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Dihydrocodeine Hydrogen Tartrate is a semi-synthetic opioid analgesic used for the treatment of moderate to severe pain and chronic cough. It acts on the central nervous system to relieve pain and suppress cough reflexes. The API is widely used in pain management formulations and antitussive preparations.
At Bluepill Express, we specialize in the high-quality manufacturing and export of Dihydrocodeine Hydrogen Tartrate API that conforms to WHO-GMP, ISO 9001:2015, and cGMP standards. Our product exhibits exceptional purity (≥99%), excellent solubility, and controlled particle size, ensuring consistent efficacy in finished dosage forms.
Dihydrocodeine Hydrogen Tartrate is a key active pharmaceutical ingredient used in tablets, capsules, syrups, and controlled-release formulations, offering reliable bioavailability and pharmacokinetic performance.
Therapeutic Applications:
- Moderate to severe pain management
- Chronic cough suppression
- Post-operative and musculoskeletal pain relief
- Adjunct in palliative care
Mechanism of Action:
Dihydrocodeine acts as an opioid receptor agonist, binding to the mu-opioid receptors in the brain and spinal cord. This binding inhibits the transmission of pain signals and suppresses the cough reflex center in the medulla, providing both analgesic and antitussive effects.
Technical Specifications:
- Chemical Name: (5α,6α)-4,5-Epoxy-3-methoxy-17-methylmorphinan-6-ol hydrogen tartrate
- Molecular Formula: C₁₈H₂₃NO₃·C₄H₆O₆
- Molecular Weight: 451.48 g/mol
- CAS Number: 125-28-0
- Appearance: White or almost white crystalline powder
- Assay (on dried basis): NLT 98.0% and NMT 102.0%
- Melting Range: 160°C – 165°C
- Solubility: Freely soluble in water and alcohol
- Storage Conditions: Store below 25°C, in airtight containers, protected from light and moisture
Pharmacological Classification:
- Therapeutic Class: Opioid Analgesic / Antitussive Agent
- Pharmacopoeial Standards: BP / EP / USP / IP
- Dosage Form Applications:
- Tablets and Capsules
- Oral Syrups and Solutions
- Controlled-release formulations
Manufacturing & Quality Standards – Bluepill Express:
- Manufactured under WHO-GMP and cGMP compliance
- High assay and stability across all production batches
- Tested by validated analytical methods (HPLC, GC, FTIR)
- Low residual solvent and impurity levels in compliance with ICH Q3C standards
- Comprehensive documentation support: COA, MSDS, DMF (available on request)
- Batch reproducibility and consistent particle size distribution
Advantages of Bluepill Express Dihydrocodeine Hydrogen Tartrate API:
- High purity (≥99%) ensuring superior performance
- DMF & CTD documentation support for regulatory filings
- Optimized solubility for reliable formulation development
- Pharmacopoeial grade compliance (BP/USP/EP/IP)
- Strong global supply network for consistent export support
Packaging & Export Details:
- Packaging Sizes: 1 kg / 5 kg / 25 kg HDPE drums with double-layer LDPE liner
- Shelf Life: 3 years when stored under recommended conditions
- Labeling: As per international export and pharmacopeial norms
- Export Markets: Africa, Middle East, Europe, Asia, and South America
- Supporting Documents:
- Certificate of Analysis (COA)
- Material Safety Data Sheet (MSDS)
- Drug Master File (DMF)
- Stability and Validation Reports
