Assured Quality Pharmaceutical Impurity Standards

Assured Quality Pharmaceutical Impurity Standards at SynThink

SynThink Research Chemicals is a reputable producer and supplier of pharmaceutical impurities and reference standard materials. The company plays a crucial role in providing pharmaceutical companies with the necessary materials to study our products’ quality, stability, and biological safety. Ensuring the highest standards of quality in these impurity standards is of utmost importance for the industry.

Comprehensive Characterization and Purity

To meet the demands of pharmaceutical companies, SynThink Research Chemicals provides impurities and reference standard materials accompanied by a Certificate of Analysis (CoA). The CoA includes a wealth of information, such as 1H-NMR, MASS, and HPLC Purity data. Additionally, the company offers additional data like 13C-NMR, CHN, and TGA upon request. SynThink maintains a commitment to purity levels above 95% (with very few exceptions), and on-demand, we can provide purity levels up to 99%.Assured Quality: Pharmaceutical Impurity Standards at SynThink

Quality Control and Assurance

SynThink Research Chemicals places a strong emphasis on quality control and assurance. Each product undergoes a strict quality control check, employing techniques such as HPLC, NMR, Mass, and physical constant measurements. The company’s dedication to accuracy is reflected in each product’s Certificate of Analysis (CoA), which details the tests performed and the purity information. This CoA is as important as the chemical itself, and SynThink recognizes the significance of transparency and accurate representation of purity levels. The company also prides itself on providing after-sales support, helping customers resolve any issues or concerns they may encounter.

Robust Protocols and Certifications

SynThink Research Chemicals understands that a reliable chemical supplier must have robust protocols, policies, and documentation. Our recent ISO 9001 certification exemplifies this commitment to quality. ISO 9001 certification validates SynThink’s assumption of being a company with proper protocols and policies. Standard Operating Procedures (SOPs) and a robust Quality Management System (QMS) are integral components of our operations, ensuring consistent quality and customer satisfaction.

Confirming Chemical Structure and Purity

In cases where the chemical structure is uncertain or lacks supporting literature, SynThink Research Chemicals employs various tests to confirm the structure and relevant characteristics, including purity. This task requires highly skilled employees and SynThink’s analytical and quality assurance teams have a firm grounding in organic chemistry. Our expertise enables us to develop tests that verify the chemical structure and ensure the purity of the materials.

Standard Testing Process

SynThink Research Chemicals follows a standard testing process to ensure the quality of our pharmaceutical impurities. Techniques such as 1H NMR spectroscopy, mass spectrometry, and Fourier transform infrared spectroscopy (FT-IR) are employed to assign structure and analyze functional groups. In cases where stereochemistry needs to be determined, specific rotation or chiral high-performance liquid chromatography (HPLC) is utilized. HPLC or gas chromatography (GC) coupled with elemental analysis aids in assessing the chemical purity.

Additional Verification Tests

SynThink Research Chemicals is open to conducting additional tests to provide further verification of the identity and purity of materials. Our R&D team understands the importance of adapting to new methodologies and is willing to invest in additional techniques and equipment to enhance our testing capabilities. For example, thermogravimetric analysis (TGA) can be employed to determine volatile components, while X-ray crystallography can reveal the atomic and molecular structure of a chemical. This dedication to thorough testing and adaptability ensures the highest quality of materials delivered to customers.

Ensuring Quality and Adaptability

SynThink Research Chemicals places a strong emphasis on ensuring quality throughout our processes. Thorough testing, coupled with the willingness of our analytical team to adapt and apply new methodologies, is key to achieving this goal. Additionally, the company remains open to incorporating additional techniques and equipment to enhance our testing capabilities. By investing in expertise and resources, SynThink maintains its commitment to delivering pharmaceutical impurities of the highest quality.

SynThink Research Chemicals serves as a reliable producer and supplier of pharmaceutical impurities and reference standard materials. Our commitment to comprehensive characterization, strict quality control, and adaptability in testing methodologies ensures the highest quality standards. With a focus on transparency, accurate representation, and customer support, SynThink Research Chemicals continues to play a crucial role in supporting the pharmaceutical industry’s quest for quality, stability, and biological safety.

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