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YBB 00292005-1-2015 PDF in English
YBB 00292005-1-2015 (YBB00292005-1-2015) PDF English
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YBB 00292005-1-2015
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Injection Vials Made of High Borosilicate Glass Tubing
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YBB 00292005-1-2015
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YBB 00292005-1-2015: PDF in English
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
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Source: Above contents are excerpted from the PDF -- translated/reviewed by: www.chinesestandard.net / Wayne Zheng et al.