Product Basic Information
| Item | Details |
|---|---|
| Product Name | Ibuprofen |
| CAS No. | 15687-27-1 |
| Synonyms | (±)-2-(4-Isobutylphenyl)propanoic acid; Advil® / Motrin® (brand names for OTC formulations) |
| Molecular Formula | C₁₃H₁₈O₂ |
| Molecular Weight | 206.28 |
| Appearance | White to off-white crystalline powder; Odorless, with a slightly bitter taste |
| Specification | - Pharmaceutical Grade: Purity ≥99.0% (HPLC); Assay (as ibuprofen) ≥98.5%–101.5%; Melting point 74–77°C; Loss on drying ≤0.5%; Heavy metals (Pb≤10ppm, Hg≤1ppm, Cd≤1ppm)- OTC/Food Grade: Purity ≥98.0% (HPLC); Compliant with FDA/EMA OTC monographs; No detectable impurities (≤0.1%) |
| Melting Point | 74–77°C |
| Solubility | Practically insoluble in water (≈21 mg/L at 25°C); Soluble in ethanol, methanol, acetone, and dilute sodium hydroxide solutions; Sparingly soluble in chloroform |
| Storage Conditions | Store in a cool (15–25°C), dry, light-protected container; Sealed to prevent moisture absorption and oxidation; Shelf life: 36 months for pharmaceutical grade, 24 months for OTC grade |
Core Functions & Applications
Ibuprofen Cas#15687-27-1exerts its pharmacological effects by inhibiting cyclooxygenase (COX) enzymes-specifically COX-1 (constitutive, involved in gastric protection and platelet function) and COX-2 (inducible, upregulated during inflammation). By blocking COX, it reduces the synthesis of prostaglandins-lipid mediators that trigger pain, inflammation, and fever. Its anti-inflammatory activity is particularly useful for conditions involving tissue swelling, while its analgesic effect targets mild-to-moderate pain. It is primarily used in human medicine, with limited veterinary applications:
1. Human Pharmaceutical & OTC Field
1.1 Pain Relief (Analgesic Use)
Acute Pain: First-line treatment for mild-to-moderate pain, including:
Headaches (tension headaches, migraines): Oral dose (200–400 mg every 4–6 hours, max 1200 mg/day for adults) to reduce pain intensity and duration.
Musculoskeletal pain (back pain, arthritis, sprains/strains): 400–600 mg every 6–8 hours (max 2400 mg/day) to alleviate pain and improve mobility.
Postoperative pain: 400–800 mg every 6–8 hours (often combined with acetaminophen for synergistic effect) to reduce opioid use.
Dental pain (toothaches, post-extraction pain): 200–400 mg every 4–6 hours, with faster onset than acetaminophen.
1.2 Inflammation Reduction (Anti-Inflammatory Use)
Chronic Inflammatory Conditions:
Osteoarthritis: 400–800 mg three times daily (max 2400 mg/day) to reduce joint pain, stiffness, and swelling-improving daily activities (e.g., walking, climbing stairs).
Rheumatoid arthritis: 800 mg three to four times daily (under medical supervision) to suppress synovial inflammation and slow joint damage progression.
Juvenile idiopathic arthritis (JIA): Pediatric dose (5–10 mg/kg every 6–8 hours, max 40 mg/kg/day) to manage pain and inflammation in children ≥6 months.
1.3 Fever Reduction (Antipyretic Use)
Acute Fever: Recommended for fever in adults and children (≥6 months) associated with infections (e.g., colds, flu, bacterial infections):
Adults: 200–400 mg every 4–6 hours (max 1200 mg/day) until fever resolves.
Children: 5–10 mg/kg every 6–8 hours (max 40 mg/kg/day), administered as oral suspensions or chewable tablets for easy dosing.
2. Veterinary Field (Companion Animals)
Ibuprofen Cas#15687-27-1 is not approved for cats (high risk of fatal renal failure due to poor metabolism) but is occasionally used off-label in dogs for short-term management of inflammatory conditions, under strict veterinary supervision:
Canine Osteoarthritis: 2–4 mg/kg body weight twice daily (max 8 mg/kg/day) for 5–7 days to reduce joint pain and improve mobility. Long-term use is avoided due to renal/hepatic toxicity risk.
Postoperative Pain in Dogs: 2–4 mg/kg twice daily for 3–5 days (combined with other analgesics like tramadol) to reduce pain after orthopedic or soft tissue surgery.
Contraindication: Never use in cats, pregnant/nursing dogs, or dogs with pre-existing renal/hepatic disease, gastrointestinal ulcers, or bleeding disorders.
Quality & Safety Assurance
As a widely used OTC and prescription medication, Ibuprofen requires rigorous quality control to ensure efficacy, minimize side effects, and comply with regulatory standards:
Raw Material & Synthesis: Produced via industrial chemical synthesis (e.g., Friedel-Crafts alkylation of isobutylbenzene with propionyl chloride, followed by hydrolysis and resolution of enantiomers). The commercial product is a racemic mixture (50% R-enantiomer, 50% S-enantiomer)-the S-enantiomer is the active form, while the R-enantiomer is partially converted to S in the body.
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 enantiomeric purity.
OTC Grade: Undergoes additional testing for dissolution rate (to ensure rapid absorption) and compliance with OTC monographs (e.g., FDA 21 CFR Part 343).
Comprehensive Testing Protocol:
| Test Item | Method | Acceptance Criterion |
|---|---|---|
| Purity & Assay | HPLC (C18 column, 220 nm detection) | Pharmaceutical grade: ≥99.0% purity; OTC grade: ≥98.0% purity |
| Related Substances | HPLC (gradient elution) | Single impurity ≤0.1%, total impurities ≤0.5% |
| Heavy Metals | ICP-MS (Inductively Coupled Plasma-Mass Spectrometry) | Pb≤10ppm, Hg≤1ppm, Cd≤1ppm |
| Dissolution Rate (Tablets) | USP Apparatus II (paddle method) | ≥80% dissolved in 30 minutes (pH 7.2 buffer) |
| Enantiomeric Purity | Chiral HPLC | S-enantiomer ≥48% (racemic mixture) |
Safety Reminders:Human Use:
Contraindications: Hypersensitivity to NSAIDs (e.g., aspirin-induced asthma); active peptic ulcer disease; severe renal/hepatic failure; third-trimester pregnancy (risk of fetal ductus arteriosus closure).
Adverse Effects: Gastrointestinal upset (nausea, ulcers-minimize with food or proton pump inhibitors), renal impairment (avoid in dehydrated patients), and rare hypersensitivity reactions (rash, anaphylaxis).
Dosage Caution: Do not exceed recommended doses (adults: max 2400 mg/day; children: max 40 mg/kg/day) to avoid toxicity.
Veterinary Use:
Strict Supervision: Only use in dogs under veterinary guidance; monitor for signs of toxicity (vomiting, diarrhea, increased thirst/urination).
Alternative for Cats: Use feline-specific NSAIDs (e.g., meloxicam) instead of ibuprofen.
Cooperation & Contact
We supply Cas#15687-27-1 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 or granulated form (10kg–500kg per order; monthly production capacity of 3000kg) for OTC tablets, suspensions, and topical gels.
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 OTC tablets), granulation (for uniform blending), and topical gel formulations.
Technical guidance: Dosage optimization for pediatric patients, dissolution testing support, and regulatory compliance with OTC monographs.
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 priority, and accessibility" and look forward to partnering with global healthcare and OTC industries!
Hot Tags: ibuprofen cas#15687-27-1, China ibuprofen cas#15687-27-1 manufacturers, suppliers, api for agriculture, api for customer relationship management, api for environmental management, api for risk management, api for survey management, api for transportation management
