Anacura

Stability study programs

Types Conditions
Forced degradation -70°C ± 10°C
Accelerated stability Vapour phase nitrogen (-196°C)
ICH stability -20°C ± 5°C
In-use stability 5°C ± 3°C
Freeze-Thaw stability/cyclic stability 25 ± 2°C/ 60 ± 5% RH
Photostability 30 ± 2°C/ 65 ± 5% RH
  30 ± 2°C/75 ± 5% RH
  40 ± 2°C/75 ± 5% RH
  Temperature controlled photostability conditions
  Customised condition

Appearance

Physical state
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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