Dextromethorphan Hydrobromide Powder

Premium Dextromethorphan Hydrobromide Powder for Pharmaceutical Manufacturing – High-Purity API Solution

Shaanxi Hongda Phytochemistry Co., Ltd. stands as a trusted manufacturer and supplier of pharmaceutical-grade Dextromethorphan Hydrobromide Powder, delivering exceptional value to global pharmaceutical companies. We have over 20 years of experience since 2001 in a 20,000 square metre manufacturing plant with 100,000-level purifying workshops and advanced extraction technologies. Our product is 99% pure and is strictly controlled by SGS-standardized labs to meet the standards of USP and EP. We produce 3000 tonnes per year, with HALAL, KOSHER, cGMP, FSSC22000 and ISO Certifications, and we provide a reliable supply, affordable prices and quick delivery of 3-7 working days for your pharmaceutical manufacturing needs.

Introduction to Product

 Dextromethorphan Hydrobromide is a centrally acting antitussive drug, commonly used, pharmaceutical grade medication. This crystalline powder is an excellent non-narcotic cough suppressant which acts via NMDA receptor antagonism at the level of the medulla oblongata. ACTIVES STABILITY: Our high purity formulation guarantees the best polymorphic stability in monohydrate form for long shelf-life and constant bioavailability. The powder is somewhat soluble in water, but easily soluble in ethanol and is suitable for a variety of pharmacological uses. This premium quality ingredient is CAS number 125-69-9, molecular formula C18H25NO·HBr·H2O and fulfils the most stringent worldwide pharmaceutical standards for complicated formulation needs.

Dextromethorphan Hydrobromide Powder Advantages

High Polymorphic Stability : This monohydrate crystal form is stable throughout temperature ranges, i.e. no degradation occurs during storage and transit, which in turn saves production waste and reformulation costs.

Optimised Particle Distribution: A bulk density of 0.45-0.65 g/mL has been engineered to provide great flowability in high speed tablet presses. This reduces content uniformity concerns and down time on automated filling lines.

Ultra-Low Impurity Profile: Related substances are reliably < 0.1% to fulfil the most severe regulatory criteria for experimental medication applications and eliminate the need for further purification stages in your formulation process.

Enhanced Control of Solubility: Consistent crystal shape leads to predictable dissolving rates, which is crucial to formulating consistent prolonged release matrices and liquid suspension formulations with low sedimentation.

Product Specification

Dextromethorphan Hydrobromide Powder Application

Extended-Release Solid Dosage Forms: This powder is the key API for 12-hour ER tablets and polistirex coated pellets. The equal dispersion of particles avoids dosage dumping and maintains consistent therapeutic plasma levels throughout the dosing period.

Multi-Component Liquid Syrups: The powder is stable at a low pH and may be used in combination cold formulations with guaifenesin or antihistamines. The powder will stay homogeneous in suspension for long shelf periods without precipitation.

Neuropsychiatric Applications: Investigational formulations for pseudobulbar affect and neuropathic pain treatment rely on high-purity grades, where NMDA antagonist characteristics need pharmaceutical perfection with minimum interference from impurities.

Production Process

Step 1 – Selecting the Raw Materials: Source Dextromethorphan Hydrobromide Powder pharmaceutical grade precursors from recognised vendors and verify the purity of the arriving materials by HPLC analysis. Result: Only 98%+ quality materials go to synthesis steps.

Step 2 – Chemical Synthesis: Carry out controlled methylation reactions under strict temperature and pH control in stainless steel reactors. Goal: Obtain required arrangement of molecules with least production of by-products.

Step 3 – Crystallisation and Purification: Recrystallise in ethanol-water systems, vacuum filter via 0.22μm membranes. Result: Get monohydrate crystals with consistent shape and <0.1% inpurities.

Step 4 – Drying and Milling Dry in a vacuum at regulated temperatures. Mill to 80-120 mesh particle size using precision grinders. Result: Free flowing powder with optimum bulk density for downstream processing.

Step 5 – Quality Testing and Packaging: Full QC testing for assay, heavy metals and microbiological before sealing in double layer PE bags in fibre drums. Result: Pharmaceutical grade substance for immediate use in formulations.

Third-Party Test Report

Third Party Testing: Our product is tested thoroughly by third party agencies such as SGS, Eurofins, etc. to ensure that our quality is validated outside of our own controls.

Pesticide Residue Analysis: Using advanced chromatographic techniques, no detectable pesticide contamination was found, complying with stringent international pharmaceutical residue standards for safe human consumption.

Heavy Metal Screening Atomic absorption spectrophotometry confirms the conformity with ICH Q3D recommendations. The levels of lead, arsenic, mercury and cadmium are far below permitted limits.

Microbiological Safety: Total Aerobic Microbial Count (TAMC), yeast, mould and pathogen testing confirms absence of Salmonella, E. coli and Staphylococcus aureus, ensuring pharmaceutical grade sterility requirements.

Why choose us?

Shaanxi Hongda Phytochemistry is a combination of manufacturing excellence and scientific innovation and is in compliance with cGMP and has various international certifications. Risk of contamination is eliminated via our 100,000-level purification workshops and our R&D teams lead by professors are constantly optimising manufacturing processes. It covers 3,000 sq.m. and has six specialised warehouses, always keeping enough stock to provide on-time delivery without any minimum order quantity. We have over 150 experienced technicians and complete traceability systems from the planting bases to finished products. We provide our pharmaceutical partners with reliable supply chains, competitive pricing structures and responsive technical support to reduce your time-to-market and operational uncertainties.

OEM/ODM Service

​​​​​​​Custom Formulation Development: Our team of 20+ R&D specialists works with your team to create custom blends, modifying particle size, coating specs or developing combination goods that fit your market positioning plan.

Flexible Packaging Solutions From bulk 25kg fibre drums to smaller research volumes, we have the packaging you need. We can customise our labels with your trademark and regulatory details for an easy market entry.

Regulatory Documentation Support Accelerate your regulatory filing procedure with FDA, EMA and other foreign health agencies using complete Drug Master Files (DMFs), Certificates of Suitability (CEPs) and stability study data.

Support for Scaling Up: Our technical staff can help you transition easily from laboratory scale trial to commercial scale production, giving formulation optimisation assistance to ensure manufacturing repeatability from pilot size batches up to multi-ton orders.

FAQ

Q: How much powder do I have to buy to get the price?

A: We can work with you on ordering as little as 1kg samples or as much as several tonnes, and there are volume savings available for recurring buying relationships.

Q: How do you guarantee batch to batch consistency?

A: We have over 15 quality checks on each manufacturing batch, including HPLC fingerprinting, and retain complete batch records traceable to the exact raw material lots used.

Q: What paperwork do you give for regulatory filing?

A: Full COA, third party test reports, stability studies, manufacturing process details, DMF references supporting ANDA and NDA submissions.

Q: Can you customize particle size for specific applications?

A: Yes, our milling systems achieve precise PSD control from 40 to 200 mesh based on your tableting or encapsulation equipment requirements.

Q: What is your typical lead time for repeat orders?

A: Standard delivery occurs within 3-7 working days for in-stock specifications, with production orders typically fulfilled within 15-20 days depending on volume.

Contact Us

Ready to secure a reliable supply of premium Dextromethorphan Hydrobromide Powder for your pharmaceutical manufacturing needs? Contact Us today at duke@hongdaherb.com  to request samples, technical data sheets, or quotations.