EXCIPIENTS

Synthetic Glycerin

Synthetic Glycerin is a unique product in that its exceptional properties make it different from those of plant origin.

Its manufacturing process guarantees the obtainment of a highly pure and stable product that complies with the highest regulatory standards of the Pharmaceutical Industry.

Origin of Synthetic Glycerin

Synthetic Glycerin, produced by Blue Cube in their Stade plant (Germany) is distributed by our Hedinger representative from their two plants located in Germany.

Hedinger, founded in 1843, makes and distributes excipients for the Pharmaceutical Industry under GMP/GDP conditions.

Thanks to their state of the art facilities, they offer laboratories that make more critical specialities (biologists, biosimilars, injectables as well as ophthalmics) Glycerin with microbiological and endotoxins subjected to a strict quality control (parenteral grade quality). For the less critical specialties (syrups, creams, gels, vaginal applicators, suppositories, ointments, child related specialities, etc…) they offer Pharma quality in the same GMP compliance.

MANUFACTURING PROCESS AND TRANSPORT SUBJECTED TO THE STRICTEST QUALITY CONTROL

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PURITY

  • It doesn’t contain allergens
  • It doesn’t contain aflatoxins
  • It doesn’t contain pesticide residues
  • In agreement with the ICH Guideline for residual solvents

STABILITY

  • Extremely low level of aldehydes. Certified by qualified personnel
  • Odorless and colorless throughout the shelflife of the product
  • Excellent shelflife. 36 months vs. 12/24 months for plant based Glycerin.

CERTIFICATES

  • Excipact
  • GMP (German Authorities)
  • ISO 9001, ISO 14001
  • OSHAS

REGULATORY QUALITY SUPPORT

  • Regulatory GMP Quality questionnaires
  • Audits
  • Technical Package
GLYCEROL (Synth.) Glycerol Ph.
Eur./USP/JP 99.7%
OPTIM™
Pharma Grade		 Glycerol Ph.
Eur./USP/JP 99.7%
OPTIM™ PLUS
Parenteral Grade		 Glycerol Ph.
Eur./USP/JP 99.7%
OPTIM™ PLUS
Parenteral Grade LA		 Glycerol 85% Ph Eur.
OPTIM™
Pharma Grade		 Glycerol 85%
Ph. Eur./ JP
OPTIM™ PLUS API
Parenteral Grade
Especificaciones del producto USP/EP/JP X X X EP EP/JP
Fabricación según normas GMP X X X X X
Distribución según normas GDP X X X X X
Re-envasado en sala blanca X X X X X
Análisis GMP completo X X X X X
Diluciones según las necesidades del cliente X X X X X
COA Firmado por Responsable Técnico X X X X X
Control de Bioburden y Endotoxinas X X X
Supervisión del proceso de llenado por un farmacéutico/químico X X X
Muestreo X X X
API grade X
Otros servicios especiales para el cliente X X X X X
Vida útil 36 meses 36 meses 36 meses 36 meses 24 meses
Opción Especificación nivel de Aldehídos X X
Recomendado para formulación de: Jarabes, cremas, geles, pomadas, aplicadores vaginales, laxantes. Oftálmicos e Inyectables Insulinas, vacunas, oftálmicos, APIs sensibles a los aldehídos, biológicos, biosimilares. Enzinas, jarabes, dentífricos infantiles, desinfección bucal infantil, cremas, pomadas. Nutrición parenteral

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Download your Glycerin catalogue.

 

Download Glycerin catalogue.