QC Flashcards

1
Q

Use according to particular state of needs to guarantee the products quality asset by its monograph and is specification

A

Special methods of analysis

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2
Q

Are made to establish purity for determine the amount of therapeutically active constituents present for the purpose of standard decision

A

Quantitative analysis of crude drugs and products

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3
Q

classification for the special methods

A

Chemical methods and biological methods

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4
Q

Ash determination, crude extractive fiber content, assay of alkaloids and volatile oils

A

Chemical methods

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5
Q

In vivo animal testing, microbiological testing and etc.

A

Biological methods

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6
Q

Usually taken as a measure of the residue from a crude drug after the process of incineration

A

Ash content

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7
Q

It represents the amount of inorganic salts naturally occurring in the drug and adhering to it

A

Ash content

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8
Q

It can also represent the level of inorganic matter that indicates a level of adulteration of a crude drugs sample

A

Ash content

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9
Q

Process of subjecting the crude drug sample to very high temperatures in order to “burn off” organic matter living in organic matter for total Ash measurement

A

Incineration

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10
Q

This is the residue remaining after application of sufficient incineration process

A

Total ash

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11
Q

This is part of the total Ash that cannot be solubilized in dilute hydrochloric acid

A

Acid insoluble ash

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12
Q

This is the processed done to crucibles to dull redness and afterwards weight is measured. The Crucible is deemed as constant weight when to 2-3 weighings do not differ by 0.5mg

A

Constant weight

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13
Q

This is a crucibles that has been heated to dull redness and until constant weight, cooled in a dessicator and weighed

A

Tared crucible

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14
Q

Define as a quantity not exceeding 500mcg

A

Negligible

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15
Q

Is a measure of inorganic matter present a impurity

A

Ash o residue yielded by an organic compound

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16
Q

Used to conduct incineration studies and temperatures for incineration

A

Electric furnace

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17
Q

Very dull red heat

A

500-550°C

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18
Q

550-700°C

A

Dull red heat

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19
Q

Bright red heat

A

800-1000°C

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20
Q

1000-1200°C

A

Yellow red heat

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21
Q

White heat

A

1200-1600°C

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22
Q

Is determine by ignition to dull redness

A

The Ash content of chemicals

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23
Q

This technique provides a means of determining the percentage of test material which is volatilized and driven off under the conditions specified

A

Loss of ignition

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24
Q

USP calamine

A

2%

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25
Q

Magnesium sulfate

A

40-52%

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26
Q

Titanium dioxide

A

0.5%

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27
Q

Zinc oxide

A

1%

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28
Q

NF Calcium phosphate

A

8%

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29
Q

Kaolin

A

15%

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30
Q

Lime

A

10%

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31
Q

Magnesium hydroxide

A

30-33%

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32
Q

Magnesium phosphate

A

20-27%

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33
Q

Also known as moisture content analysis

A

Water content

34
Q

Is a critical component of material quality and essentially a function of quality control in most production and laboratory facilities, from biological research organization, pharmaceutical manufacturers to food producers and packers

A

Water content

35
Q

Greatly influences the physical properties and product quality of nearly all substances and materials at all stages of processing and final product existence

A

Moisture content control

36
Q

In the water content determination, these influences chemical stability, crystal structure, powder flow, compaction lubricity, dissolution rate, and polymer film permeability in solid dosage forms and lead to growth of microorganisms, change in thixotropy in semi-solid dosage forms.

A

Presence of moisture

37
Q

It influences the properties of individual active ingredients and excipients, and it is essential to characterize the effect of moisture on this individual components

A

Moisture

38
Q

Six methods for determining water content

A

Gravimetric for drugs containing no constituents other than water, volatile at 105 °C

Gravimetric for drugs containing ether- soluble constituents volatile at 105°C

Azeotropic Toluene distillation

Karl fischer titration

Dew point

Electrolytic hygrometric

39
Q

For drugs which contained no constituents volatile at ____ other than ____ , about ___ of the drug is accurately weighed and dried in an oven at _____ for ___ hours. After ___ hours , the sample is Weighed and again dried at ___ hour intervals until the loss in weight is not more than____ in 1 hour of drying

A

105°C, water, 10g, 105°C, 5 hours, 5 hours, 1 hour, 0.25%

40
Q

This represents the moisture present in the sample

A

The weight loss of the drugs

41
Q

Vegetables drugs volatile substances

A

Essential oils, ethers, esters, amines

42
Q

A.K.A drying or thermal method

A

Gravimetric method

43
Q

Gravimetric method of choice are

A

1-2g chemical sample
Vegetable drugs (10g) dried for 5 hours
Biologics

44
Q

It is a better method that has been developed and was modified and is now one of the official methods for moisture determination

A

Xylene method

45
Q

Xylene method also known as

A

Azeotropic method

46
Q

Solvents used in azeotropic distillation

A

Xylene and toluene

47
Q

The primary standard use in karl fischer is

A

Sodium tartrate

48
Q

The contents of the karl Fischer reagents are

A

Anhydrous methanol
Iodine
Sulfur dioxide
Pyridine

49
Q

This prevents pyridine-sulfur complex

A

Anhydrous methanol

50
Q

This react with water to form hydroiodic acid

A

Iodine

51
Q

Reacts with water the form sulfur Trioxide

A

Sulfur dioxide

52
Q

This prevents the reversal of the reaction

A

Pyridine

53
Q

This method doesn’t use chemicals or high temperatures

A

Dew point

54
Q

This use instruments and infrared beam focused in a tiny mirror

A

Dew point

55
Q

Is an improved method in measuring the moisture content of gases less than 1 ppm

A

Electrolytic hygrometric

56
Q

The amount of insoluble in a given solvent

A

Index of purity

57
Q

Generally use for extraction with volatile solvents or small quantities of the are to be extracted

A

Soxhlet Apparatus

58
Q

The top of the extraction thimble should be ___ level of the Siphon tube

A

Above

59
Q

These are applied for the approximate determination of volatile oils contained

A

Volatile ether-soluble extractives

60
Q

These are applied for the approximately termination of active constituents associated with volatile matter contain

A

Non-volatile ethers-soluble extractives

61
Q

Most commonly employed method in the analysis of resinous substances present

A

Alcohol - soluble extractives

62
Q

Alcohol dissolves

A

Resins, benzoic acid, benzaldehyde, cinnamic acids , styrenes, vanillin and esters

63
Q

this is frequently added to the receiving flask to produce non-volatile salts from the volatile acids

A

NaOH

64
Q

Best solvents for fats and fatty oils

A

Hexane

65
Q

This method provides and index of the amount of fat sample and amount of seeds in some plant materials

A

Hexane - Soluble extractives

66
Q

Is the residue that remains undissolved after successive treatment with boiling alkali and acid

A

The crude fiber content

67
Q

Crude fiber is produced from

A

Deterioration

68
Q

is usually the outer cellular layer or protective coating, hence , a high crude fiber content as compared to product monograph usually indicates adulteration

A

Crude fiber

69
Q

This is defined as the number of mg KOH necessary to neutralize the free acids in 1g of oil, fat, wax , resins, balsam, or similar organic substances of complex composition

A

Acid value

70
Q

Also known as acid number or acidity index

A

Acid value

71
Q

For the titration of acid value, ___ concentration is the most suitable

A

0.1N

72
Q

It is defined as the number of mg of KOH required to neutralize the free acids and saponify the esters contained in 1g of fat, fatty or volatile oils , wax, resins, balsam, or other substances of similar composition

A

Saponification Value

73
Q

Also known as Koettsdorfer number

A

Saponification Value

74
Q

This is defined in the U.S.P as the substances present in oils or fats that are not saponified by alkali hydroxides but are soluble in ordinary fat solvents

A

Unsaponifiable matter

75
Q

This the number of mg of KOH required to saponify the esters in 1g of a fatty or volatile oil, fat, wax , balsam, resins , or similar substances

A

Ester Value

76
Q

Also known as ester number

A

Ester Value

77
Q

The number of grams of iodine absorbed under specified condition by 100g of oil, fat, wax, or other substances

A

Iodine value

78
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

79
Q

Is the number of milligrams of potassium hydroxide equivalent to the hydroxyl content of 1g of the substance

A

Hydroxyl value

80
Q

This constant gives an indication of identity and purity of fatty substances possessing alcoholic hydroxyl groups

A

Hydroxyl value

81
Q

Inversely proportional to the molecular weight

A

Hydroxyl value

82
Q

Corresponds closely to the hydroxyl value of fatty alcohols , and the two constants yave much the same significance with respect to identity and purity of the substances

A

Acetyl value