Calibrated Syringes, needles

Associated Analytical Procedures

Context in Practice: Example Specifications

From: Typical AAV Drug Product Specifications

This instrument is used in the context of measuring the Quality Attribute Extractable Volume with the following details:

  • Purpose / Rationale: To ensure the patient can receive the full, labeled dose from the container. Also note AAV vials are small volumes (0.5–2 mL)
  • Typical Acceptance Criteria: (per USP ). Not less than labeled volume.