Residual Solvent & Elemental Impurity Analysis
Residual solvents in drugs refer to organic solvents used during the production of active pharmaceutical ingredients (APIs) or excipients, as well as in the drug product formulation process, that cannot be completely removed. Elemental impurities are trace metals potentially present in drugs, which may originate from catalysts, formulation components, and processing containers. Excessive levels of these trace substances may lead to adverse effects, such as toxicity or reduced drug efficacy.
Protheragen Impurity leverages its elite team of scientists, state-of-the-art instrumentation, and stringent quality systems to deliver GMP-compliant, cost-effective, and highly reliable residual solvent and elemental impurity analysis services. Our mission is to become your trusted partner in impurity analysis, as accurate and reliable analytical testing is essential for ensuring regulatory compliance and safeguarding patient medication safety. If you have any requirements, please contact us promptly to obtain your customized solution and quotation.
Our Services
Protheragen Impurity provides comprehensive residual solvent and elemental impurity analysis services covering the entire drug product lifecycle, addressing diverse needs from early-stage R&D to commercial production and post-approval changes.
Residual Solvent Analysis
We develop customized analytical methods based on ICH Q3C classifications and your specific products (APIs, intermediates, excipients, or drug products) and processes. Full method validation ensures precise identification and quantification of ICH Q3C Class 1 (solvents to be avoided), Class 2 (solvents to be limited), and Class 3 (low-toxicity solvents).
| Type | Residual Solvent |
|---|---|
| Class 1 | Benzene, carbon tetrachloride, 1,2-dichloroethane, etc. |
| Class 2 | Acetonitrile, chlorobenzene, chloroform, cumene, cyclohexane, dichloromethane, etc. |
| Class 3 | Heptane, acetone, isobutyl acetate, anisole, isopropyl acetate, ethanol, pentane, etc. |
Elemental Impurity Analysis
Following ICH Q3D guidelines, we assist in analyzing elemental impurities throughout the drug manufacturing process to identify critical target elements (e.g., Cd, As, Hg, Ni). We then perform high-precision and sensitive quantitative determination of these target elemental impurities to ensure compliance with Permitted Daily Exposure (PDE) requirements.
| Type | Elemental Impurity |
|---|---|
| Class 1 | As, Cd, Hg, Pb |
| Class 2A | Co, Ni, V |
| Class 2B | Ag, Au, Ir, Os, Pd, Pt, Rh, Ru, Se, Tl |
| Class 3 | Ba, Cr, Cu, Li, Mo, Sb, Sn |
Our Technology
Inductively coupled plasma mass spectrometry (ICP-MS)
Gas chromatography-mass spectrometry (GC-MS)
Liquid chromatography-mass spectrometry (LC-MS)
Inductively coupled plasma optical emission spectroscopy (ICP-OES)
High-performance liquid chromatography (HPLC)
Others
Deliverables
Detailed experimental plan and raw data
Quantitative analysis results and validation report
Impurity structure analysis report and spectrum
Other data
Process of Our Services
Why Choose Us?
01
Expert Team
Our team is well-versed in the requirements for impurity analysis outlined in major global pharmacopoeias and regulations. We ensure that our method development, validation, and testing processes fully comply with regulatory standards.
02
Cutting-Edge Analysis Platform
We are equipped with a variety of high-sensitivity analytical instruments, ensuring the sensitivity and accuracy of impurity detection, thereby supporting drug development and registration.
03
Customized Services
We understand that every project is unique. We offer highly flexible and tailored service solutions, adapting to your project and budget to provide the most cost-effective services.
04
Efficient and Timely Delivery
We assign dedicated project managers with proven expertise to maintain real-time communication with you, guaranteeing streamlined project progression and prompt delivery of high-quality deliverables.