Phar 431 multiple choice

Which of the following must comply with USP <797> requirements

Injections

Which product below is included under USP <797> requirements?

Ophthalmic preparations

USP <797> applies to which of the following?

Pulmonary inhalation preparations

USP <797> includes which of the following as a required category?

Hazardous drugs 

Internal irrigation preparations (for cavities/wounds) must follow:

797

Risk levels in sterile compounding correlate to

Risk of microbial/chemical/physical contamination

Risk levels are used primarily to determine:

Expiration date (BUD)

USP <800> Hazardous Drug Gowning

Double gloves and shoe covers

Which statement is TRUE under USP <800>?

Gowns must be hazardous-drug compliant

Where must outer gloves be removed in HD compounding?

PEC (primary engineering control)

Particle size refers to:

Comparing dimensions of solid, liquid, or gaseous particles

Particle size distribution affects which process?

Powder flow and compression

Which dosage form is strongly influenced by particle sedimentation rate?

Suspensions/emulsions

Smaller particle size generally:

Increases surface area

Particle shape affects:

Flow and packing properties

Spherical particles are known for:

Minimum surface area/volume

Pores in particles can form due to:

Crystallization or condensation

Why is pore size important?

Affects adsorption of vapor/volatile agents

Why is particle density difficult to measure?

Microscopic pores and cracks complicate volume estimation

Good powder flow is needed for:

Uniform filling of tablet dies/capsules

Fine particles often:

Do not flow well

A factor that improves powder flow:

Spherical particle shape

Density of a powder affects:

Capsule size selection

Particle properties matter in which dosage forms?

All dosage forms (solutions, suspensions, emulsions)

Complete wetting of a particle corresponds to what contact angle?

0°

Surfactants are used to:

Improve wetting of particles

Particles in parenteral products are:

Undesired

They are commonly removed by:

Filtration

Pyrogens are typically:

Lipopolysaccharides from gram-negative bacteria

Pyrogens are dangerous because they:

Cause fever

Manufactured sterile drug products must be:

Pyrogen-free and sterile

Radiation sterilization uses:

Gamma rays

Which is a pyrogen source?

Aqueous vehicles

USP <788> tests for:

Subvisible particulate matter

Which is a sterile parenteral formulation?

Liposomes

“For injections” means:

Sterile powders to be reconstituted

Which is a compatibility concern?

Drug-diluent

Excipients are added to:

Maintain sterility/stability

Antimicrobial preservatives include:

Benzalkonium chloride

Buffers include:

Acetic acid/sodium acetate

Eutectic systems are used to:

Increase solubility and dissolution

Phase rule equation:

F = C - P + 2

Gas–liquid transitions depend on:

Temperature and pressure

Triangular phase diagrams are used for:

Emulsion formulation studies

Which is a colligative property?

Osmotic pressure

pH measures:

Proton (H₃O⁺) activity in solution

Ionization affects:

Transport across membranes

Buffers are used to:

Maintain chemical and physical stability