ASTM D565

The ASTM D565 (mineral oil) and ASTM D612 (paraffin wax) test methods cover the determination whether the sample conforms to the standard quality required for pharmaceutical use as defined by the United States Pharmacopeia, the National Formulary, or the Food and Drug Administration.

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    TC16 used for ASTM-D565 and ASTM-D612
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General

This test method is applicable to white mineral oil to check its conforniance to standard of quality required for pharmaceutical use as defined by the U.S. Pharmacopeia and the National Formulary, or the Food and Drug Administration.

Precision

This is a pass-fail test and no sestimates of precision or bias can be made

Test

The mineral oil is treated with concentrated sulfuric acid under prescribed conditions and the resulting color is compared with a reference standard to determine whether it passes or fails the test. When the oil layer shows no change in color and when the acid layer is not darker than the reference standard colorimetric solution, the oil is reported as passing the test. A blu-ish haze or a slight pink or yellow color in the oil layer should not be interpreted as a change in color.