- Overview
- Classification
- Our Services
- Our Advantages
Overview
Genotoxic impurities are substances that are capable of directly or indirectly damaging cellular DNA, thereby causing DNA mutations and associated carcinogenicity risks. The damaging effects of such impurities on DNA include chromosome breakage, insertion and modification of covalent bonds during DNA recombination and replication, among others.
Due to their potential hazards, genotoxic impurities are strictly regulated by regulatory agencies worldwide. There is a need to thoroughly evaluate and control these impurities to ensure product safety and efficacy.
Classification of Genotoxic Impurities
Known mutagenic carcinogens
Known mutagens with unknown carcinogenic potential (bacterial mutagenicity positive,a no rodent carcinogenicity data)
Alerting structure, unrelated to the structure of the drug substance; no mutagenicity data
Alerting structure, same alert in drug substance or compounds related to the drug substance (e.g., process intermediates) which have been tested and are non-mutagenic
No structural alerts, or alerting structure with sufficient data to demonstrate lack of mutagenicity or carcinogenicity
Our Services
Our company performs comprehensive testing and analysis using a variety of analytical techniques to detect, quantify and mitigate genotoxic impurities within acceptable limits as stipulated by regulatory guidelines. Our services are primarily listed below:
- Speculation of potential genotoxic impurities
- Development and validation of genotoxic impurity detection methods
- Control of genotoxic impurity levels
- Toxicology data query
- Sample detection
Our Advantages
- Expertise: Our team of experts has extensive experience in genotoxic impurity research and is able to provide accurate and reliable results utilizing the latest technologies and methods.
- Comprehensive Testing: Our company has established universal analytical methods for 12 nitrosamines and 10 sulfonate esters genotoxic impurities.
- Compliance: Our genotoxic impurity research is conducted in accordance with regulatory guidelines, ensuring that all testing meets the requirements of relevant regulatory authorities.
- Fast Turnaround Time: Our company is committed to providing fast and efficient testing services that enable clients to make informed decisions in a timely manner.