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Chemical Discipline
FDCA Form 37 Approved21 CFR Part 11 Compliant
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Residual Solvent Testing

Headspace GC and direct injection GC methods for Class 1, 2, and 3 residual solvents in APIs and drug products.

USP <467>ICH Q3CHeadspace GCClass 1/2/3
Turnaround Time5–7 working days
Solvents Covered60+ ICH Q3C solvents
Detection LimitSub-ppm levels
Regulatory AcceptanceUSFDA, EMA, ICH
● Lab Capacity ActiveForm 37 Certified

Study Protocol Support

Direct access to analytical specialists for study design, method validation, and turnaround timelines.

Submit Sample MatrixDownload Service Spec Sheet
Direct Technical Desk:+91 76240 54108
Service Scope & Regulatory Framework

Rigorous Scientific Execution Built for Global Regulatory Dossiers

Jarvogen provides ICH Q3C and USP <467> compliant residual solvent testing for APIs, drug products, and excipients. Using headspace GC-FID and GC-MS, we detect and quantify Class 1 (carcinogenic), Class 2 (non-genotoxic), and Class 3 (low toxic potential) solvents with high sensitivity and accuracy.

Compendial Standards & Regulatory Alignment:
✓ USP <467>✓ ICH Q3C✓ EP 2.4.24✓ JP
Dual-Analyst Review

100% 4-eye verification of all chromatograms, integrations, and calculations before CoA generation.

ALCOA+ Data Integrity

Direct electronic data capture with immutable audit trails, restricted rights, and disaster backups.

Technical SpecificationscGLP Compliant

Turnaround Time5–7 working days
Solvents Covered60+ ICH Q3C solvents
Detection LimitSub-ppm levels
Regulatory AcceptanceUSFDA, EMA, ICH
Quality Credentials
FDCA Gujarat Form 37ICH Compliant (Q1–Q14)21 CFR Part 11
Key Analytical Capabilities

What's Covered in the Testing Scope

Comprehensive assay, stability, and characterization endpoints validated to global pharmacopoeial standards.

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Class 1 solvents (benzene, CCl4, 1,2-DCE)Executed with validated SOPs and full raw data audit trails.
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Class 2 solvents (acetonitrile, methanol, DCM)Executed with validated SOPs and full raw data audit trails.
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Class 3 solvents (acetone, ethanol, IPA)Executed with validated SOPs and full raw data audit trails.
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Headspace GC-FID (primary method)Executed with validated SOPs and full raw data audit trails.
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GC-MS for unknown identificationExecuted with validated SOPs and full raw data audit trails.
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Method development for novel solventsExecuted with validated SOPs and full raw data audit trails.
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Limit testing and quantitative analysisExecuted with validated SOPs and full raw data audit trails.
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ICH Q3C Option 1 and Option 2 limitsExecuted with validated SOPs and full raw data audit trails.
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Pharmaceutical excipient testingExecuted with validated SOPs and full raw data audit trails.
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Regulatory submission-ready reportsExecuted with validated SOPs and full raw data audit trails.
Qualified Laboratory Infrastructure

Validated Instrumentation & Data Systems

All instruments operate with full IQ/OQ/PQ qualification, automated audit trails, and 21 CFR Part 11 software packages.

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GC-FID with Headspace Sampler

Primary method for residual solvents

IQ/OQ/PQ QualifiedALCOA+ Audit Trail
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GC-MS

Identification and confirmation of unknowns

IQ/OQ/PQ QualifiedALCOA+ Audit Trail
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Headspace Autosampler

Automated sample introduction

IQ/OQ/PQ QualifiedALCOA+ Audit Trail
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Static Headspace System

Volatile solvent analysis

IQ/OQ/PQ QualifiedALCOA+ Audit Trail
Study Execution Lifecycle

How We Execute Your Study

Standardized 4-stage laboratory workflow ensuring traceability from sample intake to CoA release.

01
Stage 01

Solvent Identification

Solvents used in synthesis identified; ICH Q3C class determined.

02
Stage 02

Method Selection

USP <467> method or validated in-house method selected.

03
Stage 03

Headspace GC Analysis

Samples analyzed by headspace GC-FID with certified reference standards.

04
Stage 04

Limit Comparison & Report

Results compared against ICH Q3C/USP <467> limits; compliance report issued.

Scientific Questions & Answers

Technical FAQs

Standard testing is delivered in 5–7 working days. Expedited priority slots are available upon request with dedicated instrument reservations and expedited QC review.
Ready for Sample Testing?

Initiate Your Residual Solvent Testing Study

Submit your sample matrix or request a pre-study analytical protocol discussion with our senior scientists today.

Schedule Scientific Consultation
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