Description

Hydrocodone Bitartrate is a high-purity pharmaceutical active ingredient, a salt form of the semi-synthetic opioid analgesic hydrocodone. It is a critical intermediate and active pharmaceutical ingredient (API) used in the formulation of prescription pain relief and antitussive medications. This compound is essential for manufacturers in the global pharmaceutical industry requiring reliable, high-quality raw materials for controlled substance production.

Application

• Pharmaceutical API: Primary use as the active ingredient in prescription analgesic tablets and capsules for moderate to severe pain management.
• Antitussive Formulations: Key component in prescription cough suppressant syrups and liquids.
• Clinical Research: Used as a reference standard and material in pharmacological studies and clinical trials.
• Controlled Substance Manufacturing: Sourced by licensed facilities for the production of Schedule II (US) / Schedule II (INCB) narcotic preparations.
• Analytical Development: Serves as a standard for HPLC, GC, and other analytical method development and validation in quality control laboratories.

Basic Information

Product Name	Hydrocodone Bitartrate
CAS No.	34195-34-1
Molecular Formula	C18H21NO3 • C4H6O6
Molecular Weight	494.5 g/mol
Synonyms	Dihydrocodeinone Bitartrate; 4,5α-Epoxy-3-methoxy-17-methylmorphinan-6-one Tartrate (1:1); Hydrocodone Hydrogen Tartrate; Hydrocodone Tartrate; NSC-19095; Dihydrocodeinone Acid Tartrate; Norcodeine Bitartrate (related); Drocodile (street name reference)
EINECS	Contact for details

Quality Control

Our Hydrocodone Bitartrate is manufactured and tested under strict quality management systems. It is produced to meet exacting standards suitable for pharmaceutical use, with comprehensive testing for identity, purity, and potency. Certificates of Analysis (COA) are provided with each batch, detailing results for assay, related substances, residual solvents, and other critical parameters. We support compliance with relevant pharmacopoeial standards (e.g., USP, EP) and regulatory frameworks (FDA, ICH Q7).

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. Access should be controlled in accordance with all applicable national and international regulations for controlled substances.

Specification

Item	Specification
Appearance	White or almost white, crystalline powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time corresponds to standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 1.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 1.5%
Residual Solvents (GC)	Complies with ICH Q3C
Specific Rotation	-90° to -95° (c=1 in H2O)

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