MONTANOX™ PPI RANGE

For injectable route: polysorbates and hydrophilic solubilisers
Polysorbates for injectable routes

The MONTANOX™ range is composed of different grades of polysorbates that can be used to solubilize active pharmaceutical and/or biological ingredients.

The PPI grades are designed for injectable administration and products are manufactured according to the Good Manufacturing Practices “GMP part II” and comply with the Ph. Eur., USP-NF, JP/JPE (and ChP for specific grades).

MONTANOX™ 20 PPI

Polysorbate 20

Chemistry	Polysorbate 20
Regulatory compliance	Ph. Eur. USP-NF JPE ChP
Administration route	Parenteral route
Market applications	Human vaccines Injectable products Bioprocessing Nasal spray Ophthalmic solutions
Functions	Solubilizer O/W emulsifier Anti aggregating agent Stabilizer
Characteristics	Hydrophilic non-ionic surfactant HLB = 17 Physical form : Clear liquid

MONTANOX™ 80 PPI

Polysorbate 80

Chemistry	Polysorbate 80
Regulatory compliance	Ph. Eur. USP-NF JP ChP
Administration route	Parenteral route
Market applications	Human vaccines Injectable products Bioprocessing Nasal spray Ophthalmic solutions
Functions	Solubilizer O/W emulsifier Anti aggregating agent Stabilizer
Characteristics	Hydrophilic non-ionic surfactant HLB = 15 Physical form : clear to yellowish liquid

MONTANOX™ 80 API

Anhydrous polysorbate 80

Chemistry	Polysorbate 80
Regulatory compliance	Ph. Eur. USP-NF JP ChP
Administration route	Parenteral route
Market applications	Human vaccines Injectable products Bioprocessing Nasal spray Ophthalmic solutions
Functions	Solubilizer O/W emulsifier Anti aggregating agent Stabilizer
Characteristics	Anhydrous grade Hydrophilic non-ionic surfactant HLB = 15 Physical form : clear to yellowish liquid

MONTANOX™ 80 LPI

Low pH Polysorbate 80

Chemistry	Polysorbate 80
Regulatory compliance	Ph. Eur. USP-NF JP
Administration route	Parenteral route
Market applications	Human vaccines Injectable products Bioprocessing Nasal spray Ophthalmic solutions
Functions	Solubilizer O/W emulsifier Anti aggregating agent Stabilizer
Characteristics	Low pH grade Hydrophilic non-ionic surfactant HLB = 15 Physical form : Clear liquid