DEXTROMETHORPHAN HYDROBROMIDE

Dextromethorphan Hydrobromide is a widely used antitussive (cough suppressant) that provides effective relief from dry, irritating, and non-productive cough. It acts directly on the cough center in the medulla oblongata to suppress the cough reflex without affecting respiratory function. Known for its excellent safety profile, Dextromethorphan is a preferred ingredient in OTC (over-the-counter) cough and cold formulations.

At Bluepill Express, we manufacture and export pharma-grade Dextromethorphan Hydrobromide API under WHO-GMP, ISO, and cGMP-certified facilities. Our API complies with IP, BP, USP, and EP pharmacopeial standards, ensuring consistent purity, superior solubility, and stability for global pharmaceutical manufacturers.

It is commonly used alone or in combination with antihistamines, decongestants, and expectorants to treat various upper respiratory tract conditions. Bluepill Express ensures controlled particle size distribution, low impurity levels, and excellent compressibility, making it ideal for syrup, tablet, and capsule formulations.

Therapeutic Applications:

• Dry or non-productive cough
• Common cold and bronchitis
• Pharyngitis and laryngitis
• Cough associated with upper respiratory tract infections
• Combination formulations with antihistamines and decongestants

Mechanism of Action:

Dextromethorphan acts on the sigma-1 receptors and the cough center in the medulla, elevating the threshold for coughing. Unlike opioid cough suppressants, it has no analgesic or addictive properties, ensuring safety and effectiveness in both adult and pediatric use.

Technical Specifications:

• Chemical Name: 3-Methoxy-17-methylmorphinan hydrobromide monohydrate
• Molecular Formula: C₁₈H₂₅NO·HBr·H₂O
• Molecular Weight: 370.33 g/mol
• CAS Number: 125-69-9
• Appearance: White or almost white crystalline powder
• Assay (on dried basis): NLT 98.0% and NMT 101.0%
• Solubility: Freely soluble in water, alcohol, and chloroform
• Melting Point: 114°C – 118°C
• Storage Conditions: Store below 30°C, protected from light and moisture

Pharmacological Classification:

• Therapeutic Class: Antitussive (Cough Suppressant)
• Pharmacopoeial Standards: IP / BP / USP / EP
• Common Formulations: Syrups, Tablets, Capsules, Lozenges, and Oral Suspensions

Manufacturing Excellence – Bluepill Express:

• Manufactured under WHO-GMP and ISO 9001:2015 certified facilities
• High assay purity (≥99%) and low impurity content
• Validated analytical methods for quality assurance (HPLC, IR, UV)
• Stable crystalline form ensuring long shelf life
• Regulatory-ready documentation for international registrations

Advantages of Bluepill Express Dextromethorphan Hydrobromide API:

• Complies with IP/BP/USP/EP pharmacopeias
• Low microbial and solvent residue profile
• Excellent flow properties for uniform formulation
• High stability under various environmental conditions
• Supplied with complete regulatory documentation (DMF, COA, MSDS)

Packaging & Export Details:

• Packaging Sizes: 5 kg, 10 kg, 25 kg HDPE drums with double inner liners
• Labeling: Export-compliant and batch traceable
• Shelf Life: 36 months from manufacturing date
• Export Markets: Asia, Africa, Middle East, Europe, Latin America
• Documentation Provided:
  • Certificate of Analysis (COA)
  • Material Safety Data Sheet (MSDS)
  • Stability Data
  • Technical Data Sheet (TDS)
  • Drug Master File (DMF) on request