What factors can impact the stability of a compounded sterile preparation?

The stability of a compounded sterile preparation is influenced by several critical factors, and the choice that lists temperature, light exposure, pH, and concentration of ingredients encompasses the broad range of these influential variables.

Temperature is vital as it affects the rate of chemical reactions and degradation of the formulation. High temperatures can accelerate the breakdown of active pharmaceutical ingredients, leading to reduced potency and increased risk of harmful byproducts. Conversely, excessively low temperatures can also impact stability, particularly in formulations that may precipitate or become denatured at cold temperatures.

Light exposure is another significant element because certain compounds can be sensitive to light. Exposure to light can degrade specific ingredients, affecting their efficacy and safety. This is why many compounded sterile preparations are stored in amber vials or containers that limit light exposure.

The pH of the preparation can dramatically affect the solubility and stability of the compounded products. Some ingredients are stable at certain pH levels but can degrade or precipitate if the pH moves outside of that range.

Lastly, the concentration of ingredients plays a role in the overall stability; higher concentrations can lead to increased likelihood of interactions or precipitation, while very dilute solutions may not maintain the same level of stability either.

Thus, recognizing that stability is affected