YBB 00292005-1-2015 English PDF (YBB00292005-1-2015)

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YBB 00292005-1-2015: Injection Vials Made of High Borosilicate Glass Tubing
YBB 00292005-1-2015
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
Injection Vials Made of High Borosilicate Glass Tubing
高硼硅玻璃管制注射剂瓶
Injection Vials Made of High Borosilicate Glass
Tubing
This standard applies to injection vials made of high borosilicate glass tubing
for directly-filling injection, sterile powder for injection and concentrated solution
for injection.
[Appearance] Take an appropriate amount of this product; conduct direct eye-
inspection under bright sunlight. It shall be colorless and transparent; the
surface shall be bright, clean, and flat without visible glass defects; no cracks
shall be found in any part.
[Identification]* (1) Coefficient of linear thermal expansion Take an
appropriate amount of this product; use the average linear thermal expansion
coefficient method for determination (YBB00202003-2015) or the linear thermal
expansion coefficient method for determination (YBB00212003-2015) to carry
out determination; it shall be (3.2 ~ 3.4) × 10-6K-1 (20 ~ 300°C).
(2) Content of boron oxide Take an appropriate amount of this product; carry
out determination using the boron oxide determination method (YBB00232003-
2015); the content of boron oxide shall not be smaller than 12%.
[Particle hydrolytic resistance at 121°C] Take an appropriate amount of this
product; carry out determination using the determination method and
classification (YBB00252003-2015) of hydrolytic resistance of glass grains at
121°C; it shall meet the requirements for level 1.
[Particle hydrolytic resistance at 98°C] Take an appropriate amount of this
product; carry out determination using the determination method and
classification (YBB00362004-2015) of hydrolytic resistance of glass grains at
98°C; it shall meet the requirements for level HGB1.
[Inner surface hydrolytic resistance] Take an appropriate amount of this
product; carry out determination using the determination method and
classification (YBB00242003-2015) of hydrolytic resistance of inner surface at
121°C; it shall meet the requirements for level HC1.
[Acid resistance]* Take an appropriate amount of this product; carry out
determination using method I of the determination method (YBB00342004-
2015) of the boiling hydrochloric acid erosion resistance of glass, it shall meet
the requirements for level 1; or carry out determination using method II of the
determination method (YBB00342004-2015) of the boiling hydrochloric acid
erosion resistance of glass; the amount of extract of alkaline oxide shall not