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Pharmacy Practice Lab > Lab 8 > Flashcards

Lab 8 Flashcards

1
Q

The stability of a pharmaceutical product not only refers to the active ingredient(s) in the product, but also…….

A

the excipients, containers, and storage conditions

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2
Q

Give the USP definition of the stability of a pharmaceutical product

A

“the extent to which a product retains, within specified limits, and throughout its period of storage and use, (shelf life), the same properties and characteristics that it possessed at the time of its manufacture.”

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3
Q

name the 5 types of stability conditions maintained throughout the shelf life of a product

A

chemical
physical
microbiological
therapeutic
toxicological

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4
Q

explain what chemical stability is

A

each active ingredient maintains its chemical integrity and labeled potency, within specified limits

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5
Q

explain what physical stability is

A

the original physical properties (appearance, palatability, uniformity, dissolution, and suspendability) are retained

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6
Q

explain what microbiological stability is

A

the stability/resistance to microbial growth is retained according to the specified requirements.

the antimicrobial agents present retain effectiveness within specified limits

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7
Q

explain what therapeutic stability is

A

the therapeutic effect of the product remains unchanged

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8
Q

explain toxicological stability

A

no significant increase in toxicity occurs

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9
Q

true or false

all processes (like manufacturing, packaging, storage, distribution, and use) can affect degradation rate and product stability

A

TRUE

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10
Q

how is QUALITY achieved?

A

by evaluating and monitoring all processes (manufacturing, packaging, storage, distribution, and use)

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11
Q

after the manufacturing of a product, what happens?

A

the product is tested under several normal conditions as well as several stress conditions

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12
Q

name the FIVE most common types of degradation reactions

A

-hydrolysis
-oxidation
-photolysis
-dehydration
-racemization

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13
Q

the RATE of degradation can often be predicted by……….

A

-the number of reacting species OR
-the order of the reaction

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14
Q

INCOMPATIBILITY describes….

A

PREVENTABLE physical and chemical reactions that can be minimized or eliminated with the use of corrective measures

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15
Q

WHEN should the physical and chemical properties of a product be evaluated and resolved?

A

when designing the formulation

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16
Q

give an example of a PHYSICAL incompatability

A

the soluble, ionized form of a drug precipitates as a result of pH change during preparation or storage

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17
Q

give an example of a CHEMICAL incompatability and the solution for it

A

-heavy metals present in water can catalyze the oxidation of penicillin, epinephrine, and phenylephrine

-chelating agents (such as EDTA) are used to sequester these heavy metals to reduce this oxidation of the product

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18
Q

a(n)_____ in temperature accelerates oxidation, reduction, and hydrolysis reactions. this leads to drug degradation

A

INCREASE

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19
Q

the rate of a reaction doubles or triples for each ________ degree rise in temperature

A

the rate of a reaction doubles or triples for each 10 DEGREE CELSIUS rise in temperature

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20
Q

evaporation causes loss of __ And ____

A

water and volatile solvents

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21
Q

what does volatile mean

A

easily evaporated

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22
Q

WHY are volatile solvents commonly used on pharmaceutical products?

A

to assist in the solubilization of non-polar drugs, dyes, flavors, and aromatic oils

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23
Q

LOSS of volatile solvents results in…..

A

a supersaturated solution that readily precipitates/crystallizes.

loses its appeal due to changes in color and odor

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24
Q

_______ may increase the temperature of the product and increase the rate of evaporation and instability

A

temperature

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25
Q

_______ substances DEGRADE in the presence of light

A

photo labile substances

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26
Q

true or false

the intensity and wavelength of the light, as well as the size, shape, composition, and color of the container may affect the rate of the reaction of the degradation of photolabile substances

A

true

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27
Q

____________ has a high energy level and is more likely to cause photo instability or photo-oxidation

A

ULTRAVIOLET RADIATION

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28
Q

____ can bleach color dyes and reduce the appeal of a product

A

light

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29
Q

______ may catalyze the formation of free-radical intermediates that initiate chain reactions and increase the rate of degradation via oxidation

A

LIGHT

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30
Q

true or false

light decreases the rate of degradation via oxidation

A

FALSE – light increases it

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31
Q

___________ are used to reduce degradation via oxidation

A

antioxidants and chelating agents

32
Q

what color glass gives considerable protection from ultraviolet radiation, but only a little protection from infrared radiation?

A

amber

33
Q

what color glass gives the BEST protection from ultraviolet radiation?

A

yellow-green glass

34
Q

give 5 examples of photolabile chemicals and drugs (sensitive to light)

A

-nitroprusside
-epinephrine
-vitamins
-riboflavin
-p-aminophenol

35
Q

chemical degradation due to oxidation, hydrolysis, and reduction is related to the ___ content in the pharmaceutical product

A

WATER

36
Q

the rate of hydrolysis is dependent on what 3 things?

A

-water content
-temperature of solution
-pH of solution

37
Q

___ and ____ are MOST LIKELY to hydrolyze in the presence of water

A

esters and beta-lactams (penicillins)

38
Q

_____ are less likely to hydrolyze as compared to esters

A

amides (acetaminophen)

39
Q

drugs containing which 5 functional groups are prone to hydrolysis?

A

-esters
-amides
-imides
-imines
-lactam

40
Q

explain hydrolysis in a zero order reaction

A

hydrolysis occurs IRRESPECTIVE of concentration
at a CONSTANT rate

41
Q

for a zero order reaction, increasing the concentration will ____________ the %-age decomposition

A

SLOW

42
Q

for first-order and higher reactions, the rate change is ______ proportional to the concentration of the active ingredient.
explain

A

DIRECTLY

increasing the concentration has no influence on the percentage decomposition

43
Q

for a ___ order reaction, a greater portion of dilute solution is destroyed within a given time

A

zero

44
Q

Hygroscopic products……

A

may absorb water and support microbial growth

(hygroscopic substances absorb water readily and liquefy to give a jelly-like appearance

45
Q

the WATER CONTENT in a pharmaceutical preparation depends on what 2 things?

A

-the moisture content in the raw material

-use of water as a solvent

46
Q

in HIGH HUMIDITY, what happens?

A

the water content of the preparation increases and preservative may not cover all of the free water – microbial growth is imminent

47
Q

_____ and _____ are the most likely to cause a clinically significant loss of drug due to hydrolysis and oxidation reactions

A

pH and elevated temperature

48
Q

true or false

it is not possible for a pH change of only 1 unit (4 to 3 or 8 to 9) to decrease drug stability by a factor of 10 or greater

A

FALSE – it is possible

49
Q

Sometimes, _______ that is used to improve solubility may result in chemical degradation

A

pH adjustment

50
Q

the _____ in aspirin is hydrolyzed to ____ and _____ in the presence of ______

A

the ACETYL ESTER in aspirin is hydrolyzed to ACETIC ACID and SALICYLIC ACID in the presence of MOISTURE

in a dry environment, the hydrolysis of aspirin is negligible

51
Q

how can acetic acid and salicylic acid be detected?

A

salicylic acid can be detected with the use of ferric chloride and by using HPLC separation techniques

formation of acetic acid can change the odor of the product

52
Q

weakly acidic and basic drugs show good solubility when ionized, but……

A

but they also tend to decompose faster

53
Q

when the pH of the solution favors the UNIONIZED FORM, what happens when the concentration exceeds intrinsic solubility?

A

precipitation

54
Q

sometimes, the use of pH adjustment to improve solubility may result in……

A

antimicrobial or sweetener ineffectiveness

55
Q

Stability studies test what attributes of the API?

A

attributes that are susceptible to change during storage and are likely to influence the quality, safety, and/or efficacy

56
Q

stability tests are conducted when the drug product is located where?

A

in its storage container and distribution packaging

57
Q

the stability information obtained from stability tests is useful in assigning ____ and ____ dates

A

beyond use dates and expiration dates

58
Q

acetaminophen is a ___ And ____ used in children and adults

A

analgesic and antipyretic (fever reduction)

59
Q

in the lab, our acetaminophen products were kept in what conditions?

A

40 degrees celsius for 3 weeks

60
Q

what is the hydrolytic product of acetaminophen? how was it detected in the lab?

A

p-aminophenol

detected using alkaline sodium nitroprusside solution

spectrophotometer used to detect color changes in the presence of p-aminophenol

61
Q

the USP limit of p-aminophenol is _____% w/w of acetaminophen

A

0.005%w/w

62
Q

the ___ reacts with ______ to give a bluish-green color

A

formed p-aminophenol reacts with alkaline sodium nitroprusside to give a bluish-green color

63
Q

explain what the “SHELF LIFE” is

A

the time period in which the API or FPP (finished pharmaceutical product) is expected to remain within the approved shelf-life specification, PROVIDED THAT IT IS STORED UNDER CONDITIONS DEFINED ON THE CONTAINER LABEL

64
Q

The API cannot be less than ____% of the labaled claim and not more than ____% degradation

A

API cannot be less than 95% of the labeled claim and not more than 1% degradation

65
Q

what is a freezer as defined by USP

A

a place where temperature is maintained thermostatically between -25 degrees celsius and -10 degrees celsisu

66
Q

what is “cold” as defined by USP

A

any temp not exceeding 8 degrees

REFRIGERATOR is a cold place (between 2 and 8 degrees celsius)

67
Q

what is a “controlled cold temperature” as defined by USP

A

temperature maintained thermostatically between 2 and 8 degrees celsius

68
Q

“cool” is defined as……

A

any tmperature between 8 and 15 degrees celsius

69
Q

what is “the temperature prevailing in a working area”

A

room temperature

70
Q

what is “controlled room temperature”

A

temperature maintained thermostatically between 20 - 25 degrees celsius

71
Q

what is “warm”

A

any temp between 30 - 40 degrees celsius

72
Q

what is “excessive heat”

A

any heat above 40 degrees celsius

73
Q

what is the USP standards for a label stating “protect from freezing”

A

-risk of breaking container
-freezing subjects the product to loss of strength, potency, or to the destrutive alteration of its characteristics

74
Q

what is a “dry place” according to the USP definition

A

a place that does not exceed 40% average relative humidity (RH) at controlled room temp, OR the equivalent water vapor pressure at other temperatures

75
Q
A

Pharmacy Practice Lab (10 decks)

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