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PH 105 > Special Methods in Pharmaceutical Analysis > Flashcards

Special Methods in Pharmaceutical Analysis Flashcards

1
Q

Employed in the determination of ash, moisture, crude fiber, extractives, estimation of alkaloidal content

A

Chemical Methods

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2
Q

those in which the effects of drugs upon microbes, animals, or animal
tissues are measured and which are employed in the absence of satisfactory
chemical methods for standardization

A

Biological Methods

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3
Q

Assay of drugs that use biologicals (such as animals) to determine their effect

A

Bioassays

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4
Q

What are some biological methods?

A

Bioassays
Microbiological Assays

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5
Q

Enumerate some commonly used bioassay

A

Corticotropin (rats)
Digitalis (pigeon)
Heparin (sheep)
Insulin (rabbits)
Oxytocin (chicken)
Parathyroid (dog)

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6
Q

Enumerate commonly used Microbiological Assays

A

Antibiotics
Vitamin B12

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7
Q

Determination of the ___ ________ of a crude drug which is a
representative of the inorganic salts that are either naturally
occurring in the drug or added as impurity for the purpose of
adulteration.

A

Ash Content

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8
Q

is generally taken to be the residue remaining after incineration

A

Ash Content

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9
Q

It is the residue remaining after incineration at 675±25°C

A

Total Ash

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10
Q

500°C to 550°C

A

Very Dull-Red

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11
Q

550°C-700°C

A

Dull-Red

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12
Q

800°C-1000°C

A

Bright Red

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13
Q

1000°C-1200°C

A

Yellow Red

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14
Q

1200°C to 1600°C

A

White

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15
Q

Part of the total ash which is insoluble in diluted HCl

A

Acid-Insoluble Ash

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16
Q

Formula for Acid-Insoluble ash

A

%AIA = wt of residue/wt of Sample (100)

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17
Q

Part of the total ash which represents soluble chlorides, alkali and
NH4 salts at 450°C.

A

Water-Soluble Ash

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18
Q

What are the sample, access to air, and what is left to the ash content technique ignition

A

Sample - inorganic
Access to Air - Yes
WHAT is left? - residue

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19
Q

What are the sample, access to air, and what is left to the ash content technique incineration

A

Sample - Organic
Access to Air - yes
WHAT is left? - Ash

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20
Q

What are the sample, access to air, and what is left to the ash content technique carbonization

A

Sample - Organic
Access to Air - No
WHAT is left? - charcoal

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21
Q

it dissolves the calcium carbonate, alkali chlorides, etc., leaving an acidinsoluble residue that consists almost entirely of silica derived from the soil adhering to the drug

A

Diluted hydrochloric acid

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22
Q

The ash content of chemicals is determined by ignition to dull
redness

A

Residue on Ignition

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23
Q

What are the applications of residue on ignition

A

Applications:
Ø It is necessary to control the amount of inorganic matter (adulteration) in substances (especially those that are intended for hypodermic administration)
ØStandard requirement (for inorganic matter): NEGLIGIBLE amount

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24
Q

Determines the percentage of test material that is volatilized and
driven off under the conditions specified.

A

Loss on ignition

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25
Q

The procedure is nondestructive to the substance under test;
however, the substance may be converted to another form such
as anhydride.

A

Loss on ignition

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26
Q

What are the procedures in the loss on ignition?

A
  1. Weigh the specime
  2. Transfer to the tared crucible an accurately weighed quantity
  3. Conduct the ignition
  4. Ignite for successive 1-hour periods
  5. Weigh the residue on ignition
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27
Q

Determination of the amount of water in an amount of sample

A

Water content

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28
Q

Water adsorped on the surface of the solid

A

Free/Unbound Water

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29
Q

water of crystallization/water of hydration

A

Bound water

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30
Q

in water content it has impurities

A

Free/Unbound Water

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31
Q

part of the crystal structure of the substance

A

Diluent

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32
Q

What are the applications of Water Contnent

A

Applications:
Ø When crude drugs are sold with a guaranteed assay for active constituent, the %active
constituent must be calculated on a dried-basis (moisture-free) as moisture adversely affect
the calculated results.
Ø Moisture promotes microbial growth (therefore, must be determined and minimized in sample
of drugs)

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33
Q

What are some water Determination methods?

A

Method 1: Titrimetric Method (Karl Fisher Method)
Method II: Azeotropic (Toluene Distillation) Method
Method III: Gravimetric Methods

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34
Q

also known as Karl Fisher Methods

A

Titrimetric Methods

35
Q

This method is the most rapid of the official methods, requires
only small sample, is specific for water, and is widely applicable in
determination of the water content of drug products.

A

Karl Fischer Method

36
Q

Involves the titration of sample in reagent methanol with the Karl
Fischer reagent, which consists of:

A
  • Iodine (OA)
  • Sulfur Dioxide (RA)
  • Pyridine (base)
  • Methanol (solvent)
37
Q

What is the Karl Fisher Reagent:

A

1mL = 5 mg of water

38
Q

What is the Primary standard, secondary standard, endpoint and titer value of Karl Fischer Method

A

Primary Standard: Sodium Tartrate
Secondary Standard: Water-methanol solution
Endpoint: Canary-yellow to amber color
Each mg of sodium tarttrate is equivalent to 0.1566 mg of water

39
Q

Endpoint is determined by the slight excess of Karl Fischer Reagent (KFR) in the solution, canary-yellow to amber.

A

Direct Titration of Karl Fischer Method

40
Q

An excess of Karl Fischer Reagent is added to the solution and the excess is backtitrated
with a standard solution of water in methanol

A

Residual Titration of Karl Fischer Method

41
Q

Amount of water is computed from the amount of electricity that was produced, 10.71C is
equal to 10 mg of water

A

Coulometric Titration of Karl Fischer Method

42
Q

What is Azeotropic-Toluene Distillation also known as?

A

Also known as Xylene Method, Azeotropic Method
(USP); Moisture Method by Toluene Distillation (NF)

43
Q

Water and Toluene forms what?

A

Azeotrope

44
Q

Based on the loss of weight of the sample after drying or the
gain in weight of the desiccant

A

Gravimetric Methods

45
Q

WHAT is Acid Value also known as?

A

Acid Index
Acid Number

46
Q

The number of milligrams of KOH (or NAOH) necessary to
neutralize the free acids in 1 g of a substance (oil, fat, wax, resin,
balsam, or similar organic substance of complex composition).

A

Acid Value

47
Q

What are the causes of free acids?

A

Hydrolysis by chemical treatment
Bacterial Action
Catalytic Action of heat and light

48
Q

Does fresh or recently prepared fatt substances contain free acids?

A

No or Little of it

49
Q

Upon _____, acid value increases

A

aging

50
Q

High Acid values are not necessarily an indication of _________.

A

rancidity

51
Q

The number of milligrams of KOH required to saponify the
esters contained in 1g of substance (fat, fatty or volatile oil, wax,
resin, balsam or other substance of similar composition)

A

Ester value

52
Q

For substances that do not contain free acids, the ester number is _____ to saponification number. This is also the difference between
the acid and saponification value

A

equal

53
Q

What is ester value analyzing what?

A

Analysis of yellow and white wax

54
Q

Saponification Value is also known as?

A

Saponification Number or Koettsdorfer Number

55
Q

The number of milligrams of KOH required to neutralize the free
acids and saponify the esters contained in 1g of substance (fat,
fatty or volatile oil, wax, resin, balsam or other substance of similar composition).

A

Saponification Value

56
Q

The substances present in oils or fats that are not saponified by
alkali hydroxides but are soluble in ordinary fat solvents.

A

Unsaponifiable number

57
Q

The number of milligrams of KOH equivalent to the hydroxyl
content of 1g of the substance.

A

Hydroxyl Value

58
Q

Gives an indication of the identity and purity of fatty substances
possessing alcoholic hydroxyl groups.

A

Hydroxyl Value

59
Q

What does low value mean in hydroxyl value?

A

Low Value

60
Q

The number of grams of iodine absorbed under specified
conditions by 100 g of a substance (oil, fat, wax or other
substance)

A

Iodine Value

61
Q

Quantitative measure of the proportion of unsaturated fatty acids
present, both free and combined as esters, that have the property
of absorbing iodine.

A

Iodine Value

62
Q

A measure of the degree of saturation of the sample

A

Iodine Value

63
Q

Based on the ability of the double bonds to absorb iodine, the xs I2
is backtitrated with 0.1 N Na2S2O3

A

Iodine Value/Iodometry

64
Q

High iodine Value (above 120)

A

Drying oils

65
Q

Low iodine Value (below 100)

A

Non drying oils

66
Q

between 100 to 120

A

Semidrying oils

67
Q

usually less than 90

A

Animal Fats

68
Q

Examples of drying oils

A

Linseed oil
Co-liver oil

69
Q

Example of nondrying oils

A

Olive oil
Almond oil

70
Q

examples of semidrying oils

A

cottonseed oil
sesame oil

71
Q

What are the methods for determining iodine value?

A

Hubl
Hanus
Wijs

72
Q

Iodine in Mercuric Chloride

A

Hubl

73
Q

Iodine in Bromine Solution (forming IBr in glacial acetic acid)

A

Hanus

74
Q

Iodine in CCl4 (forming ICl in glacial acetic acid)

A

Wijs

75
Q

Found by acetylating hydroxyl fatty acids and determining the
saponification value of the substance.

A

Acetyl Value

76
Q

The number of milligrams of KOH required to neutralize the acetic
acid obtained by the saponification of 1g of acetylated fatty acids.

A

Acetyl value

77
Q

What is volatile oils also known as?

A

Ethereal oils or essential oils or essences

78
Q

Types of Volatile oils

A

Hydrocarbons
Alcohols
Aldehydes
Ketones
Phenols
Acids
Sulfur compounds

79
Q

Residual Alkalimetry with reflux

A

Ester content

80
Q

what example is used for ester content

A

Peppermint oil for total ester

81
Q

Reaction with acetic anhydride

A

Alcohol contet

82
Q

what is the example used in alcohol content

A

Peppermint oil for total menthol

83
Q

What are the processes involved in Aldehydes and ketone?

A

Bisulfite additon
Hydroxyl amine HCl

PH 105 (6 decks)

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