Description

Cevimeline Hydrochloride Hydrate is a high-purity pharmaceutical active ingredient, specifically a cholinergic agonist. This compound is critical for its therapeutic action in stimulating exocrine gland secretions. It is primarily utilized by pharmaceutical manufacturers and research institutions in the development and production of prescription medications. The product is supplied under stringent quality control to ensure batch-to-batch consistency and reliability for sensitive applications.

Application

• Active Pharmaceutical Ingredient (API) in the manufacture of prescription drugs for treating dry mouth (xerostomia), particularly in patients with Sjögren's syndrome.
• Pharmaceutical Research & Development as a reference standard or as a key intermediate in preclinical and clinical studies.
• Formulation Development for creating various dosage forms such as tablets or capsules.
• Biochemical Research tool for studying muscarinic acetylcholine receptor (mAChR) activity and related physiological pathways.
• Contract Manufacturing for companies requiring a reliable, GMP-compliant source of this specific API.

Basic Information

Product Name	Cevimeline Hydrochloride Hydrate
CAS No.	153504-69-9
Molecular Formula	C10H17N3OS • HCl • xH2O
Molecular Weight	244.78 (Anhydrous base) / Contact for details (Hydrate)
Synonyms	Cevimeline HCl Hydrate; SNI-2011; AF102B; (2R,3R)-3-(2S)-2-Methyl-1,3-thiazolidin-3-yl]-1-azabicyclo[2.2.2]octane-2-carbonitrile hydrochloride hydrate; cis-2-Methylspiro(1,3-oxathiolane-5,3')quinuclidine hydrochloride hemihydrate; Evoxac (Brand Name API)
EINECS	Contact for details

Quality Control

Our Cevimeline Hydrochloride Hydrate is manufactured and tested to meet exacting standards suitable for pharmaceutical applications. Quality assurance protocols are designed to ensure identity, purity, strength, and composition. A comprehensive Certificate of Analysis (COA) is provided with each batch, detailing results from tests including identification, assay, impurity profile, residual solvents, and water content. Production can be aligned with current Good Manufacturing Practice (cGMP) principles upon request.

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 under conditions that minimize exposure to atmospheric humidity.

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)	As per grade requirement
Related Substances (HPLC)	Individual impurity ≤ 0.5%; Total impurities ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Heavy Metals	< 20 ppm
Specific Rotation	Contact for details

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