FINAL 02 - Shelf Life Determination

Question 1

The time period during which a drug product maintains at least 90% of its labeled potency under recommended storage conditions

Answer 1

Shelf life

Question 1

The capability of a drug substance or product to maintain its identity, strength, quality, and purity over time

Answer 1

Drug stability

Question 2

Prevents the administration of sub-potent or ineffective drugs (Importance of shelf life determination)

Answer 2

Ensures efficacy

Question 3

Avoids the potential toxicity of degraded products (Importance of shelf life determination)

Answer 3

Promotes safety

Question 4

Assists in meeting guidelines set by regulatory authorities (Importance of shelf life determination)

Answer 4

Regulatory compliance

Question 5

Provides accurate timelines for drug use to minimize waste (Importance of shelf life determination)

Answer 5

Reduces wastage

Question 6

Study of the rates of chemical reactions and the factors affecting them

Answer 6

Reaction kinetics

Question 7

Describes the relationship between the rate of reaction and the concentration of reactants

Answer 7

Order of reaction

Question 8

The time required for the concentration of the drug to decrease by half

Answer 8

Half-life

Question 9

Equation that relates the reaction rate to the temperature and activation energy

Answer 9

Arrhenius equation

Question 10

The rate of reactions independent of reactant concentration; it is the fastest order of reaction to decompose (Types of reactions)

Answer 10

Zero order reaction

Question 11

The rate is directly proportional to the concentration of one reactant (Types of reactions)

Answer 11

First order reaction

Question 12

The rate is proportional to the square of the concentration of one reactant or the product of two reactant concentrations (Types of reactions)

Answer 12

Second order reaction

Question 13

High temperatures accelerate degradation (Factors affecting drug stability)

Answer 13

Temperature

Question 14

Moisture promotes hydrolysis and microbial growth (Factors affecting drug stability)

Answer 14

Humidity

Question 15

UV light may cause photo degeneration (Factors affecting drug stability)

Answer 15

Light

Question 16

Exposure leads to oxidation (Factors affecting drug stability)

Answer 16

Oxygen

Question 17

Extreme pH conditions may destabilize drugs (Factors affecting drug stability)

Answer 17

pH

Question 18

Includes hydrolysis, oxidation, and photolysis (Types of drug instability)

Answer 18

Chemical instability

Question 19

Changes in appearance, dissolution, or aggregation (Types of drug instability)

Answer 19

Physical instability

Question 20

Growth of microorganisms in formulations (Types of drug instability)

Answer 20

Microbial instability

Question 21

Is a substance which controls the rate of reaction without itself undergoing a permanent chemical change

Answer 21

Catalysts

Question 22

Increases the rate of reaction by lowering the energy of activation (Types of catalysts)

Answer 22

Positive catalyst

Question 23

Retards/decreases the rate of reaction (Types of catalysts)

Answer 23

Negative catalyst/Inhibitor

Question 24

Relationship between temperature and reaction rate

Answer 24

Directly proportional

Question 25

Relationship between catalysts and reaction rate

Answer 25

Directly proportional

Question 26

Affects the rate depending on the order of reaction

Answer 26

Concentration

Question 27

Relationship between concentration and rate of reaction

Answer 27

Directly proportional

Question 28

Relationship between surface area and reaction rate

Answer 28

Directly proportional

Question 29

Data accumulated in a kinetic study may be substituted in the integrated form of the equations that describe the various orders (Methods of reaction order determination)

Answer 29

Substitution method

Question 30

A plot of the data in the form of a graph is used to ascertain the order (Methods of reaction order determination)

Answer 30

Graphic method

Question 31

Will be used in a zero order reaction when the half life is proportional to the initial concentration and the half-life of a first order reaction is independent of the concentration (Methods of reaction order determination)

Answer 31

Half life method

Question 32

The incapacity or incapability of a particular formulation in a specific container to remain within a particular chemical, microbiological, therapeutical, physical & toxicological specification

Answer 32

Drug instability

Question 33

Loss of volatile components (Physical or chemical degradation)

Answer 33

Physical

Question 34

Loss of H2O (Physical or chemical degradation)

Answer 34

Physical

Question 35

Absorption of H2O (Physical or chemical degradation)

Answer 35

Physical

Question 36

Crystal growth (Physical or chemical degradation)

Answer 36

Physical

Question 37

Polymorphic changes (Physical or chemical degradation)

Answer 37

Physical

Question 38

Color changes (Physical or chemical degradation)

Answer 38

Physical

Question 39

Hydrolysis (Physical or chemical degradation)

Answer 39

Chemical

Question 40

Oxidation (Physical or chemical degradation)

Answer 40

Chemical

Question 41

Decarboxylation (Physical or chemical degradation)

Answer 41

Chemical

Question 42

Isomerization (Physical or chemical degradation)

Answer 42

Chemical

Question 43

Polymerization (Physical or chemical degradation)

Answer 43

Chemical

Question 44

Happens due to sensitivity of drug to UV light; prevented by using light resistant/opaque containers

Answer 44

Photodegradation

Question 45

Happens due to degradation of esters, amides, and lactams to carboxylic acid

Answer 45

Hydrolysis and acid-base catalysis