Regulatory Open Forum

Hi!

Please could someone explain the rationale behind this statement, that I received for a product while preparing the dossier:

"Forced degradation is not applicable for this product as it is an inorganic compound".

Any help would be appreciated.

Thank you!

------------------------------
Sai Krishna Yalamanchili
Regulatory and Pharmacovigilance Associate
Mississauga ON
Canada
------------------------------

​Without far more information it would be difficult for me to state with any certainty what that statement is likely to mean but I can tell you my guess would be that it means that the item in question is essentially an inorganic compound with good thermal and temporal stability data in the literature.  The means that the product is unlikely to degrade under normal conditions seen in forced degradation studies and therefore would not be expected to cause any significant issue in terms of loss of activity or elimination based on temperature and therefore the studies are neither necessary nor completed by the vendor.  Essentially it sounds like they are saying that the product is so stable (think about something like salt crystals) that there is no real need to run a forced degradation on the material because it is going to truly show nothing that is of use and that is not already in the literature.

------------------------------
Victor Mencarelli
Director Regulatory Affairs
United States
------------------------------

Original Message:
Sent: 24-Jul-2018 15:55
From: Sai Krishna Yalamanchili
Subject: Forced degradation

Hi!

Please could someone explain the rationale behind this statement, that I received for a product while preparing the dossier:

"Forced degradation is not applicable for this product as it is an inorganic compound".

Any help would be appreciated.

Thank you!

------------------------------
Sai Krishna Yalamanchili
Regulatory and Pharmacovigilance Associate
Mississauga ON
Canada
------------------------------

Thank you, Victor!

------------------------------
Sai Krishna Yalamanchili
Regulatory and Pharmacovigilance Associate
Mississauga ON
Canada
------------------------------

Original Message:
Sent: 25-Jul-2018 08:29
From: Victor Mencarelli
Subject: Forced degradation

​Without far more information it would be difficult for me to state with any certainty what that statement is likely to mean but I can tell you my guess would be that it means that the item in question is essentially an inorganic compound with good thermal and temporal stability data in the literature.  The means that the product is unlikely to degrade under normal conditions seen in forced degradation studies and therefore would not be expected to cause any significant issue in terms of loss of activity or elimination based on temperature and therefore the studies are neither necessary nor completed by the vendor.  Essentially it sounds like they are saying that the product is so stable (think about something like salt crystals) that there is no real need to run a forced degradation on the material because it is going to truly show nothing that is of use and that is not already in the literature.

------------------------------
Victor Mencarelli
Director Regulatory Affairs
United States

Original Message:
Sent: 24-Jul-2018 15:55
From: Sai Krishna Yalamanchili
Subject: Forced degradation

Hi!

Please could someone explain the rationale behind this statement, that I received for a product while preparing the dossier:

"Forced degradation is not applicable for this product as it is an inorganic compound".

Any help would be appreciated.

Thank you!

------------------------------
Sai Krishna Yalamanchili
Regulatory and Pharmacovigilance Associate
Mississauga ON
Canada
------------------------------