Alkalinity of Glass

ALKALINITY OF GLASS
• Glass
• Glass is an amorphous inorganic product
formed by fusion of chemicals.
• Glass is said to be a frozen liquid.
• General composition of Glass
• SiO2, Na2O, K2O, CaO, MgO
• Advantages of glass
• Impermeable to gases , odour and microorganisms.
• Transparent and elegance in appearance
• Because of its high m.p and heat resistance , it can be
sterilized by dry or moist heat.
• Mostly inert to all packaging materials.
• It can be fabricated to produce variety of shapes.
• Can be easily cleaned due to its smooth surface.
• Re-useable and re-cyclable.
• Disadvantages
• Heavy weight
• Susceptibility to mechanical breakage.
• Unable to withstand sudden temperature changes
• Leaching of alkali
• Potential hazards may be caused by any of its
component , leached into pharmaceutical components.
• What is alkalinity of glass?
• From pharmaceutical point of view , it can
be defined as ;
• “ The release of alkaline contents of a glass into
the pharmaceutical product it contains “
• How Alkalinity of Glass occur?
• In all glasses, the sodium and potassium oxides
are hygroscopic; therefore, the surface of the glass
absorbs moisture from the air.
• The absorbed moisture and exposure to carbon
dioxide causes the Na2O or NaOH and K2O or
KOH to convert to sodium or potassium
carbonate.
• Both Na2CO3 and K2CO3 are also hygroscopic. In
water, especially salt water, the Na and K
carbonates in unstable glass may leach out,
leaving only fragile, porous hydrated silica (SiO2)
network. This causes the glass to craze, crack,
flake, and pit, and gives the surface of the glass a
frosty appearance.
• Example
• Vaccines prepared were tested
periodically for stability of PH and
potency. The vaccine prepared in buffered
saline solution retained potency beyond
30 months when stored at 0-5°C where as
the vaccines prepared in non-buffered
saline solution lost potency due to
increase in alkalinity.
• Types of glass:
• Glass containers suitable for packaging pharmaceuticals
may be classed in to four types. Type I, II and III are
intended for parenteral products
• Type O is intended for oral or topical use.
Type General Description Type of Test Limit

Size.ml ml of acid
I Highly resistant, Powdered All 1.0

borosilicate glass Glass
II Highly resistant, Water attack 100 or less 0.7
Soda Lime Glass
Over 100 0.2
III Moderately resistant Powdered All 8.5

Soda Lime Glass Glass
O General Purpose/ Powdered All 15
Soda Lime Glass Glass
Test for Alkalinity of Glass:
• Two types of tests are designed
• Powdered Glass Test
• Water attack test
• These tests are performed on new (not previously
used) glass containers.
• The degree of attack is determined by the amount
of alkali released from the glasses under the
conditions specified.
• This quantity of alkali is very small so strict
precautions is to be followed.
• Euipments of High quality and precision should
be used and area should be free from fumes and
excessive dust
• Apparatus used:
• An autoclave capable of maintaining a
temperature of 121 ±0.5 ċ, equipped with
a thermometer, a pressure gauge, a vent
and a rack.
• hardened-steel mortar and pestle.
• Other Equipment required are sieves
No. 20, 40 and 50 along with the pan and
cover, 250ml conical flask made of
resistant glass as specified , 2 lb
hammer, and adequate volumetric flask
• Reagents
1) Special Distilled water:

The water used in these tests has a
specific conductivity of 0.5 µ mho to 1 µ mho.
After double distillation , reject the first 10% or
15% of the distillate, and retain the remaining.
2) Methyl red solution:
Dissolve 24 mg of methyl red sodium in
sufficient purified water to make 100ml.
Neutralize the solution with 0.02 N sodium
hydroxide
Powdered Glass Test
• Take 6 or more containers. Rinse with purified water and dry
with clean and dry air
• Crush into fragments.
• Take 3 samples of 100 grams
• Crush them further separately in special mortar with
hammer.
• Nest the sieves and put the three samples combinely on the
No. 20 sieve.
• Shake the sieves for a while and remove the glass powder
from No. 20 and 40 sieves and repeat the crushing in special
mortar on them
• After that Continue the shaking process for 10 minutes.
• Collect the glass powder (excess of 10 grams) from No. 50
sieve and place in a close container and store in a desiccator
• Spread the sample on a paper.
• Pass a magnet to remove any iron particle
• Transfer sample to 250ml special conical
flask.
• Wash the sample with six 30-ml portions
of acetone
• Dry the flask along the sample for 20
minutes at 140 C. transfer to desiccator
and use within 48 hours
• Procedure
• Take 10 gram of the sample in special conical
flask
• Add 50ml of the special distilled water to this
flask and also to a blank
• Cap all flasks with special beakers so that the
bottom of the beaker fit the tip of the flasks.
• Place both in autoclave, close the autoclave
leaving the vent open and heat.
• When steam appear from the vent. Close the
vent and heat further with 1 o rise in
temperature per minute upto 121 C o.
• Hold the temperature for 30 minutes at 121C o.
then slowly cool the autoclave and remove the
flasks.
• After fast cooling, decant the water into a vessel,
and wash the residual powder with four 15 ml
portions of special distilled water, adding the
decanted washings into the main portion
• Add 5 drops methyl red solution and titrate
against 0.02 N Sulphuric acid. Record the volume
of the acid. Check the difference between volume
of sulphuric acid used for sample and blank.
• compare the difference with the table
Water Attack test
• Rinse 3 or more containers with special distilled
water
• Fill each containers upto 90 % of their over flow
capacity with special distilled water.
• Continue as in powdered glass procedure from
“cap all Flasks”. Autoclave time one hour.
• Take 100 ml sample in a 250 ml conical flask, add
5 drops of methyl red solution, and titrate with
0.02 N sulphuric acid.
• Compare the amount of sulphuric acid used in
case of sample with the blank.
• Campare with the limit in table
• Test performed after some time of storage of the
containers
• Same procedure as water attack test
• only following differences
• Solution of methyl red: 0.2 g of methyl red dissolved

in 60ml of alcohol, 7.5 ml of 0.5 N sodium hydroxide
and diluting upto 100 ml with special distilled water.
• Cover the containers with aluminum foil washed
thoroughly with acetone, instead of glass beakers
• Cool at room temperature instead of rapid cooling
after removal from autoclave. Titrate with 0.01 N
Sulphuric acid instead of 0.02N sulphuric acid.
• Limits: 1.5 ml of sulphuric acid for containers less than
or equal to 100 ml
• 0.5 ml for containers greater than 100 ml

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ALKALINITY OF GLASS

Type General Description Type of Test Limit

I Highly resistant, Powdered All 1.0

III Moderately resistant Powdered All 8.5

1) Special Distilled water:

• Solution of methyl red: 0.2 g of methyl red dissolved

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