Four Aivito amino acid excipients completed the mainstream pharmacopoeia compliance study

Pharmaceutical excipients are directly related to the declaration and quality safety of pharmaceutical preparations at home and abroad. Aivito has been deeply engaged in the field of pharmaceutical excipients for nearly 20 years, always adhering to international standards for self-requirements, for the majority of pharmaceutical preparation enterprises to supply high-quality injectable excipients in line with the international mainstream pharmacopoeia standards. Today, we would like to share with you a good news - Aivito 4 injection grade amino acid excipients have all completed the mainstream pharmacopoeia (USP, EP, ChP, etc.) compliance studies, so far, all varieties of Aivito biological products excipients line, have completed the mainstream pharmacopoeia compliance studies!

Compliance with the international mainstream pharmacopoeia standards is not only the guarantee of product quality, but also the commitment to customers and the market. Aalto's R&D and analytics team has put a lot of effort into its

Arginine (for injection)

(CDE registration number: F20230000160, DMF number: 039677);

Histidine (for injection)

(CDE registration number: F20230000159);

Arginine hydrochloride (for injection)

(CDE registration number: F20230000161, DMF number: 038726);

Histidine hydrochloride (for injection)

(CDE registration number: F20220000547, DMF: 038369);

Sucrose (for injection)

(CDE registration number: F20200000093 (A), DMF number: 035209);

Trehalose (for injection)

(CDE registration number: F20200000284, DMF number: 035566);

Tropanol

(CDE registration number: F20220000153, DMF number: 037604)

The above varieties have been subjected to rigorous pharmacopoeia compliance studies. This is another major breakthrough in our product development and quality control.

It is worth mentioning that the above products not only meet the international mainstream pharmacopoeia standards, but also achieve beyond the key indicators, a comprehensive standard of first-line imported brands, has been widely supplied to many biopharmaceutical enterprises, escort the stability and safety of biological agents, and provide help for the domestic and foreign declaration of innovative drugs!

Avito is committed to providing customers with a better service, not only by providing a pharmacopoeia compliance statement, but also by issuing a separate test report (COA) that complies with specific pharmacopoeia standards.

Biological products stabilizer, domestic guaranteed AVT!