Description

Hydroxyzine Pamoate (Ester) is the pamoate salt form of hydroxyzine, a first-generation antihistamine of the piperazine class. This specific salt form is crucial for enhancing the stability and bioavailability of the active pharmaceutical ingredient, making it suitable for solid dosage formulations. It is primarily required by pharmaceutical manufacturers and research organizations for the development and production of anti-anxiety and anti-pruritic medications.

Application

• Pharmaceutical Active Ingredient (API): Primary use in the manufacture of prescription medications for the treatment of anxiety and tension.
• Antipruritic Formulations: Key component in medications designed to relieve itching caused by allergic conditions such as chronic urticaria and atopic dermatitis.
• Pre-Anesthetic Sedation: Used in pre-operative medication to produce sedation and reduce anxiety before surgery.
• Antiemetic Adjunct: Employed as an adjunct therapy to control nausea and vomiting, particularly in postoperative settings.
• Research & Development: Serves as a critical reference standard and raw material in pharmacological research and new drug development.
• Generic Drug Manufacturing: Essential for the production of generic equivalents of branded hydroxyzine pamoate capsules and tablets.

Basic Information

Product Name	Hydroxyzine Pamoate (Ester)
CAS No.	5978-92-7
Molecular Formula	C21H27ClN2O2 • C23H16O6
Molecular Weight	763.27 g/mol
Synonyms	Hydroxyzine Pamoate; Hydroxyzine Embonate; 1-(p-Chlorobenzhydryl)-4-[2-(2-hydroxyethoxy)ethyl]piperazine Pamoate; Atarax Pamoate; Vistaril (brand name base); (±)-Hydroxyzine Pamoate; 2-[2-[4-[(4-Chlorophenyl)-phenylmethyl]piperazin-1-yl]ethoxy]ethanol compound with 4,4'-Methylenebis[3-hydroxy-2-naphthoic acid]; Fumarate (common salt alternative)
EINECS	227-795-8

Quality Control

Our Hydroxyzine Pamoate is manufactured under strict quality management systems. Each batch is tested to meet stringent specifications for identity, purity, and potency, aligning with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing results for assay, related substances, residual solvents, and microbiological attributes is provided with every shipment to ensure regulatory compliance and supply chain integrity.

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 nature, the container must be kept tightly sealed in a low-humidity environment to prevent moisture absorption and degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	NMT 5.0%
Related Substances (HPLC)	Total impurities: NMT 2.0% Any individual impurity: NMT 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Heavy Metals	NMT 20 ppm
Sulfated Ash	NMT 0.1%
Microbiological Enumeration	Complies with Ph. Eur. 2.6.12/ USP <61>

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