In the pharmaceutical industry, the quality of the final Active Pharmaceutical Ingredient (API) is intrinsically linked to the quality of its constituent intermediates. For Telmisartan, a cornerstone medication for cardiovascular health, its synthesis relies on the precise specifications of its intermediate, Telmisartan Intermediate (CAS 152628-02-9). Understanding these specifications is vital for API manufacturers, R&D scientists, and procurement specialists aiming to produce safe and effective drugs.

Critical Specifications of Telmisartan Intermediate (CAS 152628-02-9)

When you purchase Telmisartan Intermediate, several key parameters must be clearly defined and met:

  • Purity: This is perhaps the most critical specification. For Telmisartan Intermediate, a high purity level, typically ≥99.00% by GC or HPLC, is essential. Impurities in the intermediate can carry through the synthesis process, leading to lower API yields, difficulty in purification, and potentially the presence of unwanted byproducts in the final drug, which can have safety implications. Manufacturers should be able to provide detailed chromatograms and assay results.
  • Appearance: The physical form and color of the intermediate are important indicators of its quality. Telmisartan Intermediate is commonly described as a white to light yellow or light orange powder. Any significant deviation in appearance could suggest degradation or contamination.
  • Molecular Formula and Weight: The confirmed molecular formula (C19H20N4) and molecular weight (304.39 g/mol) are fundamental identifiers. Suppliers should provide this information accurately, and it should align with standard chemical databases.
  • Water Content: Excess moisture can affect the stability and reactivity of chemical intermediates. Karl Fischer titration is typically used to determine water content, which should be within specified limits (e.g., ≤0.5% or within a 5.0%-6.5% range as noted in some technical data).
  • Sulfated Ashes: This test indicates the level of inorganic impurities. A low sulfated ash content (e.g., NMT 0.3%) is desirable for pharmaceutical intermediates.
  • Individual Impurity Limits: Beyond overall purity, specific limits for individual impurities are often defined, especially those that might be difficult to remove in later stages or are known to be toxic.

Why These Specifications Matter for Manufacturers

Adhering to these specifications ensures:

  • Consistent API Quality: Predictable reaction outcomes and a final API that meets all quality benchmarks.
  • Regulatory Compliance: Meeting stringent requirements set by health authorities like the FDA, EMA, and others.
  • Process Efficiency: Minimizing purification challenges and optimizing reaction yields.
  • Product Safety: Avoiding the introduction of harmful impurities into medications.

When you are looking to buy Telmisartan Intermediate, always request a comprehensive Certificate of Analysis (CoA) from your chosen manufacturer. This document is your primary assurance of the product's quality and compliance with the stated specifications. As a dedicated supplier, we understand the critical nature of these specifications and are committed to providing Telmisartan Intermediate that meets the highest industry standards. Contact us today to inquire about pricing and bulk purchase options.