Extractable & Leachable Studies

In the current scenario where E & L studies have become mandatory to meet the safety requirements of medicines and medical devices, Daicel offers the most comprehensive Studies for various portfolio products and a broad range of packaging materials.

Our team also adopts communication and reporting channels through a project management system to match customer specific requirements. We have a team of scientists who are committed to provide the best solutions which meet the needs of pharmaceutical companies.

Daicel offers

  • Vast experience of understanding different formulations, plan and design E & L studies in accordance with current regulatory guidelines
  • In house state of the art facility for isolation and synthesis of impurities observed above AET in the leachable studies
  • Validated methods for both Simulation studies and Leachables studies
  • Risk based approach to E & L Study Design keeping the end goal in mind
  • Quick TAT’s
  • Extractable & Leachables – Quantitative Studies

Why EL testing : Safety and risk to humans

Risk associated with administration route Risk of CCS interacting with drug product
High Medium Low
Highest
  • Inhalation aerosols and solutions
  • Injections and injectable suspensions
  • Sterile powders and powders for injection
  • Inhalation powders
High
  • >Ophthalmic solutions and suspensions
  • Transdermal ointments and patches
  • Nasal aerosols and sprays
Low
  • Topical solutions and suspensions
  • Topical and lingual aerosols
  • Oral solutions and suspensions
  • Topical powders
  • Oral Powders
  • Oral tablets and oral capsules

Relationship cycle

USP Chapters dealing with E & L

Equipped with GC-HS-MS/MS, LC-MS/MS, HRMS, ICP-MS and IC

We ensure compliance with

Key Daicel Capabilities like

Packaging Materials
  • Polycarbonate
  • Rubber stoppers (Chlorobutyl, Brombutyl)
  • Cyclic Olefin copolymer
  • Polyvinyl chloride
  • Low density polyethylene (LDPE)
  • High density polyethylene (HDPE)
  • Glass vials
  • Closures
  • Plungers
Drug Products
  • The “4I’s”: Inhalants, Injectables, Infusions, Implantable
  • OINDPs (Ophthalmic, pMDI, DPI, Nasal Sprays…)
  • Dermal and Topical Applications
  • Bio disposables / Single Use Systems
  • Vaccines
  • Medical Devices
  • Label/Ink Migration
  • Parenterals
  • Peptides/Biologics/Complex Injectables
  • Feeding Tubes etc
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