miscellaneous tests in pharmaceutical quality management
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Pharmaceutical Quality Management Dr. Asra Hameed Pharm.D (JUW) [email protected]
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Miscellaneous TestsWeight/mlMoisture contentsLoss on dryingToxicity testsIdentification testEvaluation of ointmentsAsh testAlkalinity of glass
Determination Of W/Ml
Weight per milliliter
Weight per milliliter
Weight per milliliter
Loss on Drying
Loss on drying
Procedure
USP Loss On Drying
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USP Loss On Drying
DETERMINATION OF MOISTURE CONTENT
Moisture Content
Moisture contents
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Karl Fischer
2 H2O + SO2 + I2 = H2SO4 + 2 HI
German Petrochemist,1901 1958
Publication: 1935
KF ReactionSO2 + RN + ROH ------> (RNH)SO3R a sulfite compound
(RNH)SO3R + H2O + I2 + 2RN------> (RNH)SO4R + 2(RNH)I a sulfate compound Summary
H2O + I2 + SO2 + 3RN + ROH ----->(RNH)SO4R + 2(RNH)I
The solvent (generally methanol) is involved in the reactionA suitable base keeps the pH 5 - 7
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Toxicity test
Toxicity test
IDENTIFICATION TESTS
Acetylated substances
Ammonia and volatile aliphatic amines
Bismuth
Bromides
Calcium
Chlorides
Iodides
Nitrates
Potassium
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Salicylates
Sodium
SPECTROPHOTOMETRIC IDENTIFICATION TESTS
SPECTROPHOTOMETRIC IDENTIFICATION TESTS
IDENTIFICATION TESTS
CHRAROMATOGPHY IDENTIFICATION TESTS
CHRAROMATOGPHY IDENTIFICATION TESTS
CHRAROMATOGPHY IDENTIFICATION TESTS
Evaluation of Ointments
1- Physical appearance
2-Particle size determination
3-Weight variation test
4-Solubility test
5-Viscosity determination
6-Active ingredients
7-Microbial contamination
8-Metal Particle in Ophthalmic Ointments
Determination of Ash
Determination of Ash
Sulphated Ash
ALKALINITY OF GLASS
What is alkalinity?
TYPES OF GLASS
How Alkalinity of Glass occur?
Test of Alkalinity of Glass
Test Procedure for limits of alkalinity of whole Glass Container