Acetaminophen (paracetamol) CAS#103-90-2

Product Basic Information

Core Functions & Applications

Acetaminophen exerts its effects by selectively inhibiting cyclooxygenase (COX) enzymes-primarily COX-2 in the central nervous system (CNS)-reducing the synthesis of prostaglandins (mediators of pain and fever). Unlike NSAIDs (e.g., ibuprofen), it has minimal activity on peripheral COX enzymes, so it does not cause gastrointestinal irritation or anti-inflammatory effects. This makes it ideal for patients who cannot tolerate NSAIDs (e.g., those with ulcers) or do not require inflammation reduction. It is primarily used in human medicine, with limited veterinary use:

1. Human Pharmaceutical & OTC Field

1.1 Pain Relief (Analgesic Use)

Mild-to-Moderate Pain: First-line treatment for:

Headaches (tension headaches, migraines): Oral dose (325–650 mg every 4–6 hours, max 3000 mg/day for adults) to reduce pain without NSAID-related side effects.

Musculoskeletal pain (back pain, joint pain, muscle aches): 325–650 mg every 4–6 hours, often combined with opioids (e.g., codeine) for severe pain (e.g., post-surgery, cancer).

Dental pain (toothaches, post-extraction pain): 325–650 mg every 4–6 hours, with faster onset than aspirin in some patients.

Pediatric pain (earaches, teething pain): Dosed by weight (10–15 mg/kg every 4–6 hours, max 75 mg/kg/day) as oral suspensions, chewable tablets, or suppositories (for infants unable to swallow).

1.2 Fever Reduction (Antipyretic Use)

Acute Fever: Recommended as the first-line antipyretic for all age groups, including infants ≥2 months:

Adults: 325–650 mg every 4–6 hours (max 3000 mg/day) until fever resolves (e.g., from flu, colds, or infections).

Children: 10–15 mg/kg every 4–6 hours (max 75 mg/kg/day), preferred over aspirin to avoid Reye's syndrome (a rare but fatal condition linked to aspirin use in children with viral infections).

Seniors: 325 mg every 4–6 hours (lower dose to reduce renal/hepatic burden) for fever associated with age-related infections (e.g., pneumonia).

1.3 Combination Therapies

Multisymptom Remedies: A key component of OTC cold/flu medications (combined with decongestants, antihistamines, or cough suppressants) to relieve fever, headache, and body aches.

Opioid Combinations: Prescribed with opioids (e.g., hydrocodone, oxycodone) for severe pain (e.g., post-surgery, chronic back pain) to enhance analgesia and reduce opioid dosage (lowering addiction risk).

2. Veterinary Field (Companion Animals)

Acetaminophen is toxic to cats (causes irreversible liver damage and methemoglobinemia) and should never be used. It is occasionally used off-label in dogs for short-term pain/fever management, under strict veterinary supervision:

Canine Pain (e.g., Osteoarthritis): 10–15 mg/kg body weight every 8–12 hours (max 30 mg/kg/day) for 3–5 days. Long-term use is avoided due to liver toxicity risk.

Canine Fever: 10–15 mg/kg every 8–12 hours until fever resolves, with monitoring for signs of toxicity (vomiting, lethargy, jaundice).

Contraindications: Never use in cats, pregnant/nursing dogs, or dogs with pre-existing liver disease, anemia, or glucose-6-phosphate dehydrogenase (G6PD) deficiency.

Quality & Safety Assurance

As a globally used OTC and prescription medication, Acetaminophen requires rigorous quality control to ensure efficacy, prevent toxic impurities, and comply with regulatory standards:

Raw Material & Synthesis: Produced via industrial chemical synthesis (e.g., acetylation of 4-aminophenol with acetic anhydride), followed by purification via recrystallization. Critical control of the starting material (4-aminophenol) and reaction conditions prevents residual toxic impurities (4-aminophenol limits: ≤0.005% in pharmaceutical grade).

Production Process:

Pharmaceutical Grade: Manufactured in GMP-certified workshops (Class D cleanroom for tablet/capsule APIs) with strict control over particle size (for uniform dissolution) and impurity levels.

OTC Grade: Undergoes additional testing for dissolution rate (≥80% dissolved in 30 minutes in pH 5.5 buffer) and compliance with OTC monographs (e.g., FDA 21 CFR Part 343).

Comprehensive Testing Protocol:

Safety Reminders:Human Use:

Toxicity Risk: The most critical safety concern is hepatic (liver) failure from overdose (exceeding 4000 mg/day in adults). Avoid combining with other acetaminophen-containing products (e.g., cold meds) to prevent accidental overdose.

Contraindications: Hypersensitivity to acetaminophen; severe liver disease (e.g., cirrhosis).

Special Populations: Reduce dose in patients with liver impairment, alcoholism, or malnutrition (increased toxicity risk).

Veterinary Use:

Strict Supervision: Only use in dogs under veterinary guidance; have antidotes (e.g., N-acetylcysteine) available in case of overdose.

Cat Toxicity: Even small doses (e.g., 10 mg/kg) can kill cats-never administer.

Cooperation & Contact

We supply Acetaminophen in multiple grades and physical forms to meet diverse application needs:

Pharmaceutical Grade: Fine crystalline powder (1kg–100kg per order) for prescription tablets, capsules, and injectables.

OTC Grade: Powder, granulated, or micronized form (10kg–500kg per order; monthly production capacity of 5000kg) for OTC tablets, suspensions, suppositories, and combination medications.

Value-added services include:

Providing DMF (Drug Master File) and CEP (Certificate of Suitability) for pharmaceutical-grade products to support registration in the EU, US, and Asia.

Customized processing: Micronization (for rapid dissolution in pediatric suspensions), granulation (for tableting), and impurity profiling.

Technical guidance: Dosage optimization for special populations (e.g., seniors, children), regulatory compliance with OTC monographs, and overdose prevention strategies.

If you are a pharmaceutical manufacturer, OTC brand owner, or veterinary drug enterprise, please contact us for detailed cooperation:

Contact Information:

Email: sales@huarongpharma.com

Phone/WhatsApp: +86 13751168070

We adhere to the principles of "quality compliance, safety first, and global accessibility" and look forward to partnering with global healthcare and OTC industries!

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