Pune, Maharashtra Jul 10, 2024 (Issuewire.com) - Aquigen BioSciences, a leading contract research and manufacturing organization, today announced a significant expansion of its API (Active Pharmaceutical Ingredient) Impurities analysis capabilities. This enhancement aims to further support pharmaceutical companies in their pursuit of high-quality drug manufacturing and stringent regulatory compliance.
As the pharmaceutical industry continues to evolve, the importance of identifying, characterizing, and controlling impurities in drug substances has become increasingly critical. Aquigen Bio Sciences' expanded API Impurities analysis service addresses this growing need, offering cutting-edge solutions to ensure drug safety and efficacy.
"Our enhanced API Impurities analysis service represents a major step forward in our commitment to supporting the pharmaceutical industry. By investing in advanced technologies and expanding our expertise, we're enabling our clients to navigate the complex landscape of drug development and manufacturing with greater confidence and efficiency,” said the CEO of Aquigen BioSciences.
The Need for API Impurities Analysis
The need for API Impurities Analysis in quality drug manufacturing is paramount to ensuring patient safety and regulatory compliance. As pharmaceutical development becomes increasingly complex, the identification and control of impurities in Active Pharmaceutical Ingredients (APIs) have become critical aspects of the drug production process.
API impurities can arise from various sources, including starting materials, by-products of synthesis, degradation products, and contaminants. These impurities, even in trace amounts, can significantly impact drug efficacy, safety, and stability. Rigorous impurity analysis helps manufacturers:
• Ensure product quality and consistency
• Meet stringent regulatory requirements
• Minimize potential health risks to patients
• Optimize manufacturing processes
• Enhance the overall safety profile of medications
Furthermore, as regulatory bodies worldwide tighten their guidelines on impurity limits, pharmaceutical companies must employ advanced analytical techniques to detect, identify, and quantify impurities with unprecedented precision. This proactive approach not only safeguards public health but also streamlines the drug approval process, potentially accelerating time-to-market for new therapeutics.
Key Features of Aquigen's Expanded API Impurities Analysis:
- Advanced Analytical Techniques: Utilizing state-of-the-art chromatography and spectroscopy methods for precise impurity identification and quantification.
- Comprehensive Impurity Profiling: Detailed analysis of process-related impurities, degradation products, and genotoxic impurities.
- Custom Reference Standards: Development and synthesis of impurity reference standards for accurate quantification and characterization.
- Regulatory Compliance Support: Assistance in preparing impurity-related documentation for regulatory submissions.
- Method Development and Validation: Creating robust analytical methods tailored to specific API impurity profiles.
Products:
API & Intermediates: Aquigen BioSciences offers a comprehensive range of high-quality APIs and intermediates. Their products are essential building blocks for pharmaceutical synthesis, enabling researchers and manufacturers to streamline their drug development processes with reliable, pure compounds.
Impurity Standards: Impurity standards are crucial for quality control in pharmaceutical manufacturing. Aquigen BioSciences provides a wide array of precisely characterized impurities, including process-related and degradation impurities. Notably, their Nitroso impurity standards address the growing concern over nitrosamine contamination in drugs, supporting manufacturers in meeting stringent regulatory requirements.
Services:
The expansion of Aquigen's API Impurities analysis capabilities complements the company's existing portfolio of services, which includes:
- Deuterated Labelled Compound Synthesis: Aquigen offers a wide range of deuterium-labeled compounds, crucial for drug metabolism studies and pharmacokinetic research.
- Peptide Impurity Standards: Custom-made peptide impurity standards are provided to support the development and quality control of peptide-based therapeutics.
- API Impurities: The company specializes in the synthesis of API impurities, key building blocks in the production of active pharmaceutical ingredients.
- Nitrosamine Detection and Quantification: With growing concerns over nitrosamine impurities in pharmaceuticals, Aquigen offers specialized services for their detection and quantification.
- Medicinal Chemistry Services: Supporting drug discovery efforts through the design, synthesis, and optimization of novel chemical entities.
- Analytical Services: Comprehensive analytical support, including method development, validation, and impurity isolation and characterization.
Aquigen Bio Sciences understands that the journey from drug discovery to market approval is complex and challenging. Their expanded API Impurities analysis service, combined with our full suite of research and manufacturing support, positions them as a valuable partner throughout the entire drug development lifecycle.
The company's commitment to quality and innovation is evident in its state-of-the-art facilities and highly skilled team of scientists. Aquigen's laboratories are equipped with the latest analytical instrumentation, including high-resolution mass spectrometry, NMR spectroscopy, and advanced chromatography systems.
Furthermore, Aquigen Bio Sciences maintains a strong focus on regulatory compliance, ensuring that all services meet the stringent requirements of global regulatory agencies, including the FDA, EMA, and others. By providing access to specialized expertise and advanced analytical capabilities, Aquigen enables pharmaceutical companies to streamline their development processes, reduce costs, and bring life-saving medications to market more efficiently.
Conclusion:
Aquigen Bio Sciences' expanded API Impurities analysis service represents a significant advancement in the company's capabilities and a valuable resource for the pharmaceutical industry. By combining this enhanced service with its comprehensive portfolio of research and manufacturing support, Aquigen is well-positioned to play a crucial role in accelerating drug development and ensuring the quality and safety of pharmaceutical products.
For more information about Aquigen Bio Sciences' expanded API Impurities analysis service and to explore how we can support your drug development efforts, please click here to connect with us for bulk API Impurities analysis services and other research support needs.
Media Contact
Aquigen Bio Sciences bd@aquigenbio.com +91 7030123794 281/1 Plot, 41, Hinjawadi - Pirangut Rd, Kasar Amboli, Pirangut, Maharashtra 412108 https://aquigenbio.com/
