qc lab midterm Flashcards
refers to the depth or extent from one surface to another surface.
Tablet thickness
solid dosage forms usually obtained by single or multiple compression of powders or granules. in certain cases tablets may be obtained by molding or extrusion techniques, they are uncoated or coated
Tablet
a straight line passing from side to side through the center of the tablet
Diameter
the distance between the top and bottom or front and back surface of the tablet
Thickness
Tablet diameter should be controlled within a _____________________________
+ - 5% variation of standard value
Also known as “crushing strength”.
Tablet Hardness
refers to the resistance of the tablet to chipping, abrasion or breakage under conditions of storage, transportation, and handling before usage.
Hardness
The test is done by application of a load
to the edges of a tablet across a
diameter. The load is gradually increased
until the tablet fractures or break. The
value of the load at this point (crushing
force) gives a measure of the hardness of
the tablet. 3 samples are used and the
mean value is determined.
Hardness Test
Tablet hardness tester models:
- Monsato Tester
- Strong-Cobb Tester
- Pfizer Tester
- Erweka Tester
- Schleuniger Tester
- Pharma Test
- Microspan Contesar
Most primitive way and practical test for hardness of tablets
Rule of Thumb
Describes a tablet to be of proper hardness if it was firm enough to break with a sharp snap when it was held between the 2nd and 3rd fingers using thumb as fulcrum, yet didn’t break when it fell on the floor.
Rule of thumb
What is the Monsanto tester used for?
Measuring tablet hardness using a spring-loaded screw mechanism.
- It is a hand operated device in the form of a plated metal cylinder, about 150mm in length and 25 mm in diameter.
- Also known as the Stokes Hardness tester
Monsato Tester
What is the acceptable range of the monsato tester?
4 to 10 kg- ordinary compressed tablets
2 kg- sublingual tablets
2 kg- chewable tablets
10 kg- buccal tablets
- Like Stokes Monsato, it also measures the diametrically applied force required to break a tablet.
- measures the applied force in Kg required to break a tablet across its diameter. The force is produced by a manually or pressure operated pump.
-Air pump
Strong-Cobb Tester
Plier-style hardness tester with a spring compression system.
- Tablet is crushed in between the jaws of the device. The force is indicated on the dial indicator.
Pfizer Tester
Uses the principle of a steelyard balance to load a vertically sliding jaw by means of weighted beam.
-Suspended weight
Erweka Tester
- Also known as Heberlein Model
- Most widely used instrument for tablet hardness test
- The earliest version of this instrument had no motor drive, but were operated by means of a handwheel.
- Uses an ingenious arrangement of levers
- Platens
Schleuniger Tester
Apparatus manufacturers from West Germany
Pharma Test
- Designed with the object if providing measurement not only of tablet hardness, but also thickness and weight.
- This machine is unique that it can accept mixed batches of tablets of different shapes and sizes, automatically moving them to stations for the successive measurement of thickness, weight and hardness.
-can print out statistical analysis
Microspan Contestar
determines the percentage loss on tablet
in packaging, handling, and shipping.
Friability test
Makes use of a tumbling apparatus where tablets are exposed to rolling and repeated shocks from free fall within the apparatus.
Conditions: 100 revolutions in 4 minutes.
Roche Friabilator
How many tablets are used if the tablet weight is more than 650 mg?
10 tablets
How many tablets are used if the tablet weight is 650 mg or less?
20 tablets
What is the maximum acceptable weight loss for a batch to pass the friability test?
Not more than 1%
What happens if the weight loss exceeds 1%?
The test must be repeated twice and averaged
What tool is used to clean tablets before and after testing?
A #10 sieve with air pressure or soft brush
Consist of 12 standardised internal plastic baffles used to test the abrasion strength of the tablets
Abrasion Drum
Infrared radiation was
discovered by_______________ in 1800.
Sir William Herschel
___________________ is the study of interaction of electromagnetic waves
(EM) with matter.
Spectroscopy
0.7 µm to 2,5 µm
NIRS
2,5 µm to 25 µm
MIRS
25 µm to 300 µm
FIRS
________________ is the study of
the interaction of matter with light
radiation when waves travel through
the medium (matter).
Infrared spectroscopy
If there is no polarity (dipole moment)
in the molecule then the infrared
interaction is ________ and the
molecule does not produce any IR
spectrum.
inactive
The name atom was coined by _________from the Greek, α-τέµνω, meaning in Greek it cannot be cut any more or it is indivisible.
Democritus
The _________ is a combination of
periodically changing or oscillating
electric field (EF) and magnetic field (MF)
oscillating at the same frequency, but
perpendicular to the electrical field.
EM radiation
The ______________ is designed to analyze monochromatic (“one
color”) light that passes through a solution.
colorimeter
The measure of the amount of light that passes through a
solution is called _______________ it is a ratio of the intensity of the transmitted light to the intensity of the original light and is usually expressed in percentage.
Transmittance
Flame spectroscopy is used in the assay of lithium carbonate,
an antidepressant agent. This technique is used for the assay of
other elements such as potassium, sodium, and calcium in blood
and other biological samples.
