Which of the following characteristics mainly focus on safety of the product?

Is defined as the time lapse during which the drug product retains, within specified limits, the same properties and characteristics that it possessed at the time of manufacture (t=0)

Which of the following excipients that may be critical in terms of drug product stability? Select all that apply

Which of the following maintain the pH at the desire level that will ensure chemical and physical stability of an active ingredient within a dosage form?

Which of the following show dependence of the buffering capacity on the temperature, it may alter the buffer capacity and therefore impact the stability (Hygroscopicity)?

Which of the following are causes of Instability according to USP-NF? Select all that apply

Which of the following are the causes of physical instability? Select all that apply

Which of the following are the causes of chemical instability? Select all that apply

Which drugs classes are affected in the process in which chemicals interact with water molecules yielding reaction products? Select all that apply

Hydrolysis is catalyzed by acids and bases => pH effect

Which of the following statements are TRUE about, How Hydrolysis can be prevented? Select all that apply

The loss of electrons from one molecule and the receipt of electrons by another molecule.

Which of the following is accelerated by oxygen, light and moisture and we can see signs of change in color, precipitation or odor?

Which drugs classes are affected within the loss of electrons from one molecule and the receipt of electrons by another molecule? Select all that apply

Which of the following statements is TRUE if we want to avoid oxidation? Select all that apply

Which of the following excipients can be added in pharmaceutical formulations to prevent oxidation ? Select all that apply

Ability to retain sterility or resistance to microbiological growth

Which of the following titles provide the acceptable total aerobic microbial count and total combined yeast and molds count?

Which of the following are considered sources of Microbiological contamination resulting because poor aseptic techniques? Select all that apply

Which of the following are TRUE of how can we prevent microbiological instability? Select all that apply

Most water based formulations WILL REQUIRE an addition of an antimicrobial preservative to maintain microbiological stability of the drug product.

Which of the following describes the stability of drug formulations at specified storage conditions (light, temperature, humidity)?

Which of the following is a TRUE statement regarding SHELF LIFE as a kinetic parameter?

Know this (time has been setup for 10 minutes to memorize)

Expiration date and shelf life are always link to which of the following?

Which of the following statements is TRUE about Controlled room temperature?

Which of the following climate zones is represented in ZONE 1?

Which of the following climate zones is represented in ZONE 2?

Which of the following is TRUE about the Accelerated stability testing which is run 40 C and has a higher humidity of 75%?

ICH - International Conference on Harmonization of Technical Requirements for the Registration of Pharmaceuticals for Human Use regulates the stability testing.

Know this

Which of the following are TRUE about Accelerated Stability Testing? Select all that apply

The rate constant for degradation at RT is obtained by which of the following?

Know how to calculate this

Which of the following is independent of reaction order and estimates the shelf-life at a new temperature when the shelf life at an original temperature is known?

Remember the most used values for Q are 2,3,4.

An antibiotic solution has a shelf life of 48 hours in the refrigerator (5°C). What is its estimated shelf-life at room temperature (25°C)? Round to tenth decimal

The Q10 approach is independent of reaction order and estimates the shelf-life at a new temperature when the shelf life at an original temperature is known.

The Q10 approach is dependent of reaction order and estimates the shelf-life at a new temperature when the shelf life at an original temperature is known.

For every 10 °C increase in temperature the reaction rate doubles.

For every 20 °C increase in temperature the reaction rate doubles.

The Arrhenius Equation shows that the rate increases exponentially as temperature rises.

The Arrhenius Equation shows that the rate increases exponentially as temperature drops.

The Arrhenius Equation has an Empirical relationship showing the temperature effect on chemical reactions.

The Arrhenius Equation requires the reaction rate constant.

The Arrhenius Equation DOES NOT require the reaction rate constant.

Stability is officially defined as the time lapse during which the drug product retains, within specified limits, the same properties and characteristics that it possessed at the time of manufacture.

Stability is officially defined as the time lapse during which the drug product looses, within specified limits, the same properties and characteristics that it possessed at the time of manufacture.