Ibuprofen API | CAS 15687-27-1 | USP Bulk Supplier
Ibuprofen is a classic non‑steroidal anti‑inflammatory drug (NSAID) API, widely used globally for analgesic, antipyretic and anti‑inflammatory purposes. It works by inhibiting cyclooxygenase (COX) and reducing prostaglandin synthesis. It is listed on the WHO Essential Medicines List and is one of the most popular over-the-counter active ingredients. Our supplied ibuprofen meets USP / EP / BP pharmacopoeia standards, with stable impurity profile, controllable particle size and good compressibility. It is suitable for manufacturing tablets, capsules, oral suspension, chewable tablets, topical gels and veterinary formulations. We support pre-production sample testing and provide complete quality documents for registration and GMP audit.
How to Choose Ibuprofen API
Select Ibuprofen API by matching pharmacopoeia grade to your market. Review impurity profile, particle size and compressibility for your dosage form. Verify supplier GMP qualification and complete audit documents. Always test samples before bulk purchase.
COA
| Item | Specification | Result | Test Method |
| Description | A white to whitish yellow, crystalline powder, crystals, or agglomerate. | Conforms | Visual Inspection |
| Solubility | Freely soluble in acetone, in chloroform, in ethanol(95%) and in ether; practically insoluble in water. It dissolves in dilute solutions of alkali hydroxides and carbonates. | Conforms | Visual solubility test |
| Identification by IR | The infrared absorption spectrum of the sample is concordant with that of the reference standard spectrum. | Conforms | Infrared Spectrophotometry |
| Identification by UV | The ultraviolet absorption spectrum of the sample should exhibit a maximum at the same wavelength as that of the reference solution. | Conforms | Ultraviolet Spectrophotometry |
| Related substances by thin layer chromatography | The principal spot in the chromatogram of the sample solution corresponds in position and colour to that of the reference solution. | Conforms | Thin Layer Chromatography (TLC) |
| Appearance of the solution (10% solution in ethanol 95%) | Solution should be clear and colourless. | Conforms | Visual Inspection |
| Optical rotation | +0.05° to −0.05° | Conforms | Polarimetry |
| Any individual impurity by HPLC | ≤0.3% | 0.15% | HPLC |
| Impurity C by GC | ≤0.7% | 0.15% | GC |
| Loss on drying | ≤0.5% | 0.36% | Gravimetric method |
| Water | ≤0.10% | 0.04% | Karl Fischer Titration |
| Heavy metals | ≤10ppm | <10ppm | ICP-MS |
| Assay by titration | 98.5% to 101.0% | 99.63% | Titration method |
| Bulk density, loose | Informative | 0.45g/ml | Volumetric method |
| Bulk density, tapped | Informative | 0.54g/ml | Volumetric method |
| Complies with Ph.Eur.11/BP2025 and the customer´s requirements. | |||
Applications
1.Human OTC & prescription oral formulation: manufacture ibuprofen tablets, capsules, chewable tablets and oral dry suspension for fever, mild to moderate pain relief (headache, toothache, dysmenorrhea, musculoskeletal pain)
2.Anti-inflammatory finished drugs: for rheumatoid arthritis, osteoarthritis and other inflammatory joint disorders
3.Topical preparation raw material: compound gel, cream for local pain relief
4.Paediatric formulation: paediatric oral suspension (strict dose control required)
5.Veterinary formulation: veterinary antipyretic and analgesic preparations following local veterinary regulations
6.Pharmaceutical R&D: formulation development, dissolution test, stability study, compatibility research
7.Compound formula research: combined with other APIs for multi-symptom cold relief products
Benefits
1.Triple pharmacological effect: analgesic, antipyretic and anti‑inflammatory, broad clinical application
2.Meets major pharmacopoeia standards (USP/EP/BP/CP), easy for global drug registration
3.Good compressibility and adjustable particle size, fit for tablets, suspensions, topical dosage forms
4.Low single & total impurity levels, stable crystal form, consistent batch-to-batch quality
5.Complete supporting documents (COA, SDS, TDS, BSE/TSE statement) for factory audit and regulatory submission
6.Flexible bulk packaging, stable supply chain, competitive cost for mass OTC production
Side Effects & Safety Warning
1.Gastrointestinal risk: nausea, dyspepsia, stomach pain, ulceration and bleeding risk for long-term use.
2.Renal risk: fluid retention, edema, impaired renal function in susceptible populations.
3.Cardiovascular risk: increased risk of thrombotic events for high-dose or long-term NSAID use.
4.Hypersensitivity: skin rash, bronchospasm, asthma exacerbation in sensitive people.
5.Handling precaution: avoid dust inhalation; wear dust mask, goggles and gloves during powder handling.
6.Incompatible with strong oxidizing agents.
Lead Time, Shipping & Logistics
Every batch of Ibuprofen API goes through full in-house testing before release:
HPLC assay, related substances & individual impurity test
Loss on drying, melting point, particle size distribution test
Heavy metals, residual solvent, microbial limit test
Independent QC lab, calibrated testing instruments, traceable reference standard
Retention sample for every batch, 36 months retention period
Batch deviation handling and change control system following GMP
CONTACT PAGE
We are reliable bulk supplier of Ibuprofen API CAS 15687-27-1. Send us your required quantity, pharmacopoeia grade, particle size requirement and target market regulation. We will prepare formal quotation plus COA and full supporting files for your registration and factory audit.
1.Inquiry methods：
Email:alice@xaheshun.com
Whatspp:+8618509260106
Online instant messaging
2.Contact Information：
Name：Alice
Telephone :+8618509260106
Email:alice@xaheshun.com
FAQ
Q: What are the standard packaging specifications and storage conditions for Ibuprofen API?
A: Standard export packaging is usually 25kg per fiber drum lined with double-layer medical-grade polyethylene bags. It should be stored in a tightly sealed container in a cool, dry, and dark place (typically controlled at room temperature).
Q: What are the typical Minimum Order Quantities (MOQ) and lead times for Ibuprofen API?
A: YStandard pharmaceutical API MOQs typically start at 25kg (one drum). Spot inventory can usually be shipped within 3 to 5 business days, while bulk or customized orders depend on production scheduling (generally 2 to 4 weeks).
Q: What core parameters on the Certificate of Analysis (COA) require close inspection?
A:Key parameters to verify include identification tests (IR/HPLC), melting point (75–78°C), total related substances, heavy metal content, sulfated ash, and microbiological limits to ensure batch-to-batch consistency.
Q: What pharmacopoeia grades can you offer for Ibuprofen?
A: USP, EP, BP and CP grade available. COA fully matches the monograph you select.
Q:Is ibuprofen suitable for paediatric suspension?
A: Yes, particle size can be customized for suspension, buyers must follow local paediatric drug regulatory rules.
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