Description

Drotaverine Hydrochloride is a highly purified pharmaceutical active ingredient belonging to the class of isoquinoline derivatives. It serves as a potent antispasmodic agent, specifically targeting smooth muscle tissue to provide effective relief from spasms. This compound is essential for the formulation of prescription medications aimed at treating conditions such as renal colic, biliary colic, and irritable bowel syndrome. Global pharmaceutical manufacturers and research institutions rely on high-grade Drotaverine Hydrochloride for developing and producing reliable therapeutic solutions.

Application

• Pharmaceutical Formulations: Primary active ingredient in antispasmodic tablets, capsules, and injectables.
• Treatment of Renal & Biliary Colic: Used in medications to alleviate acute pain associated with kidney stones and gallstones.
• Gastrointestinal Disorders: Key component in drugs for managing symptoms of irritable bowel syndrome (IBS) and other functional bowel diseases.
• Gynecological Applications: Employed in formulations to relieve spasmodic pain related to dysmenorrhea.
• Urological Spasms: Used in treatments for bladder and urinary tract spasms.
• Active Pharmaceutical Ingredient (API) Synthesis: Serves as a critical intermediate or final API in GMP-compliant manufacturing processes.
• Clinical Research: Utilized in preclinical and clinical studies investigating new antispasmodic therapies.
• Reference Standard: Serves as a high-purity standard for quality control and analytical testing in laboratories.

Basic Information

Product Name	Drotaverine Hydrochloride
CAS No.	985-12-6
Molecular Formula	C24H31NO4 • HCl
Molecular Weight	433.97 g/mol
Synonyms	Drotaverine HCl; 1-(3,4-Diethoxybenzylidene)-6,7-diethoxy-1,2,3,4-tetrahydroisoquinoline Hydrochloride; No-Spa (brand name related); Drotin; Tetraspasmil; 4'-Ethoxy-3,4-diethoxybenzenecarbothioamide Derivative Hydrochloride; Drotaverinum Hydrochloridum
EINECS	Contact for details

Quality Control

Our Drotaverine Hydrochloride is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing to ensure it meets stringent specifications for identity, purity, and potency, aligning with pharmacopeial standards. A Certificate of Analysis (COA) documenting results for assay, related substances, residual solvents, and other critical parameters is provided with every shipment to guarantee traceability and compliance.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry, and well-ventilated area at a controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive); the container must be kept tightly sealed to protect from humidity.

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)
Related Substances (HPLC)	Total impurities: NMT 1.0% Any individual impurity: NMT 0.5%
Water (KF Titration)	NMT 0.5%
Residue on Ignition	NMT 0.1%
Heavy Metals	NMT 20 ppm
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Microbial Enumeration	Complies with Ph. Eur. 2.6.12/2.6.13

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