Description

Codeine Citrate is a pharmaceutical-grade salt of the alkaloid codeine, widely recognized for its analgesic and antitussive properties. This compound is essential for formulators requiring a reliable and consistent active pharmaceutical ingredient (API) for controlled-release and combination drug products. It serves as a critical raw material for manufacturers in the pharmaceutical industry developing prescription pain relievers, cough suppressants, and other therapeutic formulations. Global supply chains depend on high-purity, compliant sources to meet stringent regulatory standards for human health products.

Application

• Pharmaceutical API: Primary use as an active ingredient in prescription analgesic tablets and capsules for mild to moderate pain management.
• Antitussive Formulations: Key component in liquid and solid dosage forms designed as effective cough suppressants.
• Combination Drug Products: Used in fixed-dose combinations with other analgesics like acetaminophen or NSAIDs to enhance therapeutic effect.
• Clinical Research: Serves as a reference standard and building block in pharmacological studies and drug development pipelines.
• Controlled-Release Medications: Incorporated into advanced delivery systems designed for sustained, long-acting pain relief.

Basic Information

Product Name	Codeine Citrate
CAS No.	5913-73-5
Molecular Formula	C18H21NO3 • C6H8O7
Molecular Weight	539.53 g/mol
Synonyms	Morphinan-6-ol, 7,8-didehydro-4,5-epoxy-3-methoxy-17-methyl-, (5α,6α)-, 2-hydroxy-1,2,3-propanetricarboxylate (1:1); Codeine hydrogen citrate; 1-Codeine citrate; Codeine acid citrate; Codicept; Paveral
EINECS	227-671-6

Quality Control

Our Codeine Citrate is manufactured and tested to meet stringent pharmacopeial standards, including USP and EP monographs. Every batch undergoes comprehensive analytical testing for identity, potency, and purity, with strict limits on related substances and residual solvents. A Certificate of Analysis (COA) documenting all test results is provided to ensure full traceability and compliance for regulatory submissions. Our quality management system is designed to support cGMP and ISO standards for pharmaceutical active ingredients.

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 or clumping.

Specification

Item	Specification
Appearance	White or almost white, crystalline powder
Identification (IR)	Conforms
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 1.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 1.5%
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.