what is difference between assay&purity&potency?
Answers were Sorted based on User's Feedback
Answer / falguni
Assay : We compare the area of product with working
reference Standard of that product.It also may calculate as
basis, on anhydrous basis or on dried basis.
Purity : We compare the area of our product with area of
other impurities which comes in our product.
Potency : We compare the area of product with working
reference Standard of that product, but after removing the
sum of heavy metals, sulfated ash, LOD and moisture.
| Is This Answer Correct ? | 31 Yes | 4 No |
Answer / bhargav
Purity:
It is calculated by area normalisation method, it can be
directly find out by chromatograms obtained from HPLC.
% Purity = (Area of desired peak / Sum of area of all
peaks) x 100
Assay:
It is calculated against standard. It may be of following
types:
1) On as is basis = (Area of sample / Area of standard) x
(conc. of standard / conc. of sample) x potency or assay of
standard
2) On anhydrous basis = (Assay on as is basis / 100 –
moisture) x 100
3) On dried basis = (Assay on as is basis / 100 – LOD) x 100
Potency:
100 – (moisture or LOD + residual solvents + heavy metals
+ sulphated ash + impurities)
| Is This Answer Correct ? | 17 Yes | 2 No |
Answer / a.prabhakar
Purity :
It explains how pure our analyte is in the given mixture.
It is not related to the how much our analyte is in the given mixture.
i.e.: Percentage of a our analyte without impurities in HPLC.(Known or Unknown)
Assay:
It explains how much our analyte is in the given mixture (The content of our component in the given mixture).It is not related to analyte purity.
Potency :
It is measurement of our analyte how potent it is.
i.e: Purity of our analyte without all possible impurities like chromatographic impurities (HPLC, GC-Residual solvents, moisture, TLC), heavy metals, sulphated ash...etc
| Is This Answer Correct ? | 10 Yes | 0 No |
Answer / ala
in the answer above the first two definitions is true
for potency there is relation ship between potency and activity of the product as antibiotics and i am sure its related to micro lab
| Is This Answer Correct ? | 2 Yes | 5 No |
If we are getting split peak in Chromatogram,what we can do?
what is difference of uv and pda
13 Answers Akums, MSN, MSN Pharma, Shilpa Medicare,
what are the guidelines for analytical method validations?
in gas chromatography what is the difference between gas flow rate and average linear velocity ?
What is Signal to noise ratio?
what is the d/f b/w normality and molarity and molality..?
What is excipient in drug product?
what is the balance drift?
Why use only methanol,used determinationof moisture content not use other solvents
how can we decide the limit of cleaning validation? What is the criteria for it?
In which situation we require to prepare the standard solution from sample in Related substance method?
how require to interprit the method precision data of hptlc?