Description

Tramazoline Hydrochloride Monohydrate is a high-purity pharmaceutical intermediate and active ingredient. This compound is critical for the development and manufacturing of specialized nasal decongestant and ophthalmic formulations. It is primarily required by pharmaceutical companies, research institutions, and fine chemical suppliers engaged in the production of adrenergic receptor agonists. Consistent quality and reliable supply are paramount for ensuring the efficacy and safety of the final drug products.

Application

• Pharmaceutical Active Ingredient (API): Primary use as the active component in nasal sprays and eye drops for vasoconstriction.
• Research & Development: A key reference standard and building block in pharmacological studies targeting α-adrenergic receptors.
• Formulation Development: Used in the development of sustained-release and combination drug formulations for respiratory and ophthalmic conditions.
• Contract Manufacturing: Supplied to CDMOs (Contract Development and Manufacturing Organizations) for cGMP production of finished dosage forms.
• Analytical Standard: Serves as a high-purity certified reference material (CRM) for quality control and regulatory testing.
• Veterinary Pharmaceuticals: Potential application in veterinary medicinal products for similar decongestant purposes.

Basic Information

Product Name	Tramazoline Hydrochloride Monohydrate
CAS No.	74195-73-6
Molecular Formula	C13H17N3 • HCl • H2O
Molecular Weight	263.76 g/mol (monohydrate)
Synonyms	2-[(5,6,7,8-Tetrahydro-1-naphthyl)amino]-2-imidazoline hydrochloride monohydrate; Tramazolin Hydrochloride Monohydrate; Tramazoline HCl Monohydrate; Y-27152; Decongestant Y-27152; 2-(1,2,3,4-Tetrahydro-1-naphthylamino)-2-imidazoline hydrochloride monohydrate
EINECS	Contact for details

Quality Control

Our Tramazoline Hydrochloride Monohydrate is manufactured under strict quality management systems. Each batch is tested to ensure it meets stringent specifications for identity, purity, and impurity profiles, suitable for pharmaceutical applications. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results from tests including HPLC assay, related substances, residual solvents, and water content (KF). We support compliance with cGMP, ICH Q7, and relevant pharmacopoeial standards.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry, and well-ventilated area at a controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept under conditions that minimize exposure to atmospheric humidity to prevent degradation and ensure stability.

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)	5.0% - 7.5%
Related Substances (HPLC)	Total impurities ≤ 1.0% Any single impurity ≤ 0.5%
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.