Quantitative chem Flashcards
Defined as the application of quantitative analytical chemistry…
- To the analysis & determination of the purity and quality of drugs & chemicals used in pharmacy.
- To the analysis & determination of the chemical constituents found in the human body whose altered concentration during disease states serve as diagnostic aids in the practice of medicines.
- To the analysis of medicinal agents and their metabolities found in biological systems
QUANTITATIVE PHARM CHEM
importance
1.) Pharmacists must have the knowledge to advise medical practitioners on drug quality
2.) Pharmacist must alert health professionals to the influence which drugs may have on clinical laboratory methods.
3.) Pharmacists must monitor drug levels during therapy.
In case the quality of a drug product is questioned by a physician, a pharmacist is:
Responsible for initiating steps to determine if a product is defective:
- Calling and advising the drug manufacturer of the problem involving the product
- Analyzing the preparation in the prescription laboratory, borrowing needed equipment from a clinical laboratory
- Sending a portion of the sample to a private laboratory for analysis
MANIFESTATION OF A DEFECTIVE PRODUCT
- Improper Labeling
- Discoloration
- Presence of Cloudiness
- Presence of Crystals
- Presence of Precipitates
“Sum of all factors” which contribute directly or indirectly to the safety, effectiveness, and reliability of the product.
QUALITY
Refers to the “sum of all procedures” undertaken to ensure the identity and purity of a particular pharmaceutical.
Such procedures may range from the performance of single chemical experiments which determine the identity and ________ for the presence of particular pharmaceutical substance (thin layer chromatography, infrared spectroscopy, etc) to more complicated requirements of pharmacopoeial monographs.
QUALITY CONTROL
Quality control guarantees within resonance limits that a drug product:
- Is free of impurities.
- Is physically and chemically stable.
- Contains the amount of active ingredients as stated on the label.
- Provides optimal release of active ingredients when the product is administered.
REFERENCE BOOKS ON DRUG STANDARDS
British Pharmacopoeia
United States Pharmacopoeia
National Formulary
Homeopathic Pharmacopoeia of the United States
International Pharmacopoeia
From Great Britain
Product of merging by the 3 cities’ pharmacopoeia of London, Edinburgh, and Dublin in 1864
British Pharmacopoeia
1st American Pharmacopoeia, 1778
Lititz pharmacopoeia
Suggested to the medical society of NY the pharmacopoeia.
Father of USP
Dr. Lyman Spalding (January 6, 1817)
Exclusive for doctors, held every 10 years (revise USP)
In 1940, pharmacies invited and revised and updated USP every 5 years.
USP convention
Used to be a revolt/rebellious records coined as the NF of the unofficial preparations.
June 30, 1906: changed to National Formulary
National Formulary
Declared USP & NF as standards for medicinal and pharmaceutical substances.
President Theodore Roosevelt
Coined by Samuel Hahnemann
Principle: like cures like or the law of similarities (vaccines/immunizations)
Homeopathic Pharmacopoeia of the United States
Homeopathic Pharmacopoeia of the United States is coined by
Samuel Hahnemann
Published by WHO
Recommendation to national pharmacopoeia revisions
International Pharmacopoeia
First American pharmacopoeia, Lititz Pharmacopoeia, was published for use by the military hospital of the United States Army
1778
Massachusetts Medical Society published a 272-page pharmacopoeia containing information on monographs on 536 drugs and pharmaceutical preparations.
1808
Lyman Spalding submitted a plan to the medical society of the country of New York for the creation of national pharmacopoeia. He was recognized as the father of USP.
January 6, 1817 (submitted)
Draft pharmacopoeias were reviewed, consolidated, and adopted by the 1st USP convention assembled in Washington, DC.
January 1, 1820 (reviewed, consolidated, adopted)
The first USP was published in English and Latin.
December 15, 1820 (published)
The first edition of the National Formulary of unofficial preparations was published.
1888
The pharmacopoeial convention granted authority to issue supplements to the USP to maintain satisfactory standards.
1900
The title National Formulary of Unofficial Preparations was changed to National Formulary (NF).
President Roosevelt signed into law the First Federal Pure Food and Drug Act, designating both the USP and NF as establishing legal standards for medicinal and pharmaceutical substances.
June 30, 1906
Convention decided to revise the USP every 5 years while maintaining the use of periodic supplements. The NF was revised every 10 years.
1940
The USP Convention Inc. purchased the NF, unifying the unofficial compendia and providing the mechanism for a single national compendium.
1975
The first combined compendium, compromising the USP XX and NF XV, became official.
July 1, 1980
The USP 23 – National Formulary 18 was the first edition to drop the use of Roman numerals, in favor of Arabic numerals to indicate the edition.
1995
The USP-NF became an annual publication.
2002