SOP for Rounding off the Analytical Test Results

1.0 OBJECTIVE

To lay down the procedure for ‘Rounding off’ the results.

2.0 SCOPE

This procedure is applicable to round off the calculated results of the test parameters/ specifications related to Quality Control Analysis.

3.0 RESPONSIBILITY

3.1 Doing: Technical Assistant/Executive
3.2 Checking: Executive/Manager

4.0 ACCOUNTABILITY

Head of the Department

5.0 PROCEDURE

5.1 Zero value at the beginning of a number is never significant figures because they simply determine the position of decimal point. Zero value at the end of a number is considered as significant figures.
5.2 All results values shall be reported based on the limit expression.
5.3 While reporting results, express it up to one digit more after the decimal point than that it expressed in the limit.
5.4 If the digit under consideration is less than 5, it is eliminated and preceding digit remains unchanged. e.g. 99.434 --> 99
5.5 If the digit under consideration is greater than or equal to 5, it is eliminated and preceding digit is increased by 1 e.g 99.468 --> 99.47
5.6 Refer Annexure- I for a better understanding of point no. 5.2 & 5.3.

Related: Rounding off Values In GMP Documents in Pharmaceuticals

6.0 ABBREVIATION

6.1 SOP - Standard Operating Procedure

Test Parameters / Specifications	Expression of Rounding Off Results.
Assay / Content Uniformity / Dissolution / Loss on drying / Loss on ignition / Water by KF / pH / Conductivity /  Impurities / Related substances / OVI & Physical parameters	Up to one digit more than that specified in limit.

Examples Of Various Parameters For Rounding Off the value.

Sr. No.	Specification / Requirement	Un-Rounded Value	Rounded Value
1	Assay limit  >   98.0 %	97.962	97.96
		97.927	97.93
		97.955	97.96
2	Assay limit  <   101.5 %	101.557	101.56
		101.462	101.46
		101.455	101.46
3	Limit test   <   0.02 %	0.0253	0.025
		0.0157	0.016
		0.0275	0.028
4	Impurity limit    <   3 ppm	2.872	2.9
		2.754	2.8
		2.243	2.2

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