0.0
WHAT
This
document details the procedure for rounding of analytical results.
1.0 why
It is the policy of the ABC Pharmaceuticals that a written
procedure shall be followed for the rounding off analytical results in
order to make the results more meaningful and understandable.
2.0 when
This procedure is
to be applied at the time of recording the analytical data in the test
protocols/ reports.
3.0 RESPONSIBILITY
Persons along with their responsibilities are
given below:
|
S. No
|
Designation
|
Responsibility
|
|
01
|
Executive – Corporate Quality Assurance
|
To prepare and follow the SOP accordingly
|
|
02
|
Manager – Quality
Assuarance
|
To ensure implementation of SOP
|
|
03
|
Manager -
Corporate Quality Assurance
|
To ensure implementation of SOP
|
4.0 PROCEDURE
4.1 rounding of dissolution and uniformity of cantant results
4.1.1
In case of dissolution and uniformity
of content values, rounding of analytical results shall be done in first
decimal place.
4.2 rounding of impurity AND LOD OF WORKING STANDARDS results
4.2.1
In case of impurity and LOD values,
rounding of analytical results shall be done in third decimal places.
4.2.2
If the digit of fourth decimal
place is smaller than five, it shall be eliminated and preceding digit shall be
unchanged.
4.2.3
If the digit of fourth decimal
place is five or greater than five, it shall be eliminated and preceding digit
shall be increased by one.
4.3 rounding of OTHER results
4.3.1
In case of other tests,
rounding of analytical results shall be done in second decimal places.
4.3.2
If the digit of third decimal
place is smaller than five, it shall be eliminated and preceding digit shall be
unchanged.
4.3.3
If the digit of third decimal
place is five or greater than five, it shall be eliminated and preceding digit
shall be increased by one.
Table of
examples for rounding of analytical results procedure
|
Test
|
Un-rounding value
(%)
|
Rounded of value
(%)
|
|
Assay
|
99.990
99.994
99.995
|
99.99
99.99
100.00
|
|
LOD
|
1.330
1.339
1.334
|
1.33
1.34
1.33
|
|
Sieve Analysis
|
20.420
20.426
20.422
|
20.42
20.43
20.42
|
|
Test
|
Un-rounding value
|
Rounded of value
|
|
Average weight
|
580.469 mg
580.462 mg
580.465 mg
|
580.47 mg
580.46 mg
580.47 mg
|
|
Uniformity of
Weight
|
1.438
1.435
1.434
|
1.44
1.44
1.43
|
|
Dissolution
|
90.90
90.94
90.96
|
90.9
90.9
91.0
|
|
Uniformity of
Content
|
99.996
99.990
99.995
|
100.0
100.0
100.0
|
|
Impurity
|
0.0030
0.0034
0.0036
|
0.003
0.003
0.004
|
|
LOD of Working standards
|
0.2145
0.2147
0.2142
|
0.215
0.215
0.214
|
|
Weight per ML
|
0.3452
0.3215
0.3219
|
0.345
0.322
0.322
|
|
Specific Gravity
|
1.4256
1.4563
1.4580
|
1.426
1.456
1.458
|
|
Tensile Strength
|
1.4256
1.4563
1.4580
|
1.426
1.456
1.458
|
|
Yield Stress
|
0.3452
0.3215
0.3219
|
0.345
0.322
0.322
|
|
Elongation
|
1.6548
1.6254
1.6541
|
1.655
1.624
1.654
|
|
Cross- section Area
|
4.2564
2.2415
3.2141
|
4.256
2.242
3.214
|
|
Compressive Test
|
23.125
22.451
22.367
|
23.13
22.45
22.37
|
|
Autoclave Test
|
9.365
9.321
9.330
|
9.37
9.32
9.33
|
|
Test
|
Un – rounding value
(%)
|
Rounded of Value
(%)
|
|
Le – Chaterlier
Strength
|
2.562
2.435
2.564
|
2.56
2.44
2.56
|
|
Total Ash
|
1.438
1.435
1.434
|
1.44
1.44
1.43
|
|
Moisture
|
2.562
2.435
2.564
|
2.56
2.44
2.56
|
|
Acid value
|
1.987
1.256
1.364
|
1.99
1.26
1.36
|
|
Sulphated Ash
|
2.562
2.435
2.564
|
2.56
2.44
2.56
|
|
Moisture
|
1.438
1.435
1.434
|
1.44
1.44
1.43
|
|
Sugar
|
2.562
2.435
2.564
|
2.56
2.44
2.56
|
|
Peroxide Value
|
3.256
3.231
3.226
|
3.26
3.23
3.23
|
|
Iodine Value
|
9.654
9.665
9.998
|
9.65
9.67
10.00
|
|
Calorific Value
|
1.438
1.435
1.434
|
1.44
1.44
1.43
|
|
Protein
|
5.632
5.624
5.217
|
5.63
5.62
5.22
|
|
Carbohydrate
|
1.235
2.354
2.999
|
1.24
2.35
3.00
|
|
Total Fatty Matter
|
5.323
5.241
5.426
|
5.23
5.24
5.43
|
|
|
1.235
1.241
1.001
|
1.24
1.24
1.00
|
|
Active Detergent
|
2.345
2.546
2.534
|
2.35
2.55
2.53
|
|
Test
|
Un-rounding value
(%)
|
Rounded of value
(%)
|
|
Foam Height
|
1.235
1.241
1.001
|
1.24
1.24
1.00
|
|
pH
|
1.235
2.354
2.999
|
1.24
2.35
3.00
|
|
Ash Content
|
5.632
5.624
5.217
|
5.63
5.62
5.22
|
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