Description

Cevimeline Hydrochloride Salt is a high-purity pharmaceutical active ingredient primarily used as a cholinergic agonist. This compound is critical for its therapeutic action in stimulating exocrine gland secretions. It is essential for manufacturers in the pharmaceutical industry developing treatments for conditions like dry mouth (xerostomia), particularly associated with Sjögren's syndrome. Our supply ensures consistent quality and reliability for critical drug formulation and research applications.

Application

• Pharmaceutical Active Ingredient (API): Primary use in the formulation of prescription medications.
• Treatment of Xerostomia: Key component in therapies for dry mouth, especially in patients with Sjögren's syndrome.
• Cholinergic Research: Used as a reference standard and tool compound in neurological and pharmacological research.
• Pilot-Scale & Commercial Drug Manufacturing: Sourced for scale-up processes from R&D through to full-scale production.
• Quality Control & Analytical Testing: Serves as a certified reference material (CRM) for assay validation and impurity profiling.

Basic Information

Product Name	Cevimeline Hydrochloride Salt
CAS No.	107220-28-0
Molecular Formula	C10H17N3S • HCl
Molecular Weight	244.79 g/mol (Free base: 203.33)
Synonyms	Cevimeline HCl; (2R,3R)-3-(2(S)-1-Methyl-2-pyrrolidinyl)thio]-1-azabicyclo[2.2.2]octane hydrochloride; SNI-2011; AF102B; Evoxac (brand name equivalent); cis-2'-Methylspiro(1-azabicyclo[2.2.2]octane-3,5'-[1,3]oxathiolane) hydrochloride; Spiro[1-azabicyclo[2.2.2]octane-3,5'-oxathiolane] hydrochloride
EINECS	Contact for details

Quality Control

Our Cevimeline Hydrochloride Salt is manufactured under strict quality systems. Each batch undergoes comprehensive analytical testing to ensure it meets stringent specifications for pharmaceutical use, including identity, purity, and impurity profiles. A Certificate of Analysis (COA) is provided with each shipment, detailing results for assay, related substances, residual solvents, and other critical parameters. We support compliance with ICH guidelines and relevant pharmacopeial standards.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

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%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Heavy Metals	≤ 20 ppm
Sulfated Ash	≤ 0.1%

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