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What is the difference between Chromatograhic Purity And
Related substances

Answers were Sorted based on User's Feedback



What is the difference between Chromatograhic Purity And Related substances..

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 ?    75 Yes 8 No

What is the difference between Chromatograhic Purity And Related substances..

Answer / bujji reddy

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 ?    59 Yes 13 No

What is the difference between Chromatograhic Purity And Related substances..

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 ?    26 Yes 2 No

What is the difference between Chromatograhic Purity And Related substances..

Answer / bhalchandra

why increases any other impurity after manufacturing in respective product.

Is This Answer Correct ?    0 Yes 0 No

What is the difference between Chromatograhic Purity And Related substances..

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 ?    4 Yes 5 No

What is the difference between Chromatograhic Purity And Related substances..

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 7 No

What is the difference between Chromatograhic Purity And Related substances..

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 ?    2 Yes 5 No

What is the difference between Chromatograhic Purity And Related substances..

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 9 No

What is the difference between Chromatograhic Purity And Related substances..

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

What is the difference between Chromatograhic Purity And Related substances..

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 21 No

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