FAQ

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Pharma - General regulatory

Is DMF documentation available for Roquette products?

Roquette has issued several DMFs for excipients or active ingredients;
Access to these DMFs can be given upon request.
Not all excipients or actives need a DMF so Roquette has developed alternative procedures that provide access to the information required by the regulatory authorities.

For more information on this issue, please contact us or your local representative.
 

Pharma - General regulatory

What documentation is available for the CTD (Common Technical Document)?

Roquette can provide all the information requested  in the standard Common Technical Document (CTD). However, in order to simplify the customer’s NDA files, Roquette has not only submitted several DMFs to the US authorities but also several CEPs (Certificate of Suitability to the monograph) to the European Medicinal Authorities (EDQM). Roquette DMF and/or CEP Access Letters are therefore available to the NDA applicant upon request.
Moreover, in connection with the New Pharmaceutical Affairs Law (New PAL), implementation, Roquette is preparing new DMF submissions to the Japanese authorities.

For more information on this issue, please contact us or your local representative.
 

Pharma - General regulatory

Do Roquette products comply with Pharmacopeias?

Roquette products conform with the current monographs of the three reference Pharmacopoeias (USP, EP, JP/JPE). If no monograph is available, Roquette can establish the appropriate specifications.

For more information on this issue, please contact us or your local representative.
 

Pharma - General regulatory

Do Roquette’s liquid sorbitols comply with the USP/NF monograph?

Liquid sorbitol solutions contain not only sorbitol (D-glucitol) but other related hydrogenated oligomers and polymers of dextrose. All Roquette liquid sorbitols for pharmaceutical applications conform to either the USP or the NF monograph.
For historical reasons the USP monograph defines D-glucitol-rich solutions, commonly known as Crystallising Liquid Sorbitol, as containing a minimum of 64% of D-sorbitol w/w, whereas the NF monograph defines a lower-content D-glucitol syrup, known as Non-Crystallising Liquid Sorbitol, with a minimum content of 54% of D-sorbitol.

For more information on NEOSORB® Liquid sorbitol, please use our Products & Applications selection page.

Performance materials - Safety

Is POLYSORB® isosorbide diesters a non-phthalate plasticizer?

POLYSORB® ID structure is based on POLYSORB® isosorbide and plant-based fatty acids. By nature, it does not content any phthalate and is definitely a phthalate-free plasticizer.
Performance materials - Safety

Is POLYSORB® isosorbide safe?

Yes. POLYSORB® isosorbide is registered in global chemical inventories like Reach or ToSCA and the toxicological assessment has shown isosorbide was safe, without any classification.

It is free of bisphenols (like BPA, BPS or BPF), no endocrine disruptive effect has been shown and in-vitro testing on other isosorbide esters had no effect.
Performance materials - Safety

Are POLYSORB® isosorbide-based plastics BPA-free?

POLYSORB® isosorbide does not contain any Bisphenol A and so is BPA-free.

Plastics based on isosorbide are produced with co-monomers. It is recommended to contact the resin manufacturer to have more information on it.
Performance materials - Safety

Is PEIT (polyethylene-co-isosorbide terephthalate) a food contact polymer?

In Europe, isosorbide is listed as monomer that can be used to modify PET on "plastic materials and articles intended to come into contact with food" regulation.

Performance materials - Safety

Are all POLYSORB® isosorbide-based plastics approuved for food contact?

Food contact regulation depends both on country regulation and plastic type.

It is recommended to contact the resin manufacturer to have more information on it.

Performance materials - Safety

How does Roquette provide Bisphenol A alternatives?

Roquette offers POLYSORB® isosorbide, a safe plant-based monomer that can be used to replace BPA, such as in polycarbonate.
Performance materials - Safety

How does Roquette provide Phthalates Alternatives?

Roquette offers POLYSORB® ID, a safe plant-based general purpose plasticizer that can be used to replace phthalate-based plasticizers, such as DINP.
Performance materials - Polymer performance

What can be done to increase the glass transition temperature (Tg) of polyethylene terephthalate (PET)?

Polyethylene terephthalate (PET) glass transition temperature limits its use, notably in packagings subject to heating.

By introducing POLYSORB® isosorbide as co-monomer during the resin synthesis, PEIT (polyethylene-co-isosorbide terephthalate) resin is created. POLYSORB® isosorbide introduction boosts resin temperature resisitance, enabling the use of PEIT in new demanding packaging applications.

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