Description

Tramadol Hydrochloride CAS NO 22203-92-5 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, providing effective analgesia with a relatively favorable side-effect profile compared to other opioids. This active pharmaceutical ingredient (API) is essential for pharmaceutical manufacturers developing generic and branded analgesic formulations, including tablets, capsules, and extended-release products.

Application

• Pharmaceutical API: Primary use as the active ingredient in prescription pain relief medications.
• Tablet & Capsule Formulation: Direct compression or encapsulation for immediate-release oral dosage forms.
• Extended-Release Formulations: Development of controlled-release tablets for prolonged pain management.
• Analgesic Combination Drugs: Used in combination with other analgesics like acetaminophen for enhanced efficacy.
• Generic Drug Manufacturing: Sourcing for cost-effective production of bioequivalent generic pharmaceuticals.
• Clinical Research & Development: Serves as a reference standard and raw material for new drug development studies.

Basic Information

Product Name	Tramadol Hydrochloride
CAS No.	22203-92-5
Molecular Formula	C16H25NO2 • HCl
Molecular Weight	299.84 g/mol
Synonyms	Tramadol HCl; (1R,2R)-2-[(Dimethylamino)methyl]-1-(3-methoxyphenyl)cyclohexanol hydrochloride; Tramadol monohydrochloride; Tramal; Ultram; Zydol; CG 315; K 315; Contramal; Crispin; Mabron; Tradol; Tramacet (combination product); Tramundin; Tridol
EINECS	244-858-7

Quality Control

Our Tramadol Hydrochloride is manufactured under strict quality systems to meet the rigorous standards of the pharmaceutical industry. We ensure compliance with major pharmacopoeial specifications, including USP, EP, and BP monographs. Every batch is supported by a comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profiles, and is traceable to its manufacturing origin.

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 incompatible materials.

Specification

Item	Specification
Appearance	White or almost white, crystalline powder
Identification (IR)	Conforms
Identification (HPLC)	Conforms
Assay (HPLC)	98.5% - 101.0% (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	Specific range per pharmacopoeia
pH (5% solution)	4.5 - 6.0

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