Orange or citrus flavor [Regulatives / Guidelines]

posted by Dr_Dan  – Germany, 2020-02-20 10:01 (1519 d 16:35 ago) – Posting: # 21181
Views: 1,884

Dear all
It´s not a question with direct reference to bioequivalence but maybe you have some experience that you can share.
Oral formulations that are a suspension or a solution at time of administration often contain a flavoring agent. In case this is a orange or citrus flavor the German regulatory authority asks whether this flavor contains perilla aldehyd. According to EFSA (European Food Safety Authority) perilla aldehyd contains an α,β-unsaturated carbonyl group, which is a structural alert for toxicity. However, citrus fruits naturally contain perilla aldehyd and if the flavoring agent in your formulation contains natural citrus oil you can not exclude contamination with perilla aldehyd. How can one argue against the authority? Eventually drinking of orange juice is still considered harmless....
Looking forward to your reply.

Kind regards and have a nice day
Dr_Dan

Complete thread:

UA Flag
Activity
 Admin contact
22,987 posts in 4,824 threads, 1,668 registered users;
76 visitors (0 registered, 76 guests [including 4 identified bots]).
Forum time: 03:37 CEST (Europe/Vienna)

The only way to comprehend what mathematicians mean by Infinity
is to contemplate the extent of human stupidity.    Voltaire

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5