PRELIM 01 - Introduction to Pharmaceutical Analysis Flashcards
Application of the procedures of quantitative analytical chemistry
Quantitative pharmaceutical chemistry
Person responsible for initiating the steps to determine if the product is defective
Pharmacist
5 manifestations of a defective product
Improper labeling, Discoloration, Presence of cloudiness, Presence of crystals, Presence of precipitates
Defined as the sum of all factors which contribute directly or indirectly to the safety, effectiveness, and reliability of the product
Quality
Defined as the sum of all procedures undertaken to ensure the identity and purity of a particular pharmaceutical
Quality control
Pharmacopoeia originating from Great Britain; formed by combining London, Edinburgh, and Dublin’s pharmacopoeias in 1864
British Pharmacopoeia
First US pharmacopoeia published in 1778
Lititz Pharmacopoeia
Father of the United States pharmacopoeia who suggested the idea of a pharmacopoeia to the medical society of New York
Dr. Lyman Spalding
Used to be a revolt/rebellious record first coined as the “National Formulary of Unofficial Preparations”
National Formulary
Was exclusive to doctors and was held every 10 years
USP convention
President that declared USP & NF as standards for medicinal and pharmacopoeial substances
President Theodore Roosevelt
Coined by Samuel Hahnemann and was based on the law of similarities
Homeopathic Pharmacopoeia of the US
Coined the Homeopathic Pharmacopoeia of the US
Samuel Hahnemann
Published by the WHO and serves as a recommendation to national pharmacopoeia revisions
International Pharmacopoeia
Year when the Lititz Pharmacopoeia (first American pharmacopoeia) was published for use
1778
Year when the Massachusetts Medical Society published a 272-page pharmacopoeia containing information on 536 drugs
1808
Date when Dr. Lyman Spalding (father of USP) submitted a plan to the medical society of the county of New York
January 6, 1817
Date when draft pharmacopoeias were reviewed, consolidated, and adopted by the first USP convention in Washington DC
January 1, 1820
Date when the first USP was published in English and Latin
December 15, 1820
Year when the first edition of the National Formulary for Unofficial Preparations was published
1888
Year when the pharmacopoeial convention granted authority to issue supplements to the USP
1900
Date when the title “National Formulary of Unofficial Preparations” was changed to “National Formulary”
June 30, 1906
The act that President Roosevelt signed into law
Pure Food and Drug Act
Year when the USP convention decided to revise the USP every 5 years and revise the NF every 10 years
1940
Year when the USP Convention, Inc. purchased the NF
1975
Date when the first combined compendium, comprising of the USP XX and NF XV, became official
July 1, 1980
Year when the USP 23/NF 18 became the first edition to drop the use of roman numerals in favor of Arabic numerals
1995
Year when the USP/NF became an annual publication
2002
Determination of the volume of a solution of known concentration
Volumetric analysis
Based on some physical or chemical properties of a substance
Physicochemical methods
6 examples of instrumental techniques
Chromatographic, Spectrophotometric, Electrometric, Thermal conductimetric, Refractometric, Polarimetric
Separation by extraction, precipitation, or other means of the constituents to be determined
Gravimetric analysis
Those methods which require a distinct type of technique
Special methods
3 examples of special methods
Alkaloidal assaying, Saponification value, Acid value
Used to denote the agreement of an experimental result
Accuracy
Measure of the reproducibility of date within a series of results
Precision
2 types of errors
Indeterminate/Noise/Random error, Determinate error
Slight variations in a series of observations made by the same observer under identical conditions
Indeterminate/Noise/Random error
Nature that recur in constant manner in each of a series of determinations
Determinate error
Chemical being analyzed
Analyte/Active constituent
Solution of known concentration
Titrant
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
Titration
Chemical which changes color at a point very near the equivalence point
Indicator
Theoretical point at which equivalent amounts of analyte and titrant have reacted
Equivalence point/Stoichiometric point
Point at which there occurs a sudden change in some property of the mixture
End point
Determination of normality or molarity of a solution
Standardization
Concentration expression that is defined as the number of equivalents of solute per liter
Normality
Concentration expression of solution in terms of moles per liter
Molarity
Solution of known normality or molarity
Standard solution
Highly purified (about 99.99% /ultrapure) compound that serves as a reference material in titration
Primary standard
Purity (97.88%) has been established by careful chemical analysis
Secondary standard
Difference in volume and mass between the end point and equivalence point
Titration error
Direct addition of a titrant to analyte
Direct titration
Adding excess amount of acid to base to quantify with base
Residual/back titration
Needs to perform pre-treatment before titration
Indirect titration
Correcting errors, repeating the assay without the analyte
Blank titration
A reaction where an acid reacts with a base
Neutralization reaction
2 products of a neutralization reaction
Water, Salt
