4-Benzoylphenyl Methacrylate (56467-43-7), a intermediate with high purity

2021-10-14 Shanghai Massive Chemical

The purpose of establishing quality standards for intermediates is to produce API that meets specification requirements if each intermediate meets quality standards according to the established process. This requires a comprehensive assessment of API quality risks, such as properties, related substances, isomers, residual solvents, genotoxic impurities, metal ions, blazing residues, heavy metals, moisture, crystal form, particle size, etc., to find the source of these quality risks in the process.

The key control points of API quality risk in the process should be identified and corresponding control strategies should be formulated. In the case of API burning residue, where inorganic salts are used in the process, the reasonableness and effectiveness of the desalting steps in the process should be evaluated to ensure that API burning residue limits are met. The purity of intermediates is checked only by area normalization method, which only controls the risks of relevant substances, which is far from enough. Other risks, such as inorganic salts, residual solvents, and genotoxic impurities, are not controlled. Whether API is qualified on these indicators is up to luck.

On the basis of producing and supplying start materials, Massivechem are actively expanding the downstream products of pharmaceutical advanced intermediates and APIs, We cooperating with laboratories and plants both in China and India to conform the GMP management and DMF documents for such products, and actively developing newly approved (chiral) and (chiral) pharmaceutical intermediates to promote the added value of the products and improve the market competitiveness.