1. Introduction
Posaconazole (POS) 4-[4-[4-[4-[[(3R,5R)-5-(2,4-difluorophenyl)tetrahydro-5-(1H-1,2,4-triazol-1-ylmethyl)-3-furanyl]methoxy]phenyl]-1-piperazinyl]phenyl]-2-[(1S,2S)-1-ethyl-2- hydroxypropyl]-2,4-dihydro-3H-1,2,4-triazol-3-one (Fig.1)[1].Available under the brand names Noxafil oral suspension(40mg per mL) and Noxafil 100mg Gastro-resistant tablets [2] from the MSD (Merck Sharp & Dohme Ltd, Hertford Road, Hoddesdon Hertfordshire EN11 9BU United Kingdom)- Used for the Prevention of invasive Aspergillus and Candida infections in severely immune compromised adults and adolescents ≥13 years of age, including hematopoietic stem cell transplant (HSCT) recipients with graft-versus-host-disease (GVHD) and patients with hematologic malignancies and prolonged chemotherapy-associated neutropenia[3],[4],[5] The administration of drug is done orally during or immediately following a full meal or liquid nutritional supplement. …show more content…
It is also recommended by ICH that all routine impurities at or above the 0.1 % level, should be identified through appropriate analytical methods [7], [8], and [9]. In the synthesis of Posaconazole, the process related impurities are identified by MSN laboratories, they are Hydroxytriazole, Tosylated compound, Deshydroxy posaconazole and Benzylated posaconazole. (Fig.1) [10]. Therefore, it was thought worth determining the impurities of Posaconazole to ensure the quality, efficacy and safety of the active ingredient and final pharmaceutical formulation. The four processes related impurities, a method for analyzing Posaconazole in the presence of these impurities, and the degradants obtained during forced degradation studies was required to be developed for the method is to be stability
Posaconazole (POS) 4-[4-[4-[4-[[(3R,5R)-5-(2,4-difluorophenyl)tetrahydro-5-(1H-1,2,4-triazol-1-ylmethyl)-3-furanyl]methoxy]phenyl]-1-piperazinyl]phenyl]-2-[(1S,2S)-1-ethyl-2- hydroxypropyl]-2,4-dihydro-3H-1,2,4-triazol-3-one (Fig.1)[1].Available under the brand names Noxafil oral suspension(40mg per mL) and Noxafil 100mg Gastro-resistant tablets [2] from the MSD (Merck Sharp & Dohme Ltd, Hertford Road, Hoddesdon Hertfordshire EN11 9BU United Kingdom)- Used for the Prevention of invasive Aspergillus and Candida infections in severely immune compromised adults and adolescents ≥13 years of age, including hematopoietic stem cell transplant (HSCT) recipients with graft-versus-host-disease (GVHD) and patients with hematologic malignancies and prolonged chemotherapy-associated neutropenia[3],[4],[5] The administration of drug is done orally during or immediately following a full meal or liquid nutritional supplement. …show more content…
It is also recommended by ICH that all routine impurities at or above the 0.1 % level, should be identified through appropriate analytical methods [7], [8], and [9]. In the synthesis of Posaconazole, the process related impurities are identified by MSN laboratories, they are Hydroxytriazole, Tosylated compound, Deshydroxy posaconazole and Benzylated posaconazole. (Fig.1) [10]. Therefore, it was thought worth determining the impurities of Posaconazole to ensure the quality, efficacy and safety of the active ingredient and final pharmaceutical formulation. The four processes related impurities, a method for analyzing Posaconazole in the presence of these impurities, and the degradants obtained during forced degradation studies was required to be developed for the method is to be stability