EP 2.9.17 Test for Extractable Volume of Parenteral Preparations
Summary
This harmonized compendial method verifies that the extractable volume from a parenteral container meets or exceeds the nominal volume stated on the label under practical conditions of use. It applies to single-dose and multidose parenteral preparations (injections and infusions), accounting for unavoidable residual losses from container–closure systems and withdrawal technique.
Key Principles & Scope
Extractable volume testing ensures patients receive the full labeled dose, which is critical for high-potency drugs, biologics, and pediatric formulations where underdosing poses safety or efficacy risks. This test validates that manufacturing overfill strategies adequately compensate for normal withdrawal losses.
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Covers mobile (low-viscosity) and viscous (high-viscosity) liquids.
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Harmonized with USP <1> and JP 6.05 under the Pharmacopoeial Discussion Group (PDG) program and recognized as interchangeable per ICH Q4B Annex 2.
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Accounts for normal residual loss during withdrawal by using standardized techniques.
Sample size (Ph. Eur.):
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Select 1 container when the nominal volume is 10 mL or more.
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Select 3 containers when the nominal volume is more than 3 mL and less than 10 mL.
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Select 5 containers when the nominal volume is 3 mL or less.
The sample sizes defined in Ph. Eur. 2.9.17 are procedural minimums, not statistically justified sampling plans, and do not replace process capability or fill-volume control strategies.
(Note: requirements differ slightly in USP/JP.)
Withdraw contents using a dry syringe and suitable needle, expelling air bubbles.
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For viscous preparations, warming to 30–35 °C is permitted only when explicitly specified in the monograph or product labeling.
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Pooling is permitted only when the individual container volume is too small to measure accurately, as explicitly allowed in the chapter. Pooling is not a general alternative to individual testing and must not be used to mask underfilled individual containers.
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Measure volume using a graduated cylinder or gravimetrically (by weight and density)
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Acceptance:
Pooled samples: average volume ≥ nominal volume
Individual containers: each ≥ nominal volume
Official Source
Supporting Materials
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