HomeAPITramadol HCl (Tramadol Hydrochloride)

Tramadol HCl (Tramadol Hydrochloride)

Tramadol HCl (Tramadol Hydrochloride) is a widely used centrally acting synthetic opioid analgesic for the management of moderate-to-severe pain. This Active Pharmaceutical Ingredient (API) is synthesized and purified at Parand Darou Pharmaceutical Company under rigorous quality control and in accordance with the requirements of internationally recognized pharmacopoeias, including USP and BP.

Dual Mechanism of Action & Therapeutic Applications

Tramadol’s analgesic effect results from a complementary dual mechanism: weak binding to μ-opioid receptors and inhibition of norepinephrine and serotonin reuptake in the central nervous system. These actions help relieve postoperative pain, chronic musculoskeletal and joint pain, and acute traumatic pain. Parand Darou’s Tramadol HCl has a purity of at least 99.6% and an assay of 99.0% to 101.0%, calculated on an anhydrous basis.

Physicochemical Properties, Stability & Storage

Tramadol HCl is supplied as a white or almost white crystalline powder, with a melting point of 180–184°C. It is freely soluble in water and methanol and has a low water content of no more than 0.5%. Optical rotation is controlled within the range of −0.10° to +0.10°. When stored protected from light at room temperature (R.T.), the product remains chemically stable for at least 2 years.



General Information

Product Name Tramadol HCl
Chemical Name (1RS,2RS)-2-[(Dimethylamino)methyl]-1-(3-methoxyphenyl)cyclohexan-1-ol hydrochloride
Manufacturer Parand Darou Co.
CAS No. 36282-47-0
Category Pain management
Pharmacopoeia USP, BP

Specification

Molecular formula C16H25NO2·HCl Chloride content 11.6%–12.1%
Molecular weight 299.8 Sulfated ash Max. 0.1%
Appearance White or almost white, crystalline powder Residue on ignition Max. 0.1%
Solubility Freely soluble in water and methanol; very slightly soluble in acetone Purity Min. 99.6%
Water Max. 0.5% Assay 99.0%–101.0% (anhydrous basis)
Melting point 180–184°C Storage Protected from light
Optical rotation −0.10° to +0.10° Stability Stable for at least 2 years at room temperature
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Active Pharmaceutical Ingredient (API)

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