Hydroxyethyl Starch Manufacturer & Supplier in India | Swapnroop Pharma

Swapnroop Pharma · WHO-GMP Certified · +91 87670 62101

Hydroxyethyl Starch Manufacturer & Supplier in India

Hydroxyethyl Starch (HES) is a modified starch-derived polysaccharide produced by introducing hydroxyethyl groups into starch. It is a high-molecular-weight polymer whose physicochemical and functional properties depend on its molecular weight, degree of substitution, molar substitution, molecular-weight distribution and source starch.

Hydroxyethyl Starch is primarily associated with pharmaceutical and medical applications, particularly the development and manufacture of sterile colloidal solutions. Certain HES grades have been used as plasma-volume replacement materials. Because these products are administered parenterally, the applicable grade, formulation, quality controls and regulatory requirements are especially important.

Swapnroop Pharma supplies Hydroxyethyl Starch for pharmaceutical and specialty applications according to applicable grade specifications and customer requirements. As a Hydroxyethyl Starch manufacturer and supplier in India, we support bulk requirements with appropriate quality documentation and grade-specific analytical specifications.

Hydroxyethyl Starch Overview

Hydroxyethyl Starch is a modified polysaccharide derived from starch. Chemical modification of starch with hydroxyethyl groups changes its solubility, viscosity, stability and enzymatic degradation characteristics.

HES products are commonly differentiated using parameters such as:

  • Molecular weight
  • Degree of substitution
  • Molar substitution
  • Molecular-weight distribution
  • Viscosity
  • Starch source
  • Purity
  • Moisture
  • Microbiological quality

Hydroxyethyl Starch is therefore not a single uniform low-molecular-weight chemical compound. Different grades can have significantly different molecular and functional characteristics.

Chemical & Pharmaceutical Profile

Hydroxyethyl Starch is generally supplied as a white to off-white powder or granulated material before formulation into pharmaceutical products.

As a polymeric carbohydrate derivative, it does not have one fixed molecular weight. Its molecular-weight distribution and hydroxyethyl substitution are important characteristics for defining its performance.

For pharmaceutical manufacturing, particularly for parenteral products, control of molecular characteristics, impurities, bioburden and endotoxins is essential.

Pharmaceutical Applications

Depending on the specific grade and regulatory status, Hydroxyethyl Starch can be used for:

  • Pharmaceutical formulation development
  • Parenteral formulation development
  • Colloidal solution development
  • Specialty pharmaceutical formulations
  • Polymer-based formulation research
  • Pharmaceutical research and development

Historically, certain HES formulations have been used as intravenous colloid plasma-volume expanders. However, clinical use of HES-containing products is subject to specific regulatory restrictions and safety considerations that vary by jurisdiction. The application should therefore always be linked to the approved grade and current regulatory requirements.

Hydroxyethyl Starch Quality & Analytical Testing

As a Hydroxyethyl Starch manufacturer in India, Swapnroop Pharma can supply material against an approved grade-specific specification.

Quality evaluation may include:

  • Appearance
  • Identification
  • Molecular weight
  • Molecular-weight distribution
  • Degree of substitution
  • Molar substitution
  • Viscosity
  • pH
  • Moisture / loss on drying
  • Ash / residue on ignition
  • Reducing substances
  • Inorganic impurities
  • Chloride and related inorganic impurities, where applicable
  • Elemental impurities
  • Residual solvents, where applicable
  • Microbial limits
  • Bioburden
  • Bacterial endotoxins for applicable parenteral grades
  • Particle-size characteristics

Exact numerical acceptance criteria are grade-dependent and should be taken from the approved specification and current CoA.

Hydroxyethyl Starch Manufacturer in India

Swapnroop Pharma provides Hydroxyethyl Starch manufacturing and bulk supply solutions in India for pharmaceutical and specialty requirements.

Our approach focuses on controlled processing, raw-material quality, polymer characterization, batch consistency, analytical testing and appropriate documentation.

Customers looking for a Hydroxyethyl Starch manufacturer in India, Hydroxyethyl Starch supplier in India, or bulk pharmaceutical source can source the material according to their required molecular-weight and substitution profile.

Packaging & Storage

Hydroxyethyl Starch should be packed in suitable packaging that protects the material from moisture, contamination and environmental exposure.

General storage recommendations include:

  • Store in a cool and dry place.
  • Protect from moisture.
  • Keep containers tightly closed.
  • Protect from contamination.
  • Avoid excessive heat.
  • Follow the product-specific SDS and approved storage conditions.

Additional controlled handling requirements may apply to material intended for sterile or parenteral pharmaceutical manufacturing.

Documentation

Depending on customer and regulatory requirements, documentation may include:

  • Certificate of Analysis (CoA)
  • Safety Data Sheet (SDS)
  • Product specification
  • Batch information
  • Molecular-weight characterization
  • Polymer specification
  • Packaging details
  • Regulatory documentation where applicable

Why Choose Swapnroop Pharma for Hydroxyethyl Starch?

Swapnroop Pharma supplies pharmaceutical raw materials and specialty materials for customers in India and international markets. Our Hydroxyethyl Starch manufacturing and supply approach focuses on specification compliance, polymer quality, analytical documentation, batch consistency and reliable bulk supply.

For customers searching for a Hydroxyethyl Starch manufacturer, supplier or bulk source in India, Swapnroop Pharma provides a professional sourcing option for pharmaceutical and specialty applications.

Detailed Specifications

Parameter Specification
Appearance white to off-white crystalline powder
Get Bulk Quote via WhatsApp