Codeine Phosphate Hemihydrate is an essential opioid derivative and one of the most widely utilized Active Pharmaceutical Ingredients (APIs) for analgesic and antitussive therapies globally. Synthesized and processed by Parand Darou Co. under strict cGMP protocols and in compliance with USP and BP standards, this phosphate salt offers outstanding aqueous solubility, making it the preferred raw material for solid oral dosage forms (combination tablets), oral solutions, and therapeutic syrups.
Mechanism of Action & Clinical Indications
Codeine acts as a selective agonist at μ-opioid receptors. Upon hepatic O-demethylation to morphine via CYP2D6, it modulates ascending nociceptive pathways within the central nervous system to deliver potent analgesic relief. Furthermore, it exerts a direct suppressive effect on the medullary cough reflex center. Consequently, Codeine Phosphate is widely indicated in fixed-dose combinations—with paracetamol, NSAIDs, and antihistamines—for the management of mild-to-moderate pain and the suppression of dry, painful coughs.
Quality Attributes, Purity & Stability
Manufactured as a fine white or almost white crystalline powder or small, colorless crystals, Parand Darou’s Codeine Phosphate Hemihydrate guarantees a minimum purity of 98.0% and an assay between 98.5% and 101.0% (calculated on the anhydrous basis). Featuring controlled water content (< 3.0%), a defined melting range of 155–159 °C, and a solution pH of 4.0–5.0, it demonstrates superior chemical stability for at least 2 years at ambient temperature when stored in airtight, light-protected packaging.
General Information
| Product Name | Codeine Phosphate Hemihydrate | |
| Chemical Name | (5R,6S)-4,5α-Epoxy-3-methoxy-17-methyl-7,8-didehydromorphinan-6α-ol phosphate hemihydrate | |
| Manufacturer | Parand Darou Co. | |
| CAS No. | 41444-62-6 | |
| Category | Analgesic, Pain management | |
| Pharmacopoeia | BP, USP |
Specification
| Molecular formula | C18H21NO3·H3PO4·½H2O | Chloride | No opalescence is produced immediately | |||||
| Molecular weight | 406.4 g/mol | Sulfate | Max. 0.1% | |||||
| Appearance | White/almost white crystalline powder or colorless crystals | Specific rotation | -98° to -102° (dried) | |||||
| Solubility | Freely sol. in water, slightly/very slightly sol. in ethanol (96%) | Purity | Min. 98.0% | |||||
| Melting point | 155 – 159 °C | Assay | 98.5% to 101.0% (anhydrous) | |||||
| pH | 4.0 – 5.0 | 155 – 159 °C | Assay | 98.5% to 101.0% (anhydrous) | ||||
| pH | 4.0 – 5.0 |
