PHARMACUETICAL ANALYSIS 2

TERM 2 NOTES

QUALITY CONTROL FOR POWDER AND GRANULES

PARTICLE SIZE DISTRIBUTION Problem:

a. SIEVE ANALYSIS A QC analyst analyzed a new formulation of
Apparatus: Set of sieves with sieve number effervescent granules and obtained the following data.
Take note: inc sieve #, dec particle size Wt of sample- 100.0214g
Initial volume (untapped)- 106.5ml
#20- very coarse (large PS) Vol. after 10 taps- 105ml
#40- coarse Vol after 500 taps- 104 ml
#60- moderate coarse Vol after 1250 taps- 101.5ml
#80- fine Compute for the bulk and tapped density.
Receiver- very fine (small PS)

Methods:
i. Dry Sieving/ mechanical agitation POWDER FLOW
- sieve shaker (>75um) a. ANGLE OF REPOSE
- the constant 3D angle (relatively to the
angle base) assumed by a conelike pile of a material.

*Apparatus
i. Fixed funnel
• Fixed cone- constant diameter
• Free standing cone- constant height
ii. Tilting box
iii. Revolving cylinder

Formula:
tan = ht
radius

*criteria:

ii. Air Entrainment Methods

• Air set sieving-single sieve
• Sonic filter sieving

DENSITY
- measurement of the amount of mass of a substance
per unit of volume. This measurement of a pure substance has
the same value as its mass concentration.
Formula:
Ƥ= mass
volume
unit= g/ml

a. BULK DENSITY
- the ratio of the mass of an untapped powder sample
and its volume, including its interparticulate void volume.
Formula: Problem:
Ƥ bulk= mass . If the height and diameter of a powder cone were 50cm and
untapped volume 16.1 cm respectively, then the powder flow may be
unit= g/ml characterized as:

Methods:
• Graduated cylinder b. HAUSNER RATIO AND CARR’S/
• Volumeter COMPRESSIBILITY INDEX
• Vessel - measures of a powder’s ability to settle

b. TAPPED DENSITY Formula:

- an increase bulk density attained after tapping a HR= untapped volume
powder sample. tapped volume
Formula:
Ƥtapped= mass . CI= untapped vol- tapped vol x 100
tapped volume Untapped vol
unit= g/ml

Methods: Problem:
Method I- Graduated cylinder Compute for the HR, CI and identify the flow property for the
following batches of Cefipime powder.
Steps:
1. Tap 10 times (V10) Batch number Initial Vol(ml) Tapped Vol(ml)
2. Tap 500 times (V500) XCV123 99.0 89.2
3. tap 1250 times (V1250) BN45678 93.4 72.5
4. Determine the tapped volume:
- if V500 - V1250 ≤ 2ml, then V1250 is the tapped volume