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YBB60442012: Tests for Hydrolytic Resistance of Interior Surfaces
YBB 60442012
YBB
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
Tests for hydrolytic resistance of interior surfaces
Tests for hydrolytic resistance of interior surfaces
This method is suitable for the determination and grading of the water resistance of the inner
surfaces of various types of pharmaceutical glass containers, using titration methods.
This method is a surface test method. Inject test water into the test container to the specified
capacity. Heat it under specified conditions. Measure the degree of water corrosion of the
container and grade it by titrating the etching solution.
Reagents: Test water
The test water must not contain heavy metals (especially copper). If necessary, the dithizone
limit test method can be used to test it [see GB 12416.1-90 Pharmaceutical glass containers -
Hydrolytic resistance - Test method and classification (Normative)]. Its conductivity shall not
exceed 0.1 mS/m, at 25 °C ± 1 °C. The test water shall be boiled, in an aged beaker, for more
than 15 minutes, to remove dissolved gases, such as carbon dioxide. The test water shall be
neutral to methyl red. That is, when adding 4 drops of methyl red indicator solution to 50 ml of
water, it produces an orange-red color, which is equivalent to pH5.5±0.1. This water can also
be used for blank test. Test water can usually be stored in a beaker, which has a ground glass
stopper, for 24 hours, without changing its pH value.
Instruments: High-pressure steam sterilizer, burette, beaker, flask (Note: New beakers and
flasks need to be subject to aging treatment, that is, fill purified water to the top of the bottleneck;
then repeatedly process them according to the hot-pressing conditions in the measurement
method, until the purified water is neutral to methyl red).
Tested products: The number of test containers depends on the capacity of the container, the
volume of the extract solution required for one titration, the number of titration results required,
which can be calculated according to Table 1.
Determination method: The cleaning process of the tested container shall be completed within
20 ~ 25 minutes, to remove debris or dirt. Use purified water, to thoroughly clean each container
at least 2 times, at ambient temperature. Fill with purified water for later use. Empty the
container before use, rinse once with purified water and test water in turn. Then drain the