Morphine Sulfate is established as the gold standard in opioid analgesics and is one of the most strategic Active Pharmaceutical Ingredients (API) in the management of severe pain. Parand Darou Co. synthesizes this pharmaceutical compound in strict accordance with the highest international standards, adhering to major global pharmacopoeias such as USP and BP. It serves as the fundamental raw material for the production of various dosage forms, including injectable solutions (ampoules), immediate- and sustained-release tablets/capsules, and oral analgesic syrups.
Mechanism of Action & Clinical Indications
Morphine acts as a potent, specific agonist for the mu (μ)-opioid receptors in both the central nervous system (CNS) and the peripheral nervous system. Binding to these receptors inhibits the release of pain-mediating neurotransmitters (such as Substance P), induces neuronal hyperpolarization, and effectively attenuates the transmission of pain signals to the cerebral cortex. Beyond managing acute pain post-surgery and trauma, Morphine Sulfate plays a vital role in chronic cancer pain management (Palliative Care) and the relief of pain associated with acute myocardial infarction.
Quality Attributes, Purity & Storage
Parand Darou supplies Morphine Sulfate as a pentahydrate crystalline form, appearing as a white or almost white crystalline powder with excellent aqueous solubility. The product demonstrates a minimum purity of 99.0% and an assay range of 98.0% to 102.0%. It undergoes rigorous quality control, including specific tests for chloride impurities, ammonium salts, heavy metals (Iron < 5 ppm), and the limit of foreign alkaloids. Due to its sensitivity, the product must be stored in containers protected from light, with a guaranteed stability of at least 2 years under standard room temperature conditions.
General Information
| Product Name | Morphine Sulfate | |
| Chemical Name | Di(7,8-didehydro-4,5α-epoxy-17-methylmorphinan-3,6α-diol)sulfate pentahydrate | |
| Manufacturer | Parand Darou Co. | |
| CAS No. | 6211-15-0 | |
| Category | Pain management | |
| Pharmacopoeia | USP, BP |
Specification
| Molecular formula | C34H40N2O10S, 5H2O | Chloride | No precipitate/turbidity produced | |||
| Molecular weight | 759 | Ammonium salts | No odor of ammonia perceptible | |||
| Appearance | White/almost white powder | Iron | Max. 5 PPM | |||
| Solubility | Soluble in water, very slightly soluble in ethanol (96%) | Foreign alkaloids | NLT 7.5 mL required (1.5%) | |||
| Water | 10.4% to 13.4% | Purity | Min. 99.0% | |||
| Specific rotation | -107 to -110 (anhydrous) | Assay | 98.0% to 102.0% | |||
| Residue on ignition | Max. 0.1% | Storage | Protected from light | |||
| Sulfated ash | Max. 0.1% | Stability | Stable at least 2 years at R.T |
