GB/T 4771-2015 English PDF

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GB/T 4771-2015: Released alkali tests of glasses and glass containers for pharmaceutical preparations
Status: Valid

GB/T 4771: Historical versions

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
GB/T 4771-2015	239	Add to Cart	3 days	Released alkali tests of glasses and glass containers for pharmaceutical preparations	Valid
GB/T 4771-1984	239	Add to Cart	3 days	Released alkali tests of glasses and glass containers for pharmaceutical preparations	Obsolete

Similar standards

GB/T 12807   GB/T 15726   GB/Z 12414   GB/T 6582   GB/T 6580   

Basic data

Standard ID: GB/T 4771-2015 (GB/T4771-2015)
Description (Translated English): Released alkali tests of glasses and glass containers for pharmaceutical preparations
Sector / Industry: National Standard (Recommended)
Classification of Chinese Standard: N64
Classification of International Standard: 81.040.01
Word Count Estimation: 11,185
Date of Issue: 2015-12-31
Date of Implementation: 2016-07-01
Older Standard (superseded by this standard): GB/T 4771-1984
Quoted Standard: GB/T 622; GB/T 678; GB/T 686; GB/T 6682; GB/T 12805; GB/T 12808; GB/T 15723; GB/T 15724; GB/T 15725.6; GB/T 22362
Regulation (derived from): State Standard Announcement 2015 No.43
Issuing agency(ies): General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China, Standardization Administration of the People's Republic of China
Summary: This standard specifies the test method for alkaline dissolution of medicinal glass and its glass containers. This standard is applicable to the water resistance test and classification of medicinal glass.

GB/T 4771-2015: Released alkali tests of glasses and glass containers for pharmaceutical preparations

---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Released alkali tests of glasses and glass containers for pharmaceutical preparations ICS 81.040.01 N64 National Standards of People's Republic of China Replacing GB/T 4771-1984 Its pharmaceutical glass elution amount of alkali glass container experiment method Issued on. 2015-12-31 2016-07-01 implementation Administration of Quality Supervision, Inspection and Quarantine of People's Republic of China Standardization Administration of China released

Foreword

This standard was drafted in accordance with GB/T 1.1-2009 given rules. This standard replaces GB/T 4771-1984 "medicinal glass and alkali dissolution test method for glass containers." This standard and GB/T 4771-1984 The main differences are as follows. --- In the preparation of methyl red indicator solution, USP reference standards for formulated, revised the original method of preparation; --- Increases the surface etching test methods; --- Powdered glass to glass particles Law Amendment Act water test; --- Complete glass container modified to test the water in a glass container surface test; --- Increasing the terms and definitions of alkali elution volume and filling volume; --- Appendix A and Appendix B content modifications to the standard body. The standard proposed by China National Light Industry Council. This standard by National Instrument Standardization Technical Committee on Glass (SAC/TC178) centralized. This standard was drafted. Glass National Light Industry Product Quality Supervision and Inspection Center. The main drafters of this standard. Yuan Chunmei, Liang Ye. This standard replaces the standards previously issued as follows. --- GB/T 4771-1984. Its pharmaceutical glass elution amount of alkali glass container experiment method

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 leachingofalkali 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 filingvolume 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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