1

Analysis of literature data through specialized databases

We will determine the most promising ways of synthesizing the APIs under development using the ScyFinder, Reaxys, SmartChem, Google patents databases.

We will draw up a material balance for the production of APIs and, if necessary, develop a new unique method for the synthesis of APIs for patenting the developed technology.

2

Patent purity analysis

We will determine the patent purity of developments, and we will provide the deliverables in the form of a patent research report in accordance with GOST P 15.011-96 "Patent research".

3

Development of a laboratory synthesis method

At the laboratory level, we will develop a method for the synthesis of the target substance, optimize the key process and chemical parameters at each stage of its synthesis.

Based on the deliverables, we will provide a detailed report with a minute description of the relevant data explaining the result obtained and the chosen methods for the synthesis of each intermediate product with optimized process parameters.

4

Obtaining samples

At your request, we will synthesize samples of related API impurities formed in the developed laboratory synthesis technology.

5

Development of laboratory operating procedures

We will draw laboratory operating procedures for obtaining API in accordance with OST 64-02-003-2002 “Products of the medical industry. Regulations for manufacturing processes.

6

Technology scaling

We will scale up developed laboratory technology, adjust the optimal process parameters, taking into account the specifics of the equipment used.

We will confirm the reproducibility of the obtained experimental-industrial synthesis technology. Based on the deliverables, we will generate a report on scaling.

7

Development of regulations and internal standards

We will develop experimental-industrial regulations for the production of API in accordance with OST 64-02-003-2002 “Products of the medical industry. Regulations for manufacturing processes” and form internal primary and secondary standards for API samples.

8

Analytical support for the development of API synthesis.

We provide full analytical support for the development of synthesis technology. As part of analytical support, the following types of work are carried out:

Control of raw materials according to methods of analysis (MoA) in accordance with the quality certificate (CoA) of raw material suppliers. As part of the control, we will test methods of analysis from suppliers of raw materials and, if necessary, develop new methods of analysis.

We will develop criteria and carry out certification of standard samples of the plant.

We will develop methods for monitoring intermediate synthesis products and the finished product.

We will develop specifications with quality indicators and acceptance criteria for each intermediate and finished synthesis product.

We will control the quality of API batches and intermediates according to the specifications developed during the work.

We will study the stability of intermediates and APIs produced in pilot batches.

We will conduct stress studies of APIs and study the photostability of the developed APIs.

We will control the quality of pilot-scale batches and intermediates.

We will validate analytical quality control methods.

@2023