Precise Residual Solvent Testing in Pharma Labs
Headspace GC Systems Built for USP <467> Compliance
Residual solvents are impurities that remain in drug substances or packaging — and failure to control them can put products and patients at risk. SCION delivers automated, validated headspace GC solutions tailored to meet strict pharmaceutical regulatory requirements, including USP <467>, ICH Q3C, and cGMP standards.
Why Use Headspace Sampling in Pharma?
- Eliminates complex liquid prep or derivatization
- Isolates volatile impurities from complex drug matrices
- Offers superior reproducibility, traceability, and compliance
- Supports both routine QC and method development
SCION Headspace Samplers for Pharma QC
Versa Headspace Sampler – For Reliable Routine Testing
- Fully automated static headspace with precise temperature & pressure control
- Ideal for monograph-based methods (e.g., USP <467>)
- Supports 21 CFR Part 11 with Versa TekLink™ software
- Compact 12″ footprint for QC labs
Applications:
- Residual solvents in APIs and finished drugs
- Solvent residues in blister packaging
- Method verification and batch release testing
HT3 Headspace Sampler – For Method Flexibility and R&D
- Static + Dynamic headspace in one system
- Up to 300°C sample path for high-boiling solvents
- O.M. software mode for automated method development
- VOCARB trap for ppb-level sensitivity
Applications:
- ICH Q3C Class 1–3 solvent detection
- Method development across multiple matrices
- Extractables/leachables in packaging
Compliance You Can Trust
- ✔ USP <467> / EP 2.4.24 / JP 2.6.16 ready
- ✔ 21 CFR Part 11 audit trail support
- ✔ Secure user profiles & digital signatures
- ✔ IQ/OQ packages available
Supported Methods & Matrices
| Matrix Type | Typical Use | Method |
|---|---|---|
| API powders/tablets | Class 1–3 solvent screening | USP <467> |
| Drug packaging films | Residual solvents and leachables | In-house validated |
| Injectable solutions | Trace volatile solvents | ICH Q3C |
| Coated tablets | Process solvent residue verification | Custom |
Automate. Comply. Scale.
From generic drug manufacturers to contract labs, SCION helps you:
- Improve throughput with walkaway automation
- Achieve repeatable results with precision flow and heat control
- Stay inspection-ready with built-in compliance tools
Headspace Enquiry Form