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level: Level 6

Questions and Answers List

level questions: Level 6

Question	Answer
uniformity is demonstrated in two methods	Content uniformity & weight variation
dosage forms with single dose/ part of a dose of a substance in each unit	dosage units:
applicable for parenteral drug products and dosage forms in single-unit containers. It includes both the mass of the dosage form and the content of the active substance in the dosage form.	Uniformity of dosage units
Specific Product Quality tests	1 Uniformity of dosage units 2 Vehicles and added substances 3 Antimicrobial preservatives 4 Water content 5 Completeness/clarity of solutions
1 generally used as vehicle 2 may be added to render the resulting solution isotonic	1 Water for injections 2 NaCl or dextrose
1 fixed oils (vegetable origin, odorless). They must meet requirements in the test for Solid Paraffin in the Mineral oil monograph with the cooling bath maintained at 10C. 2 may be used provided they are liquid and remain clear when cooled to 10Cand has an iodine value of NMT 140	1 Nonaqueous vehicle 2 synthetic,mono- or diglycerides of fatty acids
Nonaqueous veghicles must meet the following requirements:	saponification value between 185-200; Iodine value: between 79-141 unsaponifiable matter: NMT 1.5% Acid value: NMT 0.2 Peroxide value: NMT 5.0 Water determination: NMT 0.1% Limit of Cu, Pb, Fe, Ni NMT 5ug/mL
Most used preservatives:	mercurials, phenylmercuric nitrate and thimerosal, esters of p-hydroxybenzoic acid (methyl, ethyl, propyl, butyl), phenol, benzyl alcohol, and chlorobutanol.
solid must dissolve completely, leaving no undissolved matter the constituted solution is not significantly less clear than an equal volume of diluent or of purified water contained in a similar vessel and examined similarly. Protein solutions may exhibit an inherent opalescence The constituted solution is free of particulate matter that can be observed on visual inspection.	Completeness/clarity of solutions