Dicyclomine Hydrochloride BP

About Dicyclomine Hydrochloride BP

We have become a dominant player in the market of offering our clients Dicyclomine Hydrochloride BP. It is an anticholinergic medicine, used to relieve muscle spasms in the gastrointestinal tract. This medication is not recommended in patients with gastrointestinal and urinary tract obstruction disorders. Our expert workforce uses best quality compounds, sourced from trusted vendors to process this medication. It also has some local anesthetic properties and is used in gastrointestinal, biliary, and urinary tract spasms. Dicyclomine Hydrochloride BP antagonizes muscarinic receptors on smooth muscle in the gastrointestinal (GI) tract.

Further Details: 

 

Dicyclomine Hydrochloride IP/BP/USP Dicyclomine Hydrochloride is 2-diethylaminoethyl- bicyclohexyl-1-carboxylate hydrochloride

Formula: C19H35NO2, HCl

Category: Antispasmodic.

Mol. Wt.: 345.95

Dose: 30 to 60 mg daily, in divided doses. If used as an oral solution and the solution is required to be diluted, the diluted solution should be freshly prepared.

Analysis	Specification
Description	White or almost white, crystalline powder; odourless or almost odourless.
Solubility	Freely soluble in ethanol (95%) and in chloroform; soluble in water; practically insoluble in ether.
Identification:
A:	By  infra-red absorption spectrum
B:	To 3 ml of a 0.1% w/v solution of sodium dodecyl sulphate, add 5 ml of chloroform and 0.05 ml of a 0.25% w/v solution of methylene blue, mix gently and allow to separate; the chloroform layer is blue. Add 20 mg of the substance being examined dissolved in 2 ml of water, mix gently and allow to separate; the aqueous layer is blue and the chloroform layer is colourless.
C: Chloride Test	Dissolve 10 mg in 5 ml of water and add 0.2 ml of 2M nitric acid and 0.5 ml of silver nitrate solution; a white precipitate is produced.
D: Melts	Between 172o and 174o.
Related Substances	Any secondary spot in the chromatogram obtained with solution (1) is not more intense than the spot in the chromatogram obtained with solution (2).
Sulphated Ash	Not more than 0.1%.
Loss on Drying	Not more than 1.0%, determined on 1 g by drying in an oven at 105o
Assay	Dicyclomine Hydrochloride contains not less than 99.0 per cent and not more than 101.0 per cent of C19H35NO2,HCl, calculated with reference to the dried substance.

Key Features and Benefits

Dicyclomine Hydrochloride BP provides reliable antispasmodic and anticholinergic effects, making it an essential ingredient for pharmaceutical formulations treating gastrointestinal discomfort. Its high purity level (99% or above) and precise particle size enable efficient formulation and consistent results. Manufactured to stringent quality standards, this API guarantees stability and performance when stored under recommended conditions.


Applications and Usage

Pharmaceutical manufacturers use Dicyclomine Hydrochloride BP as a core ingredient in medicines aimed at relieving smooth muscle spasms and related discomfort in the gastrointestinal tract. Its solubility in water and alcohol facilitates easy integration into various dosage forms. The products micronized form and customizable particle size streamline production processes and improve end-product quality.


Quality Assurance and Compliance

Produced under strict pharmaceutical standards, Dicyclomine Hydrochloride BP boasts a low heavy metal content (NMT 0.001%) and loss on drying less than 0.5%. Its HS Code is 29221990, and the product meets international export and manufacturing norms, ensuring compliance for global distribution. Properly sealed containers and dry, cool storage maximize shelf life and preserve efficacy.