PARTICLE SIZE DISTRIBUTION Flashcards
Techniques of particle size distribution:
a. Sieving- MOST RAPID
b. Optical microscopy
c. Electron microscopy
d. Sedimentation
e. Light scattering technique
applicable to powders and granules; in the evaluation of the flow property and compressibility
PARTICLE SIZE DISTRIBUTION
most rapid
Sieving
linear openings per square inch
Mesh #
DO NOT PASS MESH NO. 20
Coarse granule
PASS MESH NO. 20 DO NOT PASS MESH NO. 40
Good granules
BOTH PASS ON MESH NO. 20 AND 40
Fines
- Defined as the maximum angle possible between the surface of a pile of powder and the horizontal plane.
- A characteristic related to inter-particulate friction
- Fixed-funnel method
Angle of repose
index of the ability of the powders to flow, ability to settle and the inter-particulate interactions
BULK AND TAPPED DENSITY
WHAT ARE THE 3 USP METHODS OF DETERMINING WATER CONTENT?
Karl-Fischer Method
Azeotropic Method
Gravimetric Method
this is to determine the amount of water in the drug product. Water can significantly affect the chemical, physical and microbial properties of solid dosage forms.
WATER DETERMINATION
The presence of certain microorganisms in solid dosage forms may contribute to the instability of a drug product leading to reduced therapeutic activity or potentially cause adverse effects.
MICROBIAL TEST LIMIT
2 Specific Tests of MICROBIAL TEST LIMIT
- Total Aerobic Microbial Count
- Total Combined Yeasts/Molds Count
Total Aerobic Microbial Count - Medium:
Trypsicate-Soy Agar (TSA)
Total Combined Yeasts/Molds Count Medium:
Potato-Dextrose Agar (PDA)
