Ibuprofen Raw Material

Ibuprofen Raw Material | Pharmaceutical API Supplier | 99% Purity USP/EP Grade

Shaanxi Hongda Phytochemistry Co., Ltd. is a reliable producer and supplier of Ibuprofen Raw Material, offering pharmaceutical grade API with a purity of 99% and CAS No. 15687-27-1. Hongda has 20,000㎡ production facilities, 3,000 tons yearly output capacity and an SGS-certified laboratory, providing stable white crystalline powder with USP, EP and BP monograph. Complete impurity profile, HPLC validated assay findings and Certifications such as HALAL, KOSHER, ISO9001, ISO22000 and BRC are supplied with each batch, offering pharmaceutical purchasers verifiable documentation from day one.​​​​​​​

Product Introduction

Ibuprofen Raw Material is the Active Pharmaceutical Ingredient (API) that is chemically defined as (RS)-2-(4-(2-methylpropyl)phenyl)propanoic acid with molecular formula C13H18O2 and molecular weight of 206.3 g/mol.

It is a non-steroidal anti-inflammatory medicine (NSAID) that works by non-selective inhibition of COX-1 and COX-2 enzymes, which decreases prostaglandin synthesis associated with pain, fever and inflammation.

The material is a white or almost white crystalline powder with a minor unique odour. It has a melting point range of 75°C-78°C and is nearly insoluble in water but freely soluble in acetone, methanol and methylene chloride – a solubility profile that will immediately impact your formulation strategy.

Third-Party Test Report

Every batch is tested prior to shipping. Hongda has independent verification for the following important criteria via SGS and Eurofins:

· Impurity profile (HPLC): Impurity J / 4-Isobutylacetophenone and Impurity B, regulated to < 0.1%

· Residual solvents (GC) : Class 2 and Class 3 solvents validated as per ICH Q3C guidelines

· Residues of pesticides, heavy metals, microbiological counts

· Nutrition labelling and natural origin declaration where applicable

Third-party test reports available upon request. For a sample documentation package, please Contact Us at duke@hongdaherb.com.

Ibuprofen Raw Material Advantages

Controlled particle size for every grade

Hongda has standard grade (bulk density 0.3–0.5 g/mL) and micronized grade (D90 < 20 μm). The micronized version also has improved solubility rates in liquid suspensions and softgels, eliminating one of the most prevalent formulation difficulties for this hydrophobic molecule.”

Control of impurities tight

The major synthetic by-product is 4-Isobutylacetophenone (Impurity J). High levels indicate inadequate process control and are grounds for rejection of the batch under USP/EP. Hongda’s technique keeps this contaminant well below 0.1%, validated batch by batch using HPLC.

Polymorphic low LOD stability

LOD is kept below 0.5% to prevent hydrolytic breakdown and microbiological growth during storage and transit. Polymorphic consistency preserves your downstream tablet hardness and disintegration performance.

Full pharmacopoeia compliance

All lots comply with USP, EP, BP, JP and IP monographs – vital for regulatory filings in the US, EU, Japan and more.

Ibuprofen Raw Material Application

Oral solid dosage forms (tablets and capsules)

It is a DC grade material which can be used for direct compression tabletting without the need of wet granulation. Engineered crystal morphology provide the flowability and compressibility that high-speed production lines need, saving time and energy expenses.

Oral suspensions (paediatric)

Micronized-grade ibuprofen API (D90 < 20 μm) allows for a consistent dispersion in syrups so as to minimise sedimentation and provide dose uniformity – a vital factor when the hydrophobic nature of the molecule makes dispersion difficult.

Topical analgesic products

Ibuprofen is lipophilic and dissolves in organic solvents and so is ideal for gels, creams or transdermal patches for local arthritic and muscular discomfort.

Production Process

Shaanxi Hongda has about 10 contemporary production lines in 100,000-level purifying workshops in its 20,000㎡ plant.

The production flow is under strong pharmaceutical grade controls: raw material sourcing → quality screening → synthesis/extraction → purification → particle size control → in process testing → Packaging under aseptic settings.

All steps are verified in our own laboratory with SGS standards, HPLC, GC, UV spectrophotometers, atomic absorption spectrophotometers, melting point metres, automated titrators. More than 150 workshop technicians carry out daily operations with full batch traceability from input to finished product.

Why Choose Us?

· Established in 2001 with more than 20 years expertise in API and botanical extract production

• Annual production of 3,000 tons · Stock enough to guaranty delivery within 3-7 working days

· Third-party testing collaborations with SGS and Eurofins for independent verification

· Multi-market certifications: HALAL, KOSHER, BRC, ISO9001, ISO22000, cGMP, FSSC22000, ORGANIC (EU & NOP)

· 20+ university-affiliated scientists in an in-house R&D team that consistently optimises product quality

· Three specialised plantation bases and integrated vertical raw materials supply chain

Our Factory

OEM / ODM Support

Hongda is able to accommodate bespoke specification according to your formulation need. You can ask for:

· Specific grades of particle size (standard, micronized or DC)

· Custom assay ranges within pharmacopeial limitations

• Bulk quantities on pallets (27 drums/pallet, 25kg/drum)

· Private label COA formatting and white label documentation

If you are scaling a new product line, need a secondary supplier, or require complete paperwork, our team offers one-to-one support. For pricing and minimum order quantities contact our technical sales team direct.

FAQ

Q1: What is the difference between DC grade and micronized grade ibuprofen active pharmaceutical ingredient (API)?

A: DC (Direct Compression) grade has changed crystal morphology to manufacture tablets without granulation. Micronized grade D90 < 20 μm, for liquid solutions and softgels requiring quicker dissolving.

Q2: How can ibuprofen API be stored to avoid caking?

A: Store in tight, light-proof containers at temperatures below 25°C. Ibuprofen has a low melting point (~75 C) hence it can be sintered under heat or too much stacking pressure .

Q3: How do you control Impurity J (4-Isobutylacetophenone) in your product?

A:Hongda strictly monitors the synthesis process and keeps this impurity below 0.1%. All batches are tested by HPLC before to shipment. High J levels of impurity signify process failure and result in batch rejection according to USP/EP.

Q4: What pharmacopeial standards are applicable to your product?

A: The product complies with USP, EP, BP, JP and IP monographs with an assay between 97.0% and 103.0% on anhydrous basis.

Q5: Is your ibuprofen API suitable for IV formulations?

A: Standard oral grade API (acid form) is not recommended for IV administration. IV formulations require sterile, endotoxin-controlled salt forms such Ibuprofen Lysine or Sodium. Please contact us to discuss suitable grading possibilities.

Q6. Do you give Prop 65 & Nitrosamine risk declarations?

A: Indeed. We can give declarations of no nitrosamine precursors and compliance with California Prop 65 heavy metals upon request.

Contact Us

Ready to source pharmaceutical-grade Ibuprofen Raw Material? Email us at duke@hongdaherb.com and get your COA, pricing, and sample within 24 hours.