Understanding USP-NF Monographs: A Guide for Pharmaceutical Professionals

The United States Pharmacopeia--National Formulary (USP-NF) manufactures pharmaceutical monographs to define the properties of all types of medicines and oversees all labeling standards for medicines sold in the country. According to the USP-NF website, monographs are data labels displaying the chemical ingredients, purpose of the drug, handling, storage, and solution suitability levels. You use a USP-NF monograph by reading its various sections as a means of obtaining necessary medicinal information.

Things You'll Need

• Monograph

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Instructions

• 1

  Look at the monograph for a prescription drug that you have at home. Take, for example, Paroxetine Hydrochloride, a well known antidepressant, otherwise known as Paxil.

• 2

  Read the list of chemical ingredients in the upper right-hand portion of the monograph, just below the "Paroxetine Hydrochloride" title.

• 3

  Read the "Definition" section to understand the chemical concoction of the drug. Examine the "Identification" section to note how the drug is used.

• 4

  Review the "Assay" section to determine the precise procedures for using the drug. Read through the section to identify specific solution suitability levels, preparation instructions and charts.

• 5

  Examine the "Impurities" section to identify all organic and inorganic impurities in the drug. Read through the section to identify procedures for reducing impurity levels as well.

• 6

  Read the "Additional Requirements" section --- in the bottom left corner of the monograph --- to note packaging and storing, labeling and USP reference standards for the drug.