Pharmaceutical Analysis 2

Assignment

Instruction: Answer the following questions and write your answers in a 1 whole sheet of yellow
paper.

PART 1

1. Define and differentiate Zero order and First Order kinetics. Draw the graph for each.
2. Give the formula for the zero and first order equation, half-life and shelf life.

Answer the following problems:

1. A drug suspension (125 mg/mL) decays by zero order kinetics with a reaction rate
constant of 0.5 mg/mL/hr. What is the concentration of intact drug remaining after 3
days (72 hrs)?
2. How long will it take for the suspension to reach 90% of its original concentration?

3. A solution of a drug was freshly prepared at a concentration of 300 mg/mL. after 30 days
@ 25 C, the drug concentration in the solution was 75 mg/mL.

a. Assuming 1st order kinetics, when will the drug decline to one half of the original conc.?

b. Assuming zero order kinetics?

% Time (mo)
4. Determine : (Refer to the table on the right ) potency
a. Whether the decomposition is zero or first order.
b. The decomposition rate constant and half life 100 0
c. Shelf life (t90)
94.9 1

PART 2 89 2

1. Define activation energy (Ea) . How is Arrhenius equation

84 3
related to temperature? Give its equation/formula.
2. How is Shelf life estimated? Give the formula.
70.6 6
Answer the following problems:

1. 1. Consider the sulfacetamide monograph, the 1st order rate 49.9 12

constant is 9 x 10-6 s-1 at 120 C. The activation energy is 22.9
kcal/mole. Calculate the shelf life @25 C? 35.2 18
2. 1. The expiration period for a reconstituted product is 18 h at
room temperature. Estimate the expiration period when the product is stored in the ref .
3. 2. A newly reconstituted product is labeled to be stable for 24 hrs in a ref. What is the
estimated shelf life at room temperature?
4. 3. A product has a t90 of 48 hrs. in a ref. (5 C). What would t90 be at room temp.(25 C)?