Description

Morphine Monohydrate Cii (50 Mg) (As) is a high-purity pharmaceutical-grade active pharmaceutical ingredient (API) derived from the opium poppy. This compound is critical for its potent analgesic properties, serving as a benchmark opioid for managing severe pain in controlled medical settings. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions for the formulation of pain management medications, clinical studies, and as a reference standard. Consistent quality and reliable supply are paramount for its use in regulated pharmaceutical production.

Application

• Pharmaceutical Manufacturing: Primary API for the production of potent analgesic formulations, including tablets, injectables, and controlled-release systems.
• Analytical Reference Standard: Used in quality control laboratories for the identification, assay, and impurity profiling of morphine-containing products via HPLC, GC, or spectrophotometry.
• Clinical Research & Development: Serves as a key comparator in studies investigating pain mechanisms, efficacy of new analgesics, and opioid pharmacology.
• Compounding Pharmacy: Used in specialized pharmacy settings for preparing customized dosage forms for patients with specific therapeutic needs.
• Forensic Analysis: Employed as a certified reference material in forensic toxicology for the accurate quantification of morphine in biological samples.

Basic Information

Product Name	Morphine Monohydrate Cii (50 Mg) (As)
CAS No.	6009-81-0
Molecular Formula	C₁₇H₁₉NO₃ · H₂O
Molecular Weight	303.34 g/mol (Anhydrous basis: 285.34)
Synonyms	Morphine Hydrate; (-)-Morphine Monohydrate; Morphine Hydrochloride (common salt form); 7,8-Didehydro-4,5-epoxy-17-methylmorphinan-3,6-diol Monohydrate; Morphia; (5α,6α)-7,8-Didehydro-4,5-epoxy-17-methylmorphinan-3,6-diol Monohydrate; Morphin; Morphinan-3,6-diol, 7,8-didehydro-4,5-epoxy-17-methyl-, (5α,6α)-, Monohydrate
EINECS	227-966-8 (for Morphine base)

Quality Control

Our Morphine Monohydrate 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. A detailed Certificate of Analysis (COA) is provided, confirming compliance with specifications for assay, related substances, residual solvents, and microbial limits. Our quality system ensures full traceability and adherence to cGMP guidelines for pharmaceutical APIs.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a 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. Store in accordance with all local and international regulations for controlled substances.

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, anhydrous basis)	98.0% - 102.0%
Water Content (KF)	4.5% - 6.0%
Related Substances (HPLC)	Total impurities ≤ 1.0% Any individual impurity ≤ 0.5%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Microbial Enumeration	Meets USP <61> requirements

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