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level: Level 7

Questions and Answers List

level questions: Level 7

Question	Answer
Consist of drug substances and other components as dry-formulation ingredients to ensure chemical and physical stability of the presentation within final-use container Companion sterile diluent or diluent compartments may be provided to facilitate constitution to the desired final volume. lyophilized intended for final solution, solids intended for final solution, or dry solids that form viscous upon constitution	STERILE POWDERS FOR SOLUTIONS
Determine the amount of volatile matter of any kind that is driven off under the conditions specified.	Loss on Drying
Water or solvent content may have important effects on reconstitution and stability. For articles that may require water or a solvent content control, analysts should perform either the Titrimetric, Azeotropic or Gravimetric method.	Water Determination:
Unless otherwise justified, the following tests are required for solutions for injections:	1 universal tests 2 specific tests: antimicrobial preservatives
Consist of drug substances and other components as dry-formulation ingredients to ensure chemical and physical stability of the presentation within final-use container	STERILE POWDERS FOR SOLUTIONS
Unless otherwise justified, the following tests apply to sterile powders for injection:	1 universal tests
The following tests are required for suspensions for injections unless otherwise justified:	1 Universal Tests 2 Specific Tests - Uniformity of Dosage Units and Antimicrobial Preservatives
Unique drug products with unique properties and can be either solutions or suspensions. are aqueous dispersions of amphiphilic lipids and have low water solubility.	Liposomes
Unless otherwise justified, the following tests are required for liposomes:	1 universal tests 2 specific tests - globule size distribution in lipid injectable emulsions
Unless otherwise justified, the following tests apply to sterile powders for injections:	1 Universal Tests
STERILE POWDERS FOR SUSPENSIONS can be presented in several forms	1 lyophilized powder 2 microparticles that retain their integrity and are delivered as a sterile suspension
Liquid preparations of drug substances dissolved or dispersed in a suitable emulsion medium Usually are white, turbid, homogenous liquid dosage forms that contain one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.	EMULSIONS
Unless otherwise justified, the following tests are required for emulsions for injections:	1 Universal Tests 2 Specific Tests - Globule Size Distribution in Lipid Injectable Emulsions
consist of a matrix of a drug substance and a polymeric excipient that may or may not have an outer rate-controlling membrane. The polymeric excipient that may or may not have an outer rate-controlling membrane must be biocompatible but may or may not be bioresorbable.	implants for extended release
__ shaped implants for systemic delivery usually are provided in an inserter for subcutaneous or local administration such as local ocular delivery. It can also be surgically implanted for local delivery.	Cylindrically
are liquid preparations that are intended for injection into specific therapeutic targets. Typically consist of polymers in organic solvents, and upon injection the solvents migrate away from the site, leaving a gelled mass	Sterile in situ gels
injectable, resorbable __ for extended release generally range from 20 to 100 micrometers in diameter. They are embedded within a biocompatible, bioresorbable polymeric excipients. They are provided as a sterile powder in a vial or syringe.	MICROPARTICLES
They are tiny metal or polymer scaffolds used to keep arteries open following a medical intervention. The drug substance is incorporated into or onto the stent platform.	DRUG ELUTING STENTS
Drug eluting stents usually have two components of testing	1 functional tests that generally are American Society for Testing and Materials (ASTM) International methods 2 analytical tests