Impurity Profiling & Characterization

Impurity Profiling & Characterization

At Zasya, we recognize the critical importance of impurity profiling and characterization in drug discovery, development and manufacturing. Our impurity profiling and characterization services provide detailed analysis and identification of impurities, ensuring that your compounds meet the highest standards of quality and safety. Using advanced analytical techniques and state-of-the-art equipment, we offer comprehensive solutions to detect, isolate, and characterize impurities at every stage of the drug development lifecycle.

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Impurity Isolation

Impurity isolation is a key step in understanding the nature of impurities present in your compound. Zasya Life Sciences utilizes a range of sophisticated techniques such as preparative chromatography, chiral SFC and crystallization to isolate trace impurities from complex mixtures.

Our team of experts ensures that even trace-level impurities are effectively isolated, providing you with the highest purity standards for your active pharmaceutical ingredients (APIs) and drug substances. This process is essential for identifying potential risks and ensuring regulatory compliance.

Impurity Profiling

Our impurity profiling service offers a comprehensive analysis of the types and amounts of impurities present in your compounds. Using advanced techniques like HPLC, LC-MS, NMR, IR and more, we identify and quantify impurities that may be present at various stages of synthesis or in final drug products.

Impurity profiling is essential for understanding the impact of impurities on drug safety, stability, and efficacy. Our experts deliver detailed impurity profiles that help you make informed decisions about formulation and regulatory filings.

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Forced Degradation Studies

Forced degradation studies are performed to simulate the conditions under which a drug substance or drug product may degrade over time. This helps us identify potential degradation products and assess the stability of your compound.

Our forced degradation studies involve exposing your compound to stress conditions such as temperature, humidity, light, and oxidative agents. The results provide valuable insights into the stability of your drug and guide the development of robust formulations with long shelf lives.

Reference Standards Synthesis

The synthesis of reference standards is an essential part of quality control and regulatory compliance. At Zasya Life Sciences, we offer the synthesis of high-quality reference standards for APIs and their related substances. These reference standards are used in analytical testing to ensure consistency, accuracy, and reliability in your product’s quality.

Our team employs rigorous methodologies to prepare reference standards that meet the highest purity and regulatory standards (USP/ BP) ensuring that your pharmaceutical products are compliant with industry regulations and ready for market entry.
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Complete Characterization

Complete characterization of impurities is vital for understanding the chemical profile of compounds and ensuring pharmaceutical safety and efficacy. At Zasya Life Sciences, we provide a full suite of advanced analytical techniques, including NMR (JEOL 400Hz, Delta 6.0), LC-MS, HPLC, GC-MS (Shimadzu GCMS-QP2010 PLUS, GC Solution), IR, polarimetry (JASCO P-2000, Spectra Manager-II), TGA, DSC, KF analysis and pH measurement.
Our state-of-the-art instrumentation enables us to identify unknown impurities, determine their sources, and assess their impact, supporting regulatory submissions and quality assurance. With our expertise and comprehensive capabilities, Zasya ensures reliable data and insights for impurity profiling, structural elucidation, and complete compound characterization.

Purification Services

At Zasya Life Sciences, we are dedicated to providing advanced purification and isolation services our clients in the pharmaceutical, biotechnology, and research sectors.
We specialize in the purification, isolation and characterization of various compounds, including small molecules, peptides, PROTACs, NCEs, nucleosides and APIs. Our experienced analytical expert employs a diverse array of techniques such as flash chromatography and preparative HPLC and Chiral Separation (Prep-HPLC/ SFC) to deliver tailored solutions that exceed expectations.
One of the key aspects that differentiate Zasya is expertise in scale-up purification, achieved through advanced preparative and process chromatography techniques. We ensure a smooth transition from lab-scale purification to larger-scale production while maintaining consistency and reliability throughout the process.
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Why Choose Zasya for Impurity Profiling & Characterization?

We specialize in the purification, isolation and characterization of various compounds, including small molecules, peptides, PROTACs, NCEs, nucleosides and APIs. Our experienced analytical expert employs a diverse array of techniques such as flash chromatography and preparative HPLC and Chiral Separation (Prep-HPLC/ SFC) to deliver tailored solutions that exceed expectations.

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Comprehensive Services
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Advanced Analytical Technologies
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Cost-Effective Solutions
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Quality Assurance
Partner with Zasya Life Sciences for expert impurity profiling and characterization services