What are Nitrosamines?

Nitrosamine impurities pose a great risk since they are most likely carcinogenic to humans. Nitrosamines are compounds formed from the reaction of a nitroso group with an amine. Nitrosamines are produced during the interaction of secondary amines, amides, carbamates, urea derivatives, nitrites, or other nitrogenous agents with nitrogen in a +3 state.

Guideline ICH M7 (R1) categorizes nitrosamines as class 1 “known mutagenic carcinogenic” impurities. All processes that involve the use of nitrites and secondary, tertiary, and quaternary amines are prone to the formation of nitrosamine impurities.

The FDA has acknowledged the possibility of the presence of these impurities in drug products, NDMA, NDEA, NMBA, NMPA, NIPEA, NDIPA, and NDBA. Six compounds with defined limits are also included in the list of acceptable intake limits set by the FDA.

Nitrosamines Impurities

Nitrosamines’ presence in all products can be attributed to the following root causes:

  • The use of contaminated solvents, reagents, or catalysts in the API manufacturing process.
  • The presence of nitrosamine impurities in intermediates and starting materials.
  • Incorporation of nitrosating agents such as sodium nitrite (NaNO2).
  • Cross-contamination.
  • Decomposing of starting materials, intermediates, or drug substances.
  • Certain types of packaged products.

Significance of Nitrosamine Impurities Testing

Because nitrosamine impurities have the potential to be carcinogenic, they are an increasing concern in the pharmaceutical, food, and water industries. These impurities can come into existence due to a variety of reasons. Thus, nitrosamine impurities testing is essential to product safety and regulatory compliance.

Regulatory authorities like the FDA, EMA, and WHO keep strict supervision on acceptable levels of nitrosamine in pharmaceuticals. Ignoring them can lead to product recall, severe revenue loss, and health risks. To ensure the safety of public health, contamination control, and regulatory compliance, effective nitrosamine impurities testing should be performed.

Examining Methods for Nitrosamine Impurities

Finding and quantifying nitrosamine impurities is best done with the aid of sophisticated analytical tools. To provide reliable results, Chromak Research uses the latest technologies in the testing:

A very sensitive method that is useful for detecting very small quantities of nitrosamines in medicines, food, and other environmental materials.

The method of choice for Volatile nitrosamines commonly found in some drug formulations and foods.

Used to isolate and determine the concentration of nitrosamines in complex sample mixtures.

A highly useful technique in structural elucidation and verification of nitrosamine compounds.

Detects nitrosamine-containing functional groups in raw materials and even in finished products.

Using these techniques, Chromak Research provides reliable findings on the detection and quantification of nitrosamine impurities for various sectors.

Why Chromak Research is the Best Choice for Testing?

Being able to choose the appropriate laboratory for contract testing enables a company to have effective and credible results. Chromak Research is a trusted partner for testing nitrosamine impurities as a result of the following:

Professional Staff

With trained and experienced scientists and analysts, we specialize in providing accurate and reliable results in impurity profiling and risk assessment services.

Prompt and Reliable Services

Manufacturers are assisted in meeting their production schedules as we provide fast and accurate testing procedures.

Advanced Equipment

We maintain sophisticated machinery in our laboratory that allows the detection of nitrosamine impurities at the lowest possible thresholds.

Flexible Testing Options

We offer tailor-made tests specific to the needs of every client such as pharmaceutical, food, and environmental testing.

Nitrosamine Impurities Testing Compliance

Your products meet the legal and safety requirements because we observe international FDA, EMA, ICH, and USP regulations.

Why Chromak Research?

Choosing Chromak Research for your elemental impurities testing needs ensures:

  • ICH, FDA, and USP compliance.
  • The most modern analytical instrumentation.
  • Expert elemental impurities risk assessment capabilities.
  • Fully complete and accurate test results that ensure product safety and efficacy.
  • Personalized service from a professional staff, committed to the success of your project.

We are dedicated to helping the pharmaceutical industry produce safe, effective, and quality drugs at Chromak Research. Allow us to be your ally in the complexities of elemental impurities and complete regulatory compliance. Your safety, our science—let’s advance healthcare together.”.

Conclusion

Regulatory compliance and protection human health needs to be taken with care when dealing with nitrosamine impurities. Working with Chromak Research for these impurities testing ensures that product safety, quality, and compliance are achieved. Contact us now to learn more about the details of our comprehensive testing services.

When it comes to precise and reliable Nitrosamine Impurities Testing, Chromak Research is your analytical testing solutions expert.