Product Description
Hyoscine Hydrobromide BP is a highly effective anticholinergic compound widely used in the pharmaceutical industry. It is primarily utilized to treat motion sickness, gastrointestinal disorders, and muscle spasms. The compound works by inhibiting the parasympathetic nervous system, reducing muscle contractions, and alleviating discomfort caused by excessive digestive motility.
Our Hyoscine Hydrobromide BP is manufactured under strict Good Manufacturing Practices (GMP), ensuring its high purity, stability, and effectiveness in formulations. It is available in powder and crystalline forms, suitable for multiple pharmaceutical applications.
Identification
- Chemical Name: Hyoscine Hydrobromide
- Molecular Formula: C17H21NO4•HBr
- Molecular Weight: 384.26 g/mol
- CAS Number: 114-49-8
- Appearance: White to off-white crystalline powder
- Odor: Odorless or faint characteristic odor
- Taste: Bitter
Regulatory Documents & Compliance
To ensure adherence to global standards, Hyoscine Hydrobromide BP complies with the latest British Pharmacopoeia (BP) standards and meets stringent regulatory requirements. The following documentation is provided with each batch:
- Certificate of Analysis (COA)
- Material Safety Data Sheet (MSDS)
- Good Manufacturing Practice (GMP) Certification
- Regulatory Dossier Support
- Stability Data (Long-Term & Accelerated)
- Allergen & BSE/TSE Statements
Our regulatory team ensures that our Hyoscine Hydrobromide BP meets the highest safety, quality, and efficacy benchmarks, making it suitable for pharmaceutical-grade applications worldwide.
Specifications
Our product is tested as per British Pharmacopoeia (BP) standards with the following specifications:
- Identification: Conforms to BP standards
- Assay (Purity): 98.0% – 102.0%
- Solubility: Soluble in water, sparingly soluble in alcohol
- pH (5% solution): 4.5 – 6.5
- Heavy Metals: Not more than 10 ppm
- Loss on Drying: Not more than 1.0%
- Residue on Ignition: Not more than 0.1%
- Related Substances: Within BP limits
Solubility
Hyoscine Hydrobromide BP exhibits excellent solubility properties, making it ideal for pharmaceutical formulations:
- Water: Highly soluble
- Alcohol: Sparingly soluble
- Chloroform & Ether: Practically insoluble
- Aqueous Solutions: Forms a clear, colorless solution
These solubility characteristics ensure its effective absorption and bioavailability, enhancing its therapeutic efficacy in various drug formulations.
Assay
Our Hyoscine Hydrobromide BP undergoes rigorous assay testing to confirm its purity and potency. The assay is conducted via titration and high-performance liquid chromatography (HPLC) methods to guarantee:
- Minimum 98.0% – 102.0% purity
- Absence of significant impurities
- Compliance with BP monograph requirements
Chromatographic Purity
The chromatographic purity of Hyoscine Hydrobromide BP is analyzed using HPLC techniques to detect and quantify any related impurities. Our product meets the BP-defined impurity profile, ensuring that any degradation products or contaminants are well below permissible limits.
Why Choose Prism Industries Pvt. Ltd. for Hyoscine Hydrobromide BP?
At Prism Industries Pvt. Ltd., we are committed to providing high-quality, pharmaceutical-grade Hyoscine Hydrobromide BP with an unwavering focus on purity, compliance, and customer satisfaction. Here’s why our product stands out:
1. Uncompromising Quality Standards
Our Hyoscine Hydrobromide BP is manufactured in state-of-the-art GMP-certified facilities. We ensure that each batch undergoes strict quality control (QC) testing, ensuring compliance with BP standards.
2. Extensive Regulatory Support
We provide comprehensive documentation, including COA, MSDS, Stability Data, and GMP Certifications, making regulatory submissions smooth and hassle-free.
3. Competitive Pricing & Bulk Availability
We offer cost-effective solutions for bulk and long-term orders without compromising quality. Our streamlined supply chain ensures timely delivery and uninterrupted availability.
4. Advanced Analytical & R&D Capabilities
Our dedicated research and development (R&D) team continually improves our production processes, ensuring enhanced purity, stability, and performance of our Hyoscine Hydrobromide BP.
5. Global Distribution & Reliability
With a strong global presence, Prism Industries Pvt. Ltd. caters to leading pharmaceutical companies worldwide. Our efficient logistics network ensures fast and secure shipping.
6. Customization & Technical Support
We understand that every formulation has unique requirements. Our team offers customized packaging solutions and technical assistance to meet your specific needs.
Choosing Hyoscine Hydrobromide BP from Prism Industries Pvt. Ltd. ensures you receive a high-purity, compliant, and cost-effective pharmaceutical ingredient. With our strict quality controls, regulatory expertise, and global distribution network, we are your trusted partner for premium pharmaceutical raw materials.
Contact us today for bulk inquiries, technical assistance, or regulatory support and experience unmatched quality and service with Prism Industries Pvt. Ltd..
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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.