Grade:Other, Pharmaceutical Grade
HS Code:29221990
Heavy Metal (%):NMT 0.001%
Loss on Drying:Less than 0.5%
Medicine Name:Dicyclomine Hydrochloride BP
Molecular Formula:C19H35NO2·HCl
Molecular Weight:345.95 g/mol
Particle Size:Micronized, as per requirement
Physical Form:Solid
Purity(%):99% or above
Shelf Life:5 years
Smell:Other, Odorless
Solubility:Freely soluble in water and alcohol
Storage:Other, Store in cool, dry place, tightly closed container
Structural Formula:[as per image, C19H35NO2·HCl]
Taste:Bitter
Type:Other, Active Pharmaceutical Ingredient (API)
Usage:Used as anticholinergic, antispasmodic
Know More
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 BenefitsDicyclomine 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 UsagePharmaceutical 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 ComplianceProduced 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.
FAQs of Dicyclomine Hydrochloride BP:
Q: How is Dicyclomine Hydrochloride BP typically used in the pharmaceutical industry?
A: Dicyclomine Hydrochloride BP serves as an active pharmaceutical ingredient in drugs formulated to relieve gastrointestinal spasms. Its anticholinergic and antispasmodic properties help reduce smooth muscle spasms, making it valuable in the treatment of conditions like irritable bowel syndrome.
Q: What are the recommended storage conditions for Dicyclomine Hydrochloride BP?
A: It is best to store Dicyclomine Hydrochloride BP in a tightly closed container, in a cool and dry location. This helps maintain its stability, potency, and ensures its shelf life of up to five years.
Q: Where is Dicyclomine Hydrochloride BP manufactured and exported from?
A: This API is manufactured, supplied, and exported from India, in adherence to rigorous pharmaceutical-grade standards for international distribution.
Q: What is the significance of the APIs high purity and micronized form?
A: The high purity (99% or above) ensures efficacy and safety, while the micronized particle size allows for improved solubility and seamless integration into various pharmaceutical products, enhancing their bioavailability and consistency.
Q: When should Dicyclomine Hydrochloride BP be considered for pharmaceutical formulations?
A: It should be considered when formulating medications that require reliable anticholinergic and antispasmodic effects, such as treatments for gastrointestinal disorders involving muscle spasms.
Q: What are the solubility characteristics of Dicyclomine Hydrochloride BP?
A: Dicyclomine Hydrochloride BP is freely soluble in both water and alcohol, making it a versatile option for different dosage forms and formulations in pharmaceuticals.
Q: How does the manufacturer ensure the quality and safety of Dicyclomine Hydrochloride BP?
A: Through stringent quality controls, the API is produced with less than 0.001% heavy metals and less than 0.5% loss on drying, complying with international standards for pharmaceutical ingredients.