ICH Q3C & USP <467>

Residual Solvents & Volatile Organics by Headspace GC

Organic solvents used in pharmaceutical API synthesis, extraction, and formulation processes cannot be completely removed by manufacturing techniques. Satvam Research validates and executes headspace gas chromatographic methods to quantify residual volatile contaminants, including Residual Ethylene Oxide (ETO), Ethylene Glycol, Diethylene Glycol, Methanol, Acetonitrile, and DCM.

Standard Turnaround
4 - 6 business days
Testing Facility
8,500 sq. ft. cGLP Lab, Vapi
Data Integrity
21 CFR Part 11 Compliant
Regulatory Overview & Key Technical Definition

About Residual Solvent Analysis (GC/GCHS)

Satvam Research performs high-sensitivity residual solvent profiling and volatile organic analysis complying with ICH Q3C and USP <467>. Utilizing Shimadzu Nexis GC-2050 and GC-2014C gas chromatography systems with automated Headspace samplers and FID/TCD detectors, we quantify Class 1 (carcinogenic), Class 2 (toxic), and Class 3 (low toxicity) solvents down to ppm and ppb thresholds.

Testing Scope

Key Capabilities & Parameters

Conducted strictly in accordance with official compendial monographs and validated study protocols

Class 1 Solvents: Benzene, Carbon tetrachloride, 1,2-Dichloroethane, 1,1-Dichloroethene
Class 2 Solvents: Acetonitrile, Chlorobenzene, Chloroform, Hexane, Methanol, Pyridine, Toluene
Class 3 Solvents: Acetone, Ethanol, Ethyl acetate, IPA, MEK
Residual Ethylene Oxide (ETO) and Ethylene Chlorohydrin (ECH) testing
Diethylene Glycol (DEG) and Ethylene Glycol (EG) screening in liquid formulations
Infrastructure

Qualified Instrumentation Deployed

21 CFR Part 11 compliant hardware configurations governed by full IQ/OQ/PQ qualifications

Gas Chromatograph with Headspace - Nexis GC-2050 & GC-2014C
Shimadzu Corporation
Model: Nexis GC-2050 & GC-2014C

Gas Chromatograph with Headspace

Automated static headspace sample vaporization with high-sensitivity FID and TCD detection.

Compliance Architecture

Regulatory Framework & Standards

Testing protocols aligned with domestic and global health authority requirements

ICH Q3C(R8) Impurities: Guideline for Residual Solvents
USP <467> Residual Solvents (Procedures A, B, and C)
Ph. Eur. 2.4.24 Identification and Control of Residual Solvents
IP Residual Solvents Guidelines
Logistics

Sample Submission Guidelines

Dispatch specifications for guaranteed analytical integrity

Minimum Sample Qty
10 - 20 g of solid API / excipient, or 30 mL of liquid product.
Container Type
Airtight glass vials with Teflon-lined caps to prevent volatile solvent evaporation.
Storage Condition
Stored tightly closed at 2-8°C or ambient as specified.
Standard TAT
4 - 6 business days
Special Instruction: List all known organic solvents utilized in the manufacturing process.
Frequently Asked Questions

Technical & Regulatory Inquiries

What is the difference between USP <467> Procedure A and Procedure B?

Procedure A is an identification and screening method using a G43 (6% cyanopropylphenyl / 94% dimethylpolysiloxane) column. If a solvent exceeds the limit, Procedure B on a G16 (polyethylene glycol) column of differing polarity confirms the identity, followed by Procedure C for exact quantitation.

Initiate Your Residual Solvent Analysis (GC/GCHS) Testing

Contact our analytical laboratory in Vapi to review your protocol requirements, discuss sample shipping, or schedule a facility audit.

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