Glycerol Eur. Ph. min. 86,5% Vegetable Origin

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
  • Batch traceability managed through SAP system validated according to applicable GAMP requirements
  • Complying with European Regulation 1223/2009 on Cosmetic Products and subsequent amendments
  • In conformity with ECOCERT and COSMOS Standards established for cosmetic raw materials
  • Glycerol has been included in the Annex V of REACH Regulation and therefore exempted from a compulsory registration

Component #1

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


Component #2

INCI name

WATER

IUPAC name

Water

CAS number

7732-18-5

EC number (EINECS)

231-791-2

REACH Status

Water has been included in the Annex IV and therefore exempted from a compulsory registration

Chemical Formula

H2O

Molecular weight

18.02 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 “in bulk” - not less than 23.000 kg capacity
  • Plastic drums - 70 kg capacity
  • Plastic IBCs (Intermediate Bulk Containers) - 1.250 kg capacity
  • Internally coated Iron drums - 260 kg capacity
  • Plastic cans - 25 kg capacity

Downloadable file(s):

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