YBB 00362004-2015 English PDF (YBB00362004-2015)

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YBB 00362004-2015: Test and Classification for Hydrolytic Resistance of Glass Grains at 98℃
YBB 00362004-2015
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
Test and Classification for Hydrolytic Resistance of
Glass Grains at 98°C
Test and Classification for Hydrolytic Resistance of
Glass Grains at 98°C
This Method applies to the test and classification for hydrolytic resistance of all
kinds of pharmaceutical glass materials.
This Method is a material test method: take 2 g of 300 ~ 500 µm glass grains;
immerse in test water for 60 minutes at 98°C. Use titrant etching liquid to
determine the degree of attack of glass grains by water and classify.
[Test water] Test water shall not contain heavy metals (especially copper); if
necessary, use dithizone limit test method for testing; the conductivity shall not
exceed 0.1 mS/m at 25°C ± 1°C. Test water shall be boiled for more than 15
minutes in a beaker that has been ageing-treatment, so as to remove the gases
such as carbon dioxide. Test water shall be neutral to methyl red; that is, when
adding 4 drops of methyl red indicating liquid (take 0.025 g of methyl red sodium,
add water to dissolve and dilute to 100 mL) into 50 mL of water, the colour of
water turns orange red (pH 5.4 ~ 5.6). This water can be used for blank tests.
Test water can generally be stored in a ground-glass stoppered flask for 24 h
without changing its pH value.
[Apparatus] Water bath kettle (thermostatic control can be achieved),
measuring flask, conical flask (Note: Glass containers must be made of
borosilicate glass having an average coefficient of linear thermal expansion
about 3.3 × 10-6K-1; new glass containers shall undergo ageing treatment; that
is, add an appropriate amount of water into a glass container; repeat the
treatment according to thermal compression conditions specified in the test
procedures, until water turns neutral to methyl red before using), hammer,
grinding bowl and pestle made of hardened steel (Figure 1), a set of stainless
steel sieves (including sieve-A with a mesh size of 500 μm; sieve-B with a mesh
size of 300 μm; and sieve-O with a mesh size of 600 ~ 1 000 μm).