Delhi · Gurugram · Bangalore · Baddi · Bahadurgarh

Extractables & Leachables Testing — ISO 10993-18:2020

Chemical characterisation is the foundation of every modern biological evaluation — and ISO 10993-18:2020 has shifted the bar. Auriga Research provides NABL-accredited extractables and leachables (E&L) testing per ISO 10993-18:2020 for medical devices, drug-device combination products, and pharmaceutical packaging, using the Threshold of Toxicological Concern (TTC) framework as the primary risk-assessment tool.

Our analytical platform covers GC-MS for volatile and semi-volatile organics, LC-MS/MS (UHPLC-HRMS) for non-volatile organics, ICP-MS for elemental impurities, headspace GC-MS for residual solvents, FTIR for polymer ID, and TOC / IC for ionic species — all in-house in one accredited laboratory. We perform the full ISO 10993-18:2020 workflow: extraction at three solvent polarities, AET-based quantification, structure elucidation, TTC-based toxicological risk assessment, and simulated-use leachables under ISO 10993-12.

For drug-device combination products (prefilled syringes, autoinjectors, inhalers, on-body delivery systems, drug-eluting implants), E&L studies reference both ISO 10993-18:2020 and the applicable container-closure standards — USP <661.1> / <661.2>, USP <381> for elastomerics, and draft ICH Q3E alignment — assembled into a single harmonised dossier. Backed by the Arbro Group's analytical heritage — Arbro Lab since 1990, Auriga Research since 2007 — with NABL ISO/IEC 17025 accreditation, reports are accepted by CDSCO, FDA 510(k) / CDER, and EU CE Notified Bodies.

Standard extractables 20–30 days | Full E&L + TRA 6–10 weeks | Express available

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E&L Testing Capabilities

Each capability is mapped to its instrument or ISO 10993-18:2020 workflow step so regulatory and R&D teams can match scope to the biological evaluation plan at a glance.

ISO 10993-18

Extractables Profiling

Extractables profiling per ISO 10993-18:2020 across polar, semi-polar, and non-polar solvent systems.

GC-MS

Volatile / Semi-Volatile

GC-MS identification and quantification of volatile and semi-volatile organic compounds.

LC-MS/MS

Non-Volatile Organics

LC-MS/MS (UHPLC-HRMS) for non-volatile organic extractables and leachables.

ICP-MS

Elemental Impurities

Elemental impurities per ISO 10993-18 / USP <232> / <233>.

Headspace GC

Residual Solvents

Headspace GC-MS for residual solvents and volatile species.

FTIR

Material Identification

FTIR polymer and material identification.

TOC / IC

Carbon & Ionic Species

Total organic carbon and ionic species by TOC / ion chromatography.

ISO 10993-12

Simulated-Use Leachables

Simulated-use leachables studies under clinically relevant conditions per ISO 10993-12.

AET

Evaluation Threshold

Analytical Evaluation Threshold (AET) determination per ISO 10993-18:2020.

TTC

Toxicological Risk Assessment

TTC-based toxicological risk assessment (TRA) — the primary 2020-edition risk-assessment tool.

USP <661>

Combination Overlay

Drug-device combination overlay: USP <661.1> / <661.2>, USP <381>, and draft ICH Q3E alignment.

Validation

Method Development

Method development and validation for device-specific matrices.

How It Works

Get a Quote & BEP Design

Share your device type, material composition, clinical contact category, regulatory target (CDSCO / FDA / CE), and whether this is a stand-alone device or a drug-device combination. Your dedicated SPOC designs the Biological Evaluation Plan (BEP) — extraction solvents, AET, TRA scope, and any USP <661> overlay — before you dispatch anything.

Send Your Sample

Dispatch finished device units (and the drug product simulants for combination products) with a completed Test Request Form to the nearest Auriga lab. Each sample is individually bar coded and registered in YLIMS, Auriga's in-house Laboratory Information Management System, upon receipt. Extraction begins within 24 hours of sample registration.

Testing and QA Review

Your samples are extracted across the polar / semi-polar / non-polar solvent set and analysed on GC-MS, LC-MS/MS, ICP-MS, and headspace GC-MS at our Delhi laboratory. Structure elucidation, AET-based quantification, and the TTC-based toxicological risk assessment are formally reviewed by Auriga's medical-device chemistry team and signed off before the report is generated.

Receive Your NABL Report

Your NABL-accredited E&L report is delivered digitally within the committed turnaround time. Reports carry Auriga's NABL accreditation under ISO/IEC 17025:2017, cite the exact ISO 10993-18 edition / amendment applied, and are accepted by CDSCO, FDA 510(k) / CDER, and CE Notified Bodies. The full chemistry, AET workings, and TRA narrative are formatted for direct attachment to the biological evaluation file.

Turnaround Time

Service	Standard TAT	Express
Extractables profiling (3 solvents, GC-MS + LC-MS)	20–30 business days	Available
Elemental impurities by ICP-MS (USP <232>/<233>)	10–14 business days	Available
Simulated-use leachables (per time-point)	15–25 business days	On request
Method development & validation (novel matrix)	10–15 business days	On request
TTC-based toxicological risk assessment (TRA)	+ 10–15 business days	On request
Full ISO 10993-18:2020 + USP <661> dossier	6–10 weeks	On request
Gap-fill / regulatory response E&L addendum	48–72 hours	Express only

Who Needs E&L Testing

Medical device manufacturers building a Biological Evaluation Plan (BEP) per ISO 10993-1 — chemical characterisation per ISO 10993-18:2020 is the foundation of the modern BEP.
Drug-device combination product developers (prefilled syringes, autoinjectors, MDIs / DPIs, on-body delivery, drug-eluting implants) needing ISO 10993-18 + USP <661> in one dossier.
Pharmaceutical companies qualifying primary container closure systems under USP <661.1> / <661.2> and USP <381> for elastomeric components.
Implantable device manufacturers (orthopaedic, cardiovascular, ophthalmic) needing long-term leachables data for permanent-contact biocompatibility evaluation.
Companies seeking to reduce or replace animal testing through robust TTC-based chemical risk assessment.
Packaging system qualification teams running extractables on primary, secondary, and process-contact materials.
Contract manufacturers (CMOs / CDMOs) supporting downstream sponsors' biocompatibility and CCS submissions.
Regulatory consultants assembling MDR 2017/745 technical files, FDA 510(k) BEP packages, and CDSCO Form MD-9 / MD-15 dossiers.
Post-market surveillance teams investigating patient-side complaints potentially linked to leachate exposure.
Sterility-assurance teams correlating biocompatibility (ISO 10993) data with sterilisation residuals — E&L is requested with biocompatibility on nearly every sterile-device file.

Why Auriga for E&L Testing

NABL scope explicitly covering ISO 10993-18:2020

E&L chemical characterisation is explicitly listed on our NABL scope certificate under ISO 10993-18 — not a derivative. CDSCO, FDA, and CE Notified Bodies accept the report without follow-up scope verification.

Current 2020 edition with TTC framework

We test and report against ISO 10993-18:2020 using TTC-based risk assessment and formally calculated AET — the methodology current regulators expect. Reports cite the exact edition / amendment applied on every job.

GC-MS, LC-MS/MS, ICP-MS under one roof

Full analytical platform in a single accredited laboratory — no third-party sub-contracting on the elemental, volatile, or non-volatile arms of an E&L programme. Eliminates the cross-lab variance that triggers reviewer queries.

Drug-device combination capability

Built to assemble ISO 10993-18 and USP <661.1> / <661.2> / <381> data into a single harmonised dossier — the gap that catches most stand-alone device labs when a sponsor moves to a combination-product filing.

Always paired with biocompatibility

E&L is requested with ISO 10993 biocompatibility on nearly every sterile-device file — Auriga runs both arms under one project lead, with one BEP, eliminating the data-reconciliation overhead of split-lab programmes.

Arbro Group analytical heritage

Established analytical heritage through the Arbro Group (Arbro Lab since 1990, Auriga Research since 2007), with NABL ISO/IEC 17025 accreditation — the audit trail medical device, drug-device combination, and CCS sponsors look for in an E&L partner.

Related Services

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 10993-18:2020 requires extractables data as part of the chemical characterisation for biological evaluation per ISO 10993-1.

Does Auriga test per ISO 10993-18:2020 (the current edition) or the older 2005 edition?

Auriga tests per ISO 10993-18:2020 — the current edition — which introduced the Threshold of Toxicological Concern (TTC) framework as the primary risk-assessment tool, formalised the Analytical Evaluation Threshold (AET) calculation, and significantly tightened expectations for chemical characterisation depth and data quality. The 2020 revision is the version CDSCO, FDA, and EU CE Notified Bodies expect in current submissions — submissions based on the 2005 edition routinely receive deficiency letters. Every Auriga E&L report cites the exact ISO 10993-18 edition / amendment applied so reviewers can verify the methodology against their expected version.

Does Auriga support drug-device combination product E&L (container closure systems)?

Yes. For drug-device combination products — prefilled syringes, autoinjectors, dry-powder and metered-dose inhalers, on-body delivery devices, implantable drug-eluting systems — E&L studies are run against both ISO 10993-18:2020 and the applicable container-closure standards. This typically means USP <661.1> (plastics), USP <661.2> (packaging system suitability), USP <381> for elastomeric closures, and the draft ICH Q3E (E&L for biotech and small-molecule products) framework where reviewers expect alignment. Auriga assembles a single, harmonised E&L dossier that satisfies both the device biocompatibility pathway and the drug product container-closure pathway.

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 per ISO 10993-18 / USP <232>/<233>, 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 — the validation pack is delivered alongside the routine data so reviewers can verify recovery, linearity, and reproducibility.

What sample quantity is required for an E&L programme?

Sample quantity depends on device size, the number of solvent systems (typically 3: polar, semi-polar, non-polar), and whether the programme includes leachables, simulated-use studies, and method validation. A standard chemical characterisation programme typically requires 20–40 finished device units. Drug-device combination product E&L (including container closure) usually needs 40–60 units across the device, the primary container, and the drug product simulants. For large or implantable devices where unit-level sampling is impractical, a representative sample-item portion (SIP) approach is agreed at the quote stage. Confirm exact quantities with your SPOC before despatch — particularly for high-value implantables.

What is the regulatory consequence of inadequate E&L data on a biological evaluation submission?

E&L deficiencies are among the top categories of CDSCO, FDA, and CE Notified Body findings on biological evaluation files. (1) CDSCO MD-9 / MD-15 applications without ISO 10993-18:2020 chemical characterisation are returned with a biocompatibility-deficiency — typically blocking the registration timeline by 3–6 months. (2) FDA 510(k) submissions where the BEP relies on outdated 2005-edition data trigger an Additional Information (AI) request that pauses substantial equivalence review. (3) EU MDR technical files lacking TTC-based risk assessment are a leading Notified Body non-conformance. (4) Drug-device combination products where the E&L dossier does not reconcile with the container-closure (USP <661>) data attract an integrated CDER / CDRH review hold. A well-built ISO 10993-18:2020 + USP <661> dataset is materially cheaper than reacting to a deficiency cycle.

Can Auriga support contesting a CDSCO, FDA, or Notified Body finding on E&L with additional data?

Yes. Gap-fill E&L testing in response to a CDSCO deficiency, FDA AI request, or Notified Body non-conformance is a routine workflow. The path is: (1) review the regulator's specific finding with your SPOC; (2) identify whether the gap requires additional solvent extracts, a TTC-based re-evaluation against the 2020 AET, fresh simulated-use leachables, or a container-closure (USP <661>) overlay; (3) run the targeted top-up programme — not a full re-characterisation; (4) issue an NABL-accredited supplementary E&L report formatted as an addendum to the original biological evaluation. Express 48–72 hour turnaround is available for time-critical regulatory response windows.

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