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Frequently Asked Questions
Aspirin (acetylsalicylic acid) works by irreversibly acetylating and inhibiting both COX-1 and COX-2 enzymes, blocking the production of prostaglandins and thromboxanes. This provides anti-inflammatory, analgesic, antipyretic, and antiplatelet effects. Paracetamol's exact mechanism is still debated but is believed to involve inhibition of a central COX-3 variant in the brain and interaction with the endocannabinoid system and serotonin pathways. Unlike Aspirin, Paracetamol has minimal anti-inflammatory activity and does not affect platelet function, making it safer for patients with bleeding disorders or those on anticoagulant therapy.
Paracetamol is the preferred antipyretic for pediatric use because it does not carry the risk of Reye's syndrome, a rare but severe condition associated with Aspirin use in children with viral infections. Paracetamol also has a wider therapeutic window in children and is available in multiple pediatric-friendly dosage forms including oral suspensions, suppositories, and fast-melt tablets. Its lack of gastric irritation and absence of antiplatelet effects make it suitable for children with any bleeding risk or gastrointestinal sensitivity.
Our antipyretic and analgesic APIs undergo comprehensive testing including assay potency by titrimetric and HPLC methods, identification by IR spectroscopy and melting point, related substances profiling with particular attention to 4-aminophenol in Paracetamol (a genotoxic impurity) and free salicylic acid in Aspirin (a degradation product and irritant), heavy metals content, residual solvents, sulfated ash, loss on drying, and particle size distribution. For Aspirin, additional testing for acetic acid odor and stability under humid conditions is performed.
Yes, we can supply Aspirin with controlled particle size distributions tailored to specific formulation requirements. For low-dose Aspirin (75-100 mg) used in cardiovascular prophylaxis, we provide fine-grade Aspirin with D90 below 100 microns to ensure content uniformity and rapid dissolution. For enteric-coated tablets designed to reduce gastric irritation, we can supply Aspirin with coarser particle size and controlled compression characteristics that are compatible with enteric coating polymers and provide consistent release profiles.
Aspirin is highly sensitive to hydrolytic degradation, breaking down into salicylic acid and acetic acid in the presence of moisture. It requires packaging with desiccants and moisture barrier materials, and stability is monitored for free salicylic acid content as a critical quality attribute. Paracetamol is susceptible to oxidative degradation and photolytic breakdown, forming 4-aminophenol and other colored degradation products. We conduct photostability studies per ICH Q1B and use appropriate packaging with UV protection where needed. Both APIs require controlled storage conditions (25°C or below) for long-term stability.
