PHARMA TESTING

Residual Solvents Testing by GC-MS/MS Headspace

Residual solvents left behind from manufacturing processes are classified by regulators according to their toxicity, and pharmaceutical products must demonstrate they fall within permitted limits. DALPL's Pharma Testing Division tests for residual solvents using an Agilent GC-MS/MS 7010B with headspace autosampler, aligned to the current ICH Q3C(R9) framework, US FDA's Q3C guidance and Tables and List, and USP General Chapter <467>.

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GC-MS/MS
Headspace GC-MS/MS setup for residual solvent testing
Target Residual Solvents
Method Headspace GC-MS/MS
Frameworks ICH, FDA, EMA, USP
TOXICITY-BASED CLASSIFICATION

What We Test

DALPL provides comprehensive residual solvent screening and quantitation categorized by toxicity risk.

Class 1 Solvents

Solvents to be avoided. Confirming absence or compliance with strict limits.

Class 2 Solvents

Solvents to be limited. Quantitation against Permissible Daily Exposure limits.

Class 3 Solvents

Solvents with low toxic potential. Limit testing per USP <467>.

ANALYTICAL DEVELOPMENT

Method & Standards

High-precision analytical frameworks ensuring compliance across global regulatory standards.

Routine Screening

Headspace GC-MS/MS

Headspace GC-MS/MS, aligned to USP <467> Procedures for residual-solvent screening and confirmation. Analysis is performed using an Agilent GC-MS/MS 7010B with headspace autosampler.

Agilent GC-MS/MS 7010B USP <467>
Validation Support

Method Development & Validation

Method development and validation aligned to current ICH Q2(R2)/Q14 principles.

ICH Q2(R2) ICH Q14
LABORATORY CREDENTIALS

Why DALPL

Delivering high-accuracy impurity profiling with uncompromised regulatory integrity.

FDA Maharashtra, US FDA Inspected, Health Canada Approved
Our facilities operate under the highest international quality standards.
Dedicated Pharma Testing Division
Our team is experienced specifically in trace-level testing including residual solvents and elemental impurities.
US-FDA
FDA-Maharashtra
Health Canada
STEP-BY-STEP TESTING PROCESS

How It Works

DALPL follows a structured analytical process for residual-solvent testing, from requirement assessment through analysis and reporting.

01

Requirement Assessment

Review the testing requirement, pharmaceutical product and applicable residual-solvent classification/framework.

02

Analytical Approach

Define the appropriate headspace GC-MS/MS analytical approach in line with the applicable standards and testing requirement.

03

Headspace GC-MS/MS Analysis

Perform residual-solvent analysis using the documented analytical capability.

04

Results & Reporting

Provide the analytical results and reporting relevant to the agreed testing requirement.

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Get Residual Solvents Testing Support

Speak with our pharmaceutical testing specialists to discuss your method development, validation, or batch release requirements.

Get a Residual Solvents Testing Quote Talk to Our Testing Experts