Description
Acetaminophen Powder | Pharmaceutical-Grade API | Analytical Reference Standard
Welcome to BiosynLab, your premier source for high-purity pharmaceutical ingredients and analytical standards. Our Acetaminophen Powder (Paracetamol) meets USP/EP pharmacopeia standards, delivering consistent quality for pharmaceutical research, formulation development, and analytical calibration. Trusted by laboratories across Europe, the United Kingdom, and North America, this essential non-opioid analgesic serves diverse research and industrial applications.
What Is Acetaminophen?
Acetaminophen, known internationally as paracetamol and chemically designated as N-acetyl-p-aminophenol (APAP), represents one of the most extensively studied and widely utilized analgesic and antipyretic compounds in pharmaceutical history. First synthesized in 1877 and clinically introduced in the 1950s, this synthetic organic compound belongs to the para-aminophenol derivative class, distinct from NSAIDs and opioids in its mechanism of action.
Unlike traditional anti-inflammatory drugs, acetaminophen primarily acts within the central nervous system, inhibiting prostaglandin synthesis through selective COX enzyme modulation while demonstrating minimal peripheral anti-inflammatory activity. This unique pharmacological profile makes it indispensable for pain management research, fever reduction studies, and comparative analgesic investigations.
Origin and Manufacturing Excellence
Our acetaminophen powder originates from FDA-registered and EU-GMP-certified manufacturing facilities employing established pharmaceutical synthesis protocols:
Synthesis Process:
- Acetylation of p-aminophenol using acetic anhydride or acetyl chloride
- Controlled reaction conditions to minimize impurity formation
- Crystallization from aqueous or organic solvents
- Multi-stage purification achieving pharmaceutical grade
Quality Assurance:
- HPLC purity verification (≥99.9%)
- USP/EP monograph compliance testing
- Heavy metals screening (USP <231>)
- Residual solvent analysis (ICH Q3C)
- Melting point determination (168-172°C)
- pH and clarity testing
- Particle size distribution analysis
Each batch is accompanied by a comprehensive Certificate of Analysis (CoA) documenting compliance with United States Pharmacopeia (USP) and European Pharmacopoeia (EP) standards.
Chemical Profile and Specifications
Molecular Characteristics:
- IUPAC Name: N-(4-Hydroxyphenyl)acetamide
- Molecular Formula: C₈H₉NO₂
- Molecular Weight: 151.16 g/mol
- CAS Number: 103-90-2
- Appearance: White, odorless crystalline powder
- Solubility: Soluble in alcohol, acetone; sparingly soluble in water (14 mg/mL at 25°C)
- pKa: 9.5 (phenolic hydroxyl)
Available Grades:
- USP/EP Pharmaceutical Grade
- ACS Reagent Grade
- Analytical Standard Grade (for HPLC/UV calibration)
Packaging Options:
- 100g laboratory pack
- 500g research quantity
- 1kg+ bulk pharmaceutical ingredient
Research Applications and Suitability
Pharmaceutical Formulation Development: Research institutions and contract manufacturers utilize acetaminophen powder for tablet formulation studies, dissolution testing, excipient compatibility research, and novel delivery system development (sustained-release, effervescent, and bilayer formulations).
Analytical Chemistry: Essential reference material for HPLC and UV-Vis method development, acetaminophen serves as a standard for:
- Content uniformity testing
- Dissolution profile calibration
- Stability-indicating assay validation
- Impurity profiling (4-aminophenol, 4-chloroacetanilide)
Pharmacological Research: Academic laboratories investigate acetaminophen’s central analgesic mechanisms, endocannabinoid system interactions, serotonergic pathways, and the role of the endogenous opioid system in its antinociceptive effects.
Toxicology Studies: Liver toxicity research, including glutathione depletion mechanisms, NAPQI (N-acetyl-p-benzoquinone imine) formation studies, and antidote development (N-acetylcysteine efficacy).
Forensic Analysis: Reference standard for identification and quantification in post-mortem toxicology, pharmaceutical fraud detection, and quality control verification.
Suitable For:
- Pharmaceutical R&D laboratories
- University chemistry and pharmacology departments
- Contract manufacturing organizations (CMOs)
- Quality control and analytical testing labs
- Veterinary formulation research
Proper Storage and Longevity
Acetaminophen powder exhibits excellent chemical stability under recommended conditions:
Temperature: Store at controlled room temperature (20-25°C). Avoid exposure to excessive heat (>40°C) which may promote degradation to 4-aminophenol.
Humidity Control: Store in tightly sealed containers with desiccant. While not highly hygroscopic, moisture can promote hydrolysis to p-aminophenol, affecting purity and analytical results.
Light Protection: Store in amber containers or opaque packaging. Photodegradation can produce colored impurities (quinone derivatives) that compromise analytical applications.
Air Exposure: Minimize exposure to oxygen and atmospheric pollutants. Oxidation can generate p-aminophenol and other degradation products.
Shelf Life: 60 months (5 years) when stored under USP/EP recommended conditions. Retest dating applied per ICH Q1A stability guidelines.
Degradation Indicators: Discoloration (pink/brown tint), presence of p-aminophenol odor, or melting point depression indicate compromised material unsuitable for analytical use.
Premium Packaging and Presentation
All acetaminophen shipments arrive in pharmaceutical-grade packaging ensuring integrity and compliance:
- Primary Container: Amber HDPE or glass jar with induction-sealed liner
- Secondary Protection: Heat-sealed aluminum foil pouch with desiccant packet
- Tertiary Packaging: Cushioned corrugated shipping container with hazard labeling as appropriate
- Documentation: USP/EP Certificate of Analysis, Safety Data Sheet (SDS), handling guidelines, and stability data
- Traceability: Batch number, manufacturing date, retest date, and unique identifier for supply chain tracking
Safety Information and Responsible Handling
Toxicity Warning: While acetaminophen possesses an excellent therapeutic safety profile at recommended doses, pure powder presents significant acute toxicity risk. The maximum daily therapeutic dose (4g for adults) represents a small volume of powder easily subject to measurement error. Accidental overdose can cause irreversible hepatotoxicity and death.
Handling Protocols:
- Use calibrated analytical balances for all measurements
- Wear appropriate PPE (gloves, dust mask, eye protection)
- Work in well-ventilated areas or fume hoods
- Maintain spill kits and decontamination supplies
- Never consume or allow contact with mucous membranes
Regulatory Status: Acetaminophen is an over-the-counter (OTC) medication in most jurisdictions. However, bulk API sales may be subject to pharmaceutical manufacturing regulations, record-keeping requirements, and reporting obligations depending on jurisdiction and intended use. Customers are responsible for compliance with local laws regarding possession and use of pharmaceutical ingredients.
Research Use Statement: This product is sold for research, analytical, and pharmaceutical manufacturing applications. It is not intended for direct human consumption without proper formulation, quality control, and regulatory approval.
Why Laboratories Choose BiosynLab Acetaminophen
Our commitment to pharmacopeial compliance, batch-to-batch consistency, and comprehensive documentation supports your research integrity and regulatory submissions. Whether you’re developing novel formulations, validating analytical methods, or conducting mechanistic pharmacology research, BiosynLab provides the quality standards your work demands.
Order your acetaminophen powder today and experience pharmaceutical-grade excellence.
