Buprenorphine Hydrochloride (Buprenorphine HCl) is a key, advanced Active Pharmaceutical Ingredient (API) utilized extensively in the treatment and management of substance abuse (Addiction Therapy) as well as the relief of acute and chronic pain. Derived from the alkaloid thebaine, this semi-synthetic opioid is manufactured by Parand Darou Co. with the highest degree of purity, in strict compliance with the international pharmacopoeial standards of BP, USP, and IP. It serves as the primary raw material in the formulation of sublingual tablets, transdermal patches, and injectable solutions.
Mechanism of Action & Pharmacological Advantages
Buprenorphine acts as a partial agonist at the mu (μ)-opioid receptor and a potent antagonist at the kappa (κ)-opioid receptor. Its extremely high binding affinity and slow dissociation rate from the receptors result in a stable and long-lasting therapeutic effect. A significant clinical advantage of Buprenorphine is its “ceiling effect” on respiratory depression, which markedly enhances its safety profile compared to full opioid agonists, effectively minimizing the risk of abuse and fatal overdose.
Quality Attributes, Purity & Storage
Parand Darou’s Buprenorphine HCl is synthesized as a white or almost white crystalline powder. It features a high purity level of at least 99.3% and an assay range of 98.5% to 101.5% (on a dried basis). The product is rigorously controlled through quality tests, including heavy metals (< 20 ppm) and moisture content (max 1.0%). To maintain stability for at least 2 years at room temperature, it must be stored in tight, airtight containers protected from light.
General Information
| Product Name | Buprenorphine HCl | |
| Chemical Name | (2S)-2-[17-(Cyclopropylmethyl)-4,5α-epoxy-3-hydroxy-6-methoxy-6α,14-ethano-14α-morphinan-7α-yl]-3,3-dimethylbutan-2-ol hydrochloride | |
| Manufacturer | Parand Darou Co. | |
| CAS No. | 53152-21-9 | |
| Category | Addiction therapy | |
| Pharmacopoeia | BP, USP, IP |
Specification
| Molecular formula | C29H42ClNO4 | Specific optical rotation | -92 to -98 (dried) | |||
| Molecular weight | 504.1 | Sulfated ash | Max. 0.2% | |||
| Appearance | White/almost white powder | Purity | Min. 99.3% | |||
| Solubility | Sparingly soluble in water, freely soluble in methanol | Assay | 98.5% to 101.5% (dried) | |||
| Heavy metals | Max. 20 ppm | Storage | Protected from light | |||
| Water | Max. 1.0% | Stability | Stable at least 2 yrs at R.T |
