg powder in a 100 ml volumetric flask, add 60 ml 0.01 N
Hydrochloric acid and sonicate for 15 minutes. Filter, transfer 2 ml filtrate in a 100 ml volumetric flask and add
0.01N Hydrochloric acid q. s. to 100 ml. This is sample solution.

Take 30 mg Ciprofloxacin Hydrochloride in a 100 ml volumetric flask, add 60 ml 0.01 Hydrochloric acid and
shake to dissolve. Add 0.01N Hydrochloric acid q. s. to 100 ml and mix. Transfer 2 ml of this solution in a 100
ml volumetric flask and dilute to 100 ml with 0.01N Hydrochloric acid. This is standard solution.

Measure the absorbance of sample and standard solution at 276 nm in an ultraviolet spectrophotometer using
0.01 Hydrochloric acid as blank. Calculate the amount of active substance in tablet by using the following
equation:

Calculation: Potency of bulk ( % of Ciprofloxacin W/W)

As Ws 2 100 100 P 500
× × × × × × × 100
Ast 100 100 Wst 2 100 582.2
As Ws 2 100 100 P 500
× × × × × × × W mg/Tablet
Ast 100 100 Wst 2 100 582.2
Where, As = absorbance of sample solution.
Ast = absorbance of standard solution.
Wst = weight of sample taken for sample solution.
Ws = weight of standard
W = Average weight of tablet
P = potency of standard (as Ciprofloxacin HCl)

Note: 385.8 mg Ciprofloxacin hydrochloride monohydrate is equivalent to 331.4 mg Ciprofloxacin.

Requirement: Each tablet must contain Ciprofloxacin 450 mg to 550 mg.

Page 11 of 11