Control Test

Liquid Preparations

ALLPPT.com _ Free PowerPoint Templates, Diagrams and Charts

Control Test

• 1. Assay for active ingredient • 15. Crystallization and precipi-

• 2. Assay for degradation products
tation
• 3. Identification tests for the active
ingredients and possible • 16. Gas evolution
contaminants • 17. Specific gravity
• 4. Visual appearance
• 18. pH
• 5. Color
• 6. Odor • 19. Refractive index
• 7. Taste • 20. Surface tension
• 8. Redispersibility • 21. Pyrogen testing
• 9. Suspendibility
• 10. Portability
• 22. Sterility testing
• 11. Viscosity • 23. Toxicity testing
• 12. Isotonicity • 24. Storage condition
• 13. Particle size agglomeration and
• 25. Fill volume
particle distribution
• 14. Clarity • 26. Leak test
1. Assay for active ingredient
 HPLC - High Performance Liquid Chromatography is a form of column chromatography
that pumps a sample mixture or analyte in a solvent (known as the mobile phase) at high
pressure through a column with chromatographic packing material (stationary phase).
HPLC has the ability to separate, and identify compounds that are present in any sample
that can be dissolved in a liquid in trace concentrations as low as parts per trillion
 GC - Gas chromatography is an analytical technique used to separate the chemical com-
ponents of a sample mixture and then detect them to determine their presence or ab-
sence and/or how much is present. These chemical components are usually organic mol-
ecules or gases. Typical uses of GC include testing the purity of a particular substance, or
separating the different components of a mixture
 Titrations - the slow addition of one solution of a known concentration (called a titrant) to a
known volume of another solution of unknown concentration until the reaction reaches
neutralization, which is often indicated by a color change.
Assay of Degradation Products

The analytical methods used to monitor the stability of liquid involved a

generally non-specific spectrophotometric or titrimetric procedure for the
assay of the active coupled with thin layer chromatography for the estima-
tion of impurities and degradation products.
 Thin-layer chromatography is a chromatography technique used to
separate non-volatile mixtures. Thin-layer chromatography is performed on
a sheet of glass, plastic, or aluminium foil, which is coated with a thin layer
of adsorbent material, usually silica gel, aluminium oxide, or cellulose.
 Spectrophotometry is a method to measure how much a chemical
substance absorbs light by measuring the intensity of light as a beam of
light passes through sample solution. The basic principle is that each
compound absorbs or transmits light over a certain range of wavelength.
Pyrogen Test

Pyrogen Test in an in vivo test to detect pyrogens qualitatively.

Rabbits have a similar pyrogen tolerance to humans, so by observing a
change in body temperature in rabbits it is possible to make a
determination of the presence of pyrogens. This method can detect
non-bacterial endotoxin pyrogens as well as bacterial endotoxins.
Performed to check the presence or absence of pyrogens in all aqueous
parenterals. Rabbits are used to perform the test.
Redispersibility

• This test is applicable for pharmaceutical suspension. If a pharmaceutical

suspension produces sediment upon storage. It is essential that it should be
readily dispersible so that uniformity of dose is assured. The amount of shaking
required to achieve this end should be minimal.

Foe example: the test suspension is placed in a 100ml graduated cylinder, which after
storage and sedimentation is rotated through 360 ˚ at 20rpm. The endpoint is taken when
the inside of the base of the graduated cylinder is clear of sediment. The ultimate test of
redispersibility is the uniformity of suspended drug dose delivered form a product form the
first to the last volumetric dose out of the bottle. Under one or more standard shaking
conditions.
Sterility Test
Leak Test

• A leak test is used to determine if an object, product, or system

functions within a specified leak limit. Leaks occur when gas or liquid flow
through an object via an imperfection or manufacturing defect such as holes,
cracks, weak seals, etc. Leaks always flow from higher pressure to lower pres-
sure; leak testers use pressure to generate and monitor that flow.

• Common Test Types Include:

• Pressure Decay
• Vacuum Decay
• Mass Flow
• Occlusion
• Burst
• Pressure Cracking
• Chamber
Isotonicity

• For a solution to be termed isotonic (equal tone) it

must have the same osmotic pressure as a specific
bodily fluid. The easiest way to calculate the osmotic
pressure of a solution is to utilize the more easily
measured property of the freezing point depression as they are
proportional to one another. In pharmacy,
isotonicity calculations are most often performed for
parenteral and ophthalmic solutions which must have a freezing
point depression of 0.52◦C for them to be
isotonic with blood plasma and tears. Therefore a
solution is considered to be isotonic if it has a freezing point 1
of −0.52◦C.
Refractive Index

• Refractive index (RI) is used to determine the purity of the

sample. Pharmaceutical manufacturers must measure the RI of
raw materials before placing them into their production schedule.
In addition, the R&D and QC Laboratories may need to measure
the RI of the pharmaceutical product to monitor reaction changes
• The refractive index (n) of a substance with reference to air is
the ratio of the sin of the angle of incidence to the sin of the
angle of refraction of a beam of light passing from air into the
substance. It varies with the wavelength of the light used in its
measurement.
STERILITY TEST

• Sterility testing is required to ensure

viable contaminating microorganisms are
not evident in a product.
This testing is conducted by direct
inoculation or membrane filtration method
and can be performed in an isolator or
cleanroom environment.
TOXICITY TESTING

• Toxicity testing of new compounds is essential

for drug development process. The preclinical toxicity
testing on various biological systems reveal the species-,
organ- and dose- specific toxic effects of an investiga-
tional product. The toxicity of substances can be ob-
served by (a) studying the accidental exposures to a sub-
stance
(b) in vitro studies using cells/ cell lines
(c) in vivo exposure on experimental animals. This review
mainly focuses on the various experimental animal mod-
els and methods used for toxicity testing of substances.