Description

Codeine Monohydrate is a pharmaceutical-grade alkaloid derived from the opium poppy, serving as a crucial active pharmaceutical ingredient (API) and reference standard. Its primary value lies in its potent analgesic and antitussive (cough-suppressant) properties, making it a cornerstone in controlled pain management and cough relief formulations. This high-purity compound is essential for manufacturers in the pharmaceutical industry, particularly those developing and producing prescription medications, clinical research chemicals, and analytical standards.

Application

• Pharmaceutical API: Core active ingredient in the synthesis of prescription analgesic tablets, capsules, and syrups for moderate pain management.
• Antitussive Formulations: Key component in prescription-strength cough suppressants and cold/flu medications.
• Clinical Research: Used as a standard or reagent in pharmacological studies related to opioid receptors, pain pathways, and drug metabolism.
• Analytical Reference Standard: Serves as a certified reference material (CRM) in HPLC, GC, and spectrophotometry for quality control and forensic analysis.
• Chemical Synthesis: Intermediate or starting material for the semi-synthesis of other opioid derivatives and specialty pharmaceuticals.

Basic Information

Product Name	Codeine Monohydrate
CAS No.	6059-47-8
Molecular Formula	C₁₈H₂₁NO₃·H₂O
Molecular Weight	317.38 g/mol (Monohydrate)
Synonyms	Methylmorphine Monohydrate; 3-Methylmorphine; Morphine 3-Methyl Ether; Codicept; Paveral; 7,8-Didehydro-4,5α-epoxy-3-methoxy-17-methylmorphinan-6α-ol Monohydrate; (5α,6α)-7,8-Didehydro-4,5-epoxy-3-methoxy-17-methylmorphinan-6-ol Monohydrate
EINECS	200-943-0 (Anhydrous base)

Quality Control

Our Codeine Monohydrate is manufactured and tested under strict quality management systems. It meets stringent specifications for pharmaceutical applications, with testing typically aligned with major pharmacopoeial standards such as USP, EP, and BP. A comprehensive Certificate of Analysis (COA) is provided with each batch, detailing purity, identity, and impurity profiles to ensure full traceability and regulatory compliance for our global B2B clients.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). The product is light-sensitive (store away from light) and should be handled in accordance with standard pharmaceutical material handling procedures to maintain stability and potency.

Specification

Item	Specification
Appearance	White or almost white, crystalline powder
Identification (IR)	Conforms to standard
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	4.5% - 6.0%
Related Substances (HPLC)	Complies with pharmacopoeial limits
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.