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PARACETAMOL DENSE POWDER

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Paracetamol Dense Powder, also known as Acetaminophen, is a widely used analgesic (pain reliever) and antipyretic (fever reducer) API. It provides effective relief from headache, fever, muscle pain, toothache, and cold-related symptoms.

At Bluepill Express, we manufacture and export pharmaceutical-grade Paracetamol Dense Powder API with high bulk density, superior flow characteristics, and exceptional purity (≥99%), making it ideal for tablet compression, capsule formulations, and granulation processes.

Our Paracetamol Dense Powder meets IP, BP, USP, and EP standards, ensuring consistency, excellent compressibility, and optimized performance in both direct compression and wet granulation formulations.

The API is produced in WHO-GMP and ISO 9001:2015-certified facilities, maintaining compliance with global pharmaceutical standards and regulatory requirements.

Therapeutic Applications:

  • Relief of mild to moderate pain such as headache, toothache, or menstrual cramps
  • Reduction of fever and body temperature during infections
  • Suitable for paediatric and adult formulations
  • Commonly used in combination therapies with caffeine, ibuprofen, or phenylephrine

Mechanism of Action:

Paracetamol acts by inhibiting prostaglandin synthesis in the central nervous system (CNS) and blocking pain impulses. It exerts its antipyretic action on the hypothalamic heat-regulating center, helping restore normal body temperature.

Technical Specifications:

  • Chemical Name: N-(4-Hydroxyphenyl)acetamide
  • Molecular Formula: C₈H₉NO₂
  • Molecular Weight: 151.16 g/mol
  • CAS Number: 103-90-2
  • Appearance: White to off-white crystalline dense powder
  • Bulk Density: 0.6 – 0.8 g/ml (approx.)
  • Assay (on dried basis): NLT 99.0% and NMT 101.0%
  • Moisture Content: NMT 0.5%
  • Solubility: Freely soluble in alcohol and acetone; slightly soluble in water
  • Storage Conditions: Store below 25°C, protected from moisture and direct sunlight

Pharmacological Classification:

  • Therapeutic Class: Analgesic and Antipyretic
  • Pharmacopoeial Standards: IP / BP / USP / EP
  • Dosage Form Applications:
    • Tablets (500 mg, 650 mg, 1000 mg)
    • Capsules and dispersible tablets
    • Oral suspensions and syrups
    • Effervescent granules and suppositories

Manufacturing & Quality Standards – Bluepill Express:

  • Manufactured in WHO-GMP and cGMP certified plants
  • High assay purity and excellent compressibility for uniform dosing
  • Low moisture content for enhanced stability
  • DMF-ready documentation for regulatory submissions
  • Stringent analytical testing: HPLC, FTIR, UV Spectrophotometry
  • Compliant with ICH Q3A/B guidelines for impurities and stability

Advantages of Bluepill Express Paracetamol Dense Powder API:

  • High density and superior flowability for smooth tablet production
  • Excellent compressibility for direct compression applications
  • Globally accepted pharmacopoeial grade quality
  • Regulatory documentation support (COA, MSDS, DMF)
  • Bulk supply with batch-to-batch consistency

Packaging & Export Details:

  • Packaging Sizes: 5 kg / 25 kg HDPE drums with double LDPE liners
  • Shelf Life: 3 years under recommended conditions
  • Labeling: As per international regulatory and pharmacopeial standards
  • Export Markets: Europe, Africa, Middle East, Asia-Pacific, and Latin America
  • Documentation Provided:
    • Certificate of Analysis (COA)
    • Material Safety Data Sheet (MSDS)
    • Drug Master File (DMF)
    • Stability Data and Validation Reports

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