QUALITY CONTROL TESTS FOR PARENTERAL PRODUCTS

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The term quality control refers to the Parenteral Products are
sum of all prodcedures undertaken to solutions, Suspensions,
ensure the identity and purity of emulsions for injection or
particular pharmaceutical product. infusion, powders for injection
or infusion

QUALITY CONTROL TESTS:

1. LEAK TEST: Ampuls that have been sealed by fusion must be subjected to a test to determine whether or not a passageway
remains to the outside, if so all or a part of contents may leak to the outside and spoil the package.
Steps:
Subsequent
Leaks usually are The vacuum (27
while the ampoule is atmospheric pressure
detected by producing inches Hg or more)
entirely submerged in then causes the dye to
a negative pressure should be sharply
a deeply colored dye penetrate an opening,
within an released after 30 min.
solution (usually 0.5 being visible after the
incompletely sealed Only a tiny drop of
to 1.0% (w/v) ampoule has been
ampoule, usually in a dye may penetrate a
methylene blue). washed externally to
vacuum chamber small opening.
clear it of dye.

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Clarity testing is carried out to check Sterility means complete absence of

2. CLARITY TEST: 3. STERILITY TEST:
the particulate matter in the sample. all viable Micro-organism. .
Steps: White screens for Direct transfer method::
the detection of Required quantities of liquid is Aseptically transfer the specified
black particle removed from the test volume of the material from each
visual inspection is container to vessel of culture
done by holding the containers with a sterile
ampule by its neck black screens for pipette / sterile syringe. medium
against highly the detection of
illuminated screens. white particles

Detect heavy particles it Incubate the inoculated media Mix the liquid with medium
may be necessary to for not less than 14 days but not aerate excessively.
invert container but care
must be exercised to
avoid air bubble.

Continue incubation of the

transfer vessel for not less
than 7 additional days after Sterility test apparatus
transfer and total of NLT 14
Clarity test apparatus days.
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Pyrogens are products of metabolism in Membrane filtration method:
4. PYROGEN TEST: microorganisms Gm-ve bacteria produces most 1. Sterilization of filtration system and membrane filtration of
potent pyrogens. examined solution under aseptic conditions.
Rabbit Test:
1. This test basically involves the injection Sample solution which is to be tested into a Rabbits which are used as test 2. Filtration of the sample through a membrane filter having the
animals through ear vein
nominal size of 0.45µ and a diameter of 47mm.
2. The Temperature sensing probe (Clinical Thermometer, Thermosestor or similar probe) into a rectum cavity of
Rabbit at the depth of 7.5 cm, the test solution must be warmed at 37º prior to injection.
3. After filtration the membrane is removed aseptically from the
3. Then Rectal temperature is recorded at 1, 2, 3 hr subsequent to injection. metallic holder and divided into two halves.
4. This test is performed in separate area designed solely for this purpose under environmental 4. The first half is transferred into 100 ml of culture media meant for
5. Initially this test is performed on 3 Rabbits but if required results are not obtained this test is repeated on 5 fungi and incubated at 20˚ to 25 ˚c for not less than seven days.
additional
5. The other half is transferred into 100ml of fluid thioglycolate
medium and incubated at 30 to 35 ˚c for not less than 7 days.
References:
1. The theory & practice of industrial pharmacy by Leon Lachman,H.A.Liberman,special indian edition
2009, page no: 1907 -1919
LAL (Limulus Amebocyte Lysate) test: 2. Remington – the science and practice of pharmacy, 20th edition, 803- 805.
Presented By: B.Pharmacy 3rd year (2021-2025 batch):
combination of 0.1 ml of test Mohd Imran Uzair (170721881042) Mirza Kaif Baig
sample with LAL Reagent after The LAL Test is positive (170721881036)
Mohammed Yamin Salman (170721881041) Saima
incubation for 1 hr at 37 degree indicating that the presence of (170721881048)
Celsius the mixture is analyzed endotoxin. Mohammed Abrar Rayan (170721881039) Mariya Fathima
for the presence of Gel clot. (170721881033)
Under the guidance of:
Mrs. Ayesha Siddiqua Gazi