AkzoNobel SANAL® Salt has been awarded a GMP certificate for pharmaceutical starting materials (API). This means that AkzoNobel can supply customers with pharmaceutical salt for all kinds of applications, including those legally obligated to buy an API NaCl.
AkzoNobel Salt is the third manufacturer in the world to receive the GMP certificate on ICH Q7A for its SANAL® sodium chloride pharmaceutical quality products salt in its purest form. The salt is produced at the AkzoNobel Salt A/S site in Mariager, Denmark.
Sodium chloride that is free from additives and bacterial endotoxins plays an essential role in the pharmaceutical industry and in the manufacture of medical and pharmaceutical products. The GMP certificate on ICH Q7A indicates that the Mariager site complies with good manufacturing practices for APIs according to rules governing medicinal products in the EU. In March 2006, the site was also approved by the FDA as an 'active pharmaceutical salt ingredient manufacturing facility'.
AkzoNobel SANAL Salt is salt in its purest form for use in the pharmaceutical industry, medicine, cosmetic and health products. Manufacturing is subject to strict quality controls at all stages of processing in accordance with GMP ICH Q7A guidelines for the manufacture of pharmaceutical agents.
SANAL P sodium chloride pharmaceutical quality is an active ingredient in both parenteral and peritoneal solutions and a base material for haemodialysis and haemofiltration solutions as well as other pharmaceutical applications. SANAL SQ is suitable for the above as well as for the use as a fine chemical pursuant to American Chemical Society requirements in microelectronics and micro-galvanic processes.