PRELIM 01 - Introduction to Pharmaceutical Analysis

Question 1

Application of the procedures of quantitative analytical chemistry

Answer 1

Quantitative pharmaceutical chemistry

Question 2

Person responsible for initiating the steps to determine if the product is defective

Answer 2

Pharmacist

Question 3

5 manifestations of a defective product

Answer 3

Improper labeling, Discoloration, Presence of cloudiness, Presence of crystals, Presence of precipitates

Question 4

Defined as the sum of all factors which contribute directly or indirectly to the safety, effectiveness, and reliability of the product

Answer 4

Quality

Question 5

Defined as the sum of all procedures undertaken to ensure the identity and purity of a particular pharmaceutical

Answer 5

Quality control

Question 5

Pharmacopoeia originating from Great Britain; formed by combining London, Edinburgh, and Dublin’s pharmacopoeias in 1864

Answer 5

British Pharmacopoeia

Question 5

First US pharmacopoeia published in 1778

Answer 5

Lititz Pharmacopoeia

Question 5

Father of the United States pharmacopoeia who suggested the idea of a pharmacopoeia to the medical society of New York

Answer 5

Dr. Lyman Spalding

Question 5

Used to be a revolt/rebellious record first coined as the “National Formulary of Unofficial Preparations”

Answer 5

National Formulary

Question 6

Was exclusive to doctors and was held every 10 years

Answer 6

USP convention

Question 7

President that declared USP & NF as standards for medicinal and pharmacopoeial substances

Answer 7

President Theodore Roosevelt

Question 8

Coined by Samuel Hahnemann and was based on the law of similarities

Answer 8

Homeopathic Pharmacopoeia of the US

Question 9

Coined the Homeopathic Pharmacopoeia of the US

Answer 9

Samuel Hahnemann

Question 10

Published by the WHO and serves as a recommendation to national pharmacopoeia revisions

Answer 10

International Pharmacopoeia

Question 11

Year when the Lititz Pharmacopoeia (first American pharmacopoeia) was published for use

Answer 11

1778

Question 12

Year when the Massachusetts Medical Society published a 272-page pharmacopoeia containing information on 536 drugs

Answer 12

1808

Question 13

Date when Dr. Lyman Spalding (father of USP) submitted a plan to the medical society of the county of New York

Answer 13

January 6, 1817

Question 14

Date when draft pharmacopoeias were reviewed, consolidated, and adopted by the first USP convention in Washington DC

Answer 14

January 1, 1820

Question 15

Date when the first USP was published in English and Latin

Answer 15

December 15, 1820

Question 16

Year when the first edition of the National Formulary for Unofficial Preparations was published

Answer 16

1888

Question 17

Year when the pharmacopoeial convention granted authority to issue supplements to the USP

Answer 17

1900

Question 18

Date when the title “National Formulary of Unofficial Preparations” was changed to “National Formulary”

Answer 18

June 30, 1906

Question 19

The act that President Roosevelt signed into law

Answer 19

Pure Food and Drug Act

Question 20

Year when the USP convention decided to revise the USP every 5 years and revise the NF every 10 years

Answer 20

1940

Question 21

Year when the USP Convention, Inc. purchased the NF

Answer 21

1975

Question 22

Date when the first combined compendium, comprising of the USP XX and NF XV, became official

Answer 22

July 1, 1980

Question 23

Year when the USP 23/NF 18 became the first edition to drop the use of roman numerals in favor of Arabic numerals

Answer 23

1995

Question 24

Year when the USP/NF became an annual publication

Answer 24

2002

Question 25

Determination of the volume of a solution of known concentration

Answer 25

Volumetric analysis

Question 26

Based on some physical or chemical properties of a substance

Answer 26

Physicochemical methods

Question 27

6 examples of instrumental techniques

Answer 27

Chromatographic, Spectrophotometric, Electrometric, Thermal conductimetric, Refractometric, Polarimetric

Question 28

Separation by extraction, precipitation, or other means of the constituents to be determined

Answer 28

Gravimetric analysis

Question 29

Those methods which require a distinct type of technique

Answer 29

Special methods

Question 30

3 examples of special methods

Answer 30

Alkaloidal assaying, Saponification value, Acid value

Question 31

Used to denote the agreement of an experimental result

Answer 31

Accuracy

Question 32

Measure of the reproducibility of date within a series of results

Answer 32

Precision

Question 33

2 types of errors

Answer 33

Indeterminate/Noise/Random error, Determinate error

Question 34

Slight variations in a series of observations made by the same observer under identical conditions

Answer 34

Indeterminate/Noise/Random error

Question 35

Nature that recur in constant manner in each of a series of determinations

Answer 35

Determinate error

Question 36

Chemical being analyzed

Answer 36

Analyte/Active constituent

Question 37

Solution of known concentration

Answer 37

Titrant

Question 38

Analytical method in which the volume of a solution of known concentration during analysis is taken as a measure of the amount of active constituent in a sample being analyzed

Answer 38

Titration

Question 39

Chemical which changes color at a point very near the equivalence point

Answer 39

Indicator

Question 40

Theoretical point at which equivalent amounts of analyte and titrant have reacted

Answer 40

Equivalence point/Stoichiometric point

Question 41

Point at which there occurs a sudden change in some property of the mixture

Answer 41

End point

Question 42

Determination of normality or molarity of a solution

Answer 42

Standardization

Question 43

Concentration expression that is defined as the number of equivalents of solute per liter

Answer 43

Normality

Question 44

Concentration expression of solution in terms of moles per liter

Answer 44

Molarity

Question 45

Solution of known normality or molarity

Answer 45

Standard solution

Question 46

Highly purified (about 99.99% /ultrapure) compound that serves as a reference material in titration

Answer 46

Primary standard

Question 47

Purity (97.88%) has been established by careful chemical analysis

Answer 47

Secondary standard

Question 48

Difference in volume and mass between the end point and equivalence point

Answer 48

Titration error

Question 49

Direct addition of a titrant to analyte

Answer 49

Direct titration

Question 50

Adding excess amount of acid to base to quantify with base

Answer 50

Residual/back titration

Question 51

Needs to perform pre-treatment before titration

Answer 51

Indirect titration

Question 52

Correcting errors, repeating the assay without the analyte

Answer 52

Blank titration

Question 53

A reaction where an acid reacts with a base

Answer 53

Neutralization reaction

Question 54

2 products of a neutralization reaction

Answer 54

Water, Salt