Calcium Polystyrene
Sulphonate (BP/JP)
About Calcium Polystyrene Sulfonate
Usage
Calcium Polystyrene Sulfonate is an API that is mainly recommended for treatment of hyperkalaemia, a condition where patients who have too much potassium in their blood. It works by removing extra potassium to bring it back to normal levels. It is often given to people who have kidney problems and people on dialysis.
Administration
Calcium Polystyrene Sulfonate is usually consumed in a powered form with water or milk. It is generally administered orally, however in patients having gastrointestinal problems or vomiting sensation, it can be administered rectally also.
Technical Specifications
Doshion Manufactures 2 types of Calcium Polystyrene Sulfonate alternatives:
BP Grade
JP Grade
| Parameter | : | BP Grade | JP Grade |
| Appearance | : | A cream coloured fine powder, free from any foreign particles. | A cream coloured fine powder, free from any foreign particles. |
| Identification | : | Infrared absorption spectrum when compared with reference spectrum, same strong absorption confirmed and same wavelength. Confirms to qualitative reaction of calcium salt. | Infrared absorption spectrum when compared with reference spectrum, same strong absorption confirmed and same wavelength. Confirms to qualitative reaction of calcium salt. |
| Odour | : | No specific odour | No specific odour |
| Ionic Form | : | Calcium (Ca++) | Calcium (Ca++) |
| Assay for Calcium | : | Contains not less than 6.5% w/w and not more than 9.5% w/w of calcium | Contains not less than 7.0% w/w and not more than 9.0% w/w of calcium |
| Functional Group | : | - SO3– (Sulphonic) | - SO3– (Sulphonic) |
| Heavy Metal Content as Pb | : | NMT 10 ppm | NMT 10 ppm |
| Arsenic as As | : | Max 1 ppm | Max 2 ppm |
| Ammonium Content | NA | Red Litmus paper does not change to blue | |
| Loss on Drying | : | NMT 8% w/w | NMT 10% w/w |
| Particle Size | : | NMT 1 % retained on 150 µm sieve (100 BS) | NMT 1 % retained on 150 µm sieve (100 BS) |
| Micro Particles | NA | < 0.1 % | |
| Sodium Contents | : | NMT 0.1% | NMT 1.0% |
| Potassium Content | : | NMT 0.1% | NMT 0.1% |
| Potassium exchange capacity | : | Each gram exchanges NLT 1.3 mEq and NMT 2.0 mEq of potassium calculated on dried basis. | 0.053 – 0.071 gm/ gm |
| Solubility | : | Practically insoluble in water and in ethanol (96%) | Practically insoluble in water and in ethanol (96%) |
| Styrene | : | NMT 1 ppm | NMT 1 ppm |
| CAS Number | : | 37286-92-3 | 37286-92-3 |
| Molecular Formula | : | (C8H8O3S)n.nCa | (C8H8O3S)n.nCa |
Unique Features of Doshion P 548 (Calcium Polystyerene Solfonate):
Doshion P 548 complies with all the specifications of Calcium Polystyrene Sulphonate as per BP and JP Grades.
Bright color, near to white powder form material, free from any foreign matter and black particles.
Particle size is perfectly controlled as per specifications. Bulk density is also controlled to avoid floating of API during water dispersion to get uniform dispersion in water.
Meets the stringent specifications of residual solvent (EDC) and residual monomer (Styrene) as per guidelines.
Doshion’s Calcium Polystyrene Sulfonate has an earthy taste which is easier to swallow as compared to other products which might have a sour taste
Ready Stock availability with quick dispatch.
Documents Available:
DMF
CoA
MSDS
GMP Certification
Halal Certification
ISO Certification
Declarations Available:
GMO Free Declaration
TSE/BSE Certificate
Allergen Certificate
Radioactive Free Declaration
Viral Free Declaration
Gluten free Declaration
Nitrosamine free Declaration
Elemental free Declarations
Genotoxic Impurities free declaration in QSAR format
Other Important Resources
Pharma Product Docket
Monograph of Doshion P 548