Impurity Identification and Characterization
In the process of drug development and production, impurity identification and characterization are critical steps to ensure the safety, efficacy, and quality control of pharmaceuticals. Impurities may originate from raw materials, the synthesis process, degradation products, or packaging materials, and their presence can impact the stability and safety of the drug, potentially leading to toxic side effects. Therefore, impurity identification and characterization have become a cornerstone of the pharmaceutical quality control system.
In the face of increasingly complex molecules, stringent regulatory requirements, and intense market competition, choosing a partner with strong technical capabilities, deep regulatory knowledge, extensive project experience, and comprehensive service capabilities is crucial. Protheragen Impurity, with its state-of-the-art instrument platform, experienced expert team, and client-centric service philosophy, is dedicated to providing you with one-stop impurity identification and characterization services, safeguarding the development, registration, and post-market quality monitoring of drugs. If you have any needs, please feel free to contact us. Let us be your most reliable and efficient strategic partner in addressing impurity challenges on your path to new drug development and commercialization.
Our Services
Protheragen Impurity provides one-stop impurity identification and characterization services covering the entire drug development lifecycle, from early development to commercialization. Our services aim to:
Identify Unknown Impurities
Determine the chemical structure of unknown peaks or unknown substances exceeding specified limits.
Elucidate Impurity Structures
Accurately confirm the chemical structure of known impurities (including potential impurities, degradation impurities, and genotoxic impurities).
Assess Impurity Risks
Understand the source (process-related or degradation-related), formation mechanism, physicochemical properties, and potential safety risks (especially genotoxicity).
Support Regulatory Compliance
Provide comprehensive impurity study data compliant with international guidelines such as ICH Q3A(R2) for drug registration applications (such as INDs, NDAs, and ANDAs), ensuring drug safety, efficacy, and quality control.
Organic Impurity Identification and Characterization
- Starting materials
- Intermediates
- By-products
- Degradation products
- Genotoxic impurities (GTIs)
- Potential impurities
Inorganic Impurity Identification and Characterization
- Catalyst residues (e.g., Pd, Pt),
- Toxic elements (e.g., Cd, Hg, Pb, Ni )
- Other metallic elements
Residual Solvent Identification and Characterization
- Highly toxic (Class 1) (e.g., benzene)
- Limited toxicity (Class 2) (e.g., methanol)
- Low toxicity (Class 3) (e.g., ethanol)
Our Technology
High-performance liquid chromatography (HPLC)
Liquid chromatography-mass spectrometry (LC-MS)
Inductively coupled plasma mass spectrometry (ICP-MS)
Gas chromatography-mass spectrometry (GC-MS)
Nuclear magnetic resonance (NMR) spectroscopy
Others
Deliverables
Detailed analysis report
Relevant instruments used and their key parameters
Structural elucidation data (NMR, HRMS, IR, etc.)
Complete experimental procedures
Structural formula of the impurity compound (2D/3D)
Other data
Process of Our Services
Why Choose Us?
01
Professional Team
Our technical team consists of experienced pharmaceutical analysts with an average of over five years of industry experience, helping clients address challenges in impurity identification and structure confirmation.
02
World-Class Analytical Platform
We are equipped with cutting-edge equipment such as LC-MS, NMR, and GC-MS to ensure high-quality, reliable analytical data. We provide not only data but also deep interpretation.
03
Flexible Customization
We deeply understand that every project is unique. We reject a "one-size-fits-all" approach and are committed to tailoring the optimal impurity identification and characterization solution for each client.
04
Efficient Communication
We assign a dedicated project manager to each client, ensuring transparent and timely communication, proactively responding to client needs, and collaboratively advancing projects.