GLYCEROL EP min. 99,7% E422 Excipient Veg. Origin
Foods as Additive
Pharmaceuticals as Excipient
Cosmetics
Certifications and Conformities:
Complying with Specification laid down for Food Additive GLYCEROL E422 in Regulation (EU) 2023/1329
Authorization to the manufacture and storage of the Food Additive E422 GLYCEROL released by Liguria Region according to Decreto Dirigenziale n. 2363 of 27/05/2013
HACCP in place monitoring all Critical Control Points of the manufacturing process in conformity with Regulation 852/2004 concerning the hygiene of foodstuff
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 to 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 the production
Batch traceability managed through SAP system
Glycerol has been included in 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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Technical Specifications
Product Information Sheet
COSMOS Attestation