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sevelamer hcl

sevelamer hcl

Sevelamer Hydrochloride API

High-Quality Sevelamer Hydrochloride Active Pharmaceutical Ingredient

Sevelamer Hydrochloride is a pharmaceutical-grade polymeric Active Pharmaceutical Ingredient (API) widely utilized in the development of advanced renal care formulations. Manufactured under stringent quality standards, our Sevelamer Hydrochloride API delivers consistent performance, excellent purity, and reliable batch-to-batch reproducibility.

The product is produced using a controlled manufacturing process and is supported by comprehensive quality documentation, making it suitable for pharmaceutical companies serving regulated and semi-regulated markets worldwide.

Product Details

Parameter Specification
Product Name Sevelamer Hydrochloride
CAS Number 152751-57-0
Category Active Pharmaceutical Ingredient (API)
Appearance White to Off-White Powder
Grade Pharmaceutical Grade
Storage Store in a cool, dry place in tightly closed containers

Key Features

  • High Purity Pharmaceutical Grade API

  • Consistent Quality and Performance

  • Controlled Manufacturing Process

  • Excellent Stability Profile

  • Reliable Global Supply

  • Comprehensive Documentation Support

  • Suitable for Commercial Pharmaceutical Production

Applications

Sevelamer Hydrochloride API is used in the manufacture of pharmaceutical formulations intended for phosphate management and renal care applications. The product is suitable for use in oral solid dosage forms and other pharmaceutical preparations.

Packaging

Available in:

  • 1 Kg

  • 5 Kg

  • 10 Kg

  • 25 Kg HDPE Drums

Customized packaging options are available according to customer requirements.

Documentation Available

  • Certificate of Analysis (COA)

  • Material Safety Data Sheet (MSDS)

  • Technical Data Sheet (TDS)

  • Product Specifications

  • Regulatory Documentation Support

Why Choose Us?

We are committed to delivering high-quality pharmaceutical APIs through advanced manufacturing practices, strict quality control systems, and dependable customer support. Our focus on quality, compliance, and timely delivery enables us to serve pharmaceutical manufacturers across global markets efficiently.

For product specifications, quotations, and technical inquiries, please contact our sales team.



Superior Phosphate Binding

Sevelamer HCl is widely recognized for its efficacy in reducing serum phosphate levels, especially in patients undergoing dialysis. Its non-absorbable polymer structure enables it to bind dietary phosphorus in the gastrointestinal tract, thereby reducing phosphate absorption and promoting better patient outcomes.


Adherence to Quality Standards

Our Sevelamer HCl meets stringent quality and safety benchmarks, including compliance with microbial, related substance, and residual solvent standards. Rigorous testing ensures that each batch is consistent, safe, and effective, meeting expectations set by international pharmacopoeia and ICH guidelines.

FAQ's of sevelamer hcl:


Q: How should Sevelamer HCl be stored and handled?

A: Sevelamer HCl should be stored in its original HDPE drum with the inner poly liner intact, in a cool, dry place away from direct sunlight. This packaging ensures the product's stability and prevents contamination or moisture exposure.

Q: What are the main benefits of using Sevelamer HCl for patients?

A: Sevelamer HCl effectively lowers serum phosphorus without being absorbed into the bloodstream. This can help patients with chronic kidney disease manage phosphate levels, minimizing the risk of complications such as hyperphosphatemia.

Q: When should Sevelamer HCl be administered for optimal effectiveness?

A: It is typically administered with meals to maximize its phosphate-binding effects in the gastrointestinal tract. Medical professionals will determine the precise timing and dosage based on individual patient needs.

Q: Where is Sevelamer HCl most commonly used?

A: Sevelamer HCl is primarily used in hospital settings, dialysis centers, and clinics that manage patients with renal failure or chronic kidney disease who require phosphate control.

Q: What processes ensure Sevelamer HCl meets quality standards?

A: The product undergoes thorough testing for water content, chloride presence, endotoxin levels, and bulk density. It also complies with pharmacopoeia standards for microbial limits, related substances, and ICH guidelines for residual solvents, ensuring safety and consistency.

Q: How does Sevelamer HCl help in managing phosphate levels?

A: Sevelamer HCl binds dietary phosphate in the digestive tract, preventing its absorption. This phosphate binding process aids in maintaining appropriate phosphate levels in patients with compromised kidney function.

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