Press Release Summary:
- Verifies products are free from impurities and sources of contamination from containers and packaging materials
- Ensures that container closure systems in aseptic fill/finish are suitable in the development of clients
- Detects and identifies as per U.S. FDA 21 CFR 211.94(a) and European Commission Directive (2001/83/EC) standards
Original Press Release:
Dalton Pharma Services Announces New Analytical Service: Extractables and Leachables
TORONTO (PRWEB) NOVEMBER 10, 2020 - Dalton Pharma Services, a leading North-American contract drug manufacturing organization is pleased to announce the addition of extractables and leachables contract analytical testing services to our Drug Development capabilities.
Extractables are organic and inorganic contaminants such as plasticizers, elastomers, oligomers, dyes, elemental impurities etc. that can be extracted from the surfaces of packaging components under extreme conditions such as elevated temperature and pressure or with exposure to organic solvents. Leachables are defined as organic and inorganic contaminants that can be released from the surface of container closure systems under standard storage conditions.
Extractables and leachables (E&Ls) may be inherently toxic and can contaminate the drug product. The enhanced regulatory standards necessitates pharma industry to develop sensitive and accurate analytical methods to detect, identify, and quantitate extractables and leacheables in drug product, as per U.S. FDA 21 CFR 211.94(a) and European Commission Directive (2001/83/EC).
“We are excited to add extractables and leachables contract analytical testing services to our Drug Development capabilities. Dalton can now ensure that container closure systems in aseptic fill/finish are suitable in the development of our innovative clients’ new medicines. Adding this service to Dalton’s drug development and manufacturing capabilities ensures that our client’s products are free from impurities and sources of contamination in our clients products from containers and packaging materials,” said Peter Pekos, CEO Dalton, Pharma Services.
Dalton Pharma Services is a leading North American cGMP pharmaceutical organization providing integrated drug discovery, development and manufacturing services. We are FDA inspected and Health Canada approved and bring over 30 years of experience to every project. We deliver fully integrated solutions with an emphasis on speed, flexibility and quality. Our integrated services (drug discovery, formulation and process development, custom synthesis, cGMP sterile fill/finish of liquids and powders, cGMP API manufacturing and/or dosage form manufacturing and Accelerated Stability Testing) all at one location helps us to be adaptable, flexible and cost-effective.
To learn more about Dalton visit https://www.dalton.com.
Dalton Pharma Services
349 Wildcat Road