Non-Sterile Compounding

Question 1

Which chapter of the USP Compounding Compendium provides guidance on good compounding practices in preparing non-sterile compounded drug products?

Answer 1

USP Chapter 795

Question 2

diluent

Answer 2

is an inactive product used to dilute an active pharmaceutical ingredient

Question 3

trituration

Answer 3

is the process of reducing the particle size of a powder, usually by use of a mortar and pestle

Question 4

sensitivity requirement

Answer 4

is the mass needed to move the balance marker by one space

• for a class A prescription balance, the sensitivity requirement is 6 mg

Question 5

geometric dilution

Answer 5

you dilute the active ingredient and mix it well to ensure even mixture

Question 6

What is the purposed of geometric dilution?

Answer 6

to obtain an accurate measurement since many drug doses are small & hard to measure

Question 7

How do you perform geometric dilution?

Answer 7

take active pharmaceutical ingredient & add an equal amount of diluent.
grind the mixture thoroughly and than add equal amount of diluent to the mix and grind again.
repeat until all of the ingredients have been mixed together

Question 8

percent error (% error)

Answer 8

refers to the accuracy of a measurement

• in the pharmacy, the highest acceptable percent error is usually 5% but can be less in some cases

Question 9

How are the “sensitivity requirement” and “percent error” related?

Answer 9

terms are related according to the following equation:

% error = (Sensitivity Requirement/ Desired Weight) x 100 %