Compounding Flashcards

A compounder needs to prepare 200 mL of a 2% w/v solution from a 10% w/v stock solution. How many mL of stock solution are needed?

Answer: 40 mL

Using C1V1 = C2V2: (10%)(V1) = (2%)(200 mL), so V1 = 40 mL.

According to USP , Category 1 CSPs (compounded sterile preparations) with no antimicrobial preservative stored at room temperature have a BUD of:

Answer: 24 hours

USP (2023) assigns a 24-hour BUD at controlled room temperature for Category 1 CSPs without antimicrobial preservatives.

Which type of water is required for preparing compounded sterile preparations (CSPs)?

Answer: Sterile Water for Injection (WFI)

Sterile Water for Injection (WFI) meets USP standards for sterility, pyrogen limits, and ionic purity required for CSPs.

When compounding a capsule, what excipient is commonly added as a glidant to improve powder flow?

Answer: Colloidal silicon dioxide (Cab-O-Sil)

Colloidal silicon dioxide functions as a glidant by reducing interparticulate friction and improving powder flow in capsule filling.

A pharmacy must conduct media-fill testing when performing sterile compounding. The primary purpose is to:

Answer: Verify the aseptic technique of the compounder

Media-fill testing uses a growth medium in place of the drug to simulate the compounding process and verify that the compounder's aseptic technique does not introduce contamination.

Which packaging material is preferred for light-sensitive compounded preparations?

Answer: Amber glass or amber plastic containers

Amber glass or plastic protects photosensitive preparations by blocking UV and visible light wavelengths that cause degradation.

According to USP , which category of hazardous drugs requires full containment controls (C-PEC + C-SEC) even for non-sterile compounding?

Answer: NIOSH Table 1 antineoplastic drugs

NIOSH Table 1 antineoplastic (chemotherapy) agents require the highest level of containment engineering controls under USP .