Intended for use as a substance or mixture of substances in pharmaceutical manufacturing, and when used in pharmaceuticals, it becomes an active ingredient of the pharmaceutical product. This substance has pharmacological activity or other direct effects in the diagnosis, treatment, symptom relief, processing, or prevention of diseases, or can affect the function and structure of the body.

ICH Q7A definition:

A general professional term used to refer to starting materials, reagents, and solvents used in the production of intermediates or active pharmaceutical ingredients.



2. What is an intermediate?

ICH Q7A definition:

A material produced in the active pharmaceutical ingredient (API) process steps that must undergo further molecular changes or purification to become an API. Intermediates can be isolated or not.

(Note: The ICH Q7 guideline only covers intermediates produced after the starting point of API production as defined by the company.)

 

3. What is an API starting material?

ICH Q7A definition:

Refers to a raw material, intermediate, or API used to produce an API and incorporated into the API structure as a significant structural fragment. API starting materials may be commercially available, obtainable through contract or commercial agreements from one or more suppliers, or manufactured by the producer. API starting materials generally have well-defined chemical properties and structures.

So, how do we define "significant structural fragment"?

Refers to the part of the molecular structure that contributes to or is significant to the pharmacological activity of the API molecule (ICH Q7A US Q&A)

It is often misinterpreted by applicants as a fragment similar to the API structure, applicable to materials that contribute to the final molecular structure of the API, and is relative to reagents, catalysts, or solvents.

1. What is an Active Pharmaceutical Ingredient?

ICH Q7A definition:

Literal English translation: Active Pharmaceutical Ingredient, abbreviated as: API

Intended for use as a substance or mixture of substances in pharmaceutical manufacturing, and when used in pharmaceuticals, it becomes an active ingredient of the pharmaceutical product. This substance has pharmacological activity or other direct effects in the diagnosis, treatment, symptom relief, processing, or prevention of diseases, or can affect the function and structure of the body.

ICH Q7A definition:

A general professional term used to refer to starting materials, reagents, and solvents used in the production of intermediates or active pharmaceutical ingredients.

2. What is an intermediate?

ICH Q7A definition:

A material produced in the active pharmaceutical ingredient (API) process steps that must undergo further molecular changes or purification to become an API. Intermediates can be isolated or not.

(Note: The ICH Q7 guideline only covers intermediates produced after the starting point of API production as defined by the company.)

3. What is an API starting material?

ICH Q7A definition:

Refers to a raw material, intermediate, or API used to produce an API and incorporated into the API structure as a significant structural fragment. API starting materials may be commercially available, obtainable through contract or commercial agreements from one or more suppliers, or manufactured by the producer. API starting materials generally have well-defined chemical properties and structures.

So, how do we define "significant structural fragment"?

Refers to the part of the molecular structure that contributes to or is significant to the pharmacological activity of the API molecule (ICH Q7A US Q&A)

It is often misinterpreted by applicants as a fragment similar to the API structure, applicable to materials that contribute to the final molecular structure of the API, and is relative to reagents, catalysts, or solvents.