Description

Codeine Sulfate Cii (250 Mg) is a pharmaceutical-grade salt of the naturally occurring alkaloid codeine, a key opioid analgesic. This high-purity compound is essential for the controlled and effective management of moderate to moderately severe pain, as well as for its antitussive properties. It is primarily utilized by pharmaceutical manufacturers and compounding pharmacies for the formulation of prescription pain relievers, cough suppressants, and combination drug products. Consistent quality and reliable supply are critical for ensuring the safety and efficacy of the final medicinal products.

Application

• Pharmaceutical Manufacturing: Primary active pharmaceutical ingredient (API) in the production of prescription analgesic tablets and capsules.
• Antitussive Formulations: Key component in prescription-strength cough syrups and liquid medications.
• Combination Drug Products: Used in fixed-dose combinations with other analgesics like acetaminophen or aspirin for enhanced pain relief.
• Hospital & Compounding Pharmacy: Sourced for extemporaneous preparation of specific dosage forms tailored to individual patient needs.
• Clinical Research: Serves as a reference standard and raw material in pharmacological studies and clinical trials.
• Controlled Substance Production: Manufactured under strict regulatory oversight for distribution within controlled pharmaceutical supply chains.

Basic Information

Item	Detail
Product Name	Codeine Sulfate Cii (250 Mg)
CAS No.	6854-40-6
Molecular Formula	C36H44N2O10S
Molecular Weight	696.81 g/mol
Synonyms	Codeine Sulphate; Codeine Sulfate (2:1) Salt; 7,8-Didehydro-4,5α-epoxy-3-methoxy-17-methylmorphinan-6α-ol sulfate (2:1); Morphine-3-methyl ether sulfate; Methylmorphine sulfate; Codisol; Paveral
EINECS	Contact for details

Quality Control

Our Codeine Sulfate is manufactured and tested to meet stringent pharmaceutical standards. Each batch is subjected to comprehensive analytical testing, including identification, assay, and impurity profiling, to ensure it conforms to relevant pharmacopeial monographs (e.g., USP, EP). A Certificate of Analysis (COA) documenting purity, related substances, residual solvents, and other critical parameters is provided with every shipment to guarantee traceability and compliance.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept in a dry environment to prevent degradation. Ensure storage conditions comply with all applicable regulations for controlled pharmaceutical substances.

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 (Karl Fischer)	≤ 6.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5%; Total impurities: ≤ 2.0%
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.