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General Chapter does not specify whether linearity needs to be determined with a dextrorotary or levorotatory compound. USP does not provide a specific recommendation for a dextrorotary or levorotary compound. A user may consult their specific equipment manual or contact the manufacturer regarding appropriate standards.
For a linearity test, an example is shown in the Table below. The Table shows preparation sucrose solutions at nominal values of 10%, 20%, 30%, 40%, and 50% w/v and evaluates the linearity of the optical rotation. The acceptance criterion is that the R2 value should be NLT 0.99.
Table. Reference Values for Optical Rotation of Sucrose Solutions at 589 nm (sodium D-line) at a Temperature of 20°C and 25°C
Sucrose
% w/v
1-dm cell, 20 °C
Optical Rotation
(degrees)
1-dm cell, 25 °C
Optical Rotation
(degrees)
0.0
0.000
0.000
10.0
6.664
6.637
20.0
13.319
13.258
30.0
19.958
19.862
40.0
26.575
26.442
50.0
33.158
32.989
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