API Impurities

Impurities in pharmaceutical products are unwanted chemicals that remain with the active pharmaceutical ingredients (APIs), develop during formulation, or emerge as the API and medicines age. Even trace amounts of these impurities can affect the efficacy and safety of pharmaceutical products. Identifying and quantifying impurities (Impurity Profile) has become an important product quality parameter and is closely scrutinized by regulatory authorities. Consequently, pharmacopoeias and ICH guidelines specify limits and threshold values for impurities. Analyzing impurities according to these specifications is mandatory for releasing pharmaceutical products for human consumption. Impurity Profile studies are also crucial for obtaining market approval for finished dosage forms from regulatory authorities.

The identification and quantification of impurities in pharmaceutical products are conducted using Certified Impurity Standards of known purity. It is recommended to use an Impurity Standard with a purity of at least 90% for peak identification in chromatograms or for system suitability tests for resolution. When estimating the content of a specified impurity, a minimum purity of 95% is advised.

Sythicure Laboratories provides a wide range of high-purity Impurity Standards for the pharmaceutical industry, available from milligram to kilogram scale at competitive prices. With advanced technical capabilities, Sythicure Laboratories can synthesize, isolate, and purify Impurity Standards to their purest form. They offer Impurity Standards in scales ranging from milligrams to grams.

Sythicure Laboratories offers custom synthesis of impurity compounds at the milligram to gram level upon request. For non-standard Impurity Standards, additional studies such as Structure Elucidation, Characterization, and Analytical Method Validation are also conducted. These studies utilize state-of-the-art equipment including LC-MS, HPLC, H and C NMR, FT-IR, and elemental analysis (CHNS), among others.

All Sythicure Laboratories products are supplied with certificates of analysis (CoA). Standard certificates contain:

  1. Identification by 1H-NMR and Mass spectroscopy.
  2. Purity test by either HPLC or GC
  3. Other test like C NMR, TGA, C NMR, CHN, IR will be provide on request