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QC2 Review Notes

The document discusses various tests performed on pharmaceutical products and packaging materials. These include peel adhesion tests, water attack tests, sterility tests, pyrogenic tests, leakage tests, clarity tests, adulteration tests, hardness tests, disintegration tests, redispersibility tests, and powdered glass tests. Common packaging materials mentioned include glass, polyethylene terephthalate, and high-density polyethylene.

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17 views

QC2 Review Notes

The document discusses various tests performed on pharmaceutical products and packaging materials. These include peel adhesion tests, water attack tests, sterility tests, pyrogenic tests, leakage tests, clarity tests, adulteration tests, hardness tests, disintegration tests, redispersibility tests, and powdered glass tests. Common packaging materials mentioned include glass, polyethylene terephthalate, and high-density polyethylene.

Uploaded by

christinemacapas12
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as DOCX, PDF, TXT or read online on Scribd
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PEEL ADHESION TEST Measures the force required to WATER ATTACK TEST

peel away a transdermal patch. only for treated soda lime glass containers under the
RELEASE LINER PEEL TEST Measures the force controlled humidity neutralize the surface alkali.
required to separate the release liner from the adhesive Cracks ‣ Partial fractures generally found in the heel,
layer of the TDS. sometime at the shoulder
Probe Tack Method • Freaks ‣ Odd shapes and conditions that render
• This test measures the force required to separate the tip container completely unusable
of the test probe from the adhesive layer of the TDS. • Filaments ‣ Hair-like string inside the bottle
Rolling Ball Method Measures the distance traveled by a
defined ball on the adhesive layer Polyethylene terephthalate (PET)
STERILITY TEST presence or absence microorganism • High-density polyethylene (HDPE)
• Primary – membrane filtration • Polypropylene (PP)
• Direct transfer – direct inoculation Organisms
Culture Media Sterile packaging is used to ensure that drug products
• Soybean Casein Digest Medium and medical devices are safe to use.
‣ Aerobes; 20-26oC LEAKAGE TEST Pass: No signs of leakage
• Fluid thioglycolate Medium COLLAPSIBILITY TEST containers which are to be
‣ Anaerobes; 30-35oC squeezed for removing the contents.
PYROGEN Endotoxins from cell wall of G (-) CLARITY OF AQUEOUS EXTRACT Pass: Colorless
• Thermostable; not autoclavable and Free from turbidity
• High MW lipopolysaccharide Sample: Finite number of objects selected from a batch
• May cause fever, malaise, chills, and pain ADULTERATION Practice of substituting original crude
LAL Test Arsenic is yellow stain
• (+) formation of gel or development of color in Iron pale pink to deep reddish purple
presence of material endotoxins and lysate of amebocytes Lead red in color.
of Limulus polyphemus
ELECTRONIC PARTICLE COUNTER ANGLE OF REPOSE Characterize the flow property of
• Measure size, # by means of shadow cast by particles the granules/powders.
as it passes through highintensity light beam
(lightobstruction method) Stokes hardness tester (Monsanto) ✓ “spring”
MEMBRANE FILTRATION TECHNIQUE Strong cobb ✓ air-pump mechanism
• Collects particles larger than rated pore size Pfizer hardness ✓ pliers mechanism
• D/A: saturable; slow counting Erweka Tester ✓ Suspended weight mechanicm
LEAKER’S TEST Schleuniger ✓ Most widely used ✓ Eliminates operator
Negative pressure within incompletely sealed ampule variability ✓ Horizontal position
while submerged in dye sol’n Friability: Evaluates the ability to withstand
• Dye: 1% Methylene blue abrasions in packaging, handling, shipping
• (+) : – DISINTEGRATION
:The time required for the tablet to break into pieces.
Cat : Glucagon End point: Impalpable core
Chicken : Oxytocin REDISPERSIBILITY: Major consideration in assessing
Dog : PTH the acceptability of a suspension.
Pigeon : Digitalis Macromelting range time it takes for entire suppository
Rabbit : Tubocurarine to melt when immersed in constant temperature water
Metocurine :Iinsulin bath.
Rat : Corticotropin Micromelting range ‣ The melting range of the fatty
Rat (Female) : Chronic gonadotropin base.
Rat (Male) : Vasopressin
Rat (Rachitic) : Cod Liver Oil
Sheep : Heparin & Protamine sulphate

Glass very common packaging material basic structural


network is made of silicon oxide tetrahedron.
Leaching is a transfer or leaking of chemicals from the
container to the drug product.
SORPTION removal of constituents from the drug
product by the packaging material.
Amber glass is used more frequently that clear glass
because it protects the drug from UV rays, which can
damage the product.
Type I: ultra-resistant borosilicate glass
• Type II: surface treated soda lime glass
• Type III: soda lime glass
• Type IV: General purpose soda lime glass

POWDERED GLASS TEST


Tests the leaching potential of the glass
• Alkali treated with 0.02 N sulfuric acid

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