Cleared to Under 3 Class-1 Solvent Limits
Our residual solvent analysis is part of our medical device testing services — GC-based quantification run out of our Oragadam laboratory to confirm your material sits within safe residual limits.
Call 90876 86986 WhatsApp UsA processing solvent that never fully evaporates doesn’t disappear — it stays behind in the material.
This testing is one of the eight capabilities in our medical device testing services, quantifying processing solvents left behind in polymers, coatings, and finished components. Every residual solvent test run at our Oragadam lab is GC-based and referenced to ICH Q3C and USP <467> limits, so a manufacturer knows exactly what’s left in a material before it moves to the next stage of production.
What Our Residual Solvent Testing Covers
Four checkpoints, run on GC-based instrumentation
Class 1 Solvent Screening
Detecting the solvents that should be avoided altogether.
Class 2 & Class 3 Quantification
Quantifying restricted and lower-risk solvents against their limits.
Headspace GC Analysis
Vapor-phase sampling for accurate trace-level detection.
ICH Q3C / USP Limit Compliance
Comparing results against ICH Q3C and USP <467> residual limits.
Sealed, Labeled, Ready for Headspace
Every sample submitted for residual solvent testing is sealed and labeled before it’s queued for headspace sampling — keeping volatile solvents from escaping before the instrument gets a chance to detect them.
- ✓ Sealed vials to prevent solvent loss
- ✓ Unique sample reference ID at intake
- ✓ Analyst sign-off logged at every stage
Testing After the Process, Not Just Before
This testing isn’t limited to raw materials — finished tablets, capsules, and coated components can carry trapped solvent from their manufacturing process, and we screen those too.
- ✓ Finished product & component screening
- ✓ Coating and encapsulation solvent checks
- ✓ Batch-consistent solvent profiling
Where Residual Limits Matter Most
For injectable and parenteral formats, residual solvent limits are especially strict — there’s no digestive buffer between the material and the patient. Our testing gives you the margin of confidence these formats demand.
- ✓ Stricter limit checks for parenteral formats
- ✓ Vial, syringe & container-closure testing
- ✓ Documented findings included in report
How Our Residual Solvent Testing Works
Four steps, part of our broader medical device testing services
Sample Intake
Logged at our Oragadam facility with a unique reference ID.
Vial Sealing
Sample sealed to preserve volatile solvent content.
Headspace GC Run
Vapor-phase analysis on our GC instrumentation.
Certified Report
Delivered digitally, ready for your QA documentation.
Methods Behind Our Residual Solvent Analysis
| CHECK | METHOD | STANDARD |
|---|---|---|
| Class 1 Solvent Screening | Headspace GC | ICH Q3C |
| Class 2 & 3 Quantification | Headspace GC | USP <467> |
| Finished Product Screening | Headspace GC | ICH Q3C / USP <467> |
| Parenteral Format Screening | Headspace GC | ICH Q3C |
Kiyo R&D Lab – Oragadam
Our residual solvent 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 residual solvent testing check for? +
We quantify processing solvents left behind in raw materials, components, and finished products — part of our broader medical device testing services covering identity and safety of device materials.
What method do you use to detect residual solvents? +
We use headspace gas chromatography, referenced to ICH Q3C and USP <467> limits for Class 1, 2, and 3 solvents.
What is the turnaround time for this testing? +
Standard GC-based screening is typically completed within a few working days. Contact us with your sample details for an exact timeline.
Can this be combined with other testing services? +
Yes. This testing is often paired with our raw material analysis and trace metal analysis for a complete chemical profile of a material.
How do I get a quote for residual solvent testing? +
Call us at 90876 86986, message us on WhatsApp, or fill in the enquiry form below with your material details and required tests.
Get Your Materials Screened for Residual Solvents
Talk to our Oragadam lab team about residual solvent analysis as part of your medical device testing services requirement.
Call 90876 86986 WhatsApp UsRequest Residual Solvent Analysis
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