Mar 31 2010
Advanced 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.
“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”
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>."
Source:
Advanced Instruments, Inc.
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