Description

Buprenorphine Hydrochloride is a high-purity, semi-synthetic opioid partial agonist used primarily in pharmaceutical formulations. Its unique pharmacological profile makes it a critical active pharmaceutical ingredient (API) for managing chronic pain and treating opioid use disorder. This compound is essential for manufacturers in the pharmaceutical industry developing sublingual tablets, transdermal patches, and injectable solutions. Rigorous quality control ensures it meets the stringent standards required for human therapeutics.

Application

• Pharmaceutical API: Primary active ingredient in sublingual tablets for opioid dependence therapy (e.g., Suboxone®, Subutex®).
• Analgesic Formulations: Used in transdermal patches and injectable solutions for the management of moderate to severe chronic pain.
• Veterinary Medicine: Component in analgesic preparations for animal healthcare under strict regulatory oversight.
• Research & Development: Reference standard and biochemical tool in pharmacological studies targeting opioid receptors.
• Controlled Substance Manufacturing: Sourced by licensed facilities for the production of Schedule III narcotic medications.
• Generic Drug Production: Key ingredient for manufacturers developing bioequivalent generic versions of branded medications.

Basic Information

Product Name	Buprenorphine Hydrochloride
CAS No.	136232-95-6
Molecular Formula	C29H42ClNO4
Molecular Weight	504.10 g/mol
Synonyms	Buprenorphine HCl; BPN; (2S)-2-[17-Cyclopropylmethyl-4,5α-epoxy-3-hydroxy-6-methoxy-6α,14-ethano-14α-morphinan-7α-yl]-3,3-dimethylbutan-2-ol Hydrochloride; NIH 8805; RX6029-M; UM-952; CL-112302; Buprenorphine Hydrochloride USP
EINECS	Contact for details

Quality Control

Our Buprenorphine Hydrochloride is manufactured under cGMP conditions and undergoes stringent analytical testing to ensure it meets or exceeds USP/EP monograph specifications. Every batch is supported by a comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profiles. We ensure full traceability and compliance with global regulatory requirements, including FDA and ICH guidelines.

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 desiccants or inert atmosphere.

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)	98.5% - 101.5% (on anhydrous basis)
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Related Substances (HPLC)	Total impurities ≤ 1.0%; Any single impurity ≤ 0.5%
Heavy Metals	≤ 20 ppm

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