Purolite A430MR is Cholestyramine, a strong base type I anion exchange resin powder with a polystyrene matrix and quaternary ammonium functional groups. This is a pharmaceutical grade product which is an active drug for the treatment of a specific medical condition. The normal function of bile salts, secreted by the gall bladder into the intestines, is to emulsify fats and other lipids in order to promote their enzymatic hydrolysis and thereby enable transfer to the liver, via the venous circulation or the portal system. The bile salts, mainly sodium glycocholate, with smaller amounts of sodium taurocholate, act as surfactants by virtue of their dual lipophile/hydrophile character. In obstructive jaundice, an excess of these materials is present in the gastro-intestinal tract, increasing the concentration of cholesterol in the bloodstream, with accompanying hazard to the cardio-vascular system. Here and in other conditions of high blood cholesterol, it has been found that oral administration of Cholestyramine, which has a high affinity for the glycocholate and taurocholate ions is effective in reducing the blood cholesterol level. Purolite A430MR fully complies with the U.S. Pharmacopeia where it is listed under the name Cholestyramine. This product is registered with the Food and Drug Administration and has an up to date Drug Master File with the FDA .

Principal Applications

  • Cholesterol control

Advantages

  • Excellent chemical and physical stability
  • Secure, validated supply and regulatory support

Regulatory Approvals

  • Kosher
  • Manufactured under cGMP conditions
  • TSE/BSE/GMO free
  • Compliant with FDA regulation 21 CFR 173.28
  • Pharmacopeia compliant

Typical Packaging

  • Medium drum (fiber)
  • Large drum (fiber)

Typical Physical & Chemical Characteristics:

Polymer Structure Crosslinked gel polystyrene
Appearance Off white powder
Functional Group Type I Quaternary Ammonium
Ionic Form Cl-
Moisture Content (max.) 12 %
Others (Staphylococcus aureus, Pseudomonas aeruginosa, Enterobacteria) ND
Impurities Heavy Metals (max.) 20 ppm
Total Aerobes <1000 cfu/g
Total Moulds <100 cfu/g
Total Yeasts <100 cfu/g
Mean Size Typical <150 µm