PTCE Compounding 5

Question 1

A Category 1 CSP (compounded sterile preparation) is one that is:

Accepted Answer

Prepared without a sterility test and assigned a short BUD

Answer

Category 1 CSPs under USP <797> are assigned a BUD of ≤12 hours at room temperature or ≤24 hours refrigerated and do not require sterility testing.

Question 2

Which type of balance is required by USP for weighing ingredients less than 120 mg in a compounding pharmacy?

Accepted Answer

Class III prescription balance or analytical balance

Answer

A Class III torsion or analytical balance with a sensitivity requirement of 6 mg is needed for weighing small quantities accurately.

Question 3

Cocoa butter (theobroma oil) is commonly used in suppository compounding primarily because it:

Accepted Answer

Melts at body temperature (34–36°C) and solidifies at room temperature

Answer

Cocoa butter's melting point near body temperature makes it ideal for suppositories that melt after insertion to release the drug.

Question 4

Which practice is required before compounding a batch of sterile preparations to prevent cross-contamination?

Accepted Answer

Decontaminating and disinfecting the ISO Class 5 PEC with 70% IPA

Answer

Surfaces in the PEC must be cleaned with 70% isopropyl alcohol before compounding to eliminate particulate and microbial contamination.

Question 5

What is the role of a wetting agent in suspensions?

Accepted Answer

To reduce the contact angle between the powder and liquid, promoting uniform dispersion

Answer

Wetting agents like polysorbate 80 lower surface tension, helping hydrophobic powders become uniformly dispersed in the liquid vehicle.

(PTCE) Pharmacy Technician Certification Exam Practice Test