Products

ROQUETTE BIOPHARMA GRADES

Roquette provides solution for protein stability challenges impacting drug product development by introducing their plant-based pharmaceutical ingredients. These are low-endotoxin, multi-compendial range of polyols and hydroxypropyl betacyclodextrins. They also offer dextrose (monohydrate and anhydrous) for cell culture processes meeting the carbohydrate needs.

These products are contaminant-free excipients, produced in a state-of-the-art manufacturing plant (US FDA and ICH Q7 GMP compliant).

 

Product

Pharmacopeial Name

Endotoxin Limit
(IU/g)

Applications

Pearlitol BioPharma

     Mannitol

    USP/NF, EP, JP

                        ≤ 1.0

 

Used in biopharmaceutical application as protein stabilizers and as an excipient for injectable dosage forms

 

Neosorb BioPharma

     Sorbitol

     USP/NF, EP, JP

                        ≤ 1.0

Kleptose HPB BioPharma

(MS value: 0.58 - 0.68)

 Hydroxypropyl Betadex                   USP/NF, EP

                       < 5.0

Kleptose HP BioPharma

(MS value: 0.81 - 0.99)

Lycadex BioPharma

 Dextrose Monohydrate

 USP/NF, EP

                      ≤ 1.0

Suitable for use in cell culture, fill and finished applications

Dextrose Anhydrous BioPharma

 Dextrose Anhydrous               USP/NF, EP, JP

                           -

Suitable for use in cell culture applications

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