Description

Hydrocodone Phosphate is a potent opioid analgesic and antitussive agent, a key pharmaceutical intermediate and active pharmaceutical ingredient (API). Its primary value lies in its controlled, effective action for managing moderate to severe pain and persistent cough in clinical settings. This compound is essential for manufacturers in the pharmaceutical industry developing prescription medications, including combination products. Hydrocodone Phosphate CAS NO 34366-67-1 is supplied under strict quality control to meet the exacting standards required for API production.

Application

• Pharmaceutical API Synthesis: Primary use as the active ingredient in prescription analgesic and antitussive formulations.
• Controlled-Release Medication Production: Used in the development of extended-release tablets and capsules for chronic pain management.
• Combination Drug Manufacturing: Frequently formulated with non-opioid analgesics (e.g., acetaminophen, ibuprofen) to create synergistic pain relief products.
• Analytical Reference Standard: Serves as a high-purity standard in quality control laboratories for HPLC, GC, or spectroscopic assays.
• Clinical Research & Development: Utilized in preclinical and clinical studies for developing new pain management therapies and delivery systems.
• Regulatory Submission Batches: Supplied for the manufacture of batches intended for regulatory filings (e.g., ANDA, NDA) with agencies like the FDA and EMA.

Basic Information

Product Name	Hydrocodone Phosphate
CAS No.	34366-67-1
Molecular Formula	C18H21NO3 · H3PO4
Molecular Weight	405.36 g/mol
Synonyms	Dihydrocodeinone Phosphate; Hydrocodone Acid Phosphate; 4,5α-Epoxy-3-methoxy-17-methylmorphinan-6-one Phosphate; Hydrocodone Bitartrate Homologue; Narcodone; Vicodin API (related salt); Norco API (related salt); Dihydrocodeinone Hydrogen Phosphate
EINECS	Contact for details

Quality Control

Our Hydrocodone Phosphate is manufactured and tested to meet stringent pharmaceutical-grade standards. Quality assurance protocols are designed to ensure identity, purity, strength, and composition, aligning with current Good Manufacturing Practices (cGMP). A comprehensive Certificate of Analysis (COA) is provided with each batch, detailing results for assay, related substances, residual solvents, and other critical parameters. We support compliance with major pharmacopoeial standards (USP, EP, BP) as required.

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. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time matches standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 2.0%
Related Substances (HPLC)	Individual impurity ≤ 0.5%, Total impurities ≤ 1.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Heavy Metals	≤ 20 ppm
Specific Rotation	Contact for details

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