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Pharmaceutical Glass

Analytical >> Container Qualification >> Pharmaceutical Glass

To ensure you meet USP regulations regarding testing containers, AMRI provides testing for various classes of pharmaceutical glass.

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Infrared Spectrum Determination

Analytical >> Container Qualification >> Pharmaceutical Glass

Shijiazhuang Rainbowlabs pharmaceutical Technology Co. Ltd (Rainbowlabs) is a FDA-inspected laboratory set up to provide high quality laboratory testing and services to pharmaceutical companies throughout the world.

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JP <7.01> Test for Glass Containers for Injections

Analytical >> Container Qualification >> Pharmaceutical Glass

Appropriate tests are performed based on the composition and type of glass. Type I, II or III glass may be tested by all compendia, including Light Transmission as per the USP if desired.

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USP <660> Containers – Glass

Analytical >> Container Qualification >> Pharmaceutical Glass

Appropriate tests are performed based on the composition and type of glass. Type I, II or III glass may be tested by all compendia, including Light Transmission as per the USP if desired.

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EP (3.2.1) Glass Containers for Pharmaceutical Use

Analytical >> Container Qualification >> Pharmaceutical Glass

Appropriate tests are performed based on the composition and type of glass. Type I, II or III glass may be tested by all compendia, including Light Transmission as per the USP if desired.

A package endures a broad range of physical conditions. Container qualification testing labs can simulate and evaluate a package’s response to: shock, vibration, and shock vibration testing, compression testing, climatic conditions such as: high temperature/low temperature testing, humidity, altitude, and much more. Glass containers for pharmaceutical use are intended to come into direct contact with pharmaceutical products. Glass used for pharmaceutical containers is either borosilicate (neutral) glass or soda-lime-silica glass. Borosilicate glass contains significant amounts of boric oxide, aluminum oxide, and alkali and/or alkaline earth oxides in the glass network. Borosilicate glass has a high hydrolytic resistance and a high thermal shock resistance due to the chemical composition of the glass itself; it is classified as Type I glass. Soda-lime-silica glass is a silica glass containing alkaline metal oxides, mainly sodium oxide, and alkaline earth oxides, mainly calcium oxide, in the glass network. Soda-lime-silica glass has a moderate hydrolytic resistance due to the chemical composition of the glass itself; it is classified as Type III glass. Suitable treatment of the inner surface of Type III soda lime-silica glass containers will raise the hydrolytic resistance from a moderate to a high level, changing the classification of the glass to Type II. There are a number of USP, EP, JP and FDA compendia procedures designed to ensure that the container composition and functionality is appropriate for pharmaceutical products in various phases. Pharma Product Testing service providers utilizes these compendia methods, as well as client-supplied procedures for container analysis, including: Permeation Testing; Extractables Testing; Functionality Testing; Identification Testing. The Glass Grains Test combined with the Surface Glass Test for hydrolytic resistance determines the glass type. The hydrolytic resistance is determined by the quantity of alkali released from the glass under the conditions specified. This quantity of alkali is extremely small in the case of the more resistant glasses, thus calling for particular attention to all details of the tests and the use of apparatus of high quality and precision.

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