PHARM CHEM 11  USED FOR TYPE I & II only

6E. GLASS For TYPE II, no more crushing of the glass just put
water on the TYPE II glass and add it with HSO4
 Glass is formed by the silicon oxide tetrahedron.
sulfuric acid and then determine the leaching
Though boric oxide will enter into this structure,
property of the glass. This procedure is now known
most of the other oxides do not.
as WATER ATTACK TEST.
 It is composed also of varying amounts of other
oxides like sodium, potassium, calcium, B. SURACE GLASS TEST
magnesium, aluminum, boron and iron added
 similar with Water Attack Test but this only test
to impart color to the glass
for TYPE I & III from TYPE II glass and uses a
 Glass may be colored to provide protection
different acid which is the HCl.
from light by the addition of small amounts of
 determines the quality of the inner contact
metal oxides and is tested. A clear and colorless
surface for pharmaceutical preparations.
container that is made light resistant by means
of an opaque enclosure is exempt from the 2. GLASS GRAINS TEST
requirements for spectral transmission.
 test that distinguish from TYPE I to TYPE II & III
 As prescribed by pharmacopoeias, containers
with no hydrolytic resistance intact
should meet certain condition of stability to be
 may be performed either on the canes used for
used for pharmaceutical products.
the manufacture of tubing glass containers or
 Glass containers are classified according to their
on the containers
resistance to chemical attack, a test executed
by heating the glass in contact with water for 30 3. SURFACE ETCHING TEST
min at 121 0 C.
 test used to distinguish TYPE I from TYPE II
 The USP powdered glass test for glass
 used in addition to the Surface Glass Test when
containers was applied to different kinds of
it is necessary to determine whether a
glasses used as containers for parenteral
container has been surface treated and/or to
formulations.
distinguish between Type I and Type II glass
Glass types are determined from the result of USP containers.
tests.  Alternatively, the Glass Grains Test and Surface
Glass Test may be used
The following Test for Glass are:
 may be carried out either on unused samples or
1. Leaching/ Hydrolytic Resistance Test on samples used
 may be used to determine whether high
 Old Test in USP /NF hydrolytic resistance is due to chemical
 Leachability - is a property in which ions from composition or to surface treatment.
the glass container will leach out and interact
with the product, thereby reducing the stability 4. LIGHT TRANSMITTION TEST
of the product.
 used to test for colored glass
 Delamination or glass particulate formation - is
caused by the chemical attack on the glass 5. ARSENIC RESISTANCE TEST
matrix by the formulation solution, resulting in
 used to test for Arsenic content of glass
the weakening of the glass and eventual
 can only be used for TYPE I & II only
dislodgement of flakes from the glass surface.

A. POWEDERED GLASS TEST

 PROCEDURE: Crush glass then put in water and

test the water mixed with powdered / crush
glass with acid (Sulfuric Acid) to determine its
leaching property
 Table 1. DETERMINATION OF GLASS TYPES - This type is treated under controlled
temperature and humidity conditions with
CONTAINER TEST REASON sulfur dioxide or other dealkizers to neutralize
TYPE the interior surface of the container.
I, II, III Glass Grains Distinguishes - Type II glasses may be suitable for a solution
TYPE I glass from that is buffered, has a pH below 7, or is not
Test TYPE II & III reactive with glass.
sodalime silica
glass TYPE III – SODA-LIME GLASS

- These glasses are composed of relatively high

proportions of sodium oxide and calcium
oxide, a combination that renders the glass
chemically less resistant
- They melt at lower temperature, are easier to
mold into various shapes, and have a higher
thermal coefficient of expansion than Type I
- Type III glasses are suitable principally for
anhydrous liquids or dry substances.

GLASS TYPES NP – SODA-LIME GLASS

Glass containers must comply with their respective - non-parenteral glass container
specifications for identity and surface hydrolytic - not suitable for containers for parenteral
resistance to be classified as Type I, II, or III glass. Type I formulations
or Type II containers for aqueous parenteral products FOUR TYPES OF CLEAR GLASS CONTAINERS
are tested for extractable arsenic.
TYPES USES/ FUNCTIONS
TYPE I – BOROSILICATE GLASS 1. COLORLESS NO protection from light
- composed primarily of silicon dioxide and boric 2. GREEN moderate protection
oxide, with low levels of the non network- from light
forming oxide 3. BLUE slight or doesn't give
enough
- it is a chemically resistant glass (low
light protection
leachability) with low thermal coefficient of
4. AMBER superior light protection
expansion
property
- This type of container is suitable for all
products although sulfur dioxide treatment
sometimes is added to further increase its
resistance.

TYPE II – SODA-LIME TREATED GLASS

- The relatively high proportions of sodium oxide

and calcium oxide makes this glass type
chemically less resistant.
- Type II melts at lower temperature, rendering it
easier to mold into various shapes; and has a
higher thermal coefficient of expansion than
Type I
- It has a lower concentration of the migratory
oxides than Type III.
REAGENTS ADDED TO MODIFY THE CHARACTERISTICS
OR APPEARANCE OF GLASS

SPECIAL DESIRED PROPERTY

ADDITION/COMPOSITION
Large amounts of PbO Brilliance, Clarity,
with SiO2 and Na2CO3 Suitability for optical
structures; crystals or
flint glass
SiO2 , B2O3, and small Small coefficient if
amounts of Al2O3 thermal expansion;
borosillicate glass
One part SiO2 and four Ability to stop (absorb)
parts PbO large amounts of X-rays
and gamma rays: lead
glass
Large concentrations of Transparency to infrared
As2O3 radiation

SUBSTANCES ADDED IN GLASS CONTAINERS TO

IMPART COLOR