Product Description
Hyoscine Methylbromide USP is a high-quality pharmaceutical-grade antispasmodic agent used to relieve smooth muscle spasms in the gastrointestinal, urinary, and biliary tracts. It is commonly prescribed to treat irritable bowel syndrome (IBS), renal colic, and painful cramps by relaxing the muscles of the digestive system.
Unlike other antispasmodics, Hyoscine Methylbromide USP does not cross the blood-brain barrier, making it an effective choice with minimal central nervous system (CNS) side effects. It is available in tablet, injectable, and oral liquid formulations, providing rapid and long-lasting relief.
At Prism Industries Pvt. Ltd., we manufacture high-purity Hyoscine Methylbromide USP, ensuring compliance with United States Pharmacopeia (USP) standards. Our strict quality control ensures that each batch meets the highest pharmaceutical safety and efficacy criteria.
Identification
- Chemical Name: Hyoscine Hydrobromide
- Molecular Formula: C21H30BrNO4
- Molecular Weight: 440.37 g/mol
- CAS Number: [Specific CAS Number]
- Synonyms: Scopolamine Hydrobromide, Butylscopolamine
- Appearance: White or almost white crystalline powder
- Odor: Odorless
- Solubility: Freely soluble in water, slightly soluble in alcohol
- Function: Used as an antispasmodic agent to relieve smooth muscle spasms in the digestive, urinary, and biliary tracts.
Hyoscine Methylbromide USP is widely used in pharmaceutical formulations to provide fast and effective relief from muscle cramps and spasms.
Regulatory Documents & Compliance
At Prism Industries Pvt. Ltd., we ensure that Hyoscine Methylbromide USP meets global regulatory standards and provide the following regulatory documents:
- Certificate of Analysis (COA): Confirms purity, potency, and compliance with USP standards.
- Material Safety Data Sheet (MSDS): Provides safety, handling, and storage guidelines.
- Good Manufacturing Practices (GMP) Certificate: Ensures production under strict pharmaceutical-grade quality control.
- United States Pharmacopeia (USP) Compliance: Adheres to EP specifications for pharmaceutical use.
- TSE/BSE-Free Statement: Confirms that the product is free from animal-derived materials.
- Stability Data Report: Provides information on long-term stability under various conditions.
- Residual Solvents Report: Ensures compliance with ICH Q3C guidelines for safe solvent levels.
- Allergen-Free Statement: Certifies that the product is free from common allergens.
Our commitment to regulatory compliance ensures that Hyoscine Methylbromide USP meets the highest quality and safety standards for pharmaceutical formulations.
Specifications of Hyoscine Methylbromide USP
Our Hyoscine Methylbromide USP is manufactured under strict quality control conditions, meeting the following pharmaceutical specifications:
Parameter | Specification |
Appearance | White or almost white crystalline powder |
Odor | Odorless |
Identification | Positive for Hyoscine Hydrobromide |
Melting Point | 138°C – 142°C |
Solubility | Freely soluble in water, slightly soluble in alcohol |
pH (5% Solution in Water) | 5.0 – 7.0 |
Assay (Purity by HPLC) | 98.0% – 102.0% |
Loss on Drying | ≤ 1.0% |
Heavy Metals | ≤ 10 ppm |
Residual Solvents | Complies with ICH Q3C guidelines |
Microbial Limits | Complies with USP standards |
Our Hyoscine Methylbromide USP meets strict pharmaceutical standards, ensuring its purity, consistency, and safety for medical and research applications.
Solubility of Hyoscine Methylbromide USP
- Water: Freely soluble, making it ideal for injectable and liquid formulations.
- Alcohol: Slightly soluble.
- Acidic Solutions: Highly soluble, ensuring quick absorption in the body.
- Organic Solvents: Partially soluble in some organic solvents like chloroform.
Due to its high water solubility, Hyoscine Methylbromide USP is widely used in oral, injectable, and topical formulations for rapid therapeutic action.
Assay of Hyoscine Methylbromide USP
The assay of Hyoscine Methylbromide USP is performed using High-Performance Liquid Chromatography (HPLC) to ensure purity and potency.
HPLC Assay Method for Hyoscine Methylbromide USP
- Instrument: High-Performance Liquid Chromatography (HPLC)
- Mobile Phase: Acetonitrile: Water (60:40) with 0.1% phosphoric acid
- Column: C18 (250 mm × 4.6 mm, 5 µm)
- Flow Rate: 1.0 mL/min
- Detection Wavelength: 254 nm
- Injection Volume: 10 µL
- Retention Time: 5.5 ± 0.3 minutes
- Assay Specification: 98.0% – 102.0%
Chromatographic Purity by HPLC
- Mobile Phase: Acetonitrile: Phosphate Buffer (70:30)
- Column: C18 (150 mm × 4.6 mm, 5 µm)
- Flow Rate: 1.2 mL/min
- Detection Wavelength: 260 nm
- Retention Time: 5.0 ± 0.3 minutes
- Total Impurities Limit: ≤ 0.5%
Hyoscine Methylbromide USP is a highly effective antispasmodic agent with excellent solubility, purity, and stability. At Prism Industries Pvt. Ltd., we ensure top-quality production, regulatory compliance, and superior quality control for Hyoscine Methylbromide USP, making it ideal for pharmaceutical applications.
For high-quality Hyoscine Methylbromide USP, contact us today for bulk supply and customized pharmaceutical solutions.
FAQs:
Hyoscine Methylbromide USP API. The product is of pharmaceutical grade and manufactured to meet the specifications of United States Pharmacopeia (USP). It is a potent antispasmodic agent that relieves involuntary muscle spasms in the muscles of the GI, biliary and urinary systems.
The drug Hyoscine Methylbromide USP is used extensively in formulations of Tablets, injections & Oral liquid drugs in treatment of G.I. Spasm, IBS, Abdominal cramp, renal colic and biliary disorder.
Hyoscine Methylbromide USP works to relax smooth muscles and induce spasmolitic effects and it has little CNS effect due to lack of permeation across the blood brain barrier. Its quick action has made it desirable to be used in a number of pharmaceutical preparations.
Yes. Prism Industries produces Hyoscine Methylbromide USP in a manufacturing facility that is compliant with WHO-GMP and supported by proper quality management system. We produce and test every batch to comply with appropriate USP quality specifications and pharmaceutical requirements.
Our quality control checks in each batch cover identification, assay by HPLC, related substances, residual solvents, loss on drying, heavy metals, microbial limit tests and other relevant analytical tests for quality, purity and effectiveness.
Prism Industries provides regulatory documentation such as the Certificate of Analysis (COA), Material Safety Data Sheet (MSDS), GMP-related documentation, stability data, residual solvent reports, product specifications, and other quality documents required by pharmaceutical manufacturers.
Yes. We manufacture and supply Hyoscine Methylbromide USP in commercial bulk quantities for pharmaceutical companies, formulation manufacturers, contract manufacturers, and global distributors while ensuring reliable quality and timely deliveries.
Packaging The product is packed in robust, USP approved packaging that will ensure stability during storage and transit. Packaging solutions are available based on specific customer and commercialization needs.
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Related Products
Our minimum order quantities vary depending on the product:
- Active Pharmaceutical Ingredients (APIs): 1 kg
- Excipients: 5 kg
- Finished Dosage Forms: 1,000 units
- Custom Orders: Determined on a case-by-case basis
We accept the following payment methods:
- Bank Transfers: EUR, USD, GBP
- Credit/Debit Cards: Visa, MasterCard
- PayPal: For international transactions
API Pharmaceutical Manufacturing Company is a dedicated manufacturer of high-quality pharmaceutical ingredients and finished products. We control the entire production process to ensure compliance with the highest standards of quality and safety.
We primarily serve business clients in the pharmaceutical, biotech, and healthcare industries. For individual customers, we recommend reaching out to our authorized distributors.