Extractables & Leachables Testing India | ISO 10993-18 | NABL

Auriga Research provides NABL-accredited extractables and leachables (E&L) testing per ISO 10993-18 for medical devices, drug-device combination products, and pharmaceutical packaging. Our analytical laboratory performs comprehensive chemical characterisation using GC-MS, LC-MS/MS, ICP-MS, and FTIR to identify and quantify all compounds that may migrate from device materials into patients or drug products.

E&L testing is a critical component of the biological evaluation per ISO 10993-1. Chemical characterisation data feeds directly into toxicological risk assessment, reducing or eliminating the need for animal-based biocompatibility studies. Our programme supports CDSCO, FDA, and EU MDR submissions with data packages that meet current regulatory expectations.

E&L Testing Capabilities

Extractables profiling — polar, non-polar, and semi-polar solvents
GC-MS — volatile and semi-volatile organic compounds
LC-MS/MS (UHPLC-HRMS) — non-volatile organic extractables
ICP-MS — elemental impurities and heavy metals per ISO 10993-18
Headspace GC-MS — residual solvents and volatile species
FTIR — polymer and material identification
Leachables studies — simulated-use extraction per ISO 10993-12
Toxicological risk assessment (TRA) — AET-based evaluation
Method development and validation for device-specific matrices

Who Needs E&L Testing

Medical device manufacturers requiring ISO 10993-18 chemical characterisation
Drug-device combination product developers (prefilled syringes, inhalers)
Pharmaceutical companies evaluating container closure systems
Companies seeking to reduce animal testing through chemical risk assessment
Implant manufacturers needing long-term leachables data

Turnaround Time

Standard extractables profiling (GC-MS + LC-MS across three solvent systems) takes 20-30 business days. Leachables studies take 15-25 business days per time point. Complete E&L programmes with toxicological risk assessment are delivered within 6-10 weeks. Expedited timelines are available for priority regulatory submissions.

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Frequently Asked Questions

What is the difference between extractables and leachables?

Extractables are chemical compounds that can be released from a material or device component under exaggerated laboratory extraction conditions (aggressive solvents, elevated temperature). Leachables are compounds that migrate from the device into the patient or drug product under actual clinical use conditions. Extractables studies identify the worst-case chemical profile; leachables studies confirm what patients are actually exposed to. ISO 10993-18 requires extractables data as part of the chemical characterisation for biological evaluation.

What analytical techniques are used for E&L testing?

Our E&L laboratory uses a comprehensive analytical platform: GC-MS for volatile and semi-volatile organic compounds, LC-MS/MS (UHPLC-HRMS) for non-volatile organics, ICP-MS for elemental impurities and metals, headspace GC-MS for residual solvents, FTIR for polymer identification, and TOC/IC for total organic carbon and ionic species. Method development and validation are performed for each device-specific matrix to ensure accurate quantification of all extractable species.

What is the turnaround time for extractables and leachables testing?

A standard extractables study (three solvent systems with GC-MS and LC-MS analysis) takes 20-30 business days. Leachables studies take 15-25 business days depending on the number of time points and analytical methods. Method development and validation for novel device matrices add 10-15 business days. Complete E&L programmes with toxicological risk assessment take 6-10 weeks.