CRED Getting the CMC Dossier Right 2024

28/08/2024

ICH Specific Tests: Oral Liquids and Powders for reconstitution as oral liquids (2)

• Antioxidant preservative content • Acceptance criteria should ensure appropriate preservation during all the shelf life • Extractables • Should normally be performed except where development and stability data shows evidence that extractables from the container/closure systems are consistently below safe levels Alcohol content • Should be controlled if declared quantitatively on the label in accordance with relevant regulations •

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ICH Specific Tests: Oral Liquids and Powders for reconstitution as oral liquids (3)

• Dissolution: • Oral suspensions and dry powder products for resuspension • Single-point measurements for IR dosage forms • Two-stage testing for DR dosage forms • Three or more time-points for PR/ER dosage forms • Acceptance limits in line with clinical batches and available batch data • Particle size distribution • If CQA • Redispersibility • For oral suspensions which settle on storage (product sediment)

The Organisation for Professionals in Regulatory Affairs

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