Pharmaceutics & Dosage Forms

Active Pharmaceutical Ingredient API

TREtkin Madde
Also known as:Active substance · Drug substance · Active ingredient

The substance in a medicinal product that is responsible for its pharmacological activity, as distinct from the excipients; in manufacturing terms it is the drug substance produced under GMP.

In depth

An API is characterised by its chemical identity, purity, impurity profile, polymorphic form, particle size and, where relevant, salt or stereoisomeric form, all of which can influence solubility, stability and bioavailability. Its quantity per dosage unit is the product's strength, expressed either as the active moiety or as the salt, as defined in the product information.

APIs are manufactured to the GMP requirements of ICH Q7 and described in the quality module of the marketing authorisation dossier; in the Turkish KÜB the active substance is listed as 'etkin madde' in section 2 (Qualitative and quantitative composition).

Clinical pearl

Reconcile medicines by active substance rather than product name: the same active substance can appear under several product names and in combination products (for example, paracetamol in cold remedies), risking unintended duplication and overdose.

Example drugs

paracetamol
TRIn Turkish

Etkin Madde

Tıbbi üründe farmakolojik etkiden sorumlu olan ve yardımcı maddelerden ayrı tutulan maddedir; üretim bağlamında İyi İmalat Uygulamaları (GMP) koşullarında üretilen ilaç maddesidir.

Etkin madde; kimyasal kimliği, saflığı, safsızlık profili, polimorfik formu, partikül boyutu ve gerektiğinde tuz ya da stereoizomer formuyla tanımlanır; bunların tümü çözünürlüğü, stabiliteyi ve biyoyararlanımı etkileyebilir. Birim dozdaki miktarı ürünün yitiliğidir ve ürün bilgisinde tanımlandığı şekliyle aktif kısım (active moiety) ya da tuz üzerinden ifade edilir.

Etkin maddeler ICH Q7'deki İyi İmalat Uygulamaları gerekliliklerine göre üretilir ve ruhsat dosyasının kalite modülünde tanımlanır; KÜB'de 2. bölümde (Kalitatif ve kantitatif bileşim) 'etkin madde' başlığı altında yer alır.

İlaçlar gözden geçirilirken ürün adına değil etkin maddeye bakılmalıdır: aynı etkin madde farklı ürün adlarıyla ve kombinasyon ürünlerinde (örneğin soğuk algınlığı ilaçlarında parasetamol) bulunabilir; bu durum istenmeyen tekrar kullanıma ve doz aşımına yol açabilir.

Diğer adları:Etken madde · Aktif madde · Aktif farmasötik bileşen
Updated 24.09.2026 1 views Educational reference — verify against current sources before clinical use.

Read next

ExcipientYardımcı Madde

Any constituent of a medicinal product other than the active substance, added to enable manufacture, maintain stability, control release, improve acceptability or aid administration.

 Dosage FormFarmasötik Dozaj Şekli

The physical form in which a drug is manufactured and administered, combining the active substance with excipients, for example a tablet, capsule, solution, suspension, injection, cream, transdermal patch or inhalation powder.

 Salt FormTuz Formu

A form of an ionisable drug substance combined with a pharmaceutically acceptable counterion, such as hydrochloride, sodium, maleate or mesilate, chosen to improve solubility, stability, crystallinity or manufacturability.

 Good Manufacturing Practiceİyi İmalat Uygulamaları

The part of pharmaceutical quality assurance that ensures medicines are consistently manufactured and controlled to the quality standards appropriate to their intended use and required by the marketing authorization.

 International Nonproprietary NameUluslararası Mülkiyete Konu Olmayan İsim

A unique, globally recognized generic name assigned by the World Health Organization to a pharmaceutical substance, which is public property and cannot be registered as a trademark.

 Therapeutic DuplicationTerapötik Duplikasyon

The unintended concurrent use of two or more drugs with the same active ingredient, the same pharmacological class or overlapping mechanisms for the same indication, without added benefit.