USP Pharmaceutical Testing (cGMP)

SGS Polymer Solutions provides testing of Azithromycin in accordance with its relevant United States Pharmacopeia (USP) monograph.

Azithromycin is an antibiotic used for the treatment of strep throat, pneumonia, certain intestinal infections, and several other bacterial infections. 

Approaches

Identification confirmation is accomplished by using Fourier transform infrared spectroscopy (FTIR) <197K>. Liquid chromatography methods are performed for the assay and organic impurities. Pharmaceutical materials can rotate the plane of polarized light traveling through them. This can be determined by optical rotation. The FDA requires that Azithromycin be tested by optical rotation <781S>. Crystallinity <695> requirements are to be determined per the USP monograph. USP <791> for pH will also be determined. Water determination will be performed coulometrically by Karl Fischer titration per USP <921>, Method 1c. If it is labeled as Azithromycin monohydrate and has a water content of 4.0%–6.5% then Loss on Drying <891> will need to be determined.