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Posts Tagged ‘USP chapter 785’


Tuesday, March 30th, 2010

Advanced Instruments Introduces New Levels of Osmometer Standard Solutions Supporting Changes to USP <785> Osmolality Test Requirements

NORWOOD, MASSACHUSETTS, U.S.A. — March 30, 2010Advanced Instruments is pleased to introduce three new levels of Osmometer Standard Solutions to its product offering. The 200, 400 and 1000 mOsm/kg H20 level standards are NIST- traceable salt solutions that are packaged in 2mL ampules, 10 ampules per box. The kits are available for immediate release.

Products and AI Part Numbers

  • 200 mOsm/kg H20 Calibration Standard  – 3MA020
  • 400 mOsm/kg H20 Calibration Standard – 3MA040
  • 1000 mOsm/kg H20 Calibration Standard – 3MA100

The new levels were created in response to recent changes in the USP Chapter <785> Osmolality and Osmolarity. The new requirement specifies that instrument calibration must be confirmed with at least one solution that lies within 50 mOsm/kg H20 of the value of the test solution or the center of the expected range of osmolality of the test solution.

In the past, researchers were required to verify calibration with 2 solutions which spanned the expected range of the test solution, and there was no requirement for how close these levels needed to be to the test solution.

“The tighter new USP requirement created the need for a broader offering of osmolality standard solutions, particularly in the 200 to 1000 mOsm/kg range where many of the pharmaceutical, parenteral and IV drug products are formulated,” says Kelly Peterson, Product Manager.

“Pharmaceutical customers were coming to us and asking if we could provide these solutions. With our position as the industry leader in osmometry, we felt an obligation to deliver these products to our customers,” Peterson said. “These new levels complement the current AI offering of osmolality standards. Customers now have standard solutions that are commercially available in order to be fully compliant with USP General Chapter <785>.”

To learn more about these products, visit the Advanced Instruments Web site at www.aicompanies.com or call 800.225.1620 or +1 781.320.9000.

About Advanced Instruments, Inc.
Advanced Instruments, Inc., (www.aicompanies.com) and our subsidiaries: Delta Instruments and Mart Microbiology, design and manufacture instrumentation for the clinical, pharmaceutical, biotechnology, microbiology, and food laboratories. Our quality brands include Spiral Biotech, Fiske, and D & F Control Systems. The products we make help healthcare providers improve the quality of care, and industrial companies enhance quality and productivity A worldwide network of direct sales people and independent distributors supports Advanced Instruments’ products.

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Public Relations contact, Boston: Tiziani Whitmyre Inc., http://www.tizinc.com/public-relations

Advanced Instruments Introduces New Levels of Osmometer Standard Solutions Supporting Changes to USP <785> Osmolality Test Requirements

Advanced Instruments Introduces New Levels of Osmometer Standard Solutions Supporting Changes to USP <785> Osmolality Test Requirements


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