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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