AZITHROMYCIN IMPURITIES; MANUFACTURER OLYMPUS CHEMICALS & FERTILIZERS.
FDA control or regulated the entire parameters associate with the quality of the drug for the consumer’s protection. Presence of Small amount of impurity can change the pharmacological property of the any drug like efficacy, toxicity, solubility or etc and these impurities or unwanted chemicals remain with active pharmaceuticals ingredients (APIs) during production, during storage or during formulation as per ICH report.
As impurities in APIs affects the quality and safety of pharmaceuticals products, so impurity profile study of the APIs to be used in the manufacturing of the drug substances.
Thus Olympus chemicals & fertilization continuously busy in doing synthesis, isolation, identification & characterization of the known impurities as per EP/USP/BP/IP/JP, unknown impurities, and process related impurities.
Olympus chemical & Fertilizers synthesized all Azithromycin impurities as per EP/USP/BP and analysis as per pharmacopeia method, all the impurities confirm by HNMR, Mass, RT, RRT and RRF confirm by HPLC as per MOA mention in monograph, Potency of the impurity calculated by TGA, Molecular formula confirm by doing elemental analysis (CHN analysis).
Below is the list of Azithromycin impurities available with Olympus chemicals & fertilizers.
Azithromycin Impurity A (RRT – 0.83), Azithromycin Impurity B (RRT – 1.3), Azithromycin Impurity C (RRT – 0.73), Azithromycin Impurity E (RRT – 0.43), Azithromycin Impurity F (RRT – 0.51), Azithromycin Impurity G (RRT – 1.26), Azithromycin Impurity H (RRT – 0.79), Azithromycin Impurity I (RRT – 0.61), Azithromycin Impurity J (RRT – 0.54), Azithromycin Impurity L (RRT – 0.29), Azithromycin Impurity M (RRT – 0.37), Azithromycin Impurity N (RRT – 0.76), and Azithromycin Impurity P.
To know more details about Azithromycin please click on link given below