SOP ROUNDING OF ANALYTICAL RESULTS

SOP ON ROUNDING OF ANALYTICAL RESULTS

SOP ON ROUNDING OF ANALYTICAL RESULTS
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.

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
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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