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Signature
Written by
Reviewed &
Approved by
Reviewed &
Approved by
Authorized by
03 - 07 - 0054
Registration No:
068205
Shelf Life:
02 Years
Reference:
In house
Date
Declaration:
Each film coated tablet contains:
Rifaximin . 200 mg
All or part of the information contained in this document should be treated as the confidential property of Ferozsons
Laboratories Limited. It cannot be published or divulged for whatever purpose to unauthorized persons, or third parties, in any
form without the prior written permission from DQO Ferozsons Laboratories Limited.
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Tests
Appearance
Specifications
Reddish granular, mixed powder.
Absorption spectrum obtained from sample preparation
Identification
Assay (Rifaximin)
Antimicrobial activity
(Microbial assay)
90 % 110 %
90 % 110 %
APPEARANCE:
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Date
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Laboratories Limited. It cannot be published or divulged for whatever purpose to unauthorized persons, or third parties, in any
form without the prior written permission from DQO Ferozsons Laboratories Limited.
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1. Principle
2. Evaluation
3. Requirement
IDENTIFICATION (Rifaximin):
1. Principle
To identify Rifaximin.
2. Evaluation
3. Requirement
ASSAY (Rifaximin):
1. Principle
2. Evaluation
3. Requirement
90 % 110 %
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Date
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Laboratories Limited. It cannot be published or divulged for whatever purpose to unauthorized persons, or third parties, in any
form without the prior written permission from DQO Ferozsons Laboratories Limited.
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4. Procedure
As under.
Apparatus:
Volumetric flasks
Spectrophotometer
Beaker
Spatula
Analytical balance
Pipette 1 ml
Flask shaker
Funnel
Reagents:
Acetonitrile
Distilled water
Preparation of Diluent:
Mix distilled water and acetonitrile in ratio of 60: 40
Sample preparation:
Reviewed & Approved by: Sr. MQA
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Date
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Laboratories Limited. It cannot be published or divulged for whatever purpose to unauthorized persons, or third parties, in any
form without the prior written permission from DQO Ferozsons Laboratories Limited.
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Procedure:
Measure the absorbance of the final solutions of sample and standard at 235 nm using
diluent as blank.
Calculations:
Absorbance of the sample
% age = ------------------------------------- x 100
Absorbance of the standard
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1. Principle
2. Evaluation
3. Requirement
90 % 110%.
4. Procedure
As under.
Incubator
Autoclave
Face Mask
Sterile Forcep
Micropipette 20 L
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Sterile pH 7.2 Phosphate Buffer / Tryptic Soy Broth / Sterile Peptone Water
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Final Conc.
6 mm Disc
20 L
100 mg : 50 mL
0.04 mg
Dilution Method:
Grind the granular powder into fine powder and weigh accurately 330 mg of mixed
powder equivalent to 200 mg of Rifaximin.
First Dilution = Dissolve it into 100 mL of the mixture of filtered acetonitrile and H2O
(60 : 40).
Second Dilution = Then take 20 L and place on to sterile 6 mm disc.
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Final Conc.
6 mm Disc
20 L
200 mg : 100 mL
0.04 mg
Leave the inoculum to adjust & dry for 3 5 minutes (not more than 15 minutes) at
room temperature with the lid closed under the B.S.C.
After adjustment of inoculum with the agar, place antibiotic sample discs on the
inoculated plates using a sterile forcep along with standard antibiotic disc aseptically
under the B.S.C.
After placing each and every required disc, press gently with forcep to make sure
even contact with agar medium.
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Laboratories Limited. It cannot be published or divulged for whatever purpose to unauthorized persons, or third parties, in any
form without the prior written permission from DQO Ferozsons Laboratories Limited.
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%age
100
Prepare duplicate discs and place on to the medium surface in Triangular Shape
(see Fig. 2b) / Linear Direction (see Fig. 2c given below).
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Laboratories Limited. It cannot be published or divulged for whatever purpose to unauthorized persons, or third parties, in any
form without the prior written permission from DQO Ferozsons Laboratories Limited.
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Figure 2b Template for applying antibiotic discs in Triangular Shape (90 mm Diameter of Plate)
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form without the prior written permission from DQO Ferozsons Laboratories Limited.
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Figure 2c Template for applying antibiotic discs in Linear Shape (90 mm Diameter of Plate)
Antibiotic Disc
Zone of Inhibition
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Tests
Appearance
Specifications
Reddish round, biconvex tablets with break line on one side
and plain other side.
Shape
Average Weight
Weight variation
330 mg 5 %
Minimum 18/20 + 5 %
Maximum 02/20 + 10 %
Thickness
Hardness
Friability/ Breakage
Disintegration Time
Dissolution
Identification
Assay (Rifaximin)
Antimicrobial activity
(Microbial assay)
90 % 110 %
90 % 110 %
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Date
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Laboratories Limited. It cannot be published or divulged for whatever purpose to unauthorized persons, or third parties, in any
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2. Evaluation
3. Requirement
AVERAGE WEIGHT:
1. Principle
2. Evaluation
3. Apparatus
Analytical balance.
4. Requirement
330 mg 5 %
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form without the prior written permission from DQO Ferozsons Laboratories Limited.
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1. Principle
2. Apparatus
Analytical balance.
3. Test performance
Sample size:
- 20 tablets per sample
4. Evaluation
The actual mean value should not deviate more than the
specified limit to the theoretical weight.
Weigh accurately 20 tablets and calculate average weight,
then weigh individually 20 tablets.
The difference in percentage from minimum weight to
maximum weight of individual tablets should not be more than
the specified limits.
Max. deviation = Max. tablet weight Avg. weight found
Avg. weight found
Min. deviation = Min. tablet weight Avg. weight found
Avg. weight found
5. Requirement
Minimum 18/20 + 5 %
Maximum 02/20 + 10 %
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Laboratories Limited. It cannot be published or divulged for whatever purpose to unauthorized persons, or third parties, in any
form without the prior written permission from DQO Ferozsons Laboratories Limited.
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Principle
2. Apparatus
3. Method
Thickness
Diameter
Hardness
00
00.00
00.00
00.00
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6. Requirement
HARDNESS:
1
Principle
2. Apparatus
3. Method
Thickness
Diameter
Hardness
00
00.00
00.00
00.00
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5. Frequency
6. Requirement
1. Principle
2. Requirements
- Friability:
- Breakage: Nil.
3. Apparatus:
4. Method
For tablets with a unit weight equal to or less than 650 mg,
take a sample of whole tablets corresponding as near as
possible to 6.5 g. For tablets with a unit weight of more than
650 mg, take a sample of 10 whole tablets. Dusted tablets and
placed in a drum. Close the drum and fix it on the shaft in such
a way that on rotating, the tablets are taken up by the concave
side of the blade. Allow the drum to rotate 100 times (or as per
specifications).
Place the contents of the drum on the sieve and examine the
tablets for breakage. Dust off the abrased material and sieve.
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Percentage friability =
B-C
100
B
B
100
Disintegration Apparatus
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form without the prior written permission from DQO Ferozsons Laboratories Limited.
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Fill sufficient water into the vessel so that during motion, the
gauze does not come within less than 2.5 cm of the surface of
the liquid warm the water to 37 + 2oC.
Place one tablet in each of the 6 glass tubes and operate the
apparatus and determine the time taken for each tablet to
disintegrate.
3. Requirement
DISSOLUTION:
1. Apparatus
Dissolution Apparatus # 2.
2. Method
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Laboratories Limited. It cannot be published or divulged for whatever purpose to unauthorized persons, or third parties, in any
form without the prior written permission from DQO Ferozsons Laboratories Limited.
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Date
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Laboratories Limited. It cannot be published or divulged for whatever purpose to unauthorized persons, or third parties, in any
form without the prior written permission from DQO Ferozsons Laboratories Limited.
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Procedure:
Measure the absorbance of the final solutions of sample and
standard at 235 nm using distilled diluent as blank.
3. Requirement
4. Calculation
Absorbance of sample
%age = -------------------------------- x 100
Absorbance of standard
IDENTIFICATION (Rifaximin):
1. Principle
To identify Rifaximin.
2. Evaluation
Sign:
Date
All or part of the information contained in this document should be treated as the confidential property of Ferozsons
Laboratories Limited. It cannot be published or divulged for whatever purpose to unauthorized persons, or third parties, in any
form without the prior written permission from DQO Ferozsons Laboratories Limited.
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ASSAY (Rifaximin):
1. Principle
2. Evaluation
3. Requirement
90 % 110 %
4. Procedure
As under.
Apparatus:
Volumetric flasks
Spectrophotometer
Beaker
Spatula
Analytical balance
Pipette 1 ml
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Date
All or part of the information contained in this document should be treated as the confidential property of Ferozsons
Laboratories Limited. It cannot be published or divulged for whatever purpose to unauthorized persons, or third parties, in any
form without the prior written permission from DQO Ferozsons Laboratories Limited.
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Flask shaker
Funnel
Reagents:
Acetonitrile
Distilled water
Preparation of Diluent:
Mix distilled water and acetonitrile in ratio of 60: 40
Sample preparation:
Weigh and finely powder not less than 20 tablets. Transfer an accurately weighed portion of
the powder equivalent to 100 mg of Rifaximin in a 100 ml volumetric flask. Add
approximately 80 ml of diluent and shake for 40 minutes. Make volume with diluent. Filter
and discard first few ml of the filtrate. Dilute 1 ml of the filtrate to 100 ml with diluent .
Reference standard preparation:
Transfer an accurately weighed 100 mg of Rifaximin working standard in a 100 ml
volumetric flask and add about 80 ml diluent. Shake for 30 minutes to dissolve and make
volume up to the mark with diluent. Dilute 1 ml of this solution to 100 ml with diluent.
Procedure:
Measure the absorbance of the final solutions of sample and standard at 235 nm using
diluent as blank.
Calculations:
Reviewed & Approved by: Sr. MQA
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Date
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Laboratories Limited. It cannot be published or divulged for whatever purpose to unauthorized persons, or third parties, in any
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2. Evaluation
3. Requirement
90 % 110%.
4. Procedure
As under.
Incubator
Autoclave
Face Mask
Sterile Forcep
Micropipette 20 L
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Date
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form without the prior written permission from DQO Ferozsons Laboratories Limited.
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Sterile pH 7.2 Phosphate Buffer / Tryptic Soy Broth / Sterile Peptone Water
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Date
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Laboratories Limited. It cannot be published or divulged for whatever purpose to unauthorized persons, or third parties, in any
form without the prior written permission from DQO Ferozsons Laboratories Limited.
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01st Dilution
Final Conc.
6 mm Disc
20 L
100 mg : 50 mL
0.04 mg
Dilution Method:
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01st Dilution
Final Conc.
6 mm Disc
20 L
200 mg : 100 mL
0.04 mg
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Date
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Laboratories Limited. It cannot be published or divulged for whatever purpose to unauthorized persons, or third parties, in any
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%age
100
Prepare duplicate discs and place on to the medium surface in Triangular Shape (see Fig.
2b) / Linear Direction (see Fig. 2c given below).
Sign:
Date
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Laboratories Limited. It cannot be published or divulged for whatever purpose to unauthorized persons, or third parties, in any
form without the prior written permission from DQO Ferozsons Laboratories Limited.
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Sign:
Date
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Laboratories Limited. It cannot be published or divulged for whatever purpose to unauthorized persons, or third parties, in any
form without the prior written permission from DQO Ferozsons Laboratories Limited.
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Figure 2b Template for applying antibiotic discs in Triangular Shape (90 mm Diameter of Plate)
Figure 2c Template for applying antibiotic discs in Linear Shape (90 mm Diameter of Plate)
Antibiotic Disc
Zone of Inhibition
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Date
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Laboratories Limited. It cannot be published or divulged for whatever purpose to unauthorized persons, or third parties, in any
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Tests
Appearance
Specifications
An orange color, round biconvex film coated tablets with break
line on one side and plain other side.
Shape
Average Weight
343 mg 5 %
Minimum 18/20 + 5 %
Weight variation
Maximum 02/20 + 10 %
Disintegration Time
NMT. 30 minutes
Dissolution
Identification
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form without the prior written permission from DQO Ferozsons Laboratories Limited.
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90 % 110 %
90 % 110 %
APPEARANCE:
1. Principle
2. Evaluation
3. Requirement
AVERAGE WEIGHT:
1. Principle
2. Evaluation
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Date
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Analytical balance.
4. Requirement
343 mg 5 %
CONTROL OF WEIGHTS:
1. Principle
2. Apparatus
Analytical balance.
3. Test performance
Sample size:
- 20 tablets per sample
4. Evaluation
The actual mean value should not deviate more than the
specified limit to the theoretical weight.
Weigh accurately 20 tablets and calculate average weight,
then weigh individually 20 tablets.
The difference in percentage from minimum weight to
maximum weight of individual tablets should not be more than
the specified limits.
Sign:
Date
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Laboratories Limited. It cannot be published or divulged for whatever purpose to unauthorized persons, or third parties, in any
form without the prior written permission from DQO Ferozsons Laboratories Limited.
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Minimum 18/20 + 5 %
Maximum 02/20 + 10 %
DISINTEGRATION TIME:
1. Apparatus
Disintegration Apparatus
2. Method
Fill sufficient water into the vessel so that during motion, the
gauze does not come within less than 2.5 cm of the surface of
the liquid warm the water to 37 + 2oC.
Place one tablet in each of the 6 glass tubes and operate the
apparatus and determine the time taken for each tablet to
disintegrate.
3. Requirement
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Date
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Laboratories Limited. It cannot be published or divulged for whatever purpose to unauthorized persons, or third parties, in any
form without the prior written permission from DQO Ferozsons Laboratories Limited.
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DISSOLUTION:
1. Apparatus
Dissolution Apparatus # 2.
2. Method
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Laboratories Limited. It cannot be published or divulged for whatever purpose to unauthorized persons, or third parties, in any
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4. Calculation
Absorbance of sample
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form without the prior written permission from DQO Ferozsons Laboratories Limited.
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IDENTIFICATION (Rifaximin):
1. Principle
To identify Rifaximin.
2. Evaluation
3. Requirement
ASSAY (Rifaximin):
1. Principle
2. Evaluation
3. Requirement
90 % 110 %
4. Procedure
As under.
Apparatus:
Reviewed & Approved by: Sr. MQA
Sign:
Date
All or part of the information contained in this document should be treated as the confidential property of Ferozsons
Laboratories Limited. It cannot be published or divulged for whatever purpose to unauthorized persons, or third parties, in any
form without the prior written permission from DQO Ferozsons Laboratories Limited.
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Beaker 100 ml
Funnel
Filter paper
Flask shaker
Analytical balance
Spatula
Watch glass
Reagents:
Acetonitrile
Methanol
Ammonium Acetate
Distilled water
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Laboratories Limited. It cannot be published or divulged for whatever purpose to unauthorized persons, or third parties, in any
form without the prior written permission from DQO Ferozsons Laboratories Limited.
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Injection Size
20 l
Flow Rate
1.0 ml / min
Column
Wavelength
236 nm
Procedure:
Condition the column by running mobile phase and checking the UV value of the UV
detector.
When the UV detector became stable, separately inject equal volumes of 20 l of standard
preparation and the sample preparation into the chromatograph, record the chromatograms
and measure the peak responses.
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Laboratories Limited. It cannot be published or divulged for whatever purpose to unauthorized persons, or third parties, in any
form without the prior written permission from DQO Ferozsons Laboratories Limited.
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2. Evaluation
3. Requirement
90 % 110%.
4. Procedure
As under.
Incubator
Autoclave
Face Mask
Sterile Forcep
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Date
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Laboratories Limited. It cannot be published or divulged for whatever purpose to unauthorized persons, or third parties, in any
form without the prior written permission from DQO Ferozsons Laboratories Limited.
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Micropipette 20 L
Sterile pH 7.2 Phosphate Buffer / Tryptic Soy Broth / Sterile Peptone Water
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Date
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Laboratories Limited. It cannot be published or divulged for whatever purpose to unauthorized persons, or third parties, in any
form without the prior written permission from DQO Ferozsons Laboratories Limited.
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01st Dilution
Final Conc.
6 mm Disc
20 L
100 mg : 50 mL
0.04 mg
Sign:
Date
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Laboratories Limited. It cannot be published or divulged for whatever purpose to unauthorized persons, or third parties, in any
form without the prior written permission from DQO Ferozsons Laboratories Limited.
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Dilution Method:
Crush the 20 tablets and weigh accurately 343 mg of fine powder equivalent to 200
mg of Rifaximin.
First Dilution = Dissolve it into 100 mL of the mixture of filtered acetonitrile and H2O
(60 : 40).
Second Dilution = Then take 20 L and place on to sterile 6 mm disc.
01st Dilution
Final Conc.
6 mm Disc
20 L
200 mg : 100 mL
0.04 mg
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%age
100
Prepare duplicate discs and place on to the medium surface in Triangular Shape (see Fig.
2b) / Linear Direction (see Fig. 2c given below).
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Figure 2b Template for applying antibiotic discs in Triangular Shape (90 mm Diameter of Plate)
Figure 2c Template for applying antibiotic discs in Linear Shape (90 mm Diameter of Plate)
Antibiotic Disc
Zone of Inhibition
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Tests
Appearance
Specifications
An orange color, round biconvex film coated tablets with break
line on one side and plain other side.
Shape
Average Weight
343 mg 5 %
Absorption spectrum obtained from sample preparation and
Identification
Assay (Rifaximin)
90 % 110 %
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Should be absent.
Escherichia coli
Must be absent.
Staphylococcus aureus
Must be absent.
Pseudomonas
aeruginosa
Must be absent.
Salmonella Species
Must be absent.
Clostridia Species
Must be absent.
Candida albicans
Must be absent.
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APPEARANCE:
1. Principle
2. Evaluation
3. Requirement
AVERAGE WEIGHT:
1. Principle
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3. Apparatus
Analytical balance.
4. Requirement
343 mg 5 %
IDENTIFICATION (Rifaximin):
1. Principle
To identify Rifaximin.
2. Evaluation
3. Requirement
ASSAY (Rifaximin):
1. Principle
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3. Requirement
90 % 110 %
4. Procedure
As under.
Apparatus:
Volumetric flasks
Spectrophotometer
Beaker
Spatula
Analytical balance
Pipette 1 ml
Flask shaker
Funnel
Reagents:
Acetonitrile
Distilled water
Preparation of Diluent:
Mix distilled water and acetonitrile in ratio of 60: 40
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Procedure:
Measure the absorbance of the final solutions of sample and standard at 235 nm using
diluent as blank.
Calculations:
Absorbance of the sample
% age = ------------------------------------- x 100
Absorbance of the standard
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3. Requirement
4. Procedure
As under.
Oven
Incubator
Autoclave
Culture Media:
Columbia Agar
Peptone Water
Cetrimide Agar
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MacKonkey Agar
MacKonkey Broth
Preparation of Sample:
Dissolve (usually a 1:10 dilution is prepared) 10 g of Rifaxa 200 mg Tablets in Sterile
Peptone Buffered Solution / Sterile Tryptic Soy Broth. If necessary, adjust the pH to 6 8.
Further dilutions, where necessary, are prepared with the same diluent.
Neutralization of Antimicrobial Activity:
Add 1 mL Polysorbate 80 to the diluent and sterile it before use, it is used for inactivation of
antibiotic properties of the sample.
Total Aerobic Microbial Count (TAMC):
Pipette 0.5 1 mL of the prepared sample into each of two Sterile Tryptic Soy Agar
containing petri-dishes of 90 mm diameter. Spread the sample volume with the help of L
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Subculturing:
After completion of 24 hours incubation time, subculture a small aliquot (0.5 1 mL)
from mossel broth to Violet Red Bile Agar plates in duplicate. Incubate at 30 35 C
for 24 hours.
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Interpretation:
The product complies with the test if there is no growth of colonies.
Subculturing:
Shake the bottle of sample containing Tryptic Soy Broth, transfer 1 mL of Tryptic Soy
Broth to 100 mL of MacKonkey Broth and incubate at 42 44 C for 24 hours.
After completion of 24 hours of incubation time, subculture a small aliquot from
MacKonkey Broth to MacKonkey Agar plates in duplicate. Incubate at 30 35 C for
24 48 hours.
Interpretation:
If colonies grow on MacKonkey Agar plates these indicate the possible presence of
Escherichia coli. This is confirmed by identification tests.
The product complies with the test if no colonies are present OR if the identification
tests are negative.
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Subculturing:
After completion of 24 hours of incubation time, shake the bottle of sample containing
Tryptic Soy Broth, transfer 1 mL of Tryptic Soy Broth to Mannitol Salt Agar plates in
duplicate. Incubate at 30 35 C for 72 hours.
Interpretation:
The possible presence of Staphylococcus aureus is indicated by the growth of yellow
OR white colonies surrounded by a yellow zone. This is confirmed by identification
tests. The product complies with the test if colonies of the types described are not
present OR if the confirmatory identification tests are negative.
Subculturing:
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Interpretation:
Growth of colonies on Cetrimide Agar plates with yellow-green to blue-green OR
yellow-green to green coloration these indicate the presence of Pseudomonas
aeruginosa. This is confirmed by identification tests.
The product complies with the test if no colonies are present OR if the identification
tests are negative.
Subculturing:
After completion of 24 hours of incubation time, transfer 0.1 mL of Tryptic Soy Broth to
10 mL of Rappaport Vassiliadis Salmonella Enrichment Broth and incubate at 30 35
C for 24 hours.
After completion of 24 hours incubation, subculture a small aliquot on plates of Xylose
Lysine Deoxycholate Agar and incubate at 30 35 C for 48 hours.
Interpretation:
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Subculturing:
After completion of 48 hours incubation, subculture a small aliquot from each bottle of
Reinforced Clostridial Medium on plates of Columbia agar and incubate at 30 35 C
for 48 hours under anaerobic conditions.
Interpretation:
The occurrence of anaerobic growth of rods (with OR without endospores) giving a
negative catalase reaction indicates the presence of Clostridia.
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Subculturing:
After completion of 72 hours incubation, subculture a small aliquot from Sabouraud
Dextrose Broth on plates of Sabouraud Dextrose Agar and incubate at 30 35 C for
48 hours.
Interpretation:
Growth of white colonies may indicate the presence of Candida albicans. This is
confirmed by identification tests.
The product complies with the test if colonies of the types described are not present
OR if the confirmatory identification tests are negative.
Negative Controls:
To verify testing conditions, a negative control is performed using the chosen diluent in
place of the test preparation. There must be no growth of microorganisms observed /
detected. A negative control is also performed when testing the products as described
under the Testing of Products.
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TRAINING:
Training of the concerned SOP is given to the personnel of the Quality control analyst who
will be exercising the SOP. And training record is to be maintained on Annexure I.
DISTRIBUTION:
Distribution
Reviewed & Approved by: Sr. MQA
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Date
Copy No.
Signature
Date
HISTORY:
Date
June 27, 2016
Reason of Change
To replace fQ number with new PAM number and addition of
dissolution test.
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