Assay Calculation
· While doing any assay calculation the result of assay
is expressed upto one decimal place more than the significant figures stated
and then the results are rounded up or down as follows.
· If the last figure calculated is 5 to 9, the preceding
figure is increased by 1 & if it is 4 or less, the preceding figure is left
unchanged.
· To find out significant figures for particular value
refer its specification limit, e.g. if limit is 99.00 to 102.00 then two
decimals from decimal point are significant. If limit is 98 to 101 then
significant figures are without decimal point.
· Microbial Limit Test Report : The reading of count
expressed as a whole number. Pathogens reading is reported as Present /
Absent / Positive / Negative.
· Water analysis / Slit Air Sampling / Bacterial Count /
fungal Count / Settle Plate / Swab : Is expressed as a whole number.
· Microbial Assay : Any microbial assay is expressed
either in terms of percentage / microgram / milligram.
Loss On Drying
· Result of loss on drying is expressed in terms of percentage
upto second decimal place and the results are rounded up or down as mentioned
in assay calculation.
Sulphated Ash
· Result of sulphated ash is expressed in terms of
percentage upto fourth decimal place and the results are rounded up or down as
mentioned in assay calculation.
Loss On Ignition
· Result of loss on ignition is expressed in terms of
percentage upto second decimal place and the results are rounded up or down as
mentioned in assay calculation.
HPLC Calculation
· Area of standard & sample in Agilent series HPLC
system is expressed up to the third decimal place, e.g. 237.293, 2.293 etc.
NOTE : Area
of standard & sample in Thermo Separation series HPLC system is not
expressed in decimal place.
Impurity
· Any Impurity is expressed up to the third decimal
place, e.g. 0.101, 0.500 etc.
Absorbance measured on the Spectrophotometer
· Absorbance is expressed up to the third decimal place,
e.g. 0.101, 0.500 etc.
Gas Chromatography
· Area of standard & sample is expressed up to the
fourth decimal place.
Temperature & Humidity of Stability Ovens
· Temperature & humidity of stability ovens is
expressed upto one decimal place.
Temperature & Humidity of Control Sample Room
· Temperature & humidity of control sample room is
expressed as the actual temperature displayed on the Thermometer, e.g.
22°C, 25°C, etc.
Related: Requirements for Good Documentation Practice (GDP)
Related: Requirements for Good Documentation Practice (GDP)
Bin Cards
Bin Cards of
Raw Material :
· When material is received / issued in terms of kg, the
quantity is expressed upto the third decimal place & when material is
received / issued in terms of g., the quantity is expressed upto the third
decimal place.
Bin Cards of
Packing Material :
· When printed packaging material like labels, cartons,
leaflets, BOPP Tape, Corrugated boxes are issued, it is expressed in terms of
numbers.
· When unprinted packaging material like containers,
bottles are issued, it is expressed in terms of numbers.
· Printed / unprinted foil when issued is expressed in
terms of kg.
Batch Manufacturing Documents
· When material is weighed in terms of kg, the quantity
is expressed upto the second decimal place & when material is weighed in
terms of g., the quantity is expressed upto the third decimal place.
Percentage yield is expressed upto the second decimal place.
Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widelyread pharmaceutical blog since 2008. Signup for the free email updates for your daily dose of pharmaceutical tips.
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