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CEE 1 > Pharm Analysis Quiz > Flashcards

Pharm Analysis Quiz Flashcards

1
Q

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

A

Pharmaceutical Analysis

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2
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

How much it? –refers to

A

Quantification

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3
Q

What is it? – refers to

A

Identification

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4
Q

The sum total of the 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, specifications, testing,
organization, documentation and
release procedures

A

Quality Control

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6
Q

product oriented

A

Quality Control

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7
Q

process oriented

A

Quality Assurance

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8
Q

sample testing and specifications

A

Quality Control

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9
Q

audit and monitoring

A

Quality Assurance

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10
Q

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

A

Specifications

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11
Q

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

A

Compendia

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12
Q

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

A

Monograph

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13
Q

UNIVERSAL TESTS: Appearance testing

A

Description

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14
Q

UNIVERSAL TESTS:Verification of identity

A

Identification

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15
Q

UNIVERSAL TESTS:Threshold presence of related degradation
substances in the drug sample

A

Impurities

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16
Q

less than 1mg

A

Ultra Microanalysis

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17
Q

UNIVERSAL TESTS:Quantitative measure of compound in a sample

A

Assay

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18
Q

100-1000ppm

A

Trace Analysis

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19
Q

more than 100mg

A

Macroanalysis

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19
Q

based on physical and chemical properties of analyte

A

Instrumental Methods

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19
Q

1mg -10mg

A

Micro Analysis

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20
Q

10mg - 100mg

A

Semi-Micro Analysis

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21
Q

total amount of a group or class of compounds

A

Proximate Analysis

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22
Q

AKA of Accuracy

A

Trueness

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22
Q

total amount of a single, specific compound

A

UltimateAnalysis

23
Q

based on chemical reactions (stoichiometric)

A

Classical Methods

24
Q

The closeness of the actual value of 2 or more test results to each other

A

Precision

24
Q

deals with crude drugs or natural products

A

Miscellaneous/Special Method

25
Q

precision under the same
operating conditions over a
short period of time

A

REPEATABILITY or Intra-assay

25
Q

precision under the same
laboratory but with
different analysts,
apparatuses, and days

A

INTERMEDIATE or Within Laboratory

26
Q

Expresses the closeness of an actual value to the theoretical/true value

A

Accuracy

27
Q

express variation between
laboratories

A

REPRODUCIBILITY or Inter-laboratory

28
Q

A measure of capacity to remain unaffected by deliberate variations in
method

A

Robustness or Ruggedness

29
Q

Robustness or Ruggedness: is due to factors external to the method

A

Ruggedness

30
Q

Ability to assess the analyte in the presence of other substances

A

Specificity

30
Q

Robustness or Ruggedness: is due to factors internal to the method

A

Robustness

31
Q

Defined as the difference in the numerical values between a measured
value and the true value.

A

Error

31
Q

Ability to obtain result of variable data which is directly proportional to the
concentration in the sample.

A

Linearity

31
Q

Ability to discriminate between small differences in analyte concentration

A

Sensitivity

32
Q

Aka: Indeterminate Error

A

Random Error

32
Q

It is referred as the SLOPE OF CALLIBRATION CURVE

A

Sensitivity

33
Q

Aka: Determinate Error

A

Systematic Error

34
Q

Error that affects Precision

A

Random Error

34
Q

Error that affects accuracy

A

Systematic Error

34
Q

AKA: CLASSICAL METHODS

A

TITRIMETRY

35
Q

Entire procedure is repeated except that the analyte is omitted

A

Blank Titration

35
Q

Complex organic compounds capable of
changing colors which aid in the
visualization of the endpoint

A

INDICATOR

35
Q

Involves a solution of reagent of known concentration added to a solution
of analyte until reaction is judged complete

A

TITRIMETRY

35
Q

Reagent or solution of known concentration

AKA: Standard Solution or Volumetric Solution

A

TITRANT

35
Q

Compound with unknown concentration

AKA: ANALYTE OR SAMPLE

A

TITRAND

35
Q

Process of determining the exact concentration of a titrant/standard solution

A

Standardization

36
Q

Substance of high degree of purity

A

PRIMARY STANDARD

37
Q

Prepared from primary standard

A

SECONDARY STANDARD

37
Q
A
37
Q
A
38
Q
A
38
Q
A
39
Q
A
40
Q
A
41
Q
A
42
Q
A
43
Q
A

CEE 1 (12 decks)

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