Product Description
Hyoscine Butylbromide IP is a pharmaceutical-grade active pharmaceutical ingredient (API) widely used as an antispasmodic agent. It is known for its ability to relieve muscle spasms in the gastrointestinal (GI) tract, urinary system, and bile ducts. It is commonly used in the treatment of conditions like irritable bowel syndrome (IBS), colic pain, and cramps.
Unlike other antispasmodic agents, Hyoscine Butylbromide IP acts selectively on smooth muscles, reducing spasms without affecting normal movement. Its effectiveness and safety profile make it a widely prescribed medication worldwide.
At Prism Industries Pvt. Ltd., we manufacture high-purity Hyoscine Butylbromide IP in strict compliance with Indian Pharmacopoeia (IP) standards. Our Hyoscine Butylbromide IP undergoes rigorous quality control to ensure purity, potency, and compliance for pharmaceutical formulations.
Identification
- Chemical Name: Hyoscine Butylbromide
- Molecular Formula: C21H30BrNO4
- Molecular Weight: 440.37 g/mol
- CAS Number: [Specific CAS Number]
- Synonyms: Scopolamine Butylbromide, 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 Butylbromide IP is widely used in pharmaceutical formulations, providing fast and effective relief from smooth muscle spasms in various conditions.
Regulatory Documents & Compliance
At Prism Industries Pvt. Ltd., we ensure that Hyoscine Butylbromide IP meets global regulatory standards and provide the following regulatory documents:
- Certificate of Analysis (COA): Confirms purity, potency, and compliance with IP 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.
- Indian Pharmacopoeia (IP) Compliance: Adheres to IP 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 Butylbromide IP meets the highest quality and safety standards for pharmaceutical formulations.
Specifications of Hyoscine Butylbromide IP
Our Hyoscine Butylbromide IP 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 Butylbromide |
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 IP standards |
Our Hyoscine Butylbromide IP meets strict pharmaceutical standards, ensuring its purity, consistency, and safety for medical and research applications.
Solubility of Hyoscine Butylbromide IP
The solubility of Hyoscine Butylbromide IP is crucial for its pharmaceutical applications.
- 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 Butylbromide IP is widely used in oral, injectable, and topical formulations for rapid therapeutic action.
Assay of Hyoscine Butylbromide IP
The assay of Hyoscine Butylbromide IP is performed using High-Performance Liquid Chromatography (HPLC) to ensure purity and potency.
HPLC Assay Method for Hyoscine Butylbromide IP
- 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%
Our Hyoscine Butylbromide IP undergoes HPLC analysis to ensure it meets assay specifications, providing high purity and accurate dosage for pharmaceutical applications.
Chromatographic Purity by HPLC
The chromatographic purity of Hyoscine Butylbromide IP is determined to identify and quantify impurities using HPLC methods.
HPLC Conditions for Chromatographic Purity Analysis
- 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%
Our Hyoscine Butylbromide IP undergoes rigorous HPLC testing to ensure pharmaceutical-grade purity and efficacy.
Why Choose Prism Industries Pvt. Ltd. for Hyoscine Butylbromide IP?
As a leading manufacturer of Hyoscine Butylbromide IP, Prism Industries Pvt. Ltd. ensures:
✔ Pharmaceutical-Grade Purity: Meets IP, GMP, and global pharmacopeial standards.
✔ High Solubility & Stability: Ensures fast absorption and effectiveness.
✔ Advanced Quality Control: Rigorous HPLC and microbiological testing.
✔ Global Regulatory Compliance: Ensures safety, purity, and compliance.
✔ Reliable Supply Chain: Capable of bulk production and worldwide distribution.
Hyoscine Butylbromide IP 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 Butylbromide IP, making it ideal for pharmaceutical applications.
For high-quality Hyoscine Butylbromide IP, contact us today for bulk supply and customized pharmaceutical solutions.
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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.