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Impurities Testing in Pharmaceutical Products

Impurities testing for pharmaceuticals is a necessary step in creating a quality product for the market. If your company’s drug is produced with raw materials and APIs from a third-party company, an impurity testing laboratory can verify that ingredients meet quality standards and are in the correct measurements. Do not leave any part of your company’s reputation up to chance—ensure there are no contaminants or impurities in your products. With a modern, GMP-compliant lab like Avomeen, scientists can perform unknown material analyses and identify any trace materials, residuals, or impurities in a sample.

Acquire impurities testing from a reliable lab using techniques such as FT-IR, NMR, ICP-MS, LC/MD, GC/MS, and other relevant techniques. Determine a solution to any contamination issues within your pharmaceutical product and accelerate the release of your product.

Regulatory Guidelines on Impurities

Various international and national organizations regulate and control impurities including the International Conference on Harmonization (ICH), the Food and Drug Administration (FDA), and the United States Pharmacopeia (USP). While these guidelines constantly develop and change, it is important for a lab to have the latest knowledge and equipment to ensure your pharmaceutical products meet specific requirements. There are three main sources of impurities related to drug substances according to ICH guidelines:

  • Organic Impurities – These arise during the manufacturing process or storage of drug substances. Organic impurities include anything that comes from the drug or its components, and  can include known, unknown, volatile, or non-volatile compounds with sources such as starting materials, intermediates, intended by-products, and degradation products.
  • Inorganic (Elemental) Impurities- These arise from raw materials, synthetic additives, excipients, and product processes during manufacturing of the pharmaceutical.
  • Residual Solvents- These are the volatile organic chemicals, which were used during the manufacturing process or generated during production. These can have can have toxic or environmentally hazardous properties, and may be difficult to fully remove.

Why is Impurity Testing Essential?

Especially when using third-party manufacturing, pharmaceutical impurity testing addresses the purity, safety, and quality of drug substances before they are released into the open market. With so many potential impurities in all categories, including starting materials and their contaminants, leachables, degradation products, reagents, catalysts, solvents, and more—comprehensive impurities testing is required.

Whether the concern is about volatile organic impurities, heavy metals, or elemental impurities, an FDA-registered chemical analysis lab like Avomeen can help detect any trace impurities. We will identify and quantify any impurities, and establish a plan to remediate them from your manufactured product. Avomeen’s impurity analysis laboratory will ensure the safety of your customers.

Begin Impurities Testing Today

If you have a pharmaceutical product in the pipeline for your company, be sure to follow the necessary steps to ensure the finished product is safe for your customers. Avomeen can support your product development from an early stage, with a broad range of services for your pharmaceutical products. Trust the expert scientists at Avomeen for your pharmaceutical impurities testing.