m3l3 quality control tests

huh

Redispersability

It refers to the to the amount of force redisperse or resuspend the particles

-

High Vs is better

If Vs = 1.0 , flocculated equilibrium

If Vs < 1.0 , not flocculated

Vs= Vu/Vo

> 1um

the ideal size for suspensions is __

• Microscopy

• Coulter Counter

particle size measurement is determined by:

2um

preferred size for suspensions

Rheologic Property

A test for flowability and viscosity

centrifugation

Temperature and Gravitational Stress is is done by __

Zeta potential

refers to the repulsive forces among the particles

higher

A __ zeta potential is more desirable because suspensions tend to have a slower rate of settling

Dye Solubility Test

test which uses dyes which are soluble in the external phase

• Amaranth green

• Sudan red

dyes used in dye solubility test

Temperature and Gravitational Stress

test for crystal growth

crystal formation

Temperature and Gravitational Stress

high temp = __

precipitation / phase separation

Temperature and Gravitational Stress

low temp = __

Amaranth green

water soluble dye

Sudan red

oil soluble dye

w/o emulsions

fluorescence produces what emulsion

o/w

nonfluorescence produces what emulsion

o/w emulsions

lighted bulb - what emulsion

w/o

unlighted bulb - what emulsion

Cobalt Chloride Test

uses lover’s ink (blue/pink)

(anhydrous) w/o

cobalt chloride test

Blue - emulsion

(hydrous) o/w

cobalt chloride test

Pink - emulsion

w/o

upward creaming - emulsion

o/w

downward creaming - emulsion

particle size determination

The most rapid method of determining particle size is by “sieving”

course granules

sieve #20

good granules

sieve #40

fine granules

sieve #60 , 80 etc.

angle of repose

It refers to the index of flowability, it measures the frictional forces in granules

• static method - fixed cone

• kinetic method - cylinder

methods of angle of repose

criteria for angle of repose

criteria for carr’s index of compressibility

criteria for Hausner’s ratio

porosity

air spaces

moisture content

Uses the Ohaus Moisture Balance Normal moisture content is 0.55 to 2.0 %

0.55 to 2.0 %

moisture content uses the Ohaus Moisture Balance Normal moisture content is __

Low MC

__ MC indicates that the samples are prone to capping, chipping and lamination

High MC

__ MC indicates that the samples are prone to picking and sticking

microbial assay

biological assays performed with microorganisms such as bacteria and fungi

• antibiotics

• vitamins

microbial assay are commonly done with:

microbial assay of antibiotics (MBA)

a quantitative test designed to determine the concentration or potency of the entibiotic that will inhibit the growth of suceptible microorganisms

controlled

(MBA) This test is conducted under __ conditions

• Plate Method/Assay

  • 1. Agar Well method

  • 2.Kirby-Bauer method (paper disk diffusion)

  • 3.Cylinder plate/cup method

• Tube Method/ assay (turbidimetric)

methods of MBA

plate method/assay

measure the zone of inhibition

zone of inhibition / test drug table

microbial assay for vitamins

A fundamental requirement in microbial assay for the activities of vitamins is the inability of the test organism to synthesize the vitamins/factors being assayed

• Lactobacillus plantarum

• Lactobacillus leichmanii

test organisms for Microbial Assay for Vitamins

vitamin B3 (niacin)

Lactobacillus plantarum for Vitamin __

vitamin B12 (cyanocobalamin)

Lactobacills leichmanii for vitamin __

• turbudimetric method

• acid titration

methods of microbial assay for vitamins

elisa (enzyme-linked immunosorbent assay)

A biochemical technique of assay (Immunology), as it is designed to detect and quantify peptides, proteins, antibodies and hormones

elisa (enzyme-linked immunosorbent assay)

first diagnostic test for HIV (BLOOD SERUM)

pregnancy testing

diabetes screening

detection of cancer

ELISA

• Plate – based - development of color is observed

• This has replaced RIA (Radio-Immuno Assay)

1. Bovine serum albumin (BSA)

2.Non-fat dry milk

3.Casein

4.Porcine or Bovine Gelatin

protein blocking agents used in ELISA TEST KIT

1. Horseradish peroxidase

2.Alkaline phosphatase

3.Urease

4. B-galactosidase

(ELISA TEST KIT) ENZYME USED

1. hydrogen peroxide

2.tetramethylbenzidine (TMB)

(ELISA TEST KIT) substrates used

1. 3M NaOH - for AP

2.3M hydrochloric acid or sulfuric acid - for HRP

(ELISA TEST KIT) stop solutions used:

1. Phosphate buffered saline (PBS)

2.10 mM Phosphate buffer, pH 7.4

3.150 mM NaCl

4.0.05% Tween 20

(ELISA TEST KIT) wash solutions used