Residual Solvents Analysis
Residual solvents are organic volatile chemicals used or formed during the course of drug substance, excipient, and pharmaceutical product manufacture. They are never completely removed during manufacturing and, if not controlled, their existence can compromise product safety, quality, and regulatory standards. At Chromak Research, we have specialized skills in accurate detection and quantification of residual solvents using advanced analytical techniques to ensure your products meet rigid quality standards.
What are Residual Solvents?
Residual solvents are volatile organic compounds (VOCs) which may be left in drug substances or finished drug products during the manufacture process. They may be from raw materials, reaction media, or purification processes and are not typically removed entirely, especially in multicomponent products. The residues do not contribute to therapeutic activity but may pose potential toxicological risks if present in amounts greater than tolerable.
Residual solvents are classified on the basis of their risk profile by United States Pharmacopeia (USP <467> ) and the International Council for Harmonization (ICH Q3C):
Class 1 Solvents: Known carcinogens (to be avoided)
Class 2 Solvents: Should be minimized due to inherent toxicity
Class 3 Solvents: Low toxic potential
Why Residual Solvent Testing Is Important
Failure to control residual solvents and failure to test for them can result in:
Regulatory non-compliance product recalls
Risk of health risk to consumers
Brand integrity loss
Delays in regulatory product approvals
At Chromak Research, we assist with the compliance and product integrity of pharmaceutical drug makers and developers with precise and reliable residual solvent analysis.
Our Analytical Techniques
We employ sophisticated methods which detect and measure trace levels of solvents from diverse sources of samples such as APIs, excipients, and finished drug products. Our techniques include:
Gas Chromatography (GC) with Flame Ionization Detector (FID)
Volatile solvents preferred technique with high sensitivity
Gas Chromatography-Mass Spectrometry (GC-MS)
Most suited for intricate matrices and identification of unknown solvents.
High-Performance Liquid Chromatography (HPLC)
Applicable to less volatile or non-volatile solvents
International Standards Compliance
Our testing methods strictly abide by the standards of:
- USP <467> – Residual Solvents
- ICH Q3C – Impurities: Guideline for Residual Solvents
We analyze Class 1, Class 2, Class 3, and non-listed solvents to make your product safe for use and within international regulations.
Sample Types and Capabilities
Our research scientists can analyze a wide range of organic compounds, solids, and liquids. From early R&D through pilot lots, or batch release, we provide full-range test support for:
- Active Pharmaceutical Ingredients (APIs)
- Excipients
- Intermediates
- Finished dosage forms
- Experimental formulations
Sample Types and Capabilities
Our research scientists can analyze a wide range of organic compounds, solids, and liquids. From early R&D through pilot lots, or batch release, we provide full-range test support for:
Active Pharmaceutical Ingredients (APIs)
Excipients
Intermediates
Finished dosage forms
Experimental formulations
Why Chromak Research?
Three decades of pharmaceutical testing experience in the industry
cGMP-certified state-of-the-art lab facilities
Employment of validated methods and regulatory-compliant protocols
Rapid turnaround and customized testing solutions for clients
Total development support through final product release
We work in close collaboration with clients to fulfill their requirements and assist in the management of residual solvent levels within acceptable parameters to ensure product safety and regulatory compliance at each stage of development.