Calcium Phosphate Tribasic

(Penta calcium hydroxide tris (orthophosphate))

Direct Compression, USP/NF pharmaceutical grade

Application:  Calcium Phosphate Excipients for Tablet and Capsule Products

Calcium phosphates have been used in the pharmaceutical technology for many years. They have many physical and chemical properties that make them ideal candidates for the production of solid oral dosage forms. They are mainly used as fillers in order to bulk up formulations however, the function of calcium phosphates goes far beyond mere filler and the adequate utilization of their full functionality can support achieving the intended formulation goals. Calcium phosphates are inorganic substances of mineral origin and therefore are characterized by exceptional chemical stability. For the same reason, they are compatible with most of known drug substances. The few exceptions include indomethacin and tetracycline antibiotics which form with the calcium ions hardly absorbable complexes. Tribasic calcium phosphate (USP) shows incompatibility with the tocopheryl acetate which is related to the large number of hydroxyl groups on the surface of the substance.

Calcium phosphate based excipients possess many functional properties making them ideal candidates for direct compression process. Due to their favorable particle size and shape calcium phosphates exhibit excellent flowability. Furthermore, they enable to govern the flow pattern of poorly flowable powders, which allows for relatively easy preparation of tableting mixtures without the granulation. Very high density of calcium salts of ortho-phosphoric acid allows either using of larger amounts of excipients without increasing the size of the dosage form or decreasing it when the same quantity of excipient is used.

Typical Properties:

Formula                                                                Ca₅(PO₄)₃OH

CAS Number                                                        [12167-74-7]

Molecular Weight                                                502.3 g/mol

Assay (Purity)                                                       99.4%

Assay (Calcium)                                                   38.6%

Assay after ignition                                            102.5%

CaO                                                                        53.9% (Ca = 38.6%)

P₂O₅                                                                       40.5% (P = 17.7%)

P₂O₅ on anhydrous basis                                    41.4%

Loss on Ignition                                                   3.3 (800^oC)

pH                                                                           7.0 (10% suspension)

Aluminum                                                             < 200 ppm

Iron                                                                         < 400 ppm

Cadmium                                                               < 0.5 ppm

Lead                                                                       < 0.5 ppm

Arsenic                                                                  < 1.0 ppm

Mercury                                                                 < 1.0 ppm

Cobalt                                                                    < 5.0 ppm

Vanadium                                                             < 3.0 ppm

Nickel                                                                   < 6.0 ppm

Barium Test                                                         Passes Test

Chloride                                                                 0.01%

Fluoride                                                                 19 ppm

Sulfate                                                                   < 0.1 ppm

Nitrate Test                                                          Passes Test

Carbonate Test                                                    Passes Test

Identification Test                                                Passes Test

H₂O Soluble substances                                    0.2%

HCl insoluble Substances                                 < 0.1%

Dibasic Salt and CaO                                         14 ml

Retained on 0.045 mm (US 325 wet sieve)    3.0%

Median Particle Size (D₅₀)                                 5 microns

Bulk Density                                                         250 gm/l



Quality and Environmental Standards:           

Product is best to our knowledge is free of:   

                                                  Allergens

                                                  BSE/TSE (no material of animal origin being used)

                                                  GMO (Genetically Modified Organisms)

                                                  Residual Solvents

This product confirms to the following:                         

                                                 Halal and Kosher standards

                                                 Vegetarian and Vegan (mineral origin)

                                                 US-FDA GRAS-status: §182.1217

Packaging:              25 kg Bags

Storage: Store at room temperature in protected area in well closed containers.