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Common mistakes in analysis

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Moshfiqur Rahaman
Moshfiqur Rahaman

In this slide I have described the common mistakes which may happened in regular analysis and how these can be avoided simply.

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Md. Moshfiqur Rahaman Asst. Manager, Quality Control ACI HealthCare Limited Common mistakes in Analysis
Analysis A error free analysis can be distinguished into following activities: 1. Selection of appropriate STP and SPEC 2. Use of proper reagent and standard 3. Appropriate mobile phase, standard and sample preparation 4. Successful instrument run 5. Appropriately data processing, calculation and reporting
STP & SPEC Mistakes 1. Same product/material with different code number 2. Similar product/material name 3. Misunderstanding of specification requirements Check carefully the product/material and take the appropriate STP and SPEC Check for skip testing
Reagent and Standard Wrong reagent /prepared solution Different grade Different purity Different Hydration Expired reagent Incorrect standard Expired standard Purity Grade Exp. Date Strength Potency Form Check the STP well!!
Mobile phase Forget to adjust pH of buffer Use of wrong organic Wrong ratio of buffer and organic Mixing buffer and organic in measuring cylinder Improper mixing of buffer and organic Forget to degas Check STP for pH adjustment Check for appropriate organic Check and calculate for correct ratio of buffer and organic Mix buffer and organic in a beaker or preparation vessel measuring separately Mix properly following STP and degas properly before use
Standard and Sample preparation Wrong sample amount Wrong glassware used Wrong dilution Wrong filter used Missing or skipping one or more steps Check for appropriate sample amount Read the STP carefully and arrange required glassware before starting standard and sample preparation
Instrument run Selection of wrong instrument, e.g. UV instead of PDA Selection of wrong instrument method Wrong runtime selection Wrong instrument parameter set Obsolete method used Detector life ended Instrument not in state of use Instrument not in calibrated state Instrument run Appropriate Type Calibration Status Detector Life Appropriate method
Data processing, calculation and reporting Improper peak integration Wrong processing method Wrong dilution factor use for automatic calculation Wrong potency of standard used for result calculation Conversion factor missing Strength or factor of VS not used BRL, BDL, BQL not considered for impurity reporting Results not reported in CoA as per specification Check all chromatogram, baseline for prper peak integration Check the processing method properly before processing Do the calculation manually and check with the software generated result for any mistakes Use appropriate potency, conversion factor (if any) for standards Use appropriate strength/factor of VS Consider BRL, BDL and BQL for impurity reporting Report the result in CoA as per Specification
Hope that you will be able to reduce your mistake now!

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Common mistakes in analysis

  • 1. Md. Moshfiqur Rahaman Asst. Manager, Quality Control ACI HealthCare Limited Common mistakes in Analysis
  • 2. Analysis A error free analysis can be distinguished into following activities: 1. Selection of appropriate STP and SPEC 2. Use of proper reagent and standard 3. Appropriate mobile phase, standard and sample preparation 4. Successful instrument run 5. Appropriately data processing, calculation and reporting
  • 3. STP & SPEC Mistakes 1. Same product/material with different code number 2. Similar product/material name 3. Misunderstanding of specification requirements Check carefully the product/material and take the appropriate STP and SPEC Check for skip testing
  • 4. Reagent and Standard Wrong reagent /prepared solution Different grade Different purity Different Hydration Expired reagent Incorrect standard Expired standard Purity Grade Exp. Date Strength Potency Form Check the STP well!!
  • 5. Mobile phase Forget to adjust pH of buffer Use of wrong organic Wrong ratio of buffer and organic Mixing buffer and organic in measuring cylinder Improper mixing of buffer and organic Forget to degas Check STP for pH adjustment Check for appropriate organic Check and calculate for correct ratio of buffer and organic Mix buffer and organic in a beaker or preparation vessel measuring separately Mix properly following STP and degas properly before use
  • 6. Standard and Sample preparation Wrong sample amount Wrong glassware used Wrong dilution Wrong filter used Missing or skipping one or more steps Check for appropriate sample amount Read the STP carefully and arrange required glassware before starting standard and sample preparation
  • 7. Instrument run Selection of wrong instrument, e.g. UV instead of PDA Selection of wrong instrument method Wrong runtime selection Wrong instrument parameter set Obsolete method used Detector life ended Instrument not in state of use Instrument not in calibrated state Instrument run Appropriate Type Calibration Status Detector Life Appropriate method
  • 8. Data processing, calculation and reporting Improper peak integration Wrong processing method Wrong dilution factor use for automatic calculation Wrong potency of standard used for result calculation Conversion factor missing Strength or factor of VS not used BRL, BDL, BQL not considered for impurity reporting Results not reported in CoA as per specification Check all chromatogram, baseline for prper peak integration Check the processing method properly before processing Do the calculation manually and check with the software generated result for any mistakes Use appropriate potency, conversion factor (if any) for standards Use appropriate strength/factor of VS Consider BRL, BDL and BQL for impurity reporting Report the result in CoA as per Specification
  • 9. Hope that you will be able to reduce your mistake now!