SOP FOR PROCEDURE FOR ROUNDING OF THE RESULTS

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  • OBJECTIVE

To lay down a standard procedure for procedure for rounded off the results in the Quality Control Department.

  • SCOPE

This SOP is applicable to Quality Control Department

  • RESPONSIBILITY
    • Officers / Executive – Quality Control.
  • ACCOUNTABILITY
    • Manager-Quality Control and Head QA shall be accountable for compliance of this SOP.
  • ATTACHMENTS

Nil

  • PROCEDURE
    • GENERAL PROCEDURE
      • Analytical results observed in the laboratory are compared with stated limits to determine whether there is conformance with compendial requirements.
      • The observed or calculated values usually will contain more significant figure than there are in the stated limit.
      • Observed or calculated result is to be rounded off to the number of places that is in agreement with the limit.
    • PROCEDURE FOR ROUNDING OFF FIGURES
      • Where ever the rounding off is not specified and rounding off is required report the result up to two digits.
      • If the test having specific limit, report the final result on the basis of limit, the number digits after decimal points shall be same for limit and reporting value.
      • If the limit having one digit after decimal point, the result should also report one digit after decimal point.
      • If the values have more figures after the decimal place the value shall be rounded off as per the limit. If the limit has no decimal point the reporting value should be without decimal point.

Example:- Limit: NMT 101%

Calculated Value: 100.9582%

Reporting Value: 101%

  • When rounding off is required, consider a digit before the digit just after the decimal Place.
  • If this digit is smaller than 5, it is eliminated and the preceding digit is unchanged. If this digit is 5 or greater then 5, it is eliminated and preceding digit is increased by one.
  • If the second number after decimal place to be rounded off the value of second number depends on third number after decimal place.
  • If the third number after decimal place is 4 or below 4 the second number remains same and it shall not be changed.
  • Example: The observed value is 0.5612% and the limit is NMT 0.75%.

The value shall be rounding off the second number after decimal place, i.e. 6.

The third number after decimal place is 1, so the reporting value is 0.56%.

6.2.10 If the third number after decimal place is 5 or above 5, the second number shall be reported as one number more to the actual number.

Example: The observed value is 0.5672% and the limit is NMT 0.75%.

The value shall be rounding off the second number after decimal place, i.e. 6.

The third number after decimal place is 7, so the reporting value is 0.57%.

  • ROUNDING OFF FOR THE RESULTS OF VOLUMETRIC SOLUTIONS:
    • For 0.1 to 1M or N solutions, express the strength up to four digit after the decimal point.

Example: 1M/N = 1.0000

0.2 M/N = 0.2000

  • For 0.01 to less than 0.1 M/N solutions: Express the strength up to five digits after the decimal points.

Example: 0.01 M/N = 0.01000

0.05 M/N = 0.05000

  • For 0.001 to less than 0.01 M/N solutions: Express the strength up to six digits after the decimal points.

Example: 0.001 M/N = 0.001000

0.005 M/N = 0.005000

  • ROUNDING OFF FOR THE RESULTS OF IMPURITIES
    • Rounding off the reporting results for impurities shall be three digits after the decimal point and it shall be irrespective of the limit.

Example: Observed value is 0.026582%

Reporting value is 0.027%

  • ROUNDING OFF THE RESULTS OF ASSAY/ UNIFORMITY OF CONTENT
    • Rounding off the reporting results for assay/ uniformity of content shall be two digits after the decimal point and it shall be irrespective of the limit.

Example: Observed value is 99.06585%

Reporting value is 99.07%

  • The results obtained from these, like % RSD and individual values shall report 2 digits after the decimal point and it shall be the irrespective of the limit.
  • ROUNDING OFF FOR THE RESULTS FOR LIMIT TEST, BULK DENSITY, RESIDUE ON IGNITION AND OTHER ASH CONTENTS
    • Rounding off the reporting results for limit tests shall follow general procedure.
    • Rounding off the reporting results for Bulk density, Residue on ignition and any other Ash Contents shall be three digits after the decimal point and it shall be irrespective of the limit.
  • ROUNDING OFF FOR THE RESULTS FOR HARDNESS TEST:
    • Rounding off the reporting results for Hardness and Average Weight shall be one digit after the decimal point and it shall be irrespective of the limit.
  • REFERENCES

In-house

  • ABBREVIATIONS

         SOP: Standard Operating Procedure

QC: Quality Control

USP: United State Pharmacopoeia

RSD: Relative Standard Deviation

QA: Quality Assurance

NMT: Not more than

M: Molarity

N: Normality

  • DISTRIBUTION LIST

         Quality Assurance Department

Quality Control Department

10.0  HISTORY OF REVISION

Version No. Date of Revision Reason for Revision

 

SOPs