@ E422 Glycerol excipient
Glycerol Excipient E422
Glycerol excipient E422 is a food-pharmaceutical additive of vegetable origin, widely used also in the cosmetic and pharmaceutical sectors.
Specifically, this refined glycerin offers high purity and glycerol content of more than 99.5%, making it ideal for multiple applications.
Consequently, it is a versatile ingredient in many industries.
Let’s examine its characteristics, uses, and certifications that guarantee its quality and safety.
Characteristics of Glycerol Excipient E422
Certifications and Compliance of Glycerol Excipient E422
Glycerol excipient E422 is produced and distributed in compliance with numerous regulations and quality standards, including:
- EP 0496 Glycerol Monograph: Compliant with the European Pharmacopoeia.
- Regulation (EU) 2023/1329: Meets the specifications for the food additive E422.
- Regional Authorization: Authorized for production and storage by the Liguria region (Managerial Decree No. 2363 of 27/05/2013).
- HACCP: Hazard Analysis and Critical Control Points system in place according to Regulation 852/2004 on food hygiene.
- GMP Guidelines: These are produced by good manufacturing practice guidelines applicable to excipients used to make medicines.
- Quality Control: Managed via LIMS and validated according to GAMP standards.
- Traceability: Ensured through the SAP management system.
- Exclusion from REACH Registration Obligation: Included in Annex V of the REACH Regulation.
Formats and Delivery of Glycerol Excipient E422
Manufacturers can deliver glycerol excipient E422 in various formats to meet the needs of different industrial sectors.
For instance, they can supply it in tankers with a minimum capacity of 23,000 kg for bulk product delivery.
Alternatively, it is available in HDPE IBC tanks with a capacity of 1,250 kg, internally lacquered iron drums with a capacity of 260 kg, or HDPE cans with a capacity of 25 kg.
Conclusion
Glycerol excipient E422, with its high purity and vegetable origin, represents an excellent choice for multiple industrial applications.
Moreover, its compliance with strict quality and safety standards ensures its use in cosmetics, food, and pharmaceuticals, making it a versatile and reliable ingredient.
Therefore, the availability of different delivery formats ensures it can be easily integrated into various production processes while maintaining high-quality standards.