ASSIGNMENT 7: Compendial Requirements of Different Dosage Forms

Requirements of Different Dosage Forms

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Compendial Requirements of Different

Dosage Forms: Solid Preparation

Test Apparatus used Specifications Acceptance criteria

Disintegration Disintegration Test ● Beakers The test is met if all

Apparatus / Basket 1000 of the dosage units
Rack mL each have disintegrated
● Height of completely. If 1 or 2
beaker dosage units fail to
138 – disintegrate, repeat
160 mm the test on 12
● Inside additional dosage
diameter units. The test is
97- met if not less than
115 mm 16 of the total of 18
● Frequency of dosage units tested
shaft raising are disintegrated.
and lowering
basket29 –
32 CPM
● Distance of
shaft for
raising &
lowering the
basket53 –
57 mm
● Diameter of
tube holding
plates 88 –
92 mm
● Thickness of
 tube holding
plates 5 –
8.5 mm
● Six
open-ended
transparent
tubes of
length 75 –
80 mm
● Inner tube
diameter
20.7 –
23 mm
● Stainless
steel wire
cloth (square
weave
aperture)
1.8 –
2.2 mm
● Wire
diameter
0.57 –
0.66 mm

Dissolution Rotating basket ● the The drug product

apparatus to dissolution
be used; acceptance
● the criterion is based
composition on the high
and volume solubility of the
of the drug substance. If
dissolution an alternate
medium; acceptance
● The rotation criterion is
speed of the proposed, the
paddle or sponsor/applicant
basket; should provide
● the additional data to
preparation support the
of the test proposed
and acceptance
reference criterion.
solutions;
● the time, the
method and
 the amount
of sample to
be
withdrawn or
the
conditions
for
● continuous
monitoring;
the
preparation
of the
sample and
the
reference
solution;
the method
of analysis;
and
● the limits of
the quantity
or quantities
of active
pharmaceuti
cal
ingredient(s)
required to
dissolve
within a
prescribed
time.

Content uniformity Friabilitor Concentration of The relative

the active standard
component(s) in deviation (RSD) of
each of ten a 30-unit
randomly selected sample must not
dosage exceed 7.8
units using the percent per USP
method acceptance
described in the criteria for content
referenced uniformity.
monograph or other
appropriate method
of
analysis
Weight Variation Analytical balance 80 mg or less: has The tablet passes
a the USP
maximum allowable test if no more than
difference of 10%. two
More than 80 mg tablets exceed the
but less percentage limit
than 250 mg – has and no tablet
a deviates more than
maximum allowed twice the
difference percentage limit.
of 7.5%. 250 mg or
more - has a
maximum allowable
difference of 5%.
Function: To
confirm the
consistency of the
dosing unit
and thus support
the safety,
identity and quality
of the
product.

Hardness Monsanto Tester, Tablet Diameter - 4 Oral tablets should

Pfizer,Strong Cobb to 40 mm have a
Tester, Erweka, and Printer Speed - 48 hardness of 4-10
Schleuniger lpm kg;
Force Increase - 2 however, the
Kp/sec. Measuring hypodermic and
Range - HT-300: chewable tablets
0.5 - 30 Kp must have a
HT-500: 0.8 - 50 Kp hardness of 3 kg
(or equivalent Sc or and the
N) sustained-release
tablets
must have between
10 and
20 kg to be
accepted.

Friability Friabilitor Drum attachment - To be considered

Horizontal acceptable,
to axis of the mean weight
Instrument loss from
Internal Diameter - three samples must
 283.0 to be not
291.0 mm (287.0 ± greater than 1.0
4.0 mm) percent.
Depth - 36.0 to 40.0
mm
(38.0 ± 2.0 mm)
Outer Diameter of
Central
Ring - 24.5 to 25.5
mm (25.0
± 0.5 mm)
Curved Projection
with inside
Radius (Extends
from middle

Powder fineness Sieve/Test Sieve, Not extra than 5% For the laser
as well as of the diffraction
Screens openings can method, the limits
Particle Size exceed 1.04 of D10, D50 and
Analyzer by instances the D90 are often used
Laser Diffraction nominal length as acceptance
for 125-mm mesh, criteria. D50 is
to 1.45 200 μm, which
instances the corresponds
nominal to 50% of the
opening for 20-µm particles below
mesh. Maximum 200 μm (ie the
individual opening mean
(for any beginning) diameter). Similarly,
degrees D10 and
from 1.0472 D90 are 74 µm and
instances the 411 µm, indicating
nominal length for that 10% of the
125-mm particles are under
mesh to 1.seventy 74 µm
five and 90% of the
instances the particles are
everyday mesh under 411 µm,
for 20-µm mesh. respectively.Sieving
Function of Laser Method:
diffraction acceptance criteria
particle length can be
analyzer - They are established for
used to degree the D10, D50 and
sizes of debris in a D90 using a similar
 cloth. Function of approach
Test Sieve - Test to the laser
sieves are diffraction
measuring method.
gadgets used to
decide the
dimensions and
length
distribution of
debris in a cloth
pattern the use of
cord mesh
of various openings
to split
debris of various
sizes. It is
crafted from
stainless-steel or
brass.

Visual appearance Micrometer and Micrometer: Tablet thickness

Vernier 0-25mm - 0.004mm must be
Caliper accuracy within ±5% of a
25-50mm-0.004mm standard
accuracy value.
50-75mm-0.005mm tablet diameter: For
accuracy tablets with a
75-100mm-0.005m diameter of less
m than 12.5 mm, the
accuracy average
100-125mm-0.006 percentage
mm deviation value
accuracy must not exceed ±
125-150mm-0.006 5%, and
mm for tablets with a
accuracy diameter of
150-175mm-0.007 12.5 mm or more, it
mm must not
accuracy exceed ± 3%.
175-200mm-0.007
mm
accuracy
Function - Used to
make
precise linear
measurements
 of dimensions such
as
diameter, thickness,
and
length of solids
Vernier Caliper
Range - 300 mm
Resolution -
0.02mm to
0.05mm
Tolerance -
±0.03mm
(±0.0015 in.)
0-150mm/0.6” -
±0.03mm
accuracy,
0.1mm/0.0005”
resolution.

Moisture content Moisture Analyzer, Vacuum Oven Water content

Pharmaceutical Temperature Range reduction in
Oven -Room tablet formulation It
(Vacuum oven, and temperature +5°C is
Hot air to primarily
oven) 200°C/300°C/400° determined by the
Karl Fischer C API and varies by
Titration Method Vacuum Range - ingredient.
or Loss on drying Up to -760 However, it is
(for some mmHg preferable to be
solids) Standard setting in 1%. The spike
oven – recovery should be
depends on the 90 to 110 percent
material that using the
is used and its Karl Fischer
boiling point Titration Method. A
(must be below 50 percent water
material’s spike is
boiling point) recommended.
Function - Used to Hydranal 0.1
dry heat- sensitive (100PPM, 10%
materials such as error acceptance)
powder to remove Hydranal 1.0
moisture (1,000PPM, 3%
Pharmaceutical error acceptance)
Oven - ambient to 10.0 Hydranal
 around 300° (10,000PPM)

Microbiological bioMérieux's It is a rapid ScanRDI mean

burden ScanRDI alternative log10 MPN
technology for minus compendial
detecting sterility
microbial method mean log10
contaminants in a MPN:
filterable drug If the lower
product. The one-sided 95.25
method uses a percent confidence
viability dye limit on
that labels live the paired
microbes difference was less
captured by a filter than the
membrane acceptance criteria
through which the were met. greater
drug than -0.1549, which
product has is
passed. log10 (0.70)

Storage condition Pharmaceutical Temperature Range The acceptance

Stability Test - 10°C~65°C criteria for a
Chamber Temperature standard stability
Resolution - 0.1℃ chamber
Temperature with a set point of
fluctuation - ±0.5℃ +37°C is
Humidity Range - that no
20-98%RH measurement
Humidity within
Fluctuation - the chamber differs
±3%RH by more
Illuminance - than 2°C.
0-10000LX
Light levels - 0-5
levels
Temperature:
25°C±2°C and
Humidity :
60%±5%H for
Long term studies
Temperature:
30°C±2°C and
Humidity :
 65%±5%H for
Intermediate
conditions
studies
Temperature:
40°C±2°C and
Humidity :
75%±5%H for
accelerated
conditions
studies

Compendial Requirements of Different Dosage

Forms: Liquid Preparation

Test Apparatus Used Specifications Appearance Criteria

Visual appearance In a light The physical

Light Transmittance transmittance appearance of
Meter meter, products is critical for
the color of a patient
sample of syrup adherence and
is checked by compliance, so they
passing light should be good
through the sample. looking and elegant.
The The syrup should be
percentage of light clear
transmission is and not cloudy, with no
compared to bubbles, as these
established light conditions
transmission may lower the
rates for different sample's
grades. When grade
using it, make sure
that
there are no
 fingerprints on
the syrup test bottle
and that
the syrup sample is
bubble-
free and cloudy.
Any of these
conditions can
reduce the
light transmitted
through the
sample and thus
reduce the
quality of the
sample.
In the visual
inspection,
ingredients and end
products
are carefully
examined to
ensure they are
correct

Suspendability Graduated Cylinder The device Particles are typically

comprises a long very
tubular test fine to micronized, as
container, a with
clamp, a force topical products in
measuring which the
sensor and a drug is suspended
holder, the (less than
clamp being 25 microns). Particle
clamped at the size and physical
upper end of the properties of raw
test materials are
container, the test unimportant in
container syrups, elixirs, or
being carried by the solution
holder dosage forms where
through the clamp nothing
Tilting the is suspended. They
test container by a can, however,
certain influence the rate of
angle theta, the dissolution of such raw
The lower materials during the
 end of the container manufacturing
is placed process. When
at the center of a the product is
test end of compounded, raw
the force measuring materials with finer
sensor, and a particle sizes may
central axis line of dissolve
the faster than those with
test end is larger
perpendicular to particle sizes. Thus,
the horizontal Q=80%
plane. The in 30 minutes
invention also
provides a
method of testing
suspension
suspensibility by a
centroid
method using the
apparatus. The
device and method
have
the following
characteristics:
the test data is
accurate, the
error is small, the
multiple test
consistency of the
same
suspension is good,
and the
suspensions with
different
suspensibility can
be well
distinguished.

Pourability and Capillary Capillary The ability to predict

Viscosity Viscomoter, viscometer: how
Vibrational measures time products will behave
Viscometer, Falling taken for a when
sphere Viscometer , defined quantity of they reach consumers
Ostwald’s fluid to is
Viscomoter and flow through a critical, so testing them
Rotational capillary with for
 Viscometer known diameter accurate and
and length consistent
and then compared viscosity measurement
with time of the
required to flow by product is essential.
a liquid of Thus
known viscosity each product has
specific
viscosity values and is
measured.

Isotonicity Cryoscopic Method Isotonic values can When osmotic

be pressure is
determined from equivalent to body fluid
the pressure, it is then
colligative accepted.
properties of
solutions. With this
method,
the amount of each
substance needed
for an
isotonic solution
can be
calculated from the
freezing
point depression
values. A
solution that is
isotonic with
blood has a
temperature of
0.52 ᵒC. Therefore,
the
freezing point of the
drug
solution must be
adjusted to
this valve.Many
pharmaceutical
textbooks
typically list the
break-in
freezing point
required to
achieve isotonicity
 from these
values.

Specific gravity Specific – Gravity Specific Gravity According to the USP,

bottle / Function is specific gravity is the
pycnometer, and used when a ratio of
Hydromete pharmacist the weight of a
wishes to convert measured
the weight volume (density) of a
of an ingredient or liquid to
preparation to an equal volume of
volume or vice water at a
versa. Liquid given temperature
materials are (25°C). Substances
often subject to with a specific
transformations. gravity of 1 are
Specific gravity is neutrally
also used buoyant water. Those
to calculate the with a DC greater than
equivalent 1 are denser than
concentration of a water and, barring the
preparation effects of surface
based on weight or tension, will sink in it.
volume. Specific Those with a DC less
gravity is found in than 1
automated are less dense than
pharmaceutical water
equipment used by and will float on it. The
pharmacists to decrease in density
prepare indicates the presence
admixtures for total of air
parenteral pockets
nutrition (TPN). The
purpose
of the specific
gravity of large
volume liquids to be
mixed is
to determine the
weight of the
components (eg.
dextrose, amino
acids and water).

pH pH meter PH Meter A pH An accepted pH range

meter is an of ±
 tool used to degree 0.75 was designated
hydrogen as
ion activity in Quality Control .A pH
solutions - in less than 7 is acidic
different words, this and
tool a pH greater than 7 is
measures acidity / basic. After calibration,
alkalinity of the standard
a solution. The buffer at 0.01 should
diploma of be able
hydrogen ion to reach pH 7.4 and
interest is in the 9.7.Weakly acidic
end expressed as drugs are
pH level, which easily absorbed in a
commonly levels low pH
from environment such as
1 to 14. The direct the
analyzing stomach. Whereas
Laboratory pH weakly
meter (Digital) basic drugs are not
operable at 230V absorbed
+/- 10V until they reach the
A.C., 50 Hz higher pH
strength deliver medium in the small
with vital cable intestine.
connections
and different
popular add-ons
required for easy
operation. Display:
It ought to have
Thin
Film Transistor
(TFT) show of
extra than four inch
color
(Blue/Red/Green/Y
ellow)
show for higher
imaginative
and prescient of
readings with

Refractive index Refractometer Range: Brix is the standard

Refractive index unit of
(nD) : 1.3000 measurement. Water,
 to 1.7000 for
Brix : 0.0 to 95.0% example, has a
Minimum Scale: refractive
Refractive Index index of 1.33, toluene
(nD) : 0.001 should
Brix : 0.5% have a refractive index
Accuracy: of
Refractive index 1.4964 to 1.4974, and
(nD) : carbon
±0.0002 tetrachloride should
Brix : ±0.1% have a
Measurement refractive index of
Temp.: 1.4598 to
1.4608.

Pyrogen Testing Pyrogen Testing is Pyrogen Tele Rabbit Pyrogen Test

a Method Thermometer : (RPT)
based on animal Range: 0 - 60 °C Each rabbit's response
specifically Resolution: 0.1 °C is
RPT (Rabbit Accuracy: ± 0.2% assessed by the
pyrogen test) FS, ± 1 difference
that has Tele Digit between the initial
Thermometer Input: RTD temperature and the
Pyrogen (PT-100) or IC highest
In vitro method Sensor recorded temperature.
Test for monocyte Channels: 6 The
activation Channels, switch response of the 3
(MAT) which uses selectable rabbits is
ELISA the sum of the
preparation: responses and
that consists of can be concluded as
Pipettes, a follows:
plate washing If there is a
device, an temperature rise
ELISA reader of 0.6⁰C or more above
(photometer), and a the
computer with. normal temperature
evaluation software measured before
are injection,
standard pieces of then the dissolution
equipment. test is considered
pyrogenic.
If the sum of the
answers is
not greater than 1.4⁰C
and
 one of the rabbit's
answers is
less than 0.6 ⁰C, then
the
product passes the
test.
If the sum of the
responses is
greater than 1.4⁰C or
one of
the rabbits has a
response of
0.6⁰C or more,
continue the
test with 5 rabbits.
If the test is conducted
with 5
rabbits, then if the sum
of the
answers of all rabbits
is
greater than 3.7⁰C and
the
individual reaction of
no more
than 3 rabbits is
greater than
0.6⁰C, the product
passes the
test.

Sterility Testing Sterilizers, Sterilizers destroy The test is valid if

autoclaves or growth of
eliminate all forms each of the aggregated
of microorganisms is
microbial life on the observed
surface of within 3 days for
an object or liquid bacteria and
to prevent 5 days for fungi. If
the transmission of growth is
disease not sufficiently
associated with the observed
use of the within 3 days for
product. bacteria and
5 days for fungi, the
test is
 An autoclave is a considered valid.
machine Sterility Test by Direct
that uses Inoculation
pressurized steam Clear vials indicate the
to kill harmful product is sterile.
bacteria, viruses, Cloudy (cloudy) areas
fungi and spores. in the
They are heated to medium indicate
a suitable microbial
sterilization growth. Specimens
temperature for a that turbid
specified period of the medium are
time. transferred
on day 14 of the test
and
incubated for four
days.Growth-positive
specimens require
additional
processing, such as B.
Identification and
storage. M

Storage condition Liquid formulations Liquid formulations The temperature

should be such as ranges from
stored in airtight, syrups and 2 to
light- suspensions can The temperature is
resistant containers support the growth 8°C. This
and in of temperature slows the
the refrigerator to microorganisms. rate of
ensure Since microbial growth as
maximum stability refrigeration inhibits well as
such as microbial chemical reactions The
glasses. growth, liquid extremely
preparations Cold storage is used
without for
preservatives biodegradable drugs,
should vitamins, and
be stored in the chemicals. conditions
refrigerator. Store
medications that
require refrigeration
in an
area inside the
refrigerator
that maintains a
 constant
temperature
Function: It bridges
the time
difference between
when
goods are
produced and
when they are
ultimately
consumed, as there
is always
a time difference
between
production and
consumption.

Leak test Yatherm Leak Test Output options Take a calibrated

ApparatusOutput include analog stopwatch
options include voltage, analog and start the timers of
analog current, the
frequency or leak test apparatus
frequency and the pwatch at the
modulated, and trip same time. Take note
or alarm of the readings at
signal. Some leak 60-second,
test include 180-second, and
an analog front 300-second intervals.
panel with Acceptance criteria:
potentiometers, each
dials, and interval must last 10
switches. Others seconds. The external
have a party calibrated
digital front panel the vacuum gauge.
configured Calibration frequency:
with a keyboard or every
menus. Serial port, twelve months (for the
parallel port, and/or timer, vacuum gauge
full application and vacuum
software leak test holding capacity).
kits are
also available.

Fill volume Constant level Constant level For Single-Unit

Filling Filling: The Containers,
Apparatus, level is checked by the average volume of
 Gravimetric, and adjusting liquid
Volumetric the level of the obtained from the ten
tank. Variations in containers is greater
container than
dimensions can 100%, and the volume
result in of
variations in net fill each of the ten
per unit. containers is
Gravimetric: between 95% and 110
vessels are percent of the volume
volumetrically filled declared on the label.
with If A is
liquids to a true, then
specified weight. The average volume is
Typically limited to less
filling large than 100% of what is
containers or high stated
viscosity on the labeling.
products. It cannot However, the
be used in volume of no container
high-speed is
automatic greater than 95 % to
equipment. 110 %.

Compendial Requirements of Different Dosage

Forms: Semi-solid Preparation
Test Apparatus used Specifications Acceptance criteria

Visual appearance Infrared Electromagnetic Because of light

spectrophotometer radiation scattering,
ranging between semisolids may
400 cm1 appear "creamy
and 4000 cm1 white." Personal
(2500 and care compositions
20 000 nm) is and
passed through methods for
a sample and is preparing these
absorbed by personal care
the bonds of the compositions
molecules in the include the
sample incorporation of a
causing them to polyol polyester
stretch or that is the
bend. The reaction product of
wavelength of the an
radiation absorbed aliphatic polyol that
is does not
characteristic of the contain an ether
bond group and
absorbing it. benzoic acid, with
Wavelength range: the
50–1000 resultant polyol
mm (Far infrared), polyester
2.5–50 having a refractive
mm, (Middle index at
infrared), 0.8– 25° C
2.5 mm (Near
infrared)
Wave number
range:
20010 cm1 (Far
infrared), 4000200
cm1
(Middle infrared),
12 5004000
cm1 (Near
infrared). Energy
range:
0.025–0.0012 eV
(Far
infrared), 0.5–0.025
 eV

Viscosity Rotational Apparent viscosity For rotational

viscometer should be measurements
tested at the time of with T-bar spindles,
batch the
release and initially single-point
at the viscosity value
scheduled time for determined at a
stability maximum
testing. It is suitable speed of 12 rpm is
for both recommended. The
Newtonian and viscosity
non- Newtonian should ideally be
systems. Among measured
the most commonly only during the first
used downward
gauges. Based on movement.
the Otherwise, a pre-
principle that the sheared sample is
liquid whose measured, resulting
viscosity is being in lower viscosity
measured is values. Thus
cut between two viscosity shows
surfaces. In that its acceptance
these viscometers, criteria
one of the depends in a
surfaces is specific product
stationary and the
other is rotated by
an external
impeller, and the
liquid fills
the space between
them.

Softening range Ring and Ball tester In the ring and ball The softening point
test, the value of
sample is the two readings
immersed in a should not
thermostatic liquid exceed 1.0 °C for
bath along bitumen
with a thermometer softening points
and 40-60 °C and
gauge to measure 1.5 °C for bitumen
the softening
 distance. Function: points 61-80 °C.
Ensures drugs Otherwise,
meet the the test is deemed
requirements set invalid and
before releasing to must be repeated
avoid
error.

Loss of water Karl Fischer The Karl Fischer Acceptance criteria

Method Method is are
based on the supported by data
reaction of on the
sulfur and iodine; drug product's
the water
endpoint will be absorption.
reached after
the water used has
been
consumed.
Function: To
determine the
effect of water on
the drug,
specifically the
physical and
chemical stability of
its active
ingredients, as well
as other
factors.

Consistency and Laser Wavelength Wave interference Previous reference

homogeneity Fourier is used to data is
Interferometer measure used to support the
homogeneity and acceptance criteria
consistency; it for the
consists of a Laser Wavelength
source, an Fourier
interferometer, an Interferometer.
amplifier, and a
detector;
these components
aid in
determining the
homogeneity
of the
 pharmaceutical
product. Function:
Aids in ensuring the
therapeutic strength
of the
drug, which is also
a
requirement for its
approval.

pH pH meter Power Require When a proposed

ments - 230 V range for a
ac +10%, 50 Hz product is justified,
Range- 0.0 to 14.0 pH level
pH acceptance criteria
Accuracy +/- 0.1 pH apply.
Probe - pH
electrode
Display- Seven
Segment
Display
Relative Humidity -
5 to 90%
non condensing
Function: The pH of
a product
influences its
bioavailability;
the use of pH
testers allows

Release rate of Dissolution tester Dissolution testers When dissolution

active ingredient measure has a
from dosage form the time of significant impact
dissolution in a on
simulated fluid in a bioavailability, the
37°C acceptance
controlled criteria should be
environment to set so that
determine the batches with
release rate of unacceptable
an active bioavailability are
ingredient. rejected.
Function: Helps to
avoid rapid
saturation and
 elimination,
allowing potent
drugs to be
delivered safely
while
minimizing side
effects.

Sterility Testing Ionizing Radiation, Function: Sterilizers The test will be

Membrane destroy considered
filtration, and Direct all microorganisms valid if each of the
Inoculation on an added
item's surface or in microorganisms
a liquid to grows within
prevent disease 3 days for bacteria
transmission and 5
associated with days for fungi. The
their use in test is
medical and considered valid if
laboratory growth is
settings to sterilize not properly
laboratory observed within
equipment and 3 days for bacteria
waste. Heat and 5
kills all days for fungi.
microorganisms,
including bacteria
and spores, during
autoclaving. Heat is
provided by
pressurized
steam

Storage condition Refrigerator and Temperature, air, According to the

appropriate light, and USP, the
temperature and humidity, as well as proper temperature
humidity drug- range for
level. related factors such a controlled room is
as the between
active ingredient, 15°C and 30°C.
dosage They should
form (tablet, be stored at room
solution, etc.),
Compendial Requirements of Different Dosage
Forms: Aerosol

Test Apparatus Used Specifications Appearance

Criteria

Spray test Spray itself, Testing The pure propellant The spray
Paper, and Cyclic and impingement
Corrosion concentrate dip method on a piece
tubes have of paper
already been that has been
cleaned, and treated with the
any defects in the Dye-Talc mixture.
valve and The
spray pattern have particles that strike
been the paper
checked. Function: cause the die to fall
Aids in the into the
elimination of any paper, indicating
pure that the
propellant present spray was effective
in the in
concentration carrying out its
functions.

Leak test Leak Testing The change in The maximum

Machine, Crimp’s pressure allowable
Dimension, Vacuum indicates the leakage rate per
leak,Cylinder Head presence of air minute inch
 Valve, and PT LT in free space. It is of nominal pipe size
available shall be
as a scratcher and 0.18 cubic inch (3
for cubic
accurately centimeter).
measuring vapor
pressure. This was
achieved
by measuring the
crimp value
and by comparison.
Finally,
the valve housing is
checked
by passing the filled
containers through
a water
bath. Function:
Detects any system
that performs well
within a
specific leak limit
set to security
overshelf life.

Pressure Pressure Gauge, Iodine is produced. Aerosol containers,

measurement Compound at the anode including
Gauges such as combines with metal and glass,
vacuum & the water in the must
pressure. sample When withstand
everything has pressures ranging
been from 140 to 180
consumed, excess PSIG
The presence of (pounds per square
iodine is inch
detected gauge) at 130
electrometrically, degrees
indicating the Fahrenheit.
endpoint. Function:
Helps maintain
sterility of a drug
product.

Moisture Karl Fischer Carrier gas used in Critical moisture

determination apparatus gas content for
chromatography meeting spray
 must be dry, performance
oxygen-free, and requirements is
chemically between 280
inert. Helium is the and 330 ppm, and
most that this
commonly used formulation (at 210
gas because ppm
it is safer than but moisture level) is
more stable for 24
efficient than months.
hydrogen, has a
wider range of flow
rates, and
is compatible with
many
detectors. Function:
Aids in determining
the percentage of
water in a
given substance,
indicating
whether or not it is
ready for
use.

Propellant Infrared valves have been Aerosol propellants

Spectrophotometry removed can be
and Gas and filled with liquefied petroleum
Chromatography specific gas
solutions. For 2 (LPG), chlorinated
seconds, the carbons
valves were fully (CFCs), a
actuated. combination of the

Valve delivery Continuous Spray 25 valves were Deliveries of 54 uL

accuracy Valve and collected and or less
Metering Valves filled with specific should be kept
solutions. For 2 within a 15%
seconds, the valves tolerance. While
were fully actuated. deliveries of
Repeat 55 to 200 uL should
for a total of two be
individual limited to 10%. The
deliveries from valves
each of the 25 are rejected if 4 or
test units. Function: more are
 Aids in the outside the limit. If
provision of an 3 delivery
appropriate exceeds the limit,
amount of repeat the
medication, which 25 valve test.
is critical in the
delivery of
scified tolerances.

Particle Size Cascade Impactor The cascade Aerosol deposition

distribution impactor works on
on the principle of cascade impactor
carrying stages 0, 1, and 2
particles in the air corresponds to
stream particles 5.1-10 pm.
through a series of Aerosol
smaller jet deposited on
impactors. The stages 3, 4, and
heavier and 5 of the cascade
larger particles are impactor
impacted corresponds to
on the slide with the particles
larger ranging in size from
opening, and as the 1 to 5
openings um. Aerosol
get smaller, the collected on
velocity of the stages 6, 7, and in
air increases, the cascade
depositing the impactor's final filter
Aerosol deposition corresponds to
on particles
cascade impactor smaller than 1 um.
stages 0, 1, and 2
corresponds to
particles 5.1-10 pm.
Aerosol
deposited on
stages 3, 4, and
5 of the cascade
impactor
corresponds to
particles
ranging in size from
1 to 5
um. Aerosol
collected on next
 larger particles on
the
next slide.
Function: Aids in
indicating
the quality and
performance
of the
aforementioned
drug
product.

Storage condition Pressurized Aerosols need to Temperatures

instruments be stored in should not rise
a dry area away above 40° Celsius.
from It should
sunlight. it must be be stored in a
avoided to well-ventilated
be stored in the and cool
basement or environment.
sunken areas. it
needs to be
far from areas of
high
temperature as it
can be
flammable.
Function: Aids in
the
preservation of the
general
condition in which a
product
is stored.