Enhanced TDS
Knowde-enriched technical product data sheet
Identification & Functionality
- Pharma & Nutraceuticals Functions
- Technologies
- Product Families
Features & Benefits
- Features
Product grades: Non-sterile
Manufacturing site :Xellia Pharmaceuticals ApS, Copenhagen, Denmark
Release site :Xellia Pharmaceuticals ApS, Copenhagen, Denmark
Site registered :Other health authorities
Applications & Uses
- Markets
- Applications
- Applications
Administered intravenously as a colloidal complex with sodium deoxycholate or as a liposomal formulation.
The low germ and endotoxin content makes Xellia’s amphotericin B particularly suitable for parenteral use.
Properties
Regulatory & Compliance
- Certifications & Compliance
- Grade
- Compliance
Ph. Eur.
USP
JP- Regulatory documentation
EU Drug Master File (DMF)/Certificate of Suitability (CEP)
US Drug Master File (DMF)
Letter of Access (LoA)
Packaging & Availability
- Packaging Type
- Packaging sizes
0.1 kgA*
0.5 kgA*
1 kgA*- Packaging material
Primary: Polyethylene bag, with plastic seal
Secondary: Two polyethylene bags, heat sealed
Tertiary: Aluminum container
Storage & Handling
- Shelf-life
2 Years
- Storage conditions
Below 8°C (46°F)