Meloxicam Powder

High-Purity Meloxicam Powder for Pharmaceutical Manufacturing | 99% COX-2 Selective NSAID API with Superior Bioavailability Solutions

As a trusted manufacturer and supplier of pharmaceutical-grade active ingredients, Shaanxi Hongda Phytochemistry Co., Ltd. specializes in producing premium Meloxicam Powder with 99% purity, meeting stringent international standards for NSAID API production. Our micronised formulation has the answer to the bioavailability dilemma for BCS Class II substances, providing a uniform particle size distribution (D90 < 10 microns) which is necessary for optimum dissolving rates of final dosage forms. With 20,000-sqm cGMP-certified facility, state-of-the-art HPLC testing equipment and over 20 years of experience in pharmaceutical manufacturing, we can provide you with stable polymorph-controlled material that guarantees predictable therapeutic performance for your tablet, capsule and injectable formulations.

Product Introduction

It is a non-steroidal anti-inflammatory medication of the enolic acid (oxicam) group, with specific COX-2 inhibitory action via a preferred enzyme targeting method. This light yellow crystalline powder is amphoteric with two pKa values of 1.1 and 4.2. It is nearly insoluble in water but sensitive to formulation environment with control of pH. The substance is the essential API for making oral solid doses for osteoarthritis and rheumatoid arthritis and veterinary pain management solutions. Our pharmaceutical grade powder is stringently standardised for polymorph to guarantee the stable enolic form (Polymorph I), which is crucial to consistent dissolving characteristics across batch manufacturing.

Test Report from Third Party

Independent Verification Standards: We subject our goods to extensive third-party testing at SGS and Eurofins labs for full regulatory compliance and pharmaceutical safety.

Heavy Metals Analysis: ICP-MS testing indicates all heavy metal concentration (lead, arsenic, cadmium, mercury) is within USP <232> and EP 2.4.27 standards. Total heavy metals is generally <5ppm.

Residual Solvent Screening: Gas chromatography validation according to ICH Q3C recommendations to ensure that synthesis solvents (methanol, xylene, THF) are within Class 2 and Class 3 solvent limits for patient safety in final formulations.

Microbiological Safety: Total aerobic microbial count and yeast/mold enumeration exceed the standards of pharmaceutical grade for non-sterile API applications with TAMC <1000 CFU/g and TYMC <100 CFU/g.

Product Specification

Meloxicam Powder Advantages

Pharmaceutical-Grade Polymorph Control: Our production technique creates only the thermodynamically stable Polymorph I (enolic tautomer), preventing the danger of crystal habit transition during storage that might put at risk dissolution kinetics and bioequivalence in your formulations.

Advanced Micronization Technology: Micronization technology offers a closely regulated particle size distribution with reproducible D50 values of around 5 microns, which addresses the poor water solubility problem of BCS Class II APIs and allows for fast drug release profiles.

Superior Purity Profile: High performance synthesis techniques provide assay purity >99% with strict control on process associated impurities, especially the amide degradation product to levels substantially below the pharmacopeial limits, thereby lowering the risk during stability studies.

Improved Flowability Characteristics: The surface modification methods are intended to increase the powder flowability and compressibility indices that will allow direct compression and wet granulation processes on high-speed tablet manufacturing lines without segregation problems.

Application of Meloxicam Powder

Pharmaceutical Manufacturing for Humans: Our powder is used as the main Active Pharmaceutical Ingredient for the manufacture of 7.5mg and 15mg oral tablets and capsules to treat osteoarthritis and rheumatoid arthritis. Its consistent particle distribution ensures compliance with content uniformity requirements in large-scale production batches.

Veterinary Medicine Formulations: Commonly used for the preparation of injectable solutions and oral suspensions in pain management for companion animals and livestock. Specific solubilisation techniques, such as tromethamine complexation or cyclodextrin inclusion, are needed for these formulations to produce stable aqueous formulations.

Specific Compounding Uses: Allows compounding pharmacies to formulate tailored transdermal gels and topical creams. Particle size control allows penetration of the stratum corneum for localised anti-inflammatory impact with less systemic exposure.

Research & Development Projects: Supports pharmaceutical innovation in innovative systems for drug administration using Meloxicam Powder including nanoparticle suspensions, solid lipid dispersions, and self-emulsifying systems for drug delivery to further improve bioavailability profiles.

Production Process

Step 1 - Raw Material Synthesis and Purification: Pharmaceutical-grade precursors undergo controlled condensation reactions under nitrogen atmosphere with continuous monitoring of reaction parameters, yielding crude Meloxicam that is subsequently crystallized from controlled solvent systems to achieve initial purity targets.

Step 2 - Polymorph Standardization and Crystallization: The crude material undergoes temperature-controlled recrystallization using validated solvent ratios, producing exclusively the stable Polymorph I crystal structure, confirmed through differential scanning calorimetry and X-ray powder diffraction analysis.

Step 3 - Micronization and Particle Engineering: Dry Meloxicam crystals pass through jet milling equipment under cryogenic conditions, achieving target particle size distribution while preventing thermal degradation, followed by air classification to remove oversized particles.

Step 4 - Quality Testing and Sterile Packaging: Final powder undergoes comprehensive HPLC assay verification, impurity profiling, residual solvent screening, and microbial testing in our SGS-standard laboratory before aseptic filling into double-layer PE bags within fiber drums under ISO Class 7 cleanroom conditions.

Why Choose Us

Shaanxi Hongda Phytochemistry has over 20 years of experience in pharmaceutical manufacture with 20,000 square meters of cGMP production base, 10 contemporary production lines and 100,000-level purification workshop. Our quality infrastructure is an SGS-standardized laboratory with HPLC, GC, spectrophotometric analytical equipment and professor-level experts to ensure that every batch fulfils worldwide pharmacopeial standards. Our Certifications include HALAL, KOSHER, FSSC22000, ISO22000, ISO9001 and we provide pharmaceutical-grade chemicals trusted by businesses across Europe, North America and Asia. We have 3,000 square meters warehouse with ready stock for 3-7 days delivery Our dedicated customer care staff offers technical assistance throughout your product development lifecycle.

Product Package

OEM / ODM Support

Custom Formulation Development: Our team of 20+ pharmaceutical experts work with your technical team to produce optimised formulations to solve particular issues for your target dosage form including dissolving needs, excipient compatibility and stability.

Custom Particle Size: We modify micronization settings to provide custom particle size distributions compatible with your production equipment capabilities and desired release profiles for immediate release tablets or sustained release matrix systems.

Regulatory Documentation Support Complete Drug Master File (DMF) preparation support includes manufacturing process descriptions, analytical method validation data, stability studies and GMP compliance documents to accelerate your product registration deadlines.

Flexible Packaging Solutions We also have specific moisture-barrier systems for demanding storage settings. We can provide bespoke package configurations from 100g lab size samples to 500kg bulk containers, in addition to the typical 25kg fibre drums.

Our Exhibitions

FAQ

Q: What distinguishes your pharmaceutical-grade material from standard industrial quality?

A: We have rigorous polymorph verification to ensure only stable Form I crystals, pharmaceutical grade impurity control with amide <0.1% and verified micronization for consistent D90 <10μm particle size distribution.

Q: Can you provide regulatory support for new drug applications?

​​​​​​​A: Yes, we provide extensive documentation including Certificates of Analysis, stability data, manufacturing process details, and can generate Type III Drug Master Files to support ANDA and NDA filings.

Q: What's your quality control approach for batch-to-batch consistency?

A: There are more than 15 quality checkpoints for each manufacturing batch, including HPLC purity assay, particle size laser diffraction, residual solvent GC screening and microbiological testing, before a batch is released. Retention samples are maintained for two years.

Q: Do you provide technical assistance for formulation problems?

A: Yeah, totally. Our pharmaceutical development team offers free consulting on solubility improvement options, excipient compatibility and dissolution optimisation suited to your production needs.

Q: What is your minimum order quantity for trial batches?

A: We accommodate research needs starting from 100g sample sizes, with full commercial production capabilities scaling to multi-ton annual supply agreements supported by stable pricing structures.

Contact Us

Ready to enhance your pharmaceutical formulations with premium Meloxicam Powder backed by rigorous quality assurance and technical expertise? Contact us directly at duke@hongdaherb.com  and discover how Shaanxi Hongda Phytochemistry's manufacturing excellence.