COMPENDIAL REQUIREMENTS FOR LIQUID DOSAGE FORMS Flashcards
What are the general (universal) tests of pharmaceutical products?
Assay
Identification test
Water content determination
Packaging test
Limit test
Refers to a combination of drug substances and excipients to facilitate dosing, administration, and delivery of the medicine to the patient.
DOSAGE FORM
identification test, organoleptic test, physical and chemical test, limit test, packaging
Qualitative test
limit test, assay, water content determination
Quantitative test
these are pharmaceutical formulations which contain a mixture of active drug components and nondrug components (excipients) dissolved or suspended in a
suitable solvent or mixtures of solvents.
Liquid Dosage Forms
STERILE/PARENTERALS
- STERILITY TEST
- TEST FOR PYROGENS
- SAFETY TEST
- PARTICULATE MATTER TEST
- LEAKER’S TEST
determination of the presence of viable organisms
STERILITY TEST
Methods of sterility test:
Primary – membrane filtration
Direct transfer – Direct Inoculation
Test for effectiveness of sterilization process
Biological indicators
Moist heat
Bacillus stearothermophilus
Dry Heat
Bacillus subtilis
Ethylene oxide
Bacillus stearothermophilus
Radiation
B. pumilus
B. tearothermophilus
B. subtilis
are fever causing substances
pyrogens
Methods of test for pyrogens
Bacterial Endotoxin test (BET)
Pyrogen Test
- is derived from the horseshoe crab
- limulus amebocyte lysate from Limulus polyphemus or Tachypleus tridentatus
LAL reagent
Two Methods
Gel-clot formation
turbidimetric method
need standard endotoxin and series of dilution of known concentration of standard endotoxin
Gel-clot formation and turbidimetric method
quantitative fever response test
Rabbit Pyrogen Test
Light Obscuration Particle Count Test → Electronic particle counters
PARTICULATE MATTER
Advantages of PARTICULATE MATTER:
constant in-process measurement
quickly identify, size and count the particles
provides trend analysis to identify the problem
Disadvantage of particulate matter:
requires routine preventive maintenance and calibration
à Membrane filtration
microscopic Particle Count Test
Advantages of Microscopic Particle Count Test:
allows collection of the particles larger than rated pore size
microscopic identification of particle types and materials
Disadvantages of Microscopic Particle Count Test:
slow counting and sizing on membrane surface
requires top and bottom lighting to distinguish all particle
determine the integrity of the seal Negative pressure within incompletely sealed ampule while submerged in dye solution
Rinse dye from outside
LEAKER’S TEST
dye of leakers test
1% Methylene Blue
Types of Ampule seal
Tip seal
Pull Seal
submerge the pressurized part in water and look for bubbles, which indicate a leak.
Tip seal
a sealed container or package is placed in a vacuum chamber, and a vacuum is applied to simulate real-world conditions and identify any leaks or seal failures.
Pull Seal
