Dear Vijay,
Are these combinations (80% and 40% with lactose) have monographs in Ph.
Eur?
COS will be given to only Ph. Eur monographs.
Dilip Degwekar
-----Original Message-----
From: RegAffairs@www2.pharmweb.net
[mailto:RegAffairs@www2.pharmweb.net]On Behalf Of Vijay Kirpalani
Sent: 24 August, 2001 3:12 AM
To: RegAffairs
Subject: COS query
Dear Sirs,
I want to submit an application for COS to EDQM.
The product is Isosorbide 5-Mononitrate (ISMN) (its monograph figures
in the Ph.Eur.)
The query is :-
The Ph.Eur. list the product as "Diluted Isosorbide-5-mononitrate"
The diluents as per Ph.Eur are Lactose or Mannitol
The % of diluent is NOT mentioned
We make ISMN = 99 + % quality
80 % quality diluted with Lactose
40 % quality diluted with Lactose
To apply for a COS , would I require to submit "separate" applications and
data
for each of the following :- 99 % +
80 %
40 % ???
Would the stability data also need to be separately done with samples of
99%, 80 % and 40% ?
I would appreciate some advice on this matter.
Thank you, and warm regards
Vijay Kirpalani
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