European Pharmacopoeia 2.2.5

, which signifies the ratio of the density of the substance at 20 °C to the density of water at the same temperature. If density at 20 °C ( ρ20rho sub 20

| Problem | Possible Cause | Solution | |---------|----------------|----------| | Non-reproducible weights | Air bubbles in pycnometer | Degas sample (ultrasonic bath) | | Drifting results | Temperature fluctuation | Check bath thermostat; insulate | | Pycnometer weight changes | Dirty or wet exterior | Use lint-free cloth; calibrate cleanliness SOP | | Digital meter error | Viscosity mismatch | Use appropriate viscosity correction factor | | Outliers with solids | Air trapped in solid pores | Vacuum degas before weighing |

However, the core method described in remains unchanged in its physical principles, ensuring backward compatibility with decades of pharmaceutical monographs. european pharmacopoeia 2.2.5

If you implement Ph. Eur. 2.2.5 in your lab, validation parameters include:

Or, relative to water at $4^\circ C$: $$d_4^20 = \frac\textMass of substance at 20^\circ C\textMass of equal volume of water at 4^\circ C$$ , which signifies the ratio of the density

For liquids and solids, the reference is unless otherwise stated in the individual monograph. For gases, the reference is air at the same temperature and pressure .

This article is for informational purposes and does not replace the official text of the European Pharmacopoeia. Always refer to the current legally binding version for regulatory compliance. This article is for informational purposes and does

It is useful to compare Ph. Eur. 2.2.5 with similar chapters:

For global compliance, a laboratory testing products for EU markets must strictly follow Ph. Eur. 2.2.5, not USP <841>.

A pycnometer is a glass flask with a close-fitting stopper that has a capillary hole running through it. This design ensures that the volume of liquid held by the flask is constant.