Description

Glass can be classified into different types based on USP criteria.


 

Parameters:

(1) composition

(2) intended use

Composition

Intended Use

Suitable for Parenteral Drugs

USP Type

borosilicate

aqueous solutions, sterile solutions

Yes

I

soda-lime, treated (exposure to sulfur dioxide fumes)

buffered aqueous solutions with pH < 7.0

Yes

II

soda-lime glass, untreated

dry powders, oily or greasy (oleaginous) materials

possibly

III

soda-lime glass, general purpose

tablets, oral solutions, oral suspensions, ointments, external liquids

No

NP

 

where:

• NP = nonparenteral

• Soda-lime glass is composed primarily of calcium oxide, silica and soda (sodium hydroxide)

• NP and Type III glass have limited resistance to heat shock and cannot be autoclaved.

 

Features of the glass:

(1) temperature range (best for borosilicate glass or soda-lime with increased silica)

(2) chemical resistance (greatest for borosilicate glass, least for NP)

(3) nonreactivity with contents

(4) breakage resistance

(5) expansion coefficient

(6) color

(7) opacity

(8) cost (higher for more desirable qualities)

 


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