In the pharmaceutical industry, the purity of Active Pharmaceutical Ingredients (APIs) is not merely a quality metric; it's a cornerstone of patient safety and therapeutic efficacy. For manufacturers formulating with Mefenamic Acid (CAS 61-68-7), a widely used non-steroidal anti-inflammatory drug (NSAID), understanding and ensuring API purity is paramount. This article highlights the critical purity specifications for Mefenamic Acid and emphasizes the benefits of sourcing from a trusted Chinese manufacturer.

The Importance of Mefenamic Acid Purity

Mefenamic Acid's therapeutic effect relies heavily on its chemical integrity. Impurities, even in small amounts, can:

  • Affect Efficacy: Reduced API purity can lead to lower potency in the final drug product, diminishing its effectiveness in relieving pain and inflammation.
  • Introduce Toxicity: Certain impurities can be toxic or cause adverse side effects, posing significant risks to patients.
  • Impact Stability: Impurities can affect the stability of the API and the final drug formulation, leading to shorter shelf lives or degradation.
  • Cause Regulatory Issues: Failing to meet stringent purity standards set by regulatory bodies can result in product recalls or rejection of marketing applications.

Key Purity Specifications for Mefenamic Acid

Reputable manufacturers and suppliers of Mefenamic Acid adhere to specific quality standards, often outlined in pharmacopeias like the British Pharmacopoeia (BP), United States Pharmacopeia (USP), or European Pharmacopoeia (EP). Critical specifications include:

  • Assay: This measures the actual content of Mefenamic Acid in the sample. A minimum assay of 99.00% is typically required for pharmaceutical-grade Mefenamic Acid.
  • Loss on Drying (LOD): Indicates the amount of volatile matter, primarily water, present. A low LOD (e.g., 0.50% maximum) is crucial for stability and accurate dosing.
  • Related Substances: This category encompasses various organic impurities that may arise during synthesis or storage. Strict limits are set for individual known impurities, unknown impurities, and the total amount of related substances (e.g., 0.20% maximum for related substances).
  • Specific Impurities: For Mefenamic Acid, specific impurities like 2,3-dimethylaniline might have defined maximum allowable limits (e.g., 100.00 ppm).
  • Heavy Metals and Ash Content: Limits on sulphated ash (e.g., 0.10% maximum) and heavy metals (e.g., Copper at 10.00 ppm maximum) ensure the absence of undesirable inorganic contaminants.

Sourcing High-Purity Mefenamic Acid from China

When seeking a supplier for Mefenamic Acid, especially from China, it is vital to partner with a manufacturer that demonstrably upholds these high purity standards. As a leading producer and supplier, we understand these critical quality parameters. Our Mefenamic Acid is manufactured under strict quality control protocols, ensuring it meets the exacting requirements of the pharmaceutical industry. We provide detailed Certificates of Analysis with each batch, verifying the purity and compliance of our product.

By choosing our company as your Mefenamic Acid supplier, you are assured of receiving an API that is not only competitively priced but also meets the highest standards of purity, supporting the development of safe and effective pharmaceutical products. We encourage pharmaceutical manufacturers to inquire about our Mefenamic Acid (CAS 61-68-7) and our commitment to quality.