Quantification, characterization, and control of impurities are key parameters in product development in terms of pharmaceutical or drug products. Impurities are unwanted chemicals that stain in active pharmaceutical ingredients (API) or drug formulations. The impurities can arise during synthesis or from sources like raw materials, solvents, reagents, intermediaries, reaction by-products, or catalysts. The amount of impurities found in these products determines the safety of the final products. This is why purity enrichment is crucial in the product development stage.
Impurity Identification & Characterization
During the product development stage, unknown compounds can arise from impurities that can be formed in the manufacturing or storage. Regularity bodies require identification of the impurities present in the new drug’s substance and characterize their structure. At Aral Research, we have expertise in analyzing impurities, API, and metabolites in products across different modalities. We offer NMR, gas chromatography, HPLC, high-resolution mass spectrometry, and LCMS analysis in Ahmedabad. Our team serves as your extended team to offer customized purity enrichment in accordance with the FDA, CDSCO, EMA, and other regulatory bodies. Our commitment further extends to our dedicated expertise in analyzing drugs and products for clinical trial support. With our proven techniques and well-established labs, we efficiently evaluate the efficacy and safety of your products.
Types of Impurities
- Organic Impurities: These are found during drug manufacturing or storage.
- Inorganic Impurities: These are found in drug manufacturing, including reagents, inorganic salts, heavy metals, or catalysts.
- Residential Solvents: These are introduced in the preparation stage.
Our Purity Enrichment Solutions Include:
- Nuclear Magnetic Resonance (NMR)
Some unknown impurities are difficult to quantify and characterize. Our NMR analysis in Ahmedabad is a powerful analytical technique for structural elucidation of unknown purities. It determines how the atoms of a specific molecule are interconnected, hence determining purity.
- Gas Chromatography
GC is used to assess the residential solvent impurities of API or drug products, drug samples, toxicological testing, VOCs, food & beverages, cosmetics, and odorous compounds.
- High Ultra Performance Liquid Chromatography and Liquid Chromatography Mass Spectrometry (HPLC/UPLC & LCMS)
The HPLC/UPLC techniques are of profound significance in evaluating impurity profiles and quantification of impurities for API and drug products. Impurity analysis is performed by HLPC with mass analysis, and UV detects and measures all impurities in a sample and offers more efficient and precise results. Moreover, technologies like UPLC provide major enhancements in throughputs and sensitivity, benefiting the process of product release and identification of drug-related impurities.
- High-Resolution Mass Spectrometry
High-resolution mass analysis provides an orthogonal perspective to structural data evaluation in terms of unknown impurity characterization. Mass spectrometry offers precise mass data that is resolved for the computation of the molecular composition of unknown impurities.
Aral Research offers comprehensive support in the identification and quantification of impurities in drug substances and pharmaceutical products. We are a full-fledged research laboratory that specializes in supporting product development, including analytical, drug, and impurity characterization. We provide exceptional analytical solutions for our client’s research and development challenges and tailor these solutions to align with their needs. To know more about analytical services, call us today.
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