Purity Enrichment Services: Enhancing the Quality and Safety of Chemical Compounds

Posted on November 28, 2024November 28, 2024 by aralresearch_admin

Detailed analysis of chemical compositions provides valuable information. This allows chemical problem-solving, supports R&D efforts, and most importantly, enhances the quality and safety of the chemical formulation of products. Purity enrichment analysis is the application of various analytical techniques to get detailed data on the chemical structure and concentration of the components in the sample of interest. This helps in product development, the concentration of specific components like APIs that impart a specific function to the product, and solving manufacturing problems. With Aral Research, you can be confident in the quality and safety of your chemical compounds.

Purity Enrichment for Chemical Compounds

Purity enrichment plays a crucial role in different stages of research and development in chemical development. It involves the identification and isolation of unknown materials in chemicals, polymers, packaging, and other materials. To ensure the quality and safety of chemical compounds, various analytical techniques like gas or liquid chromatography, mass spectrometry, preparative LCMS, and other methods are used. Aral Research has a broad spectrum of analytical services to characterize unknowns and impurities to produce reliable results. We employ gas chromatography, mass analysis, and purity by HPLC in Ahmedabad to detect irregularities, trace levels, and impurities in our state-of-the-art laboratory.

Purity Enrichment for Diverse Chemical Compounds

Agrochemicals & Pesticides: These chemical-based products play a pivotal role in global food production; however, regulatory hurdles can lead to market delays. We employ advanced analytical services like impurity screening by LCMS to achieve a well-characterized product.
Basic & Industrial Chemicals: Chemical raw materials from petrochemicals, basic organics, and intermediaries for chemical processes need to comply with quality and regulatory standards. We can assist you in quality control testing and impurity analysis and guide you through the process.
Speciality Chemicals: Speciality chemicals or performance chemicals are used as an ingredient in the final product to improve the manufacturing process. Our team tests the chemical composition and physical properties of your speciality chemicals to meet and exceed quality and safety and ensure optimal performance characteristics.
Pharmaceutical Chemicals: We provide analytical services for API, NCEs, and drug product formulations that can affect the final stability and shelf life of medical compounds.

The presence of impurities and unknown components at even trace levels can impact the final product. Aral Research, with its years of experience and commitment to excellence, can assist you with purity enrichment to identify the impurities and unknown components. Our team is adept at solving the toughest and most challenging analytical problems. Our lab is equipped with the most advanced instruments for mass analysis, lyophilisation, and HPLC service in Ahmedabad. We employ proven methodologies to efficiently isolate and identify a component to determine the source of impurity. To discuss your research and analysis requirements, call us today.

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Importance of Purity Enrichment Services in Product Development

Posted on September 17, 2024September 26, 2024 by aralresearch_admin

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.

Read Now:- Why do purity enrichment services matter in Pharmaceutical Manufacturing?

Why do purity enrichment services matter in Pharmaceutical Manufacturing?

Posted on August 27, 2024August 29, 2024 by aralresearch_admin

In pharmaceutical manufacturing, the importance of high-purity components cannot be overstated. The presence of impurities, especially API-related impurities, can impact the quality, safety, and efficacy of the drugs. The presence of even small amounts of unwanted components can influence the effectiveness and safety of pharmaceutical products. Analytical methods can easily accurately measure the levels of chemical impurities. Methods like mass spectroscopy and gas chromatography detect the presence of impurities and identify the amounts.

Understanding Pharmaceutical Impurities

Pharmaceutical impurities are unwanted chemicals in API (active pharmaceutical ingredients) or drug formulations. These impurities can arise in synthesis or from other sources like reagents, solvents, catalysts, or reactions from by-products. This is why identification, quantification, and control of impurities are crucial.

Purity Enrichment Services in Pharmaceutical Manufacturing

Aral Research offers purity enrichment services for pharmaceutical manufacturing and biologics development. We provide flash chromatography and HPLC service in Ahmedabad to isolate and purify specific compounds from complex mixtures. Our analytical team leverages the latest technology and methodology to perform product characterization and analytical testing to support drug discovery and formulation.

Preparative Liquid Chromatography: Since the impurities in the drug are present in low quantity, detailed analysis can be done using isolation of impurities. Preparative LC helps to isolate impurities in adequate amounts.
LCMS: LCMS is a highly sensitive and specific analytical tool that is used to detect, identify, and quantify product impurities. Our LCMS analysis in Ahmedabad allows for the unambiguous identification of unknown traces of impurities.
Gas Chromatography: GC is a standard analytical tool for the analysis of volatile organic impurities. A combination of GC and mass analysis can be used to identify and quantify residual solvents.

Benefits of Purity Enrichment Services for Pharmaceutical Manufacturing

Enhance Product Quality: Ensure your products are free from impurities and contaminants and meet quality standards.
Regulatory Compliance: Our purity enrichment services ensure pharmaceutical companies meet regulatory requirements.
Safety & Efficacy: Ensures the drugs are of precise quality and safe from usage.
Consistent Quality: We help contribute to consistency in all batches to maintain drug efficiency.

At Aral Research, we specialize in providing qualitative analytical data with precise interpretation to help clients with research requirements. So whether you are looking for mass analysis, LCMS analysis, lyophilisation, or HPLC/UPLC, we’ve got you covered! Call us to discuss your research requirements.

Category: Purity Enrichment