Description

Cevimeline Hydrochloride is a high-purity pharmaceutical active ingredient, a muscarinic receptor agonist primarily used in the treatment of dry mouth associated with Sjögren's syndrome. This compound is critical for formulators requiring a reliable and consistent API to ensure therapeutic efficacy and batch-to-batch uniformity in finished pharmaceutical products. It is essential for manufacturers in the global pharmaceutical and research sectors developing specialized oral care and cholinergic therapies.

Application

• Pharmaceutical API: Primary active ingredient in prescription medications for xerostomia (dry mouth).
• Sjögren's Syndrome Therapy: Formulation into tablets or capsules for systemic treatment of autoimmune-related salivary dysfunction.
• Research & Development: Used in preclinical and clinical studies exploring muscarinic acetylcholine receptor functions.
• Drug Product Manufacturing: Sourced by CMOs and pharmaceutical companies for the production of finished dosage forms.
• Reference Standard: Serves as a high-purity analytical standard for quality control laboratories.

Basic Information

Product Name	Cevimeline Hydrochloride
CAS No.	153504-70-2
Molecular Formula	C10H17NOS•HCl
Molecular Weight	219.77 g/mol (Free base: 183.31 g/mol)
Synonyms	Cevimeline HCl; (2R,3R)-3-(2S)-1-Methyl-2-pyrrolidinyl]-1,2,3,4-tetrahydro-2,3-naphthalenediol hydrochloride; SNI-2011; AF102B; Evoxac (Brand Name); 2'-Methylspiro[1-azabicyclo[2.2.2]octane-3,5'-[1,3]oxazolidin]-2'-one hydrochloride
EINECS	Contact for details

Quality Control

Our Cevimeline Hydrochloride is manufactured under strict quality management systems. Each batch is tested to ensure it meets high-purity standards suitable for pharmaceutical applications, with comprehensive analysis including identification, assay, and impurity profiling. A Certificate of Analysis (COA) detailing all test results against relevant specifications is provided with every shipment to guarantee supply chain integrity and regulatory compliance.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a low-humidity environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time matches reference
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Individual impurity ≤ 0.5%; Total impurities ≤ 1.5%
Optical Rotation	Specific range provided on COA

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