Pharm Analysis Quiz

Question 1

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

Answer 1

Pharmaceutical Analysis

Question 2

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

Answer 2

Quality

Question 3

How much it? –refers to

Answer 3

Quantification

Question 3

What is it? – refers to

Answer 3

Identification

Question 4

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

Answer 4

Quality Assurance

Question 5

Part of CGMP concerned with
sampling, specifications, testing,
organization, documentation and
release procedures

Answer 5

Quality Control

Question 6

product oriented

Answer 6

Quality Control

Question 7

process oriented

Answer 7

Quality Assurance

Question 8

sample testing and specifications

Answer 8

Quality Control

Question 9

audit and monitoring

Answer 9

Quality Assurance

Question 10

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

Answer 10

Specifications

Question 11

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

Answer 11

Compendia

Question 12

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

Answer 12

Monograph

Question 13

UNIVERSAL TESTS: Appearance testing

Answer 13

Description

Question 14

UNIVERSAL TESTS:Verification of identity

Answer 14

Identification

Question 15

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

Answer 15

Impurities

Question 16

less than 1mg

Answer 16

Ultra Microanalysis

Question 17

UNIVERSAL TESTS:Quantitative measure of compound in a sample

Answer 17

Assay

Question 18

100-1000ppm

Answer 18

Trace Analysis

Question 19

more than 100mg

Answer 19

Macroanalysis

Question 19

based on physical and chemical properties of analyte

Answer 19

Instrumental Methods

Question 19

1mg -10mg

Answer 19

Micro Analysis

Question 20

10mg - 100mg

Answer 20

Semi-Micro Analysis

Question 21

total amount of a group or class of compounds

Answer 21

Proximate Analysis

Question 22

AKA of Accuracy

Answer 22

Trueness

Question 22

total amount of a single, specific compound

Answer 22

UltimateAnalysis

Question 23

based on chemical reactions (stoichiometric)

Answer 23

Classical Methods

Question 24

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

Answer 24

Precision

Question 24

deals with crude drugs or natural products

Answer 24

Miscellaneous/Special Method

Question 25

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

Answer 25

REPEATABILITY or Intra-assay

Question 25

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

Answer 25

INTERMEDIATE or Within Laboratory

Question 26

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

Answer 26

Accuracy

Question 27

express variation between laboratories

Answer 27

REPRODUCIBILITY or Inter-laboratory

Question 28

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

Answer 28

Robustness or Ruggedness

Question 29

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

Answer 29

Ruggedness

Question 30

Ability to assess the analyte in the presence of other substances

Answer 30

Specificity

Question 30

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

Answer 30

Robustness

Question 31

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

Answer 31

Error

Question 31

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

Answer 31

Linearity

Question 31

Ability to discriminate between small differences in analyte concentration

Answer 31

Sensitivity

Question 32

Aka: Indeterminate Error

Answer 32

Random Error

Question 32

It is referred as the SLOPE OF CALLIBRATION CURVE

Answer 32

Sensitivity

Question 33

Aka: Determinate Error

Answer 33

Systematic Error

Question 34

Error that affects Precision

Answer 34

Random Error

Question 34

Error that affects accuracy

Answer 34

Systematic Error

Question 34

AKA: CLASSICAL METHODS

Answer 34

TITRIMETRY

Question 35

Entire procedure is repeated except that the analyte is omitted

Answer 35

Blank Titration

Question 35

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

Answer 35

INDICATOR

Question 35

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

Answer 35

TITRIMETRY

Question 35

Reagent or solution of known concentration AKA: Standard Solution or Volumetric Solution

Answer 35

TITRANT

Question 35

Compound with unknown concentration AKA: ANALYTE OR SAMPLE

Answer 35

TITRAND

Question 35

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

Answer 35

Standardization

Question 36

Substance of high degree of purity

Answer 36

PRIMARY STANDARD

Question 37

Prepared from primary standard

Answer 37

SECONDARY STANDARD