QC Flashcards
Use according to particular state of needs to guarantee the products quality asset by its monograph and is specification
Special methods of analysis
Are made to establish purity for determine the amount of therapeutically active constituents present for the purpose of standard decision
Quantitative analysis of crude drugs and products
classification for the special methods
Chemical methods and biological methods
Ash determination, crude extractive fiber content, assay of alkaloids and volatile oils
Chemical methods
In vivo animal testing, microbiological testing and etc.
Biological methods
Usually taken as a measure of the residue from a crude drug after the process of incineration
Ash content
It represents the amount of inorganic salts naturally occurring in the drug and adhering to it
Ash content
It can also represent the level of inorganic matter that indicates a level of adulteration of a crude drugs sample
Ash content
Process of subjecting the crude drug sample to very high temperatures in order to “burn off” organic matter living in organic matter for total Ash measurement
Incineration
This is the residue remaining after application of sufficient incineration process
Total ash
This is part of the total Ash that cannot be solubilized in dilute hydrochloric acid
Acid insoluble ash
This is the processed done to crucibles to dull redness and afterwards weight is measured. The Crucible is deemed as constant weight when to 2-3 weighings do not differ by 0.5mg
Constant weight
This is a crucibles that has been heated to dull redness and until constant weight, cooled in a dessicator and weighed
Tared crucible
Define as a quantity not exceeding 500mcg
Negligible
Is a measure of inorganic matter present a impurity
Ash o residue yielded by an organic compound
Used to conduct incineration studies and temperatures for incineration
Electric furnace
Very dull red heat
500-550°C
550-700°C
Dull red heat
Bright red heat
800-1000°C
1000-1200°C
Yellow red heat
White heat
1200-1600°C
Is determine by ignition to dull redness
The Ash content of chemicals
This technique provides a means of determining the percentage of test material which is volatilized and driven off under the conditions specified
Loss of ignition
USP calamine
2%
Magnesium sulfate
40-52%
Titanium dioxide
0.5%
Zinc oxide
1%
NF Calcium phosphate
8%
Kaolin
15%
Lime
10%
Magnesium hydroxide
30-33%
Magnesium phosphate
20-27%