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This long discussion seems to have established that 'active substance' is preferred in Europe, where UK English is used; 'active ingredient' is preferred in the US; and 'active principle' (which I was taught) is "old fashioned" and deprecated. (P.S. Maybe it's time for me to retire!)
my daughter and yes, "active substance" is what appears on the prospectus of 2 recently prescribed drugs, where it used to say active ingredient, so it seems to be the current standard. I put "rules" in quotation marks because I always liked to think of myself as a bit of a rebel. But pay no attention, I'm really just morphing into Victor Meldrew in my dotage… It's just that I believe in "if it's not broke don't fix it" and their criteria for choosing one form or another seem a bit ropey or vague. But I'm sure they know what they're doing in the lofty heights of Brussels :)
I think it's a bit more than eeny meeny miny moe, although their (the European Medicines Agency's Working Group on Quality Review of Documents) reasoning may be subtle I guess it's well-founded. For example, I reckon they prohibit "ingredient" simply to avoid the food analogy. :@)
IMHO, a lot of current EU criteria like this seem to have been selected on an "eeny meeny miny moe" basis. I haven't used any UK prescribed meds for a while, but as far as I recall, all the prospectuses used the term "active ingredient". I'll give my mother a call later and ask what it says on her meds, she has plenty of them....
... ... is the way I've always translated this on packaging for cosmetics and medical prospectuses. However, the "official" bodies like the FDA or EMEA (EMA?) will have their own preferred forms. Personally, "active substance" still sounds odd to me, and "active principle" seemed rather old-fashioned.
I used to use 'active ingredient' until I was told it *must* be 'active principle'. I think this term will always be in flux. The old rule in Theory of Terminology was to pick one term and standardize it so everyone would stick to it. This is a perfect example of why they invented the rule.
While "active ingredient" is a deprecated term for Patient Leaflets in the EU, you will find it, and a few other terms, including API, drug substance, etc., used in European clinical trials which aren't bound by EMA terminology.
I use "active substance" nowadays because I translate for a European audience, but you may want to use "active ingredient", because you are probably closer to the sphere of influence of the FDA than to that of the EMA (formerly EMEA).
In my opinion "active principle" is perfectly correct, but it seems to have gone out of favour.
I take it from your references that different countries/organizations/clients seem to prefer different terms (EMA prefers "active substance", FDA uses "active ingredient", etc.). You should probably just pick your choice according to the preference of your addressee.
Automatic update in 00:
8 mins confidence:
active pharmaceutical ingredient
Explanation: This seems to be common usage in this context:
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A Stability-Indicating Ultra-Performance Liquid ... - Oxford Academic https://academic.oup.com/chromsci/article-pdf/50/4/368/10927...
by KH Bindu - 2012 - Cited by 10 - Related articles
specificity of the method in the presence of degradants. The .... **Active pharmaceutical ingredient** standards and samples were ... light studies, the monitoring period was 10 days. Peak purity of the principal peak in the chromatogram of the diluted stressed samples of paliperidone was assessed using a photo diode array.
HPLC for Pharmaceutical Scientists - Page 490 - Google Books Result https://books.google.es/books?isbn=0470087943
Yuri V. Kazakevich, Rosario LoBrutto - 2007 - Science
System Suitability Parameters Determined as a Function of Temperature System Suitability 17°C 18°C 19°C 20°C 21°C 22°C 23°C 24°C 25°C RS > 4 ... For drug substance (**active pharmaceutical ingredient**) and formulation development, both ruggedness and robustness experiments to study a new molecular entity (NME) ...
Simple and Rapid RP-HPLC Method to Determine the Purity of the ... https://www.researchgate.net/.../236644939_Simple_and_Rapid_...
Dec 20, 2017 - The different analytical performance parameters such as linearity, precision, specificity, limit of detection, limit of quantification, robustness and ... proposed method is highly sensitive, precise and hence successfully applied to the chromatographic purity of lamivudine **active pharmaceutical ingredient (API).**
Lisa McCarthy Spain Local time: 13:09 Works in field Native speaker of: English PRO pts in category: 59