ortho-Phosphoric acid

Finding the right excipient that matches your needs as well as regulatory demands can be a complicated challenge in formulation. With our application know-how and regulatory expertise, we support you in every step of development, scale-up, and production.
As part of our Emprove^® Program, our raw materials are offered with extensive documentation facilitating compliance of your pharma and biopharma product, full supply chain transparency and risk mitigation. Our SAFC^® portfolio of high-quality products for biopharmaceutical and pharmaceutical formulation and production withstands strict quality control procedures and is produced according to applicable cGMP guidelines.

Phosphoric acid can be used as acidifying agent in a variety of pharmaceutical formulations and processes.

The following cations are harmonized with the ICH Q3D limits:

• Cadmium (Cd): from <= 0.0001% to <= 0.000020%
• Mercury (Hg): from <= 0.0001% to <= 0.000030%
• Lead (Pb): from <= 0.0001% to <= 0.000050%
• Copper (Cu) gets 1 NKS more: from <= 0.002% to <= 0.0020%

The batch values are set to 30% of the Option 1 limit in each case. The MiBio parameters TAMC and TYMC are set to statistical testing and analyzed only once a year (periodic testing).

Concentrated phosphoric acid is approx. 85% H₃PO₄ (aqueous).

Emprove is a registered trademark of Merck KGaA, Darmstadt, Germany

SAFC is a registered trademark of Merck KGaA, Darmstadt, Germany