Genotoxic Impurity analysis

Genotoxic impurity analysis is undeniably an important factor for testing within the pharmaceutical industry and in any chemical-derived products. Genotoxic impurities (GIs) are, even in trace quantities, DNA-reactive elements that have the propensity to damage one’s genetic material. They possess the capability of causing harmful changes to the DNA chain, which is highly likely to lead to cancerous growths. This is the prime reason why there are some very strict regulations regarding the detection, identification, and quantification of such impurities by ICH, EMA, and USFDA. At Chromak Research, we focus on Genotoxic impurity analysis so that your products follow international safety measures.

According to the ICH M7 guidelines, a genotoxic impurity can be classified into three sub-categories, which are organic and inorganic impurities, and also residual solvents. Such impurities could be added while synthesizing APIs, their excipients, or even during the preparation of formulations. The unparalleled potency for harm means that perilous levels of even minute amounts of a substance make it essential to analyse genotoxic impurities.

Having genotoxic impurity analysis is crucial for any corporation. Without proper detection, a high hurt will occur. That’s why at Chromak Research we follow all protocols guided by ICH M7, EMA, and USFDA so we screen every possible DNA-reactive compound at a minimal level for max efficiency. This helps avoid danger from human recall, regulations, and maintain diagnostic care.

At Chromak Research, we provide an entire range of services that address your needs for genotoxic impurity analysis. Including:

Genotoxic impurity (GI) profiling within APIs and finished pharmaceutical products.

GI testing method development and validation.

Toxicological Risk Assessment (TRA) of the associated risks.

Impurity potential stability and degradation pathways.

Regulatory documentation.

To formulations, we individually test tablets, emulsions, suspensions, creams, and lotions. Our services for the analysis of genotoxic impurities will meet your expectations during the launch of a new product as well as in the re-evaluation of existing formulations.

As with all services offered by Chromak, the accuracy of our laboratory work relies on proprietary analysis software, high-performance instrumentation, and diverse methodologies. The following analytical tools are representative of the industry undertaken at our company and represent our goals regarding precision:

With the aid of our equipment, we are able to confirm compliance with international protocols for the safety of products through the detection of genotoxic impurities at minimal concentrations.

We offer risk characterization evaluations, offering expertly tailored work in Toxicological Risk Assessment and support in TRA. TRA evaluates the level of risk that a pharmaceutical product may pose to its users for low-level genotoxic contaminants. This involves setting Acceptable Intake (AI) limits and Control Justification Limits on scientific scrutiny. This tactic guarantees the efficiency and safety of your test products within the expectations of regulations.

In-depth analysis of Genotoxic Impurities is one of the more sophisticated testing services available. Chromak Research has earned the trust of numerous pharmaceutical companies due to the following.

In order to stay compliant with regulations, performing genotoxic impurity analysis in conjunction with a Toxicological Risk Assessment Analysis is almost mandatory. These services, however, where transparency and accountability are non-negotiable pillars, are provided by Chromak Research. Given our commitment towards safety and meeting regulatory expectations alongside analytical sensitivity, we are the most suitable service provider.

Get in touch with Chromak Research to understand how our offering in equipment and expertise in genotoxic impurity analysis can facilitate a more controlled go-to-market strategy for your product.