![]() (24) The interaction of the FMD-active principal ingredient was reported for fenfluramine (an anorexic agent that bears a secondary N-ethylamine) as evidenced by the conversion into an N-methyl derivative. (23) This formaldehyde adduct was also found in Avapro film-coated tablets (irbesartan 18.75 and 37.5 mg) during the long-term stability studies, due to the use of propylene glycol in the tablet coating material─Opadry II white. At a trace level of 8 ppm, this compound could generate a 1% hydroxymethyl degradant with the drug substance BMS-203452 in the clinical parenteral formulation (10 mg/mL) upon storage at 5 and 25 ☌. (18,19)įormaldehyde (FMD) is one of the commonly existing impurities in excipients used in pharmaceutical dosage forms such as microcrystalline cellulose, starch, polyethylene glycol, polysorbates, hydroxypropyl cellulose, lactose, and crospovidone. (12) In addition, there has been growing interest in hydrogen bonding between paracetamol and other compounds such as water, (13,14) ethanol, acetone, (15) hypromellose, (16) 4,4′–bipyridine, (17) or between paracetamol molecules.
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