PARACETAMOL

Paracetamol API (also known as Acetaminophen) is a widely used analgesic and antipyretic agent indicated for the relief of mild to moderate pain and the reduction of fever. It is commonly employed for headache, muscle pain, arthritis, backache, toothache, menstrual cramps, and post-operative pain.

At Bluepill Express, we are a WHO-GMP, ISO 9001:2015, and cGMP-certified manufacturer and exporter of Paracetamol Active Pharmaceutical Ingredient (API). Our API meets USP, BP, IP, and EP pharmacopeial standards, ensuring high purity, consistent particle size, and excellent stability for oral, injectable, and combination formulations.

Paracetamol acts by inhibiting prostaglandin synthesis in the central nervous system, reducing pain perception and lowering elevated body temperature. Unlike NSAIDs, it does not exhibit significant anti-inflammatory activity or cause gastrointestinal irritation, making it safe for long-term use in recommended doses.

Therapeutic Applications:

• Fever reduction (antipyretic)
• Mild to moderate pain relief (analgesic)
• Headache, migraine, and tension pain
• Muscle aches and joint pain
• Post-operative and post-vaccination pain
• Pediatric and adult formulations

Mechanism of Action:

Paracetamol selectively inhibits COX (cyclooxygenase) enzymes in the CNS, reducing prostaglandin production, which decreases pain perception and fever. Its minimal effect on peripheral COX ensures low risk of gastrointestinal irritation or bleeding, distinguishing it from traditional NSAIDs.

Technical Specifications:

• Chemical Name: N-(4-hydroxyphenyl)acetamide
• Molecular Formula: C₈H₉NO₂
• Molecular Weight: 151.16 g/mol
• CAS Number: 103-90-2
• Description: White crystalline or granular powder
• Assay (on dried basis): NLT 98.5% and NMT 101.5%
• Melting Point: 168°C – 172°C
• Solubility: Slightly soluble in water, freely soluble in alcohol and acetone
• Storage Conditions: Store below 30°C, in a tightly closed, moisture-free container

Pharmacological Classification:

• Therapeutic Class: Analgesic / Antipyretic
• Pharmacopoeial Standards: IP / BP / USP / EP
• Dosage Form Applications:
  • Tablets (500 mg, 650 mg)
  • Capsules
  • Oral suspensions and syrups
  • Intravenous injections
  • Combination products with opioids or antihistamines

Quality & Manufacturing – Bluepill Express Standards:

• Produced in WHO-GMP and ISO-certified facilities
• High assay purity (≥99%) and low impurity levels
• Verified using HPLC, UV, and IR spectrophotometric methods
• Batch-to-batch consistency with long-term stability
• Complies with USP/BP/IP pharmacopeial standards
• Full documentation available: COA, MSDS, DMF on request

Advantages of Bluepill Express Paracetamol API:

• High solubility and flow properties for easy formulation
• Consistent particle size ensuring uniform dosing in tablets or suspensions
• Regulatory-ready API suitable for export to global markets
• Reliable bulk supply for large-scale production
• Long shelf-life and stability under recommended conditions

Packaging & Export Details:

• Packaging Sizes: 1 kg / 5 kg / 25 kg HDPE drums with LDPE inner liner
• Shelf Life: 3 years under recommended storage
• Labeling: Compliant with international pharmacopeial and regulatory norms
• Export Markets: Europe, Africa, Asia-Pacific, Middle East, Latin America
• Documentation Provided:
  • Certificate of Analysis (COA)
  • Material Safety Data Sheet (MSDS)
  • Drug Master File (DMF – on request)
  • Stability and regulatory compliance certificates