ASYNCHRONOUS ACTIVITIES – QUALITY CONTROL II

(LECTURE AND LABORATORY)

DATE GIVEN: October 27, 2020

DATE OF SUBMISSION: NOVEMBER 5, 2020 (on or before 12 NN)
DISCUSSIONS WILL CONTINUE ON NOVEMBER 5, 2020

JESSA MAE M. LATORRE BSPH IV

RESEARCH AND DISCUSS (in a brief and concise manner and terms) THE
FOLLOWING:

1. Friability Test
a. Tablet Processing Problems
- Capping – Large of fines in the granulation
- Motting – A colored drug used along with colorless excipients;
improper mixing of a colored binder solution.
- Lamination – Oily or waxy materials in granules; too much
hydrophobic lubricant.
- Crackling – Large size of granules; too dry granules; Tablet
expand; Granulation too cold.
- Chipping – Sticking on punch faces; too dry granules; too much
binding causes chipping at bottom.
- Sticking – Granules not dried property; Too little or improper
lubricant; Too much binder; oily or waxy materials.
- Picking – Granules not dried properly; Too little or improper
lubrication; Low melting point substances, may soften from the
heat of compression.
- Binding – Too moist granules; Insufficient or improper lubricant;
Too coarse granules.
- Double Impression – Free rotation of either upper punch or lower
punch during ejection of a tablet

2. Tablet Thickness and Hardness Tests

- Tablet thickness is measured with a vernier caliper, thickness
gauge or automated equipment (Automatic weight, hardness,
thickness, and tablet diameter test instrument). The thickness of a
tablet should be controlled within ±5% variation of a standard
value depending on the size of the tablet.

3. Quality Control Tests for the following:

a. Sterile Products – Leakage Test; Clarity test; Sterility Test; Pyrogen Test
b. Solutions – Appearance; Viscosity; Clarity testing; pH value
 c. Suspensions – Appearance; Photo microscopic test; Color, oudour &
taste; pH value; Porability; Viscosity; Redispresibility; Particle size
d. Emulsions – Appearance; Clarity Testing; pH value; Viscosity; Rheology;
Drug content uniformity; Particle size distribution; Densities of phases

4. Spectrometry
a. Range of wavelengths of Radiant energy
- As frequency decreases, radiant energy and wavelength
increase.

b. Branch of Spectrometry
- Spectrophotometry – deals with measurement of the radiant
energy transmitted by a body as a function of the wavelength.

c. Laws of Spectrophotometry
- Bouger’s Law – each layer of equal thickness of the medium
absorbs an equal fraction of the energy traversing it.
- Beer’s Law – the absorptive capacity of a dissolved substance is
directly proportional to its concentration in a solution.

d. Methods of Spectrometry
- Mass spectrometer
- NMR spectrometer
- Optical spectrometer

e. Formulas – Dissolution Analysis

- Can be expressed via the Noyes-Whitney equation:

dm D S
= (Cs−C)
dt h

Where;
Dm/dt= Solute dissolution rate
M= mass of dissolved materials (kg)
t = time (s)
A= surface are of the solute particle (m2)
D= diffusion coefficient (m.s-1)

f. Give one (1) example of Dissolution Analysis problem. Indicate complete

computations
−7 3 −4
dM ( 1,75 x 10 ) ( 2.5 x 10 ) ( 0.35−2.110 )
= =1.22/ se c
dt 1.25 x 10− 4
 5. Chromatography
a. Classification of Chromatographic Methods
- Bed Shape – Column chromatography; Planar chromatography
- Physical State of the mobile Phase – Gas chromatography; Liquid
chromatography
- Mechanism of Separation – Ion exchange chromatography; Size
Exclusion chromatography; Expanded Bed absorption
chromatography.

b. Rf or Retention Value Formula

Distan ce travelled by the compound

Rf =
distance travelled by the solvent front

c. Give 2 (two) examples of Rf value problems. Indicate complete

computations.
6 mm
- Rf = =0.33
18 mm

12mm
- Rf = =0.38
32mm

6. Stability
a. Methods on Stability Testing
- Accelerated stability testing- used to determine the types of
degradation products
- Testing uner less rigorous conditions.

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