Description

Orphenadrine Citrate is the citrate salt form of orphenadrine, a centrally acting skeletal muscle relaxant with anticholinergic properties. This high-purity active pharmaceutical ingredient (API) is critical for ensuring the efficacy and safety of formulated pharmaceutical products. It is primarily required by pharmaceutical manufacturers for the production of medications used to relieve muscle spasms and associated pain.

Application

• Pharmaceutical API: Primary active ingredient in prescription muscle relaxant medications.
• Tablet Formulation: Used in the manufacture of oral solid dosage forms for the treatment of acute musculoskeletal conditions.
• Combination Therapies: May be formulated in combination with analgesics for enhanced pain relief.
• Generic Drug Manufacturing: Serves as a key component for producers of generic pharmaceutical products.
• Clinical Research: Used as a reference standard or raw material in preclinical and clinical studies.
• Veterinary Medicine: Potential application in veterinary pharmaceuticals for muscle relaxation in animals.

Basic Information

Product Name	Orphenadrine Citrate
CAS No.	4596-23-0
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; Brocasipal; Disipal; Mephenamin; Norflex; Norgesic; Orfen; Orfidal; Orphenadrine Acid Citrate
EINECS	Contact for details

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 identity, purity, and strength, aligning with pharmacopeial standards. A Certificate of Analysis (COA) documenting results for assay, related substances, residual solvents, and other critical parameters is provided with every shipment to guarantee supply chain transparency and regulatory compliance.

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.

Specification

Item	Specification
Appearance	White or almost white, crystalline powder
Identification (IR)	Conforms
Identification (HPLC)	Conforms
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Related Substances (HPLC)	Individual impurity: NMT 0.5% Total impurities: NMT 1.5%
Water (KF)	NMT 1.0%
Residue on Ignition	NMT 0.1%
Heavy Metals	NMT 20 ppm
Residual Solvents (GC)	Complies with ICH Q3C
Microbial Enumeration	Complies with Ph. Eur. 2.6.12/2.6.13

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