Aqueous Solution Checklist

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					DRUG SUBMISSION SCREENING CHECKLIST FOR AQUEOUS SOLUTIONS

Drug Product Information Drug product: Lot number: Expiry date:

Reference Product Information Reference product: Lot number: Expiry date:

Route of Administration Test Parameter Description, colour, clarity, expiry Drug Potency Potency, preservative Potency, salt, solvent pH Viscosity Surface Tension Specific Gravity Antimicrobial Effectiveness Testing Microbial Quality Partition Coefficient, where applicable Sterility Pyrogens, Endotoxin Particulate Matter Foreign Matter Fill Volume Uniformity of Mass Osmolality, Osmolarity Buffer Capacity Droplet Size or Volume, Drug Content per Drop, Quantity per spray, as appropriate Oral Drops Dose and Uniformity of Dose Injectable C NC NC C C C C C NC n/a C NC NC NC NC NC n/a C C n/a Inhalation C NC NC C C C C C NC n/a C NC NC n/a NC n/a n/a C C C Nasal C NC NC C C C C C NC NC C C n/a n/a n/a n/a NC C C C Ophthalmic C NC NC C C C C C NC n/a C NC n/a n/a NC n/a n/a C C C Oral * C NC NC C C C C C NC NC C n/a n/a n/a n/a n/a NC n/a C n/a Otic C NC NC C C C C C NC NC C NC n/a n/a NC n/a n/a C C C

n/a

n/a

n/a

n/a

C

n/a

C=comparative test; NC=non-comparative test; n/a=not applicable. * orally administered solutions may be either aqueous or alcohol-based; all other solutions, regardless of the route of administration, must be aqueous.


				
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