GLYCEROL Eur. Ph. min. 99,5% Vegetable Origin – Excipient

GLYCEROL Eur. Ph. min. 99,5% Vegetable Origin - Excipient

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Vegetable Origin GMO Free Refined Glycerine with a content of glycerol higher than 99,5% suitable to be used in:

Pharmaceuticals as Excipient

Certifications and Conformities:

Complying with European Pharmacopoeia (Eur. Ph.) monograph 0496 GLYCEROL
Complying with United States Pharmacopoeia (USP) monograph GLYCERIN
Manufactured and distributed in compliance with GMP guidelines applicable for products used as Excipient in drug products.
Quality Control managed through a LIMS validated according to applicable GAMP requirements
The product is released by an identified person independent from production
Batch traceability managed through SAP system validated according to applicable GAMP requirements
Glycerol has been included in the Annex V of REACH Regulation and therefore exempted from a compulsory registration

INCI name GLYCERIN
IUPAC name Propane-1,2,3-triol
CAS number 56-81-5
EC number (EINECS) 200-289-5
REACH Status Glycerol has been included in the Annex V and therefore exempted from a compulsory registration
Chemical Formula C3H8O3
Molecular weight 92.09 g/mol

Clear and colorless, viscous and syrupy liquid, miscible in all proportion with water and lower aliphatic alcohols, hygroscopic, bacteriostatic, with a remarkable thermal stability

24 months from the manufacturing date

(Stability Testing performed according EMEA guidelines CPMP/QWP/122/02, rev. 1 corr “Guideline on Stability Testing: Stability Testing of Existing Active Substances and Related Finished Products”)

The product can be delivered in:

Tankers for product delivery of bulk – not less than 23.000 kg capacity
Plastic IBCs (Intermediate Bulk Containers) – 1.250 kg capacity
Internally coated Iron drums – 260 kg capacity
Plastic cans – 25 kg capacity

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