How could I identify its starting material. Its have chemical structure and its reacts with chemical and first structure formation of molecule.for that any list available from website.
Normally, the ‘API-starting material’ is defined in the regulatory filing by the applicant and approved
in the regulatory reviewing process. Additional guidance is provided to define and justify ‘API starting
material’ derived from various sources [ICH Q11, Section 5].
API Starting Material (ICH Q7)
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. An API
Starting Material can be an article of commerce, a material purchased from one or more
suppliers under contract or commercial agreement, or produced in-house. API Starting
Materials are normally of defined chemical properties and structure.
The selection principle about “significant structural fragment” has frequently been misinterpreted as
meaning that the proposed starting material should be structurally similar to the drug substance.
However, as stated in ICH Q11, this general principle is intended to help distinguish starting materials
from reagents, catalysts, solvents, or other raw materials.
The term “significant structural fragment” is not intended to dictate the selection of either a very early
or a very late intermediate as the starting material. A proposed starting material may be defined
downstream from a commercially available chemical, provided that there are multiple chemical
transformation steps between the proposed starting material and the drug substance, and provided the
justification addresses the ICH Q11 general principles. The presence of a “significant structural
fragment” should not be the sole basis for starting material selection. Starting materials justified solely
on the basis that they are a “significant structural fragment” probably will not be accepted by regulatory
authorities, as the other general principles for the appropriate selection of a proposed starting material
should also be considered.
Thank you for giving useful information
Can any body tell about ASTM guidelines
ASTM International, formerly known as American Society for Testing and Materials, is an international standards organization that develops and publishes voluntary consensus technical standards for a wide range of materials, products, systems, and services.
ASTM is a national organization that is a part of ISO organizations. ‘ISO’ is an international organization that has representations from all countries including ASTM. ISO establishes documents and updates the standards of testing materials with global consensus from the experts of the associated national organizations.
ASTM’s laboratory testing standards are instrumental in specifying the standard dimensions, design, and make of the various equipments and instruments used in the laboratory for scientific experiments and procedures. These standards help laboratories, manufacturers, and other users and producers of such apparatuses in ensuring good quality and workmanship.
ASTM’s pharmaceutical application standards cover process control, design, and performance, as well as quality acceptance/assurance tests for the pharmaceutical manufacturing industry. These pharmaceutical application standards are valuable to manufacturers of pharmaceuticals and pharmaceutical equipment, federal agencies, design professionals, professional societies, trade associations, financial organizations, and academia.
For further details please refere ASTM website: astm.org/Standards
Can any body tell about the procedure for submission of new product for regulatory body