Methadone HCl is a synthetic opioid analgesic and a vital Active Pharmaceutical Ingredient (API) primarily utilized in addiction therapy and the management of chronic pain. Parand Darou Co. synthesizes this product in strict adherence to international standards, including USP and BP, ensuring the highest level of purity and GMP compliance. It serves as the fundamental raw material for the formulation of various oral dosage forms, such as methadone tablets and syrups.
Mechanism of Action & Clinical Indications
Methadone acts as a potent full agonist of mu (μ)-opioid receptors and functions as an N-methyl-D-aspartate (NMDA) receptor antagonist. Due to its long half-life and gradual onset, it effectively prevents acute withdrawal symptoms and cravings, playing a central role in Medication-Assisted Treatment (MAT) programs. Furthermore, its NMDA antagonist properties make it a highly effective option for managing chronic, neuropathic, and refractory cancer pain that may be resistant to other analgesics.
Quality Attributes, Purity & Storage
Parand Darou supplies Methadone HCl as a white or almost white crystalline powder, demonstrating a minimum purity of 99.7% and an assay range of 99.0% to 101.0% (calculated on the dried substance). The product exhibits high solubility in water and ethanol, with a melting point of 233–236 °C. It undergoes rigorous quality control, including moisture analysis (Max. 0.5%) and pH testing (4.5–6.5), ensuring stability for at least 2 years when stored in light-protected, airtight containers at standard room temperature.
General Information
| Product Name | Methadone HCl | |
| Chemical Name | (6RS)-6-(Dimethylamino)-4,4-diphenylheptan-3-one hydrochloride | |
| Manufacturer | Parand Darou Co. | |
| CAS No. | 1095-90-5 | |
| Category | Addiction therapy | |
| Pharmacopoeia | USP, BP |
Specification
| Molecular formula | C21H28ClNO | Optical rotation | -0.05° to +0.05° | |||
| Molecular weight | 345.9 | Sulfated ash | Max. 0.1% | |||
| Appearance | White/off-white powder | Purity | Min. 99.7% | |||
| Solubility | Soluble in water, freely soluble in ethanol | Assay | 99.0% to 101.0% | |||
| Melting point | 233 – 236 °C | Storage | Light-protected | |||
| pH | 4.5 – 6.5 | Stability | At least 2 years (R.T) | |||
| Water | Max. 0.5% |
