defined as the sum of all factors which contribute directly or indirectly to the safety, effectiveness, and the reliability of the product.
Quality Control guarantees within reasonable limits that a drug product:
occurs by slight variations in a series of observations made by the same observer, under identical conditions.
occurs in a constant manner in each of a series of determinations.
made by the analyst
caused by faulty procedure
Erros of Method
difference between the mean and the true value
absolute error/true value
difference between the largest and smallest results
calculated by finding the differences between the individual results and the mean, regardless of sign, then adding these differences and dividing by the number of determination
Relative Average Deviation - FORMULA
Relative Average Deviation usually expressed as
preferred measure for precision
Relative Standard Deviation - FORMULA=
also called as coefficient variation
Relative Standard Deviation
as an ionic or molecular substance capable of giving up a proton
as an ionic or molecular substance capable of uniting with a proton