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 |
What is difference between silica used in TLC and HPLC column
4 Answers Cipla, Meghmani Organics,
What is difference between" LOD" AND "VACCUME LOD"
what is protocol ? plz Explain me
what is the conductivity of hplc grade water?
How will decide to use HPLC OR GC for developing method for unkown compund
wt is difference between assay and purity in hplc?
how can give the expiry period and restadardisation of volumetric solution
0 Answers Meenaxy Pharma, SRF,
What is shaking level in GC?
why require to do water content for drug product?
2. Two grams of Benzoic acid are dissolved in 200 ml of water and extracted with 200 ml of diethyl ether. The distribution coefficient of benzoic acid is 100, and its dissociation constant is 6.5 10-5. Calculate the distribution ratio (D) of benzoic acid at pH 2, 5, and 6. 3. Calculate D at pH 2 to 10 (1 unit apart) in the above problem, and plot D versus pH.
Why dissolution test is not performed in all of the products
we calibrate HPLC once in 6 months while iam doing calibration i came to know that calibration was failed. then how can i justify that the samples analyzed on the system during this 6 months was wright? how can i forward in to the next step for those batches?