一般描述
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.
應(yīng)用
Polysorbate 80 is used to stabilize biomolecule formulations ａnd as solubilizer, emulsifier ａnd wetting agent in small molecule formulations. Polysorbates are known to degrade via autoxidation ａnd hydrolysis. Degradation products can have a negative impact on the stability of the protein as well as the small molecule API. To reduce this risk, the polysorbate high-purity grade contains a low amount of impurities, especially peroxide.
Intended for high-risk applications, this Emprove® Expert grade contains bioburden ａnd endotoxin limits.
包裝
1371710100 / 100ml / glass bottle
1371711000 / 1L / glass bottle
法律信息
Emprove is a registered trademark of Merck KGaA, Darmstadt, Germany
SAFC is a registered trademark of Merck KGaA, Darmstadt, Germany
TWEEN is a registered trademark of Croda International PLC
