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Codeine Phosphate Hemihydrate is a semi-synthetic opioid analgesic and antitussive widely used in the treatment of mild to moderate pain and persistent cough. It acts on the central nervous system (CNS) to suppress cough and reduce pain perception. Due to its excellent pharmacokinetic profile, it is a key active pharmaceutical ingredient (API) in the production of pain-relief tablets, cough syrups, and combination formulations with paracetamol or ibuprofen.
At Bluepill Express, we ensure the highest manufacturing standards for Codeine Phosphate Hemihydrate API, complying with WHO-GMP, ISO 9001:2015, and cGMP certifications. Our product offers high assay purity (≥99%), consistent crystallinity, and controlled moisture content, providing stable and reproducible results in formulations.
This API is widely supplied to regulated and semi-regulated markets and is suitable for use in both oral solid dosage forms and liquid preparations.
Therapeutic Applications:
- Relief of mild to moderate pain
- Suppression of non-productive cough
- Management of post-operative or chronic pain
- Used in combination formulations with paracetamol or aspirin for enhanced analgesic effect
Mechanism of Action:
Codeine acts as a μ-opioid receptor agonist, reducing pain by altering the perception and emotional response to discomfort. It also depresses the medullary cough center, providing effective relief from persistent, dry cough.
Technical Specifications:
- Chemical Name: 7,8-Didehydro-4,5α-epoxy-3-methoxy-17-methylmorphinan-6α-ol phosphate (1:1), hemihydrate
- Molecular Formula: C₁₈H₂₄NO₇P·½H₂O
- Molecular Weight: 406.4 g/mol
- CAS Number: 41444-62-6
- Appearance: White or almost white crystalline powder
- Assay (on dried basis): 98.0% – 102.0%
- Melting Range: 195°C – 198°C
- Solubility: Freely soluble in water, slightly soluble in alcohol
- Storage Conditions: Store below 25°C, in a tightly closed container, protected from light and moisture
Pharmacological Classification:
- Therapeutic Class: Opioid Analgesic / Antitussive
- Pharmacopoeial Standards: BP / EP / USP / IP
- Dosage Form Applications:
- Tablets and Capsules
- Oral Syrups and Elixirs
- Effervescent and Combination Pain-Relief Formulations
Manufacturing & Quality Standards – Bluepill Express:
- Produced under WHO-GMP and cGMP certified facilities
- Validated analytical methods (HPLC, GC, FTIR) ensure purity and consistency
- DMF and CTD documentation available upon request
- Batch-to-batch reproducibility with low impurity levels
- Complies with ICH Q3C & Q3A impurity guidelines
- Supplied with complete regulatory documentation: COA, MSDS, and Stability Reports
Advantages of Bluepill Express Codeine Phosphate Hemihydrate API:
- High purity (≥99%) and controlled crystallinity
- Pharmacopoeial grade (BP/EP/USP/IP) compliance
- Consistent particle size distribution for smooth formulation development
- Comprehensive regulatory documentation for export and registration
- Global supply network covering Africa, Asia, Europe, and the Middle East
Packaging & Export Details:
- Packaging Sizes: 1 kg / 5 kg / 25 kg HDPE drums with double-layer LDPE liner
- Shelf Life: 36 months under recommended storage conditions
- Labeling: Compliant with international export regulations
- Export Documentation:
- Certificate of Analysis (COA)
- Material Safety Data Sheet (MSDS)
- Drug Master File (DMF)
- Stability Data Sheet
