Author Topic: Active Pharmaceutical Ingredients(API) vs Intravenous(IV) Electrolytes Sampling  (Read 1848 times)


  • Newbie
  • *
  • Posts: 1
  • City: Johannesburg
  • Organisation: Adcock Ingram Healthcare
Dear Forum members

Should electrolytes for IV use (eg. Sodium Chloride, Glucose Monohydrate, etc.)be controlled in the same manner as APIs in terms of sampling plans?

Can one say without doubt that this class of substances can be categorised in the same class as APIs for it to be sampled 100%, as required for APIs?

Do the definitions of API make provision for such substances? Could these substances be regarded as APIs for all intents and purposes in their IV preparations forms?

Mlungisi Zulu


  • Newbie
  • *
  • Posts: 1
  • City: London
  • Organisation: GMP Consultant
Hi Mlungisi,
So far as Europe is concerned, the definition of API "Any substance or mixture of substances intended to be used in the manufacture of a drug (medicinal) product and that, when used in the production of a drug, becomes an active ingredient of the drug product. Such substances are intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure and function of the body." (Eudralex Vol 4 Part 2, with my emphasis) makes it clear that electrolytes in electrolyte infusions ARE considered to be APIs.
HOWEVER, you need also to look at the registration details for the products, which would give an unequivocal definition for your particular products - eg glucose or salts may be present in some infusions for osmotic purposes, not therapeutic ones.

Regarding sampling though, Annex 19 of the EU Guidelines makes no distinction between active substances and excipients: for parenterals it is expected that all containers be sampled for identification. The rest of the testing should be based on your documented assessment of risk, which for parenterals normally results in a decision of "full testing per the marketing Authorisation/Pharmacopoeia"

Other jurisdictions may have other interpretations: I'm not enough of an expert to advise!

Hope this helps,


Chris Barnett
CMBarnett Pharma Services Ltd


  • Newbie
  • *
  • Posts: 29
  • City: mumbai
  • Organisation: Bharat Book Bureau
Active pharmaceutical ingredients is chemically active substance which produce desired effect in the body..It is not a singular substance but the culmination of several herbs and ingredients.
chrismbarnett has shared  nice information related to this thread..I appreciate for your great writing


Search the V1 and V2 PharmWeb Discussion Forum Archive