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1. Hydrolytic Resistant Test
Kainat
2017-Pharmd -027
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2. Quality control testing of Glass
Test for surface hydrolytic resistance
Light transmission tests for colored glass
Test for hydrolytic resistance of powdered glass.
Light transmission tests for colored glass
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Glass is one of the most widely used material for parenteral
products.
 Each glass container must be to be tested by following manner:

3. Hydrolytic Resistant Test
 Surface hydrolytic resistance test
 Powder glass hydrolytic test
Principle:
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referred as Alkalinity
Test.
Alkali leached is determined
Container is filled with water
Specified autoclaving condition for time period.
Titrated against the acid at
it will give the amount of alkali

4. Surface Glass Test
Wash container with carbon dioxide free water
Fill the container with CO2 free water( 90%)
Close with Aluminum foil
Autoclave at 100-120◦ for 20 min
Maintain at 120 for 1 hr
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5. At lower temperature for 40 mins
Remove containers and cool
Titrate it within one hour
Titrate with 0.01M HCL( end point colorless)
Repeat with the same volume of CO2 free water
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6. Applications
Released alkalinity is measured
Release of glass constituents are measured: silicate, borate,
sodium, and aluminum
and the release of some impurities as copper and lead.
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7. Powdered Glass Test
Hammer the container and collect 100g glass
Fragments shouldn’t be greater than 25mm
Powder it to obtain 20g fragment to retain
on 250microns
Magnet passing to purify
Now perform as per previous test by adding
100ml CO2 free water and match with the IP
specifications
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8. References:
• https://www.pharmapproach.com/glass-containers-for-
pharmaceutical-use/
• https://pubmed.ncbi.nlm.nih.gov/15113075/
• https://www.slideshare.net/shwetashelke35/glass-as-a-packaging-
material-in-pharmaceutical-packaging-71496789
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