Precision Down to 4 Parts Per Million
Our trace metal analysis is part of our medical device testing services — ICP-based elemental impurity screening, run out of our Oragadam laboratory to keep catalyst residues and leachable metals within safe limits.
Call 90876 86986 WhatsApp UsEven trace levels of the wrong element can turn a safe material into a liability.
Our trace metal analysis is one of the eight capabilities in our medical device testing services, screening raw materials, components, and finished devices for elemental impurities and catalyst residues down to trace levels. Every trace metal analysis run at our Oragadam lab is referenced to ICH and USP elemental impurity limits, so results are documented and defensible in your quality file.
What Our Trace Metal Analysis Covers
Four checkpoints, run on ICP-based instrumentation
Elemental Impurity Screening
Quantifying elemental impurities present in raw materials and finished devices.
Catalyst Residue Detection
Tracing manufacturing catalyst residues left behind in a material.
Leachable Metal Screening
Checking for metals that could leach out of a device into a patient.
ICH/USP Limit Compliance
Comparing results against ICH Q3D and USP elemental impurity limits.
A Second Look, Before the Instrument
Before any sample reaches our ICP instrumentation, our analysts visually review it for consistency and flag anything unusual — a manual check that keeps this result trustworthy from the very first step.
- ✓ Visual sample consistency review
- ✓ Unique sample reference ID at intake
- ✓ Two-analyst sign-off before testing begins
Naming Exactly Which Element
Our trace metal analysis doesn’t stop at “metals present” — every element detected is identified and quantified against its own regulatory limit, from common catalyst metals to less common trace elements.
- ✓ Element-by-element identification
- ✓ Quantification against individual limits
- ✓ Full elemental panel available on request
Down to a Single Component
This testing isn’t limited to bulk raw material — individual components, coatings, and finished parts can be screened on their own, giving you a clear picture of where an elemental impurity is actually coming from.
- ✓ Component-level and bulk material testing
- ✓ Source-tracing support for flagged results
- ✓ Documented findings included in report
How Our Trace Metal Analysis Works
Four steps, part of our broader medical device testing services
Sample Intake
Logged at our Oragadam facility with a unique reference ID.
Sample Digestion
Prepared into solution for elemental screening.
ICP Analysis
Elemental screening on ICP-based instrumentation.
Certified Report
Delivered digitally, ready for your QA documentation.
Methods Behind Our Trace Metal Analysis
| CHECK | METHOD | STANDARD |
|---|---|---|
| Elemental Impurity Screening | ICP-OES / ICP-MS | ICH Q3D |
| Elemental Limit Compliance | Comparative Limit Testing | USP <232>/<233> |
| Catalyst Residue Detection | ICP-Based Screening | ICH Q3D |
| Leachable Metal Screening | Extractables-Based ICP Testing | USP <232>/<233> |
Kiyo R&D Lab – Oragadam
Our trace metal analysis and medical device testing services are based at No.13, Srinivasa Perumal Street, Panapakkam, Serapanacheri, Greater Chennai, Tamil Nadu 601301.
Frequently Asked Questions
What does this testing service cover? +
Our trace metal analysis screens raw materials, components, and finished devices for elemental impurities, catalyst residues, and leachable metals — part of our broader medical device testing services covering identity and safety of device materials.
What method do you use for this testing? +
We use ICP-based (ICP-OES/ICP-MS) instrumentation, referenced to ICH Q3D and USP <232>/<233> elemental impurity limits.
What is the turnaround time for trace metal analysis? +
Standard elemental screening is typically completed within a few working days. Contact us with your sample details for an exact timeline.
Can trace metal analysis be combined with other services? +
Yes. Trace metal analysis is often paired with our raw material analysis and residual solvent analysis for a complete elemental and chemical profile.
How do I get a quote for trace metal analysis? +
Call us at 90876 86986, message us on WhatsApp, or fill in the enquiry form below with your material details and required tests.
Related Medical Device Testing Services
Get Your Materials Screened for Trace Metals
Talk to our Oragadam lab team about this testing as part of your medical device testing services requirement.
Call 90876 86986 WhatsApp UsRequest Trace Metal Analysis
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