In the ever-evolving field of pharmaceuticals, ensuring the purity and safety of drug products is paramount. At Materials Analytical Services (MAS), we are at the forefront of this mission, leveraging cutting-edge technologies and methodologies to provide comprehensive trace metal testing. Located at 3945 Lakefield Ct, Suwanee, GA 30024, MAS is proud to announce the verification of USP 233 by ICP-MS, ready to serve the diverse needs of the pharmaceutical industry.
For over a century, the United States Pharmacopeia (USP) 231 was the standard for heavy metal testing in pharmaceutical samples. However, due to its limitations, it has now been replaced by USP 232 Elemental Impurities Limits and USP 233 Elemental Impurities Procedures. This transition marks a significant advancement in the industry, mandating the use of USP 233 by 2018 to enhance the accuracy and reliability of impurity testing. Learn more in our pharmaceutical testing page.
Contact with manufacturing equipment, residual catalysts, and raw materials can introduce elemental impurities into drug products. The implementation of USP 232/233 redefines the testing process for these impurities. Procedures 1 and 2, integral to these standards, offer detectability, repeatability, and specificity that surpass the subjective colorimetric tests used in USP 231. Find out more about our chemical analysis.
USP 233 requires rigorous method validation, whether as a limit test or a quantitative test. Limit tests focus on precision, while quantitative validation demands accuracy at 50%, 100%, and 150%. Techniques such as ICP-OES and ICP-MS provide superior analytical capabilities, with ICP-MS measuring mass fragments to a higher degree of precision.
The presence of impurities can cause toxicity, unwanted side effects, and impact drug stability. USP 232/233 address these issues by providing a modernized approach to testing. These new methods enable pharmaceutical labs worldwide to update their techniques and instrumentation, ensuring complete digestion and retention of volatile elements through methods like closed vessel microwave digestion.
MAS utilizes the Agilent 7500 ICP-MS, a state-of-the-art instrument that offers high-temperature ICP sources coupled with mass spectrometry. This technology excels in handling both simple and complex matrices with minimal matrix interferences, making it an ideal choice for trace metal analysis.
With the support and collaboration of the FDA and the pharmaceutical industry, USP has made significant strides in updating outdated methodologies. These advancements underscore the importance of modern, accurate testing procedures in safeguarding the quality and safety of pharmaceuticals.
Incorporating the same level of precision as in our trace metal testing, the HITACHI FE-SEM SU 8230 is pivotal in advancing materials research, offering breakthrough imaging capabilities that elevate our understanding in key industries.
The HITACHI FE-SEM SU 8230 is a state-of-the-art microscope that excels in detailed imaging, utilizing enhanced brightness and high spatial resolution to provide unparalleled insights into material structures in industries like biotechnology and semiconductors. This technology sets new standards, pushing the boundaries of analytical capabilities.
At MAS, we are committed to providing top-tier analytical services. Visit us at 3945 Lakefield Ct, Suwanee, GA 30024, or contact us at 770-866-3200 to learn more about our capabilities in trace metal testing and how we can assist your pharmaceutical needs.
A new bipartisan bill, "Esther's Law," seeks to ban hazardous water beads in children's toys due to their severe risks when ingested. Materials Analytical Services (MAS) plays a crucial role in ensuring toy safety through rigorous testing and analysis. MAS helps identify potential hazards and ensure compliance with safety standards, preventing dangerous products from reaching the market. Learn how MAS contributes to safeguarding children's health and promoting a safer environment for play.
The March 2024 recall of Jool Baby's Nova Baby Infant Swings underscores the critical need for rigorous safety testing of children's products. The recall was due to a suffocation hazard caused by an incline angle greater than 10 degrees. At Materials Analytical Services (MAS), we provide comprehensive testing and analysis to ensure product safety and compliance, helping manufacturers prevent hazards and costly recalls. Learn more about the importance of safety testing and how MAS supports manufacturers in producing safe children's products.
As a manufacturer of children's products, ensuring safety and compliance is crucial, especially in the growing consumer-to-manufacturer (C2M) market. With the direct connection to consumers online, it's essential to maintain high standards for safety and quality to meet both regulatory requirements and parental expectations.
In early 2024, the Consumer Product Safety Commission (CPSC) proposed significant updates to enhance product safety, including mandatory electronic filing of Certificates of Compliance for all imported CPSC-regulated products, broadening the definition of "importer" to include a wider range of stakeholders, and introducing detailed requirements for certificate content alongside a new five-year record retention period. Aimed at ensuring products entering the U.S. market meet safety standards, these changes emphasize accountability across the supply chain and enhance the CPSC's ability to monitor compliance. To navigate these complex regulations, Materials Analytical Services (MAS), a premier U.S.-based analytical and technical assistance laboratory, offers its expertise in product testing and compliance, providing essential support to companies aiming to meet these rigorous safety standards and protect consumer well-being.