11 Calibration Solutions for Osmometry
11.2 Restrictions on the Use of the Calibration and Reference
Materials
-
They may not be used to clean contact lenses or the like.
-
They may not be used in human injections or infusions, neither in its pure form nor in mixtures with
human bodily fluid samples.
11.3 Composition
GONOTEC Calibration standards 100, 300, 500, 850, 2000 mOsmol/kg and OSMOREF
®
290
mOsmol/kg NaCl/H
2
O
850
2000
290
100
300
500
mOsmol
mOsmol
mOsmol
mOsmol
mOsmol
mOsmol
Sodium chloride
3,088 kg
9,463 kg
15,916 kg
27,178 kg 63,960 kg
9,124 kg
Ph.Eur./USP
Water for injection
purposes as bulk
Ph.Eur./USP
ad 1000 l
ad 1000 l
ad 1000 l
ad 1000 l
ad 1000 l
ad 1000 l
For precise concentration information, see the analysis certificate on the package insert of each batch.
11.4 Safety and Handling Information
Calibration and reference materials are not dangerous according to EC Directive 67/548/EEC.
Poison class
(Switzerland):
F (no poison class)
German water
hazard class
(WGK):
1 (weak hazardous to water)
Storage class
(German
association of
chemical
industries, VCI):
10-13 (miscellaneous liquids and solids)
According to GLP/institute requirements/regulations on the federal, national, and
local level
Disposal
Please note:
The calibration and reference materials are
chemicals
. Observe all relevant
precautions
and
regulations
(do not swallow, do not taste, always wear gloves, etc.)
Container:
clear glass OPC ampoules
Nominal volume:
1 ml
The ampoules have a breaking ring with a breaking ring color (blue dot). The ampoule can be opened
manually by breaking it off at this point. Follow all safety precautions for the handling of glass
(splintering, breakage, etc.).
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Calibration Solutions for Osmometry
