Impurity Identification USA

Considering life sciences and pharmaceutical companies, product cleanliness is not merely a ‘compliance burden’; it significantly threatens patient health and product efficacy. The evaluation of impurities is one of the prime activities of quality assurance (QA) and quality control (QC) functions in drug development and manufacturing.

Here at Chromak Research, we accompany our clients from raw materials through to the finished product by offering comprehensive impurity identification services compliant with USP, NF, AOAC, and FCC standards.

What is Impurity Identification?

In pharmaceutical quality control, impurity identification is defined as the detection, isolation, and characterization of unrecognized chemical components that may exist in a given material, such as a finished pharmaceutical product, raw material, or excipient.

They can be synthesized in the process of synthesis, formulation, or as degradation products. Whether you are formulating a new drug or analyzing a commercial product, the detection and identification of these impurities are crucial for regulatory needs and consumer protection.

Significance of Impurity Identification

The significance of identifying impurity lies in its ability to ensure product consistency, regulatory acceptance, as well as therapeutic reliability. Any organic or inorganic impurities, even residual solvents, can jeopardize safety, stability, and therapeutic activity of a drug. Chronic illness places an enormous strain on the healthcare system, especially when combined with other complex conditions.

Prominent bodies like the EMA and the USFDA require a comprehensive evaluation of a drug’s impurities. Using our state-of-the-art testing laboratories guarantees that your impurity information meets international standards.

Our Services – From Raw Materials to Product Release

We, at Chromak Research, offer a complete spectrum of repeatable actions from the Impurity research and associated analytics which include:

USP, NF, AOAC, FCC Testing

We verify compliance and accuracy of pharmacopeial and non-pharmacopeial grade materials for food and drug use using USP, NF Standards, AOAC, and FCC Testing.

Raw Materials and Excipients Testing

Guarantee consistency of product formulation by revealing the presence of impurities in active ingredients, excipients, and other grade scope.

Confirmatory Testing

Trust your data to sophisticated analytical techniques with unknown or uncertain results, which we confirm with.

Product Release Testing

Execute comprehensive testing and certification for your finished goods to ensure safety and quality.

Dissolution Testing

Analyse the release profile of new and commercial drug products for regulatory and performance assurance.

Our scientists employ a systematic approach to impurity profiling, backing everything from initial-stage R&D to batch release testing for international markets.

Our Equipment – State-of-the-Art Analytical Instruments

Accurate impurity identification calls for state-of-the-art equipment and expert interpretation. Here at Chromak Research, we utilize the most advanced instruments for impurity identification testing in the industry, which include:

  • High-Performance Liquid Chromatography (HPLC)
  • Gas Chromatography (GC)
  • Liquid Chromatography-Mass Spectrometry (LC-MS)
  • Gas Chromatography-Mass Spectrometry (GC-MS)
  • Inductively Coupled Plasma Mass Spectrometry (ICP-MS)
  • UV-Vis Spectrophotometry

Advanced spectroscopy and chromatography with mass spectrometry allow for the accurate measurement of low-concentration contaminants or impurities and add significant value to your development and regulatory documents.

Toxicological Risk Assessment (TRA) and Impurity Analysis

We also provide Toxicological Risk Assessment (TRA) services to assist in the identification of potential health hazards of impurities, as well as the identification of impurities. This is particularly important if unidentified peaks are identified in chromatograms. We incorporate TRA along with impurity profiling to confirm that your product is safe and compliant.

Why Choose Chromak Research?

Choosing the right laboratory for impurity identification is very important for regulatory approval as well as for the safety of the product. The following professional sectors are served by Chromak Research for the greatest pharmaceutical companies across the globe:

Standards set by USP, NF, AOAC, and FCC are followed in conducting the tests.

We supervise all steps of the process starting from the control of raw materials to the marketing of the finished product.

Modern technology captures relevant information at any chosen unit or level of detail.

Our practitioners are specialists in chemistry and analysis and are equipped with rich experience in impurity profiling and regulatory affairs.

We provide, as agreed, the requisite deliverables about quality within the timelines stipulated by you.

Conclusion

The identification of impurities in a sample is a considerably complex exercise and forms part of the comprehensive quality assurance function performed within the Chemistry and Pharmacy domains.

At Chromak Research, we have unrivaled equipment, all the relevant services, and the capability to stand by a claim of compliance, meaning that we become your service provider of choice for all your impurity test needs.

Whether a new product or an addition to an existing product line, we provide the accuracy and reliability you need to proceed with absolute confidence.

Reach out to Chromak Research to find out about our vast array of services related to impurity identification, and allow us to guide you along the journey to safe, compliant, and extremely high-quality products.