Description

Codeine Phosphate Dihydrate is a high-purity pharmaceutical active ingredient, a salt form of the naturally occurring alkaloid codeine. This compound is essential for its potent analgesic and antitussive (cough-suppressant) properties, offering a critical balance of efficacy and controlled potency. It is a fundamental raw material for the global pharmaceutical industry, primarily used in the formulation of prescription pain relief and cough medication. Our supply ensures the stringent quality and reliable consistency required for GMP manufacturing processes.

Application

• Pharmaceutical Analgesic Formulations: A key active ingredient in prescription-grade tablets and capsules for the management of mild to moderate pain.
• Antitussive Preparations: Serves as the primary therapeutic agent in liquid and solid dosage forms designed to suppress unproductive coughs.
• Combination Drug Products: Used in fixed-dose combinations with other analgesics like acetaminophen or aspirin to enhance pain relief efficacy.
• Clinical Research & Development: Employed as a reference standard and starting material in pharmacological studies and the development of new therapeutic entities.
• Controlled-Release Drug Delivery Systems: Incorporated into advanced matrix systems designed for sustained pain relief over extended periods.

Basic Information

Product Name	Codeine Phosphate Dihydrate
CAS No.	67183-66-8
Molecular Formula	C₁₈H₂₁NO₃ · H₃PO₄ · 2H₂O
Molecular Weight	406.37 g/mol
Synonyms	Codeine Phosphate Sesquihydrate; Morphine-3-methyl ether phosphate; 3-Methoxymorphine phosphate salt; Methylmorphine phosphate; Codicept; Paveral; Codipront; Codipertussin; (5α,6α)-7,8-Didehydro-4,5-epoxy-3-methoxy-17-methylmorphinan-6-ol phosphate
EINECS	Contact for details

Quality Control

Our Codeine Phosphate Dihydrate is manufactured and tested to meet the stringent requirements of major pharmacopoeias, including USP, EP, and BP monographs. Every batch undergoes comprehensive analytical testing for identity, potency, and purity, with strict control over related substances and residual solvents. A Certificate of Analysis (COA) documenting all test results against release specifications is provided with each shipment to ensure full traceability and regulatory compliance for our pharmaceutical partners.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a low-humidity environment to prevent degradation and ensure stability throughout its shelf life.

Specification

Item	Specification
Appearance	White or almost white, crystalline powder
Identification (IR)	Conforms
Identification (Phosphate)	Conforms
Assay (HPLC)	98.5% - 101.0% (anhydrous basis)
pH (5% solution)	4.0 - 5.0
Specific Rotation	-98° to -102°
Water Content (KF)	7.0% - 9.0%
Related Substances (HPLC)	Individual impurity ≤ 0.5%; Total impurities ≤ 1.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm

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