Dicyclomine Hydrochloride IP

About Dicyclomine Hydrochloride IP

We are famous amongst our customers as a trustworthy organization engaged in offering Dicyclomine Hydrochloride IP. This medications is ideal for treating a certain type of intestinal problem called irritable bowel syndrome. It helps to reduce the symptoms of stomach and intestinal cramping. This medication works by slowing the natural movements of the gut and by relaxing the muscles in the stomach and intestines. Dicyclomine Hydrochloride IP belongs to a class of drugs known as anticholinergics/antispasmodics. It is recommended to take this medication by mouth with or without food.

Further Details:    

 

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.

Superior Quality and Regulatory Compliance

Dicyclomine Hydrochloride IP adheres strictly to Indian Pharmacopoeia standards, ensuring pharma-grade quality with a purity not less than 99%. Rigorously tested for heavy metals and loss on drying, it meets the most stringent quality benchmarks required by global and local markets.


Versatility in Pharmaceutical Formulations

With its excellent solubility in water and ethanol, and customizable particle size, Dicyclomine Hydrochloride IP is readily incorporated into a wide range of dosage forms including tablets, capsules, and syrups. Its characteristic odorless nature and solid physical form further enhance its applicability.


Long Shelf Life and Stability

This API maintains its efficacy and stability for up to five years when stored appropriately. Its solid form, strict control of moisture content, and resistance to contamination make it a reliable ingredient for sustained pharmaceutical manufacturing and distribution.