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YBB 00242003-2015: Test and Classification for Hydrolytic Resistance of Interior Surfaces at 121 ℃
YBB00242003-2015
YY / YBB
National Drug Packing Container (Material) Standard
Test and classification for hydrolytic resistance of
interior surfaces at 121 °C
ISSUED ON. AUGUST 11, 2015
IMPLEMENTED ON. DECEMBER 01, 2015
Issued by. China Food and Drug Administration of PRC
3. No action is required - Full-copy of this standard will be automatically and
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Test and classification for hydrolytic resistance of
interior surfaces at 121 °C
This method is applicable to the determination and classification of hydrolytic resistance of
interior surfaces of various types of medicinal glass containers by titration method.
This method is a surface test method. The test water is injected into the test container to a
prescribed capacity AND heated under the specified conditions. The degree of water erosion
of the container is measured by titration of the etching solution AND classified.
Test water. The test water shall not contain heavy metals (especially copper), if necessary,
it may use the dithizone limit test method to perform testing; when the conductivity is 25 °C
± 1 °C, it shall not exceed 0.1 mS/m. Test water shall be boiled in the aged beaker for 15
minutes or more to remove carbon dioxide and other gases. Test water shall be natural when
adding the methyl red, that is, if the 50 ml of water is added by 4 drops of methyl red indicator
solution (methyl red sodium 0.025 g, dissolved in water and diluted to 100 ml), the water color
will change into orange red (pH 5.4 ~ 5.6). The water can be used for blank testing. Test
water can usually be stored in a flask with a glass stopper for 24 hours without pH change.
Instrument and device. pressure steam sterilizer, burette, beaker, and flask (note. glass
containers shall be made by the borosilicate glass having an average linear thermal
expansion coefficient of about 3.3 × 10-6 K-1. The new glass containers shall be subjected to
aging treatment before use, that is, adding appropriate amount of water into the glass
container, treating it repeatedly in accordance with the hot pressing conditions in the
determination method, until the water is in neutral to methyl red.
Product under test. The number of the product under test depends on the capacity of the
container, the volume of the extract required for the primary titration, and the number of
titration results required, as calculated in Table 1.
Table 1 Number of containers required for the determination of hydrolytic resistance
by titration method
Capacity (ml)
(equivalent to filling
volume)
Minimum number of
container required for one
titration (pieces)
Volume of extract required
for one titration (ml) Number of titrations
≤ 3 10 25.0 1
> 3 ~ 30 5 50.0 2
> 30 ~ 100 3 100.0 2
> 100 1 100.0 3
Determination method. The product under test shall be cleaned within 20 ~ 25 min to
remove the debris or dirt. At room temperature, USE water to thoroughly clean each container
for at least 2 times; FILL it full of water to prepare for use. EMPTY the container before use;
USE water and test water to flush it respectively for one time; MAKE the container be
completely dried.
TAKE the product under test which is cleaned; ADD test water to 90% of its full capacity; as
for the small capacity container such as ampoules, FILL the water to the shoulder of the
container; USE an inverted beaker (subjected to aging treatment) or other appropriate
material to cover the opening. PLACE the product under test into the pressure steam sterilizer;