Purolite C100CaMR is an Active Pharmaceutical Ingredient in bulk complying with the British and Japanese Pharmacopeia where it is listed as "Calcium Polystyrene Sulfonate". Chemically, it is a non-solvent, powdered, strong acid cation exchange resin in calcium form. Calcium Polystyrene Sulfonate is normally used to reduce serum levels of potassium and to remove excess potassium from the body in patients with hyperkalemia associated with anuria or severe oliguria. Calcium polystyrene sulfonate can also be useful to control blood potassium levels in patients requiring dialysis or in patients on regular hemodialysis therapy

Principal Applications

  • Potassium control

Advantages

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

Regulatory Approvals

  • Kosher
  • Manufactured under cGMP conditions
  • TSE/BSE/GMO free
  • Pharmacopeia compliant

Typical Packaging

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

Typical Physical & Chemical Characteristics:

Polymer Structure Crosslinked gel polystyrene
Appearance Odourless buff powder
Functional Group Sulfonic acid
Ionic Form Ca2+
iron content (max.) 100 ppm
Lead content (max.) 10 ppm
Residual potassium (max.) 0.1 %
Potassium exchange capacity 1.3 - 2 mg/ dry g (potassium form)
Microbial:bile-tolerant Gram-negative bacteria 100 CFU/g (max.)
Sodium content (dry weight) 0.1 %
pH in DI water 6 - 9.5
Assay for calcium 6.5 - 9 % (Dry basis)
Particle size 1 % max. retained on a 150 µm sieve
Loss on drying 7 %
Residual styrene 1 ppm