PRX 340 Ofner part

drug compounds

active pharmaceutical ingredient which can come from natural or synthesized sources

ex: hydromorphone HCl

dosage forms

a unit containing the pharmaceutical ingredient

ex: Hydromorphone HCl tablets

drug product

dosage form that has been placed in a container and properly labeled

general notices

applying to tests, assays, definitions

ex: definitions of water and alcohol

general chapters

give information on equipment, procedures, and are referenced from individual monographs

drug monograph

a publication that contains specific informaiton for a drug or class of related drugs

structure

chemical name, molecular weight

definition

percent of API present (purity)

indentification

qualitative chemical tests

assay

chemical quanitification of API

impurities

specific chemicals and their assay and allowed amounts

dissolution

how fast unit releases drug and it dissolves

uniformity of dosage units

allowed variation of API content in each dosage form

USP/NF

the information is on the API, the dosage form, and product

includes required API content of the dosage form

package inserts of drug products have data from USP testing

compounding

process of combining or altering ingredients to prepare a medicaiton by a pharmacist for an individual patient based on a prescription

non sterile compounding

used to prepare a dose or formulation that is not commercially available

potable water

drinkable like from tap, for hand and equipment washing

purified water

distilled, for use in water containing formulations and rinsing equipment and utensils

sterile compounding

must be conducted with strict procedures to prevent contamination of the drug

irrigation

liquid washes used in the body cavity

carcinogenic

cancer causing

teratogenic

causes fetal disabilites or malformations or reproductive toxicity

genotoxic

damages DNA, can cause cancer

Beyond use date (BUD)

type of expiration date based on general experimental evidence of drug degradation, microbial contamination, container failure