Study Set Content:
defined as the sum of all factors which contribute directly or indirectly to the safety, effectiveness, and the reliability of the product.
Quality
Quality Control guarantees within reasonable limits that a drug product:
- is free of impurities
- physically and chemically stable
- contains amount of active ingredients as stated on the label
- provides optimal release of active ingredients when the product is administered
occurs by slight variations in a series of observations made by the same observer, under identical conditions.
Indeterminate Errors
occurs in a constant manner in each of a series of determinations.
Determinate Errors
made by the analyst
Personal errors
caused by faulty procedure
Erros of Method
difference between the mean and the true value
Absolute Error
absolute error/true value
Relative error
difference between the largest and smallest results
Range
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
Average Deviation
Relative Average Deviation - FORMULA
- Average Deviation / mean
Relative Average Deviation usually expressed as
- percent or as parts per thousand
preferred measure for precision
Standard Deviation
Relative Standard Deviation - FORMULA=
- Standard Deviation / mean x 100
also called as coefficient variation
Relative Standard Deviation
as an ionic or molecular substance capable of giving up a proton
Acid
as an ionic or molecular substance capable of uniting with a proton
Bronsted-Lowry Base
- substances which upon dissolving in water increases the concentration of Hydronium Ions thus increasing the acidic properties of the solution.
Acid
- are those capable of giving up one proton per molecule or ion
Monoprotic Acids
- are those capable of giving up two proton per molecule or ion
Diprotic Acids
