Paracetamol P-201 BP

Description

Paracetamol P-201 BP (Acetaminophen BP)

Paracetamol P-201 BP (CAS: 103-90-2), also known as Acetaminophen, is a high-purity, pharmaceutical-grade analgesic (pain reliever) and antipyretic (fever reducer). The “P-201” designation refers to a specialized, direct-compression or microencapsulated powder grade engineered specifically to optimize tablet manufacturing, ensure uniform particle size distribution, and provide excellent flowability during high-speed tableting operations. Fully compliant with the British Pharmacopoeia (BP) monograph, it is a core active pharmaceutical ingredient (API) in global medicine.

Key Features & Functional Benefits

• Dual Action Pain & Fever Relief: Inhibits central prostaglandin synthesis to effectively alleviate mild-to-moderate pain (headaches, toothaches, dysmenorrhea, musculoskeletal pain) and lower elevated body temperatures.

• Direct Compression & Superior Flow: Grade P-201 is milled and processed to minimize dusting, prevent capping/lamination during compression, and deliver consistent die filling without requiring extensive pre-granulation steps.

• Gastrointestinal Safety Profile: Unlike non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or aspirin, Paracetamol does not cause gastric mucosal irritation, making it suitable for patients with sensitive stomachs or ulcers.

• BP Pharmacopeial Compliance: Manufactured under strict cGMP protocols to guarantee exceptionally low impurity levels (such as 4-aminophenol limits) and optimal dissolution kinetics.

  Technical Specifications & Product Properties

  Property	Specification / Typical Value
  Chemical Name	N-(4-Hydroxyphenyl)acetamide
  CAS Number	103-90-2
  Pharmacopeial Standard	British Pharmacopoeia (BP) / Ph. Eur.
  Grade Designation	P-201 (Direct Compression / Powder Grade)
  Assay (Dry Basis)	99.0% – 101.0%
  Appearance	White, odorless crystalline powder
  Melting Point	168℃- 172℃
  4-Aminophenol Impurity	≤ 50ppm
  Loss on Drying	≤ 5%

  Primary Applications in Manufacturing

• • Oral Solid Dosage Forms: Used as the primary API in single-ingredient or combination immediate-release tablets, caplets, and hard gelatin capsules.

  • Multi-Symptom Cold & Flu Formulas: Commonly blended with decongestants (e.g., phenylephrine, pseudoephedrine), antihistamines, and caffeine for comprehensive cold relief remedies.

  • Effervescent & Pediatric Suspensions: Formulated into fast-dissolving effervescent granules or oral liquid suspensions for pediatric and geriatric patient populations.