GB/T 4771-2015Released alkali tests of glasses and glass containers for pharmaceutical preparations (English PDF)
药用玻璃及其玻璃容器碱溶出量试验方法
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Issued by
SAMR; SAC
Level / Type
National · Recommended
Issue date
December 31, 2015
Implementation date
July 1, 2016
Scope
GB/T 4771-2015 is the English-translated version of 药用玻璃及其玻璃容器碱溶出量试验方法.
GB/T 4771-2015 is the Chinese standard "Released alkali tests of glasses and glass containers for pharmaceutical preparations". Its scope clause reads: This standard specifies the pharmaceutical glass and glass containers alkali dissolution test method.
This standard applies to the water resistance test and classification of pharmaceutical glass. Its clauses include terms and definitions.
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Document preview — GB/T 4771-2015
National Standard of the People's Republic of China
- ICS
- 81.040.01
- Classification
- N 64
- Replacing
- GB/T 4771-1984
Issued by: State Administration for Market Regulation; Standardization Administration of the PRC
Contents
- 1 Scope
- 2 Normative references
- 3 Terms and Definitions
- 3.1 Alkaline elution amount
- 3.2 Filling volume
1 Scope
This standard specifies the pharmaceutical glass and glass containers alkali dissolution test method.
This standard applies to the water resistance test and classification of pharmaceutical glass.
2 Normative references
The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein
Member. For undated references, the latest edition (including any amendments) applies to this document.
GB/T 622 chemical reagent hydrochloric acid
GB/T 678 chemical reagent alcohol (ethanol)
GB/T 686 chemical reagent acetone
Laboratory use specifications and test methods GB/T 6682 Analysis
GB/T 12805 Laboratory glassware Burettes
GB/T 12808 Laboratory glassware single marking pipette
GB/T 15723 laboratory glassware dryer
GB/T 15724 laboratory glassware beaker
GB/T 15725.6 laboratory glassware grinding mouth flask
GB/T 22362 Laboratory glassware flask
3 Terms and Definitions
The following terms and definitions apply to this document.
3.1 Alkaline elution amount
Glass particles or glass containers with deionized or distilled water under heat and pressure, part of the alkali metal ions are leached glass surface, immersed
How much alkaline elution amount of analysis, the quality of the glass units precipitated bases within 0.02mol/L hydrochloric acid solution volume or surface glass container consumption
Volume 0.01mol/L hydrochloric acid solution was precipitated alkali consumed to represent, then according to the standard classification.
3.2 Filling volume
Test vessel was charged with distilled or deionized water volume.
Note. For bottles, enema and syringe filling volume should be 90% of capacity mouthful; for ampoules, the filling volume should to shoulder.
Principle 4
This test method is the inner surface of the glass containers or glass test certain processed into particle size of the glass particles.
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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 pages — is available in the English PDF.
Similar standards
Editions of GB/T 4771
| Edition | Title | Revision | Status |
|---|---|---|---|
| GB/T 4771-2015 | Released alkali tests of glasses and glass containers for pharmaceutical preparations | current edition | Current |
| GB/T 4771-1984 | Released alkali tests of glasses and glass containers for pharmaceutical preparations | previous edition | Superseded |
This page sells the current edition, GB/T 4771-2015. Earlier editions are listed for reference only.
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