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[2ND YEAR] PH 108.1 - Physical Pharmacy (Lab) > FINAL 02 - Shelf Life Determination > Flashcards

FINAL 02 - Shelf Life Determination Flashcards

1
Q

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

A

Shelf life

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1
Q

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

A

Drug stability

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2
Q

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

A

Ensures efficacy

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3
Q

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

A

Promotes safety

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4
Q

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

A

Regulatory compliance

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5
Q

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

A

Reduces wastage

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6
Q

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

A

Reaction kinetics

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7
Q

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

A

Order of reaction

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8
Q

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

A

Half-life

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9
Q

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

A

Arrhenius equation

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10
Q

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

A

Zero order reaction

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11
Q

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

A

First order reaction

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12
Q

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

A

Second order reaction

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13
Q

High temperatures accelerate degradation (Factors affecting drug stability)

A

Temperature

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14
Q

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

A

Humidity

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15
Q

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

A

Light

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16
Q

Exposure leads to oxidation (Factors affecting drug stability)

A

Oxygen

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17
Q

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

A

pH

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18
Q

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

A

Chemical instability

19
Q

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

A

Physical instability

20
Q

Growth of microorganisms in formulations (Types of drug instability)

A

Microbial instability

21
Q

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

A

Catalysts

22
Q

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

A

Positive catalyst

23
Q

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

A

Negative catalyst/Inhibitor

24
Q

Relationship between temperature and reaction rate

A

Directly proportional

25
Q

Relationship between catalysts and reaction rate

A

Directly proportional

26
Q

Affects the rate depending on the order of reaction

A

Concentration

27
Q

Relationship between concentration and rate of reaction

A

Directly proportional

28
Q

Relationship between surface area and reaction rate

A

Directly proportional

29
Q

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)

A

Substitution method

30
Q

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

A

Graphic method

31
Q

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)

A

Half life method

32
Q

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

A

Drug instability

33
Q

Loss of volatile components (Physical or chemical degradation)

A

Physical

34
Q

Loss of H2O (Physical or chemical degradation)

A

Physical

35
Q

Absorption of H2O (Physical or chemical degradation)

A

Physical

36
Q

Crystal growth (Physical or chemical degradation)

A

Physical

37
Q

Polymorphic changes (Physical or chemical degradation)

A

Physical

38
Q

Color changes (Physical or chemical degradation)

A

Physical

39
Q

Hydrolysis (Physical or chemical degradation)

A

Chemical

40
Q

Oxidation (Physical or chemical degradation)

A

Chemical

41
Q

Decarboxylation (Physical or chemical degradation)

A

Chemical

42
Q

Isomerization (Physical or chemical degradation)

A

Chemical

43
Q

Polymerization (Physical or chemical degradation)

A

Chemical

44
Q

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

A

Photodegradation

45
Q

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

A

Hydrolysis and acid-base catalysis

[2ND YEAR] PH 108.1 - Physical Pharmacy (Lab) (13 decks)

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