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S-AMLODIPINE BESILATE IP/BP/EP/USP
S-AMLODIPINE BESILATE IP/BP/EP/USP

S-AMLODIPINE BESILATE IP/BP/EP/USP

Price 1800 INR/ Kilograms

MOQ : 25 Kilograms

S-AMLODIPINE BESILATE IP/BP/EP/USP Specification

  • Melting Point
  • 205-210C
  • Moisture (%)
  • 1.0%
  • Loss on Drying
  • 1.0%
  • Molecular Weight
  • 567.05 g/mol
  • HS Code
  • 29420090
  • Heavy Metal (%)
  • 0.001%
  • Assay
  • 99.0% (HPLC)
  • Molecular Formula
  • C20H25ClN2O5.C6H6O3S
  • Place of Origin
  • India
  • Storage
  • Store in a cool, dry place; keep container tightly closed
  • Residue on Ignition
  • 0.1%
  • Other Names
  • S-Amlodipine Besilate, S-Amlodipine Benzene Sulfonate
  • CAS No
  • 111470-99-6
  • Type
  • Pharmaceutical Raw Material
  • Grade
  • Pharma Grade
  • Usage
  • Active Pharmaceutical Ingredient (API) for antihypertensive and calcium channel blocker formulations
  • Purity
  • 99% Min
  • Appearance
  • White to off-white powder
  • Application
  • For use in pharmaceutical preparations for hypertension and angina
  • Raw Material
  • Amlodipine intermediate
  • Smell
  • Odourless
  • Color
  • White
  • Form
  • Powder
  • Impurities
  • Single impurity 0.5%; Total impurities 1.0%
  • Shelf Life
  • 24 months
  • Identification
  • Consistent with reference standards by IR, HPLC, and chromatographic purity
  • Optical Rotation
  • [] 25/D = +23.0 to +27.0 (c=1, methanol)
  • Regulatory Documentation
  • DMF, COA, MSDS, and regulatory support available
  • Microbial Limits
  • Total bacterial count: 10 CFU/g; Yeast & Molds: 10 CFU/g
  • Manufacturing Standard
  • Complies with IP/BP/EP/USP quality standards
  • Packaging
  • Available in 1 kg, 5 kg, and 25 kg HDPE or Aluminium drums
  • Solubility
  • Freely soluble in methanol, sparingly soluble in ethanol, insoluble in chloroform
  • Usage Specification
  • Suitable for oral dosage forms (tablet, capsule)
 
 

About S-AMLODIPINE BESILATE IP/BP/EP/USP

S-amlodipine besylate is a specific form of amlodipine besylate, used to treat hypertension (high blood pressure) and chronic stable angina. It works by relaxing blood vessels and improving blood flow, which helps to lower blood pressure and reduce the frequency of chest pain episodes.

High-Quality Pharmaceutical Raw Material

S-Amlodipine Besilate is renowned for its high purity and compliance with international pharmacopeial standards (IP/BP/EP/USP). Each batch undergoes rigorous quality control, including identification by IR and HPLC, ensuring consistent performance and safety for end-use in oral dosage forms. The product is produced in certified facilities in India and meets strict microbial and impurity specifications.


Versatile Application and Secure Packaging

The API's stable white to off-white powder form allows ease of formulation into tablets and capsules for the treatment of hypertension and angina. It is available in 1 kg, 5 kg, and 25 kg packaging options, utilizing HDPE or aluminium drums to safeguard quality during transit and storage. This variety supports efficient supply chain management for pharmaceutical manufacturers.


Regulatory Compliance and Support

S-Amlodipine Besilate is supported by a full suite of regulatory documents, including DMF, COA, and MSDS. As a manufacturer, supplier, and trader based in India, we ensure that you receive comprehensive regulatory assistance, facilitating smooth product registration and formulation approvals worldwide.

FAQ's of S-AMLODIPINE BESILATE IP/BP/EP/USP:


Q: How is S-Amlodipine Besilate commonly used in pharmaceutical applications?

A: S-Amlodipine Besilate serves as an active ingredient in oral dosage forms such as tablets and capsules, mainly for antihypertensive and calcium channel blocker medications prescribed for hypertension and angina.

Q: What quality standards does S-Amlodipine Besilate comply with?

A: The product meets international pharmaceutical standards, specifically IP, BP, EP, and USP. It is also backed by regulatory documents such as DMF, COA, and MSDS, and produced with strict impurity, microbial, and heavy metal limits.

Q: When should S-Amlodipine Besilate be stored and how is its shelf life maintained?

A: It should be stored in a cool, dry place with the container tightly closed. Proper storage helps maintain its shelf life of up to 24 months, ensuring the powder remains stable and effective for pharmaceutical compounding.

Q: Where is S-Amlodipine Besilate manufactured and can it be sourced globally?

A: Manufactured in India, S-Amlodipine Besilate is available to clients worldwide, with reliable supply, quality assurance, and complete regulatory support for global pharmaceutical markets.

Q: What packaging options are available for S-Amlodipine Besilate, and why are these important?

A: It is supplied in HDPE or aluminium drums of 1 kg, 5 kg, or 25 kg to protect against moisture and contaminants during transport and storage, ensuring the product remains within specification.

Q: What are the main benefits of using this API for drug manufacturers?

A: Using S-Amlodipine Besilate enables manufacturers to create well-characterized, stable formulations that comply with pharmacopeial standards. Its quality assurance, consistent supply, and regulatory documentation streamline both production and registration processes.

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