Description

Tramadol Hydrochloride is a centrally acting synthetic opioid analgesic used for the management of moderate to moderately severe pain. Its primary value lies in its dual mechanism of action, combining mu-opioid receptor agonism with inhibition of norepinephrine and serotonin reuptake. This product is essential for the formulation of generic and branded pharmaceutical preparations, serving the needs of the global pharmaceutical manufacturing and research sectors. CAS NO 194602-08-9 identifies this specific chemical entity.

Application

This active pharmaceutical ingredient (API) is utilized in the development and production of various therapeutic formulations. Key applications include:

• Pharmaceutical Manufacturing: As the core API in immediate-release and extended-release oral tablets and capsules.
• Analgesic Formulations: For the production of generic pain management medications.
• Clinical Research: As a reference standard in pharmacokinetic and pharmacodynamic studies.
• Drug Development: In the R&D of novel analgesic delivery systems and combination therapies.
• Hospital Compounding: For specialized preparations where commercial dosage forms are unsuitable.

Basic Information

Product Name	Tramadol Hydrochloride
CAS No.	194602-08-9
Molecular Formula	C16H25NO2 • HCl
Molecular Weight	299.84 g/mol
Synonyms	(1R,2R)-2-[(Dimethylamino)methyl]-1-(3-methoxyphenyl)cyclohexanol hydrochloride; Tramadol HCl; CG 315; K 315; Tramal; Ultram; Zydol; Tradol; Contramal; Crispin; Mabron; Ralivia; Ryzolt; Rybix ODT
EINECS	Contact for details

Quality Control

Our Tramadol Hydrochloride is manufactured and tested to meet stringent pharmacopeial standards. Quality is assured through a comprehensive analytical program that includes identification, assay, and impurity profiling. We provide full traceability and support regulatory submissions. Certificates of Analysis (COA) confirming compliance with specifications such as USP, EP, or in-house pharmacopeia are available for every batch upon request.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry, and well-ventilated area at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed to protect from moisture. Keep away from heat and incompatible materials.

Specification

Item	Specification
Appearance	White or almost white crystalline powder
Identification (IR)	Conforms
Identification (HPLC)	Conforms
Assay (HPLC)	98.5% - 101.5% (on anhydrous basis)
Water (KF)	≤ 0.5%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Individual impurity: ≤ 0.15% Total impurities: ≤ 0.5%
Optical Rotation	+0.10° to +0.30° (c = 5 in water)

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.