Description

Drotaverin Hydrochloride is a synthetic antispasmodic agent belonging to the isoquinoline class, widely recognized for its potent smooth muscle relaxant properties. Its primary value lies in its high selectivity for the phosphodiesterase IV (PDE4) enzyme, making it a critical active pharmaceutical ingredient (API) for targeted therapeutic applications. This compound is essential for pharmaceutical manufacturers developing formulations to treat conditions involving smooth muscle spasms, such as renal colic, biliary colic, and dysmenorrhea.

Application

• Pharmaceutical API: Primary use as the active ingredient in antispasmodic and vasodilator drug formulations.
• Tablet & Capsule Manufacturing: Used in solid oral dosage forms for the treatment of abdominal pain and cramps.
• Injectable Solutions: Formulated for parenteral administration in hospital settings for acute spastic conditions.
• Veterinary Medicine: Employed in veterinary pharmaceuticals for managing spasms in animals.
• Clinical Research: Serves as a reference standard and raw material in pharmacological R&D for studying smooth muscle physiology.
• Combination Therapies: Used in fixed-dose combination drugs alongside analgesics for enhanced therapeutic effect.

Basic Information

Product Name	Drotaverin Hydrochloride
CAS No.	14009-24-6
Molecular Formula	C24H31NO4·HCl
Molecular Weight	433.97 g/mol
Synonyms	Drotaverine Hydrochloride; 1-(3,4-Diethoxybenzylidene)-6,7-diethoxy-1,2,3,4-tetrahydroisoquinoline Hydrochloride; No-Spa (brand name component); Drotin; Tetraspasmin; Deprolen; Hydrochloride salt of Drotaverine
EINECS	237-819-7

Quality Control

Our Drotaverin Hydrochloride is manufactured under strict quality management systems, targeting compliance with pharmaceutical grade standards such as ICH Q7 and GMP guidelines. Every batch is subjected to comprehensive analytical testing including identity, purity, and impurity profile verification. A Certificate of Analysis (COA) detailing all test results is provided with each shipment to ensure full traceability and regulatory support for our clients.

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). Due to its hygroscopic nature, the container must be kept tightly sealed after opening to prevent moisture absorption, which can affect stability and potency.

Specification

Item	Specification
Appearance	White or almost white crystalline powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	98.5% - 101.0% (on anhydrous basis)
Water (KF)	≤ 0.5%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Total impurities ≤ 1.0% Any single impurity ≤ 0.5%
Microbial Enumeration	Meets Ph. Eur. 2.6.12/2.6.13 requirements

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