Product Description
Hyoscine Methyl Bromide is a well-known antispasmodic agent used in the pharmaceutical industry to relieve smooth muscle spasms in the gastrointestinal, urinary, and biliary tracts. It is commonly utilized in treating conditions such as irritable bowel syndrome (IBS), colic, and other digestive disorders. This active pharmaceutical ingredient (API) works by blocking the action of acetylcholine, thereby reducing involuntary muscle contractions.
At Prism Industries Pvt. Ltd., we specialize in the manufacturing and supply of Hyoscine Methyl Bromide, ensuring the highest standards of purity and quality to meet global pharmaceutical demands.
Identification
Chemical Information:
Chemical Name: Hyoscine Methyl Bromide
Molecular Formula: C17H21NO4Br
Molecular Weight: 386.26 g/mol
CAS Number: 114-49-8
IUPAC Name: (1S,3S,5S)-3-(Hydroxyacetoxy)-8-methyl-8-azabicyclo[3.2.1]octane bromide
Appearance: White or off-white crystalline powder
Melting Point: 208-220°C
Odor: Odorless
Solubility: Soluble in water, slightly soluble in ethanol
Regulatory Documents & Compliance
At Prism Industries Pvt. Ltd., we comply with the highest regulatory standards to ensure the safe production and distribution of Hyoscine Methyl Bromide. Our commitment to quality and compliance is reflected in the following certifications and documentation:
GMP (Good Manufacturing Practices) Certification
ISO 9001:2015 Certification
Certificate of Analysis (COA) for Every Batch
Drug Master File (DMF) Submission
REACH Compliance for European Standards
U.S. FDA Compliance for API Manufacturing
Material Safety Data Sheet (MSDS) for Safety Guidelines
Stability Studies as per ICH Guidelines
Our regulatory team ensures that all our products, including Hyoscine Methyl Bromide, meet the stringent international quality standards required by the pharmaceutical industry.
Specifications
Our Hyoscine Methyl Bromide meets the following specifications:
| Parameter | Specification |
|---|---|
| Appearance | White or off-white crystalline powder |
| Identification | IR, UV, and HPLC methods confirmed |
| Melting Point | 208-220°C |
| Specific Rotation | Between +10° and +12° |
| Loss on Drying | NMT 1.0% |
| Residue on Ignition | NMT 0.1% |
| Heavy Metals | NMT 10 ppm |
| Assay (HPLC) | 98.0% – 102.0% |
| Chromatographic Purity (HPLC) | NLT 99.0% |
Solubility
Hyoscine Methyl Bromide exhibits good solubility properties that make it highly suitable for pharmaceutical applications:
Water: Highly soluble
Ethanol: Slightly soluble
Methanol: Soluble
Chloroform: Insoluble
Ether: Insoluble
This solubility profile ensures the compound’s effectiveness in oral and injectable formulations.
Assay
Our Hyoscine Methyl Bromide undergoes rigorous assay testing to ensure its potency and purity:
Assay Method: High-Performance Liquid Chromatography (HPLC)
Acceptance Criteria: 98.0% – 102.0%
Purpose: Confirms the active content of the compound
Precision: Meets pharmaceutical-grade requirements
Chromatographic Purity by HPLC
To maintain superior quality, we employ HPLC testing to determine the chromatographic purity of Hyoscine Methyl Bromide:
Purity Level: Not less than 99.0%
Detection Method: UV detection at 210-220 nm
Retention Time: Matches reference standard
Impurity Profile: Below acceptable pharmacopeial limits
Our stringent analytical testing ensures that our Hyoscine Methyl Bromide is free from harmful impurities and meets global pharmaceutical standards.
Why Choose Prism Industries Pvt. Ltd. for Hyoscine Methyl Bromide?
At Prism Industries Pvt. Ltd., we take pride in being a leading manufacturer and supplier of Hyoscine Methyl Bromide. Here’s why our product stands out:
1. Premium-Grade API Manufacturing
We adhere to GMP guidelines to manufacture pharmaceutical-grade Hyoscine Methyl Bromide, ensuring high purity and potency in every batch.
2. Advanced Quality Control & Assurance
Our in-house laboratory performs extensive testing, including HPLC analysis, stability studies, and impurity profiling, to guarantee the best quality product.
3. Regulatory Compliance & Global Reach
We comply with U.S. FDA, EU GMP, and ICH guidelines, making our Hyoscine Methyl Bromide suitable for pharmaceutical markets worldwide.
4. Competitive Pricing & Reliable Supply Chain
Our cost-efficient manufacturing processes and robust supply chain management ensure that our customers receive top-quality API ingredients at competitive prices.
5. Customization & Bulk Supply Capabilities
We offer tailored formulations and bulk quantities to meet the specific needs of pharmaceutical companies and researchers.
6. Ethical & Sustainable Manufacturing
Our processes align with eco-friendly and sustainable production methods, ensuring minimal environmental impact.
Conclusion
Hyoscine Methyl Bromide is a crucial API used in various pharmaceutical applications, including the treatment of spasms, IBS, and pre-operative medication. At Prism Industries Pvt. Ltd., we uphold the highest standards of manufacturing, quality control, and compliance to deliver superior Hyoscine Methyl Bromide to our global clients.
Our commitment to precision, regulatory adherence, and customer satisfaction makes us a trusted supplier in the pharmaceutical API industry. Partner with us for premium-quality Hyoscine Methyl Bromide, tailored to meet your formulation needs.
For inquiries, bulk orders, or technical support, contact Prism Industries Pvt. Ltd. today!
FAQs:
Hyoscine Methyl Bromide is a pharmaceutical active ingredient with anticholinergic and antispasmodic properties. It is used in pharmaceutical applications where control of smooth muscle spasms is required.
Prism Industries Pvt. Ltd. is a Hyoscine Methyl Bromide manufacturer in India, supplying pharmaceutical-grade API to pharmaceutical companies and B2B customers for domestic and international requirements.
Hyoscine Methyl Bromide is primarily used as an antispasmodic pharmaceutical ingredient. It is associated with formulations intended to help manage smooth muscle spasms in the gastrointestinal, urinary, and biliary tracts.
Hyoscine Methyl Bromide may also be referred to as Methscopolamine Bromide. Buyers should confirm the exact chemical identity and specification through the product’s technical and regulatory documentation before use.
The molecular formula listed for Hyoscine Methyl Bromide is C17H21NO4Br, with a molecular weight of approximately 386.26 g/mol.
The CAS number currently listed for Hyoscine Methyl Bromide on Prism Industries’ product page is 114-49-8. Customers should verify the required chemical identity against the latest COA and technical documentation when placing an order.
Hyoscine Methyl Bromide is generally supplied as a white or off-white crystalline powder and is described as odorless.
Prism Industries lists a chromatographic purity of not less than 99.0% by HPLC for Hyoscine Methyl Bromide. Batch-specific results should always be confirmed through the Certificate of Analysis.
The listed assay specification for Hyoscine Methyl Bromide is 98.0%–102.0% by HPLC. Analytical testing helps confirm the active content and consistency of the API.
Yes. Hyoscine Methyl Bromide has good water solubility. It is also listed as soluble in methanol and slightly soluble in ethanol, while being insoluble in chloroform and ether.
Yes. Prism Industries provides a Certificate of Analysis (COA) for Hyoscine Methyl Bromide batches. The COA provides batch-specific analytical and quality information.
Yes. An MSDS for Hyoscine Methyl Bromide is available to provide relevant information regarding safe handling, storage, hazards, and other safety considerations.
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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.