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

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

  • Pharmaceuticals as Active Principle Ingredient (API)

Certifications and Conformities:

  • Complying with European Pharmacopoeia (Eur. Ph.) monograph 0496 GLYCEROL, General Monograph 02334, General Test 51000
  • Complying with United States Pharmacopoeia (USP) monograph GLYCERIN
  • Manufactured and distributed in compliance with GMP guidelines applicable for substances used as API in drug products (“EudraLex - Volume 4 - Part II: Basic Requirements for Active Substances used as Starting Materials”)
  • Availability of the Certificate of Suitability (CEP) released by EDQM
  • Availability of “Active Substance Master File” in CTD format
  • Quality Control managed through a LIMS validated according to applicable GAMP requirements
  • 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:

  • Plastic cans (Large opening) - 25 kg capacity

Downloadable file(s):

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