ARSENIC & POWDER GLASS TEST OF AMPULES AND VIALS

Why we perform this test??

This test is official in USP. The container is crushed and sieved to produce uniform particles of which a definite weight of taken. The control of the particle size and weight of powder ensures that a constant surface area is exposed to the solution. Because all of the glass (not just the surface layer) is examined and extraction is enhanced by the rough surfaces of the particles, this is a severe test, and, if a glass passes, it is unlikely that containers made from it will give trouble while is use.

Nevertheless, the technique is tedious and is not applicable to surface treated containers (sulphured or siliconed) because crushing would expose the alkaline glass below the surface. This test can be used for determining the nature of a glass or for distinguish between two types of glasses, such as neutral or surface – treated.

From the glass containers, alkaline constituents (oxides of sodium, potassium, calcium, aluminum, etc.) are leached into purified water under conditions of elevated temperatures. When the glass is powdered the leaching of alkali can be enhanced in the powdered is critical.

The principle involved in the powdered glass test in estimate the amount of alkali leached form the glass powder. The amount of acid that is necessary to neutralize the released alkali (a specified limit) is specified in the pharmacopoeia.
The quality of glass containers is defined by measuring their resistance to chemical attack. In addition, Type I containers for aqueous parenteral preparations are tested for arsenic release, and colored glass containers are tested for light transmission.

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