GLYCEROL Eur. Ph. min. 86,5% Vegetable Origin - Excipient

GLYCEROL Eur. Ph. min. 86,5% Vegetable Origin – Excipient

Vegetable Origin GMO Free Refined Glycerine diluted with purified water suitable to be used in:

 Pharmaceuticals as Excipient

 Cosmetics

Certifications and Conformities:

 Complying with European Pharmacopoeia (Eur. Ph.) monograph 0497 GLYCEROL
 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
 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 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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You will receive in the email the files referring to the product listed below:

pdf Technical Specifications

pdfProduct Information Sheet

pdfCOSMOS Attestation

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