Description

Hydromorphone Sulfate is a potent semi-synthetic opioid analgesic derived from morphine. It is a critical active pharmaceutical ingredient (API) valued for its significant pain-relieving properties, making it essential for managing severe acute and chronic pain. This high-purity compound is primarily utilized by pharmaceutical manufacturers in the production of injectable solutions, tablets, and other controlled-release formulations for clinical use.

Application

• Pharmaceutical API: Core ingredient in the manufacture of potent analgesic medications for severe pain management.
• Hospital Formulations: Used in injectable solutions for post-operative pain and pain associated with major trauma or cancer.
• Controlled-Release Drug Delivery: Incorporated into extended-release tablet and capsule formulations for sustained pain relief.
• Palliative Care Medications: A key component in pharmaceuticals designed for end-of-life and hospice care to ensure patient comfort.
• Reference Standard: Serves as a high-purity analytical standard for quality control and regulatory testing in laboratories.
• Clinical Research: Used in preclinical and clinical studies investigating new pain management therapies and delivery systems.

Basic Information

Product Name	Hydromorphone Sulfate
CAS No.	25333-57-7
Molecular Formula	C17H21NO6 · H2SO4
Molecular Weight	423.45 g/mol (for the sulfate salt)
Synonyms	Dihydromorphinone Sulfate; 4,5α-Epoxy-3-hydroxy-17-methylmorphinan-6-one Sulfate; Hydromorphone Hydrochloride (common salt form); Dilaudid (brand name); Palladone; Numorphan; Hymorphan
EINECS	Contact for details

Quality Control

Our Hydromorphone Sulfate is manufactured under strict quality systems to meet the rigorous standards required for pharmaceutical actives. Quality is assured through comprehensive analytical testing, including HPLC for purity and identity confirmation. We provide full traceability and support regulatory submissions with detailed documentation. Certificates of Analysis (COA) compliant with USP/EP monographs are available upon request.

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 maintain stability and potency.

Specification

Item	Specification
Appearance	White or almost white crystalline powder
Identification (IR)	Conforms to standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water (KF)	≤ 5.0%
Residue on Ignition	≤ 0.1%
Related Substances (HPLC)	Individual impurity ≤ 0.5%; Total impurities ≤ 2.0%
Heavy Metals	≤ 20 ppm

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