What does a monograph contains?
A monograph is a comprehensive systematic study of a particular taxonomic group. Monographs try to review all the facts about a taxonomic group, species descriptions (includes morphology, phenology, ethnobotany, distribution, specimens cited, common names, etymology, etc.)
What is monograph in pharmaceutical inorganic chemistry?
Definition: The opening statement of a monograph is one that constitutes an official definition of the substance, preparation or other article that is the subject of the monograph. In some monographs of pharmaceutical preparations the statement is given in terms of principle ingredient(s).
What is the importance of monograph in pharmacy?
Monographs articulate the quality expectations for a medicine including for its identity, strength, purity, and performance. They also describe the tests to validate that a medicine and its ingredients meet these criteria.
What is monograph in pharmaceutical chemistry?
A monograph is a written document that reflects the quality attributes of medicines approved by the U.S. Food and Drug Administration (US FDA). Some of these attributes include: Identity – Tests to identify that a particular substance is the medicine that it claims to be.
What are the contents of monograph in pharmaceutical chemistry?
1.2.1 Monograph The appendices include standards for apparatus, reagents and solutions, indicators, reference substances, test animals, calculation of results, other chemicals techniques, processes etc. of the concerned pharmaceuticals.
What is USP and NF?
The USP–NF is a combination of two compendia, the United States Pharmacopeia (USP) and the National Formulary (NF). It contains standards for medicines, dosage forms, drug substances, excipients, biologics, compounded preparations, medical devices, dietary supplements, and other therapeutics.
What is monograph in pharmacy Slideshare?
MONOGRAPH. Provide a reliable basis for judging the quality of the drug substances Way to control Adulterated and contaminated medicines Set standards for the quality , purity , strength Concise description of a single substances Reference for pharmaceutical drug specifications. 6. INDIAN PHARMACOPOEIA
What is pharmaceutical monograph?
A Product Monograph is a factual, scientific document on a drug product that, devoid of promotional material, describes the properties, claims, indications and conditions of use of the drug and contains any other information that may be required for optimal, safe and effective use of the drug.
What are NF standards?
Share. The United States Pharmacopeia (USP) and National Formulary (NF) are the official standards for all prescription and over-the-counter medicines, dietary supplements, excipients and other healthcare products manufactured and sold in the United States.