SOP ON ROUNDING OF ANALYTICAL RESULTS
SOP ON ROUNDING OF ANALYTICAL RESULTS
1.0 WHAT This document details the procedure for rounding of analytical results.
2.0 Why It is the policy of the XXX Pharmaceuticals that a written procedure shall be followed for the rounding off analytical results to make the results more meaningful and understandable.
3.0 When This procedure is to be applied at the time of recording the analytical data in the test protocols/ reports.
4.0 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
|
5.0 PROCEDURE
5.1 Rounding of dissolution and uniformity of content results
5.1.1 In case of dissolution and uniformity of content values, rounding of analytical results shall be done in the first decimal place.
5.1.2 If the digit of the second decimal place is smaller than five, it shall be eliminated and the preceding digit shall be unchanged.
5.1.3 If the digit of the second decimal place is five or greater than five, it shall be eliminated and the preceding digit shall be increased by one.
5.2 Rounding of impurity AND LOD OF WORKING STANDARDS results
5.2.1 In case of impurity and LOD values, rounding of analytical results shall be done in third decimal places.
5.2.2 If the digit of the fourth decimal place is smaller than five, it shall be eliminated and the preceding digit shall be unchanged.
5.2.3 If the digit of the fourth decimal place is five or greater than five, it shall be eliminated and the preceding digit shall be increased by one.
5.3 Rounding of OTHER results
5.3.1 In case of other tests, rounding of analytical results shall be done in second decimal places.
5.3.2 If the digit of the third decimal place is smaller than five, it shall be eliminated and the preceding digit shall be unchanged.
5.3.3 If the digit of the third decimal place is five or greater than five, it shall be eliminated and the preceding digit shall be increased by one.
|
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
|
|
Para
Phenyldiamine Content |
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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