API: Active Pharmaceutical Ingredients, Key starting material and its role in API

02 of 2019

Hello Friends,

In the first blog we have talked about the API and Excipients, Now we can move forward about the Industry.

Mainly the tablets are made by two forms:

1. API 

2. Formulation

Here we are understanding about the API, 

For manufacturing of any API, required Raw Materials , KSM(Key Starting material ), and Solvents.

For manufacturing of drug so many raw material are used along with water/ solvents, but  here plays an important role by KSM: Key starting material. 

As the name is, It is 'Key' material which is must required for manufacturing of drug, KSM may be one or more than one for an API. KSM is also a raw material , It is also known as 'Starting Material'. 

Now the question is why it called KSM or Starting material  ? 

An API starting material is a raw material, intermediate or an API that is used in the production of an API and that is incorporated as a significant structural fragment into the structure of the API.

I think you required more clarity on it .

As we know that every chemical compound or solvent having as chemical structure, therefore every raw material and solvent having a chemical structure including KSM and API is also have a chemical structure. So according to the definition A part of the chemical structure of KSM, proceeded upto manufacturing of Finish API, and you can notice this part of structure in final API, 

Several reactions going on during the manufacturing of an drug but KSM remain available as a part of structure. But the other raw materials only available in the structure for a particular reaction

Here you noticed a new word "Intermediate" in the definition, 

Intermediate is a product which is produced in between the reaction, it is isolated in between and can be hold for sometimes before starting the next stage, It is also normally analyzed by HPLC analysis to confirm the reaction completion or process is going correctly. For an example any API is produced in 5 stages, than API is produced after 5th stage, but Intermediate product isolated after 1st , 2nd , 3rd and 4th stage.  In other way we can assume them as intermediate is in-between stations of API. 

                                                                                             ......Cont.

Other blogs:

1st of 2019: API: Active Pharmaceutical Ingredients Working and Experiences: Pharma Industry

Link:  https://phamra.blogspot.com/2019/05/hi-im-anupam-working-in-pharmaceutical.html

3rd of 2019: API: Active Pharmaceutical Ingredients, What is CGMP and its requirement in brief

Link: https://phamra.blogspot.com/2019/05/api-active-pharmaceutical-ingredients_9.html

If you required more clarity on the topic than you can also comment or can Email me on anupamdubey16@gmail.com. I'll try to resolve your problems.