19 March 2021
Pharmaceutical grade polysorbates compliant with the major pharmacopoeias including the Chinese pharmacopoeia
MONTANOX™ polysorbates from SEPPIC are polyethoxylated sorbitan esters. These hydrophilic surfactants play a triple role: 1) They are used as emulsifiers to formulate oil in water emulsions – 2) as solubilisers for active ingredients with low solubility – and 3) as antiaggregants for biological active ingredients. The polysorbates are stable in acidic or basic media and in the presence of electrolytes and are compatible with other surfactants.
A suitable grade for every application
The MONTANOX™ range is composed of monoesters of lauric, stearate or oleic fatty acids. Each of them have a degree of ethoxylation of 20 and are characterised by their HLB (Hydrophilic-Lipophilic Balance). There are two pharmaceutical grades: PPI and PHA PREMIUM. The PPI grade is designed for injectable administration and products are manufactured according to the Good Manufacturing Practices “GMP part II”. The PHA PREMIUM grade is designed for oral and topical administration and products are manufactured according to IPEC’s GMPs.
PPI grade solubilisers also compliant with Chinese Pharmacopoeia
It is compulsory to register all excipients included in drugs sold on the Chinese market with the Chinese authorities. Compliance to the Pharmacopoeia is mandatory for the registration of new drugs in China. It ensures the quality, the safety and the efficacy of the excipient and then of the marketed drugs. From the MONTANOX™ range, we offer polysorbate 20 and polysorbate 80 PPI grade which are compliant with the Chinese Pharmacopoeia (ChP).
In addition to ChP, the MONTANOX™ 20 and 80 PPI is compliant with EP, JP, JPE and USP pharmacopoeia. The PHA Premium range complies with the EP and USP pharmacopoeia.