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YBB 00342004-2015

YBB 00342004-2015_English: PDF (YBB00342004-2015)
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YBB 00342004-2015English120 Add to Cart 0--10 minutes. Auto-delivered. Test for Resistance to Attack of Glass by Boiling Hydrochloric Acid YBB 00342004-2015 Valid YBB 00342004-2015
 

BASIC DATA
Standard ID YBB 00342004-2015 (YBB00342004-2015)
Description (Translated English) (Glass - Resistance to attack by boiling hydrochloric acid assays)
Sector / Industry Medical & Pharmaceutical Packaging Industry Standard
Classification of Chinese Standard C08
Word Count Estimation 3,324
Date of Issue 2015-08-11
Date of Implementation 2015-12-01
Older Standard (superseded by this standard) YBB 0034-2004
Regulation (derived from) China Food & Drug Administration Announcement 2015 No.164

YBB 00342004-2015
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
Test for Resistance to Attack of Glass by Boiling
Hydrochloric Acid
Test for Resistance to Attack of Glass by Boiling
Hydrochloric Acid
This standard applies to the test for resistance of all kinds of pharmaceutical
glass containers and tubes to attack of boiling hydrochloric acid.
In accordance with different test principles and methods, it includes the
gravimetric method and the flame photometric method or the atomic absorption
spectrometric method.
Method I -- The gravimetric method
This method is to immerse about 100 cm2 of glass sample in boiling 6 mol/L ±
0.2 mol/L hydrochloric acid for 6 hours; then determine the mass of loss per unit
surface area.
[Preparation of test samples] Cut samples into glass tubes or pieces in
regular shapes, with a total surface area 100 cm2 ± 10 cm2. Sections are finely
ground; no fire shall be used for polishing. The newly cut surface area shall not
be greater than about 10% of the total surface area. Use water to clean; then
use absolute ethyl alcohol or acetone to rinse; dry in the drying oven for 45
minutes at 150°C; transfer to the desiccator to cool for 45 minutes; weigh
precisely, accurate to 0.1 mg; record the mass (m1). Use the same method to
prepare 2 samples.
When testing the acid resistance of glass materials, the effect of the surface
structure shall be considered, and samples shall be pretreated using mixed acid.
The operation is as follows: place samples in the plastic beaker; add the mixed
solution of 40% hydrofluoric acid solution - 2 mol/L hydrochloric acid solution
(1:9) to fully immerse them; use the magnetic stirring apparatus to stir for 10
minutes; use tweezers (the head is cladded with plastic or platinum; use diluted
hydrochloric acid for treatment prior to use; and then use water to wash) to take
out samples; as specified above, conduct washing, drying, cooling and
weighing.
[Determination method] In the conical flask, add 800 mL of 6 mol/L ± 0.2 mol/L
hydrochloric acid solution; heat to boiling; use platinum wire to suspend the
samples in the boiling acid (samples shall be fully immersed and suspended at
the center); mount the condenser above the bottle mouth; after boiling uniformly
for 6 hours (Figure 1), take out samples; use water to clean; dry in the drying
oven for 45 minutes at 150°C; transfer to the desiccator to cool for 45 minutes;
weigh precisely, accurate to 0.1 mg; record the mass (m2).