Advanced Instruments OsmoTECH PRO - Standards and Controls

• Quality Control
• This section outlines the quality control materials and their intended use as recommended by
Advanced Instruments for the OsmoTECH PRO Osmometer. It is recommended that laboratories
incorporate these materials into your quality control management system.
• Regulatory Guidance
• United States Pharmacopeia (USP) Standard 785: Confirm the instrument calibration with a
solution such that the osmolality of the Standard Solution lies within 50 mOsm/kg of the
expected value of the Test Solution or the center of the expected range of osmolality of the Te st
Solution.
1
• European Pharmacopeia (EP)
2
and Japanese Pharmacopeia (JP)
3
may also be referenced.
Standards and Controls
1 United States Pharmacopeia (USP) Standard 785 Osmolality and Osmolarity (2009). United States Pharmacopeia.
2 European Pharmacopeia (EP) Standard 7.3, Section 2.2.35 Osmolality (2012). European Pharmacopeia.
3 Japanese Pharmacopeia (JP) Standard XVI, Section 2.47 Osmolarity Determination, Japanese Pharmacopeia