SOP for Rounding off the Analytical Test Results : Pharmaceutical Guidelines

SOP for Rounding off the Analytical Test Results

Standard operating procedure to round off the analytical test results in quality control.

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.

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






Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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