Anacura

Batch Release

Appearance

Physical state
Color
Clarity
Visible particles

Identity

Purity - Product related impurities

Starting materials/intermediates/degradants
Chiral purity

Purity - Process related impurities and contaminants

Residual solvents

Quantity

Assay API
Uniformity of dosage unit
Assay preservatives
Dissolution

General quality testing

pH
Viscosity
Subvisible particles
Hardness/disintegration/friability
Microbiology
Moisture

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