In the pharmaceutical industry, the quality and consistency of excipients are non-negotiable. These inert ingredients play a crucial role in the performance, stability, and safety of drug products. Hypromellose Acetate Succinate (HPMCAS) is a prime example of an excipient where stringent quality control is paramount. NINGBO INNO PHARMCHEM CO.,LTD. is committed to providing pharmaceutical-grade HPMCAS that meets rigorous international standards, ensuring reliable and effective drug formulations.

Key Specifications for Pharmaceutical Grade HPMCAS

Pharmaceutical grade HPMCAS is characterized by a set of critical specifications that guarantee its suitability for use in human medicines. These specifications typically cover physical properties, chemical composition, and purity. Understanding these parameters is vital for formulators and quality control departments. Key specifications include:

  • Appearance: Pharmaceutical grade HPMCAS is generally a white to off-white powder or granules, with a faint acetic acid-like odor and a barely detectable taste.
  • Viscosity: This parameter indicates the molecular weight and chain length of the polymer, influencing its film-forming and solubilizing properties. Typical viscosity ranges are specified in solution under controlled conditions (e.g., 2.4-3.6 mPa.s for certain grades).
  • Chemical Substitution Levels: The percentages of acetyl and succinoyl groups, along with methoxy and hydroxypropoxy content, are precisely controlled. These substitution levels dictate the pH-dependent solubility and overall performance of the HPMCAS in enteric coating and solid dispersion applications. For instance, different grades like AS-LF, AS-MF, and AS-HF are defined by their specific acetyl and succinoyl content, affecting their opening pH.
  • pH Solubility: This is a critical functional parameter, defining the pH at which the polymer dissolves. Pharmaceutical grades will specify an opening pH range, typically above 5.5, for enteric coating applications.
  • Loss on Drying: Measures the moisture content, which is important for stability and processing. Typically, this should be less than 5.0%.
  • Residue on Ignition: Indicates the level of inorganic impurities. For pharmaceutical use, this is usually kept very low, often ≤0.20%.
  • Heavy Metals: Strict limits are imposed on heavy metal content (e.g., ≤0.001%) to ensure patient safety.
  • Free Acetic and Succinic Acids: These residual acids from the manufacturing process are controlled to minimal levels (e.g., ≤1.0%) to avoid impacting formulation stability or taste.

Compliance with Pharmacopeias

A hallmark of pharmaceutical grade HPMCAS is its compliance with major pharmacopeial monographs, such as the United States Pharmacopeia/National Formulary (USP/NF), Japanese Pharmacopoeia (JP), and European Pharmacopoeia (EP). These monographs set the official standards for identity, strength, quality, and purity, ensuring that the HPMCAS used in drug products meets the highest international benchmarks. When you buy HPMCAS, verifying its compliance with these pharmacopeias is essential.

NINGBO INNO PHARMCHEM CO.,LTD.: Your Partner in Quality HPMCAS

At NINGBO INNO PHARMCHEM CO.,LTD., we understand that the success of your pharmaceutical formulations relies on the quality of our excipients. We rigorously control our manufacturing processes to ensure that our HPMCAS consistently meets or exceeds these critical specifications and pharmacopeial requirements. Our commitment to quality assurance means that you can rely on our HPMCAS for predictable performance in enteric coating, solid dispersion, and other advanced drug delivery applications. Partner with us for your HPMCAS needs and ensure the integrity and efficacy of your pharmaceutical products.

By prioritizing these specifications and adhering to strict quality management systems, NINGBO INNO PHARMCHEM CO.,LTD. provides pharmaceutical manufacturers with the confidence that their drug products will be safe, effective, and compliant with regulatory expectations.