Wattle Pharmacy Prep

Sterile products
Practice questions with explanations

Sterile products belongs to Medicinal chemistry and biopharmaceutics, which makes up about 10% of the Overseas Pharmacist Readiness Assessment (OPRA®). Answer each question yourself before opening the explanation.

1. Why must a parenteral solution be free of visible particles?

  1. Particles change the taste of the solution
  2. Particles reduce the shelf life only
  3. Visible particles are acceptable if small
  4. Particles can occlude capillaries, cause phlebitis, granulomas or embolism, and indicate a quality failure
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D. Particles can occlude capillaries, cause phlebitis, granulomas or embolism, and indicate a quality failure

Injected particulates cannot be cleared as they would be from the gut, so they lodge in the microcirculation. Every ampoule and bag is inspected against light and dark backgrounds before use, and in-line filters are used for products at risk of precipitation. Visible particulate matter is also a signal that something has gone wrong in manufacture or admixture.

2. Why are certain intravenous products protected from light during administration?

  1. All intravenous products require light protection
  2. Light increases the infusion rate
  3. Light makes the solution taste unpleasant
  4. Photodegradation can reduce potency or generate toxic products, so light-protective bags and giving sets are used
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D. Photodegradation can reduce potency or generate toxic products, so light-protective bags and giving sets are used

Drugs such as some cytotoxics, nitroprusside, amphotericin and certain vitamins degrade in light, and parenteral nutrition generates peroxides under light exposure, which matters especially in neonates. Amber giving sets and covers are used where specified. It is a product-specific requirement rather than a universal one.

3. Why is water for injections different from purified water?

  1. It is simply purified water in a different container
  2. It is produced and stored to control endotoxin as well as microbial and chemical purity, and is required for parenteral preparations
  3. It contains added preservative
  4. It is sterile but contains electrolytes
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B. It is produced and stored to control endotoxin as well as microbial and chemical purity, and is required for parenteral preparations

Water for injections is produced by distillation or an equivalent process and held hot or circulating to prevent biofilm and endotoxin accumulation, and it is tested for bacterial endotoxin. Purified water meets chemical and microbial specifications but not the endotoxin requirement, so it is used for oral and topical preparations only.

These are 3 of the 20 questions on sterile products in the app.

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More topics in Medicinal chemistry and biopharmaceutics

Dosage form design · Drug stability and degradation · Functional groups and drug classes · Pharmaceutical excipients · Solubility and partitioning · Structure-activity relationships