Description

Orphenadrine Citrate is a high-purity pharmaceutical active ingredient, a citrate salt of the centrally acting skeletal muscle relaxant orphenadrine. It is a critical intermediate and active pharmaceutical ingredient (API) essential for the formulation of effective muscle spasm therapeutics. This compound is primarily required by pharmaceutical manufacturers and research institutions engaged in the development and production of prescription medications for musculoskeletal conditions.

Application

• Pharmaceutical API: Primary use as the active ingredient in prescription muscle relaxant medications for treating acute musculoskeletal pain and discomfort.
• Tablet & Capsule Formulation: Direct compression or granulation for solid oral dosage forms in GMP-certified facilities.
• Clinical Research Material: Serves as a reference standard and raw material for preclinical and clinical studies on muscle relaxants.
• Generic Drug Manufacturing: Sourcing for the production of bioequivalent generic versions of branded muscle relaxant drugs.
• Veterinary Pharmaceuticals: Potential application in veterinary medicine for the management of muscle spasms in animals.
• Analytical Reference Standard: Used in quality control laboratories for identity, assay, and impurity testing via HPLC and other chromatographic methods.

Basic Information

Product Name	Orphenadrine Citrate
CAS No.	4682-36-4
Molecular Formula	C₂₄H₃₁NO₈
Molecular Weight	461.51 g/mol
Synonyms	Orphenadrine Citrate; Orphenadrine Hydrogen Citrate; N,N-Dimethyl-2-[(o-methyl-α-phenylbenzyl)oxy]ethylamine Citrate; 2-[(2-Methylbenzhydryloxy)ethyl]dimethylamine Citrate; Biorphen; Banflex; Norflex; Disipal; Citrate salt of Orphenadrine; Mephenamin citrate
EINECS	225-130-8

Quality Control

Our Orphenadrine Citrate is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing to ensure it meets stringent specifications for pharmaceutical use, including identity, purity, and impurity profiles. We provide full traceability and support regulatory filings. Certificates of Analysis (COA) documenting compliance with in-house pharmacopeial standards are available for every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry, and well-ventilated area at controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed after opening to prevent moisture absorption, which can affect stability and handling properties.

Specification

Item	Specification
Appearance	White or almost white, crystalline powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water (KF Titration)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Total impurities ≤ 1.0%; Any single impurity ≤ 0.5%
Specific Rotation	Contact for details

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