What is the difference between Chromatograhic Purity And
Related substances
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Answer / priyesh mistry
Related substance tests are established after complete
impurity profiling of respective substane where as
Chromatographic purity demonstarte the actual amount of the
substance present with unknown impurities.
| Is This Answer Correct ? | 80 Yes | 9 No |
Related substances means Quantification of Specified
Impurities and unspecified impurities against Reference
standards Exclusively.
Chromatographic Purity means Unspecified impurities by area
noramlisation method.
| Is This Answer Correct ? | 64 Yes | 13 No |
Answer / pradosh sahoo
Chromatographic Purity means presence of unknown impurity, calculated by % area (area normalization method), where as Related Substance means the presence of both specified & unspecified impurity calculated against reference standard.
| Is This Answer Correct ? | 37 Yes | 3 No |
Answer / kashyap
Chromatographic purity is a USP terminology where impurities are reported by area normalization methods.
Related substances (as per ph.Eur) impurities are reported by diluted standard method.
| Is This Answer Correct ? | 7 Yes | 5 No |
Answer / bhalchandra
why increases any other impurity after manufacturing in respective product.
| Is This Answer Correct ? | 0 Yes | 0 No |
Answer / sameer jagtap
chromatographic purity is calculated by area normalisation
method it gives the percentage of the main product and
related substances by HPLC gives you the Impurity profile
(known + unknown impurity)present in the product.
| Is This Answer Correct ? | 3 Yes | 5 No |
Answer / chalapathi rao.n
purity test of product is equal to related substance test.purity is product peak area% other than known,unknown impurities area%
| Is This Answer Correct ? | 5 Yes | 10 No |
Answer / gs
In Sample way, Related substance (RS) are associated with
Raw material (API/Excipients)that comes along with desired
raw material either known and/or unknown and Chromatographic
Purity means identified as known and unknown.
| Is This Answer Correct ? | 2 Yes | 7 No |
Answer / basha
Chromatographic purity means which will give area % of
active ingredients as well as known impurities & unknown
impurities with rference standard.Realated subsances are
may be organic,inorganic and residual solvents(may be
degraents, by
products,contaminents,starting materials,etc)
| Is This Answer Correct ? | 4 Yes | 10 No |
Answer / s kumar
chromatographic purity means wich is not calculated by
diluted standard.ie,the purity is linear with
concentration.In genearally final drug products calculated
and quantyfied with their diluted standards this is called
as related substances mehod
| Is This Answer Correct ? | 4 Yes | 22 No |
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