34 Questions
What is the name of the chemical formula of acetaminophen?
C8H9NO2
What type of analysis uses only 5 mg of a sample?
Microanalysis
What is the name of the first pharmacopeia in the US?
Lititz Pharmacopeia
In what year was the first combined USP-NF published?
1980
What type of analysis involves the accurate measurement of weight?
Gravimetric Analysis
What is an example of an optical method of analysis?
Spectrophotometry
What is the reference standard for acetaminophen?
United States Pharmacopeia
What is the purpose of a pharmacopeial monograph?
To provide standards for the quality of a drug
What is the range for physical tests and determinations, microbiological tests, chemical tests and assays, and biological tests and assays?
1 to 999
What type of information is provided in the range of 1000 to 1999?
General Information
Where are monographs for dietary supplements and ingredients found?
A separate section of the USP
What is the purpose of a monograph?
To provide a specification by way of a name, definition, description, tests, procedures, and acceptance criteria
What is included in the USP-NF?
A combination of the United States Pharmacopeia and the National Formulary
What is the purpose of a reference standard in a monograph?
To provide a standard against which a substance can be compared
What type of information is included in a monograph?
A range of information including chemical structure, chemical name, purity rubric, and more
What is the purpose of identification tests in a monograph?
To identify the substance and confirm its identity
Who published the First National Formulary in 1820?
American Pharmacists Association
In which year was the title of the National Formulary designated by the Federal Pure Food and Drug Act?
1906
What is the primary purpose of the General Notices Section in USP?
To present basic assumptions and default conditions for USP and NF
What is the frequency of USP revision and publication since 2002?
Annually, effective every 1st of May
What is the significance of the year 1975 in the history of USP-NF?
USP acquired NF and Drug standards Laboratory from APhA
What is the topic of the 6th section of the General Notices in USP?
Prescribing and dispensing
What is the date of the Department Order that declared the Phil Pharmacopeia as the official book of standards and reference for pharmaceutical products and crude plant drugs in the Philippines?
March 29, 2004
In what year was the first British Pharmacopeia published?
1864
What is the frequency of revision of the British Pharmacopeia?
Annually
In what year was the International Pharmacopeia published by the World Health Organization (WHO)?
1951
What is the name of the first American formulary compiled by General William Brown?
Lititz Pharmacopeia
Who were the key figures involved in the development of the first US Pharmacopeia?
Dr. Lyman Spalding, Dr. Samuel Mitchill, and Dr. William Brown
What is the primary principle of Volumetric Analysis?
Measurement of volume of a solution of known concentration
Which of the following is NOT a classical method of analysis?
Electroanalytical analysis
What is the term used to describe the process of reacting a substance with another substance to form a precipitate?
Precipitation
Which of the following types of analysis involves the measurement of weight?
Gravimetric analysis
What is the term used to describe the process of reacting a substance with another substance of known concentration?
Titration
Which of the following is an instrumental method of analysis?
Spectrophotometry
Study Notes
Methods of Analysis
- Classified into three categories: Classical, Instrumental, and Misc
- Classical methods include Volumetric and Gravimetric analysis
- Volumetric analysis involves measuring the volume of a solution of known concentration required to react with the desired constituent
- Gravimetric analysis involves accurate measurement of weight by making it react quantitatively with another substance, usually a precipitant
Pharmacopeia
- A book of standards and reference for pharmaceutical products and crude plant drugs
- Examples: British Pharmacopeia (BP), United States Pharmacopeia (USP), International Pharmacopeia (IP), and European Pharmacopeia (EP)
- History of USP:
- First US Pharmacopeia published in 1820
- First National Formulary (NF) published in 1888
- President Theodore Roosevelt signed the first Federal Pure Food and Drug Act in 1906, establishing legal standards for medical and pharmaceutic substances
- USP acquired NF and Drug Standards Laboratory from APhA in 1975
- First combined USP-NF published in 1980
- USP revised and published annually, made official every 1st of May each year
Parts of USP
- General Notices: presents basic assumptions, definitions, and default conditions for the interpretation and application of USP and NF
- General Chapters:
- Enforceable chapters (1-999) for physical tests, microbiological tests, chemical tests, and assays
- General information chapters (1000-1999) with no mandatory requirement
- Chapters above 2000 apply to dietary ingredients or supplements
- Monograph: provides a specification by way of a name, definition, description, tests, procedures, and acceptance criteria, and sometimes packaging and labeling requirements
- Examples of General Chapters: Weights and Balances, Alcohol Determination, Melting Range or Temperature, etc.
Parts of a Monograph
- Chemical structure and formula
- Purity rubric
- Packaging and storage
- Reference standard
- Identification tests
- Corresponding tests for chemical and physical constants
- Assay procedure
- Water content
Examples of Monographs
- Acetaminophen monograph:
- Chemical structure and formula
- Identification test
- Assay
- Test for impurities
- Specific test
- Packaging and storage
- Reference standard
Review Questions
- Microanalysis involves the use of only 5mg of a sample
- Gravimetric analysis involves the accurate measurement of weight
- Spectrophotometry is an example of an optical method of analysis
- The first pharmacopeia in the US is the Lititz Pharmacopeia
- The first combined USP-NF was published in 1980
This quiz covers various methods of analysis in analytical chemistry, including classical, instrumental, and miscellaneous techniques such as titration, spectrophotometry, and electroanalytical methods.
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