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[ORAL EXAM] Pharm Analysis Flashcards

1
Q

Concerned with either the identification or quantification of one or more substances in a given sample of pharm interest

A

Pharmaceutical Analysis

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2
Q

Reveals the identification of an element or compound in a sample

A

Identification

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3
Q

The totality of characteristics or features of a product that bear on its capacity to satisfy stated or implied needs

A

Quality

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3
Q

Determination and exact amount of an exact analyte

A

Quantification

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4
Q

Responsible for operation and process

A

Quality Assurance

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4
Q

Sum total of organized arrangements made with the objective of ensuring that products are of the quality required for their intended use

A

Quality Assurance

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5
Q

Part of CGMP concerned with sampling, specification, testing, organization, documentation

A

Quality Control

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6
Q

Responsible for testing and sampling of the drug products

A

Quality Control

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7
Q

Process Oriented

A

Quality Assurance

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8
Q

Product Oriented

A

Quality Control

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9
Q

Document that contains a list of tests, references to analytical procedures and appropriate acceptance criteria

A

Specification

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10
Q

A written standard that describes an article like a drug substance, drug product, excipients or compounded preparation

A

Monograph

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10
Q

A collection of data gathered and presented in the form of a book

A

Compendia

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11
Q

Universal Tests: Appearance Testing

A

Description

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12
Q

less than 1mg

A

Ultra Microanalysis

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12
Q

Universal Tests: Threshold presence of related degradation substances in the drug sample

A

Impurities

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12
Q

Universal Tests: Quantitative measure of compound in a sample

A

Assay

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12
Q

100ppm - 1000ppm

A

Trace Analysis

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13
Q

1mg - 10mg

A

Micro Analysis

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13
Q

Universal Tests: Verification of Identity

A

Identification

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14
Q

10mg-100mg

A

Semi-Microanalysis

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15
Q

100mg+

A

Macroanalysis

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15
Q

Nature of method based on chemical reactions

A

Classical Methods

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16
Q

Total amount of a single and specific compound

A

Ultimate analysis

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16
Total amount of a group or class of compounds
Proximate analysis
17
Nature of method based on physical and chemical properties of analyte
Instrumental Methods
18
Nature of method that deals with crude drugs or natural products
Miscellaneous/Special Methods
19
Aka Accuracy
Trueness
20
Error in analysis
Accuracy
20
Closeness of an actual value to the theoretical/true value
Accuracy
21
Closeness of an actual value of 2 or more test results to each other
Precision
22
Precision under the same laboratory but with different analysts
Intermediate Within-Laboratory
22
Precision under the same operating conditions in a short period of time
Repeatability Intra-assay
23
Due to factors external to the method
Ruggedness
24
Express variation between laboratories
Reproducibility Inter-laboratory
25
Due to factors internal to the method
Robbubstness
25
A measure or capacity to remain unaffected by deliberate variations in method
Robustness or Ruggedness
26
AKA Specificity
Selectivity
27
Referred to as the slope of callibration curve
Sensitivity
27
Ability to asses the analyte in the presence of other substances
Specificity
28
Ability to discriminate between small differences in analyte concentration
Sensitivity
29
Ability to obtain results of variable data which is directly proportional to the concentration in the sample
Linearity
30
Defined as the difference in numerical values between a measured value and the true value
Error
31
AKA Random Error
Indeterminate Error
32
AKA Systemic Error
Determinate Error
33
Error that affects precision
Random Error
34
Error that affects accuracy
Systemic Error
35
Titrimetry is also known as?
Classical Methods
36
Involves solution of reagent of known concentration added to a solution of analyte until reaction is judged complete
Titrimetry
37
Titrant is also known as?
Standard Solution/Volumetric Solution
38
Titrand is also known as?
Analyte/Sample
39
Reagent of known concentration
Titrant
40
Reagent of unknown concentration
Titrand
41
Complex organic compounds capable of changing colors which aid in the visualization of the endpoint
Indicator
42
Actual point at which the reaction is observed to be complete
End Point
43
The point at which a chemically equivalent of titrant has reacted with analyte
Equivalence Point
44
Equivalence Point AKA?
Stoichiometric Point/Theoretical Point
45
Process of determining the exact concentration of a titrant/standard solution
Standardization
46
Substance of high degree of purity
Primary Standard
47
Makes use of indicators to make observation of endpoint possible (Can be indicated by Titration)
Visual Titration
47
Prepared from primary standard
Secondary Standard
48
Equivalence point is signified by a sharp change in potential of the solution
Potentiometric Titration
49
Equivalence point is signaled by a change in electrical conductivity
Electrometric Titration
50
Analyte is reacted with Titrant after rendering it soluble in titration medium
Direct Titration
51
Analyte undergoes preliminary treatment prior to titration
Indirect Titration
52
Indirect titration uses this to convert sample to another compound
Auxiliary Reagent
53
Two titrants are used wherein one VS is added in excess then unreacted excess is back titrated with the other VS
Residual Titration
54
The difference between the end point and the stoichiometric point
Blank Titration
55
Titration with no analyte
Blank titration
56
SA+SB
Phenolphthalein Methyl Orange Methyl Red
56
What is the titrant and titrand in Acidimetry
Titrant: Acid Titrand: Base
56
What is the titrant and titrand in Alkalimetry
Titrant: Base Titrand: Acid
57
WA+SB
Phenolphthalein
58
WA+WB
No indicator
59
SA+WB
Methyl Orange, Methyl Red
60
Azo Dyes: What color does Methyl orange give to Acid and Base?
Acid: Pink Base: Yellow
60
Azo Dyes: What color does Methyl yellow give to Acid and Base?
Acid: Red Base: Yellow
61
Azo Dyes: What color does Methyl red give to Acid and Base?
Acid: Red Base: Yellow
62
Phthalein: What color does Thymolphthalein give to Acid and Base?
Acid: Colorless Base: Blue
62
Volumetric Solution of Aqueous Acidimetry
HCl and H2SO4
62
Phthalein: What color does Phenolphthalein give to Acid and Base?
Acid: Colorless Base: Pink
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CEE 1 (12 decks)

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