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
Magnesium sulfate
40-52%
26
Titanium dioxide
0.5%
27
Zinc oxide
1%
28
NF Calcium phosphate
8%
29
Kaolin
15%
30
Lime
10%
31
Magnesium hydroxide
30-33%
32
Magnesium phosphate
20-27%
33
Also known as moisture content analysis
Water content
34
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
Water content
35
Greatly influences the physical properties and product quality of nearly all substances and materials at all stages of processing and final product existence
Moisture content control
36
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.
Presence of moisture
37
It influences the properties of individual active ingredients and excipients, and it is essential to characterize the effect of moisture on this individual components
Moisture
38
Six methods for determining water content
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
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
105°C, water, 10g, 105°C, 5 hours, 5 hours, 1 hour, 0.25%
40
This represents the moisture present in the sample
The weight loss of the drugs
41
Vegetables drugs volatile substances
Essential oils, ethers, esters, amines
42
A.K.A drying or thermal method
Gravimetric method
43
Gravimetric method of choice are
1-2g chemical sample Vegetable drugs (10g) dried for 5 hours Biologics
44
It is a better method that has been developed and was modified and is now one of the official methods for moisture determination
Xylene method
45
Xylene method also known as
Azeotropic method
46
Solvents used in azeotropic distillation
Xylene and toluene
47
The primary standard use in karl fischer is
Sodium tartrate
48
The contents of the karl Fischer reagents are
Anhydrous methanol Iodine Sulfur dioxide Pyridine
49
This prevents pyridine-sulfur complex
Anhydrous methanol
50
This react with water to form hydroiodic acid
Iodine
51
Reacts with water the form sulfur Trioxide
Sulfur dioxide
52
This prevents the reversal of the reaction
Pyridine
53
This method doesn't use chemicals or high temperatures
Dew point
54
This use instruments and infrared beam focused in a tiny mirror
Dew point
55
Is an improved method in measuring the moisture content of gases less than 1 ppm
Electrolytic hygrometric
56
The amount of insoluble in a given solvent
Index of purity
57
Generally use for extraction with volatile solvents or small quantities of the are to be extracted
Soxhlet Apparatus
58
The top of the extraction thimble should be ___ level of the Siphon tube
Above
59
These are applied for the approximate determination of volatile oils contained
Volatile ether-soluble extractives
60
These are applied for the approximately termination of active constituents associated with volatile matter contain
Non-volatile ethers-soluble extractives
61
Most commonly employed method in the analysis of resinous substances present
Alcohol - soluble extractives
62
Alcohol dissolves
Resins, benzoic acid, benzaldehyde, cinnamic acids , styrenes, vanillin and esters
63
this is frequently added to the receiving flask to produce non-volatile salts from the volatile acids
NaOH
64
Best solvents for fats and fatty oils
Hexane
65
This method provides and index of the amount of fat sample and amount of seeds in some plant materials
Hexane - Soluble extractives
66
Is the residue that remains undissolved after successive treatment with boiling alkali and acid
The crude fiber content
67
Crude fiber is produced from
Deterioration
68
is usually the outer cellular layer or protective coating, hence , a high crude fiber content as compared to product monograph usually indicates adulteration
Crude fiber
69
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
Acid value
70
Also known as acid number or acidity index
Acid value
71
For the titration of acid value, ___ concentration is the most suitable
0.1N
72
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
Saponification Value
73
Also known as Koettsdorfer number
Saponification Value
74
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
Unsaponifiable matter
75
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
Ester Value
76
Also known as ester number
Ester Value
77
The number of grams of iodine absorbed under specified condition by 100g of oil, fat, wax, or other substances
Iodine value
78
Quantitative measure of the proportion of unsaturated fatty acids present, both free and combined as esters, that have the property of absorbing iodine
Iodine value
79
Is the number of milligrams of potassium hydroxide equivalent to the hydroxyl content of 1g of the substance
Hydroxyl value
80
This constant gives an indication of identity and purity of fatty substances possessing alcoholic hydroxyl groups
Hydroxyl value
81
Inversely proportional to the molecular weight
Hydroxyl value
82
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
Acetyl value