Oxycodone HCl is a potent semi-synthetic opioid analgesic used extensively in the clinical management of moderate to severe pain. Parand Darou Co. synthesizes this Active Pharmaceutical Ingredient (API) utilizing advanced manufacturing processes, ensuring strict adherence to global pharmaceutical standards, including USP and BP. It serves as a vital raw material for the formulation of various dosage forms, such as immediate-release and extended-release tablets, capsules, and oral analgesic solutions.
Mechanism of Action & Clinical Indications
Oxycodone acts as a pure agonist for mu (μ)-opioid receptors and, to a lesser extent, kappa (κ)-opioid receptors within the central and peripheral nervous systems. Binding to these receptors inhibits the transmission of pain signals in the ascending spinal pathways and alters the perception of pain in the brain. Oxycodone is distinguished by its favorable oral bioavailability compared to other opioids, making it a highly effective therapeutic choice for managing cancer pain, severe post-surgical pain, and chronic refractory pain conditions.
Quality Attributes, Purity & Storage
Parand Darou’s Oxycodone HCl is produced as a white to almost white, hygroscopic crystalline powder. The product demonstrates a minimum purity of 98.5%, with an assay range of 98.5% to 101.5% (calculated on the dried substance). It undergoes stringent quality control, including tests for related substances, residue on ignition, and specific optical rotation. Given its hygroscopic nature, the product must be stored in airtight containers and protected from light to ensure a shelf-life stability of at least 2 years under standard room temperature conditions.
General Information
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USP, BP
| Product Name | Oxycodone HCl | |||
| Chemical Name | 4,5α-Epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride | |||
| Manufacturer | Parand Darou Co,0.05);”>Chemical Name | 4,5α-Epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride | ||
| Manufacturer | Parand Darou Co. | |||
| CAS No. |
Specification
| Molecular formula | C18H22ClNO4 | Sulfated ash | Max. 0.1% | |||
| Molecular weight | 351.82 | Ethanol | Max. 1.0% | |||
| Appearance | White/off-white powder, hygroscopic | Purity | Min. 98.5% | |||
| Solubility | Freely soluble in water, sparingly soluble in ethanol | Assay | 98.5% to 101.5% | |||
| Water | Max. 7.0% | Storage | In airtight containers, light-protected | |||
| Residue on ignition | Max. 0.05% | Stability | Stable at least 2 years at R.T | |||
| Specific rotation | -140 to -148° |
