DI CALCIUM PHOSPHATE DIHYDRATE IP/BP/USP
| Total Aerobic microbial count Total yeast and mold count Escherichia Coli Salmonella | In House | Cfu/gm Cfu/gm Absent/g Absent/g | — — — — | 1,000 100 Absent/g Absent/g | Complies Complies Complies Complies | |
| Pathogens | Absent | — | Absent | Complies | ||
| O V I (ORGANIC VOLATILE IMPURITES) | Meets the requirement | — | Meets | Complies | ||
| B S E / TSE | Absent | — | Absent | Complies |
DI CALCIUM PHOSPHATE ANHYDROUS IP/BP/USP
| Total Aerobic microbial count Total yeast and mold count Escherichia Coli Salmonella | In House | Cfu/gm Cfu/gm Absent/g Absent/g | 1,000 100 Absent/g Absent/g | Complies Complies Complies Complies |
TRI CALCIUM PHOSPHATE IP/BP/USP
| TESTS | RESULTS | SPECIFICATION |
| Description | Complies | White crystalline powder about loss |
| Solubility | Complies | Complies as IP |
| Identification | Complies | AB) Complies as I.P |
| Acid in soluble Substance | Complies | N.M.T. 0.1% |
| Arsenic | 2 PPM | 5 ppm Max |
| Heavy Metals | 21 ppm | 40 ppm max |
| Barium | Complies | To pass test |
| Iron | 112 ppm | 200 ppm max |
| Carbonate | Complies | To pass test |
| Chloride | 300 ppm | 500 ppm Max |
| Sulphate | 0.2 ppm | 0.6% Max |
| Nitrate | Complies | To pass test |
| Reducing Substance | Complies | To pass test |
| Proteinous impurities | Complies | To pass test |
| Loss in ignition | 1.2% | N.M.T 8% |
| MONO calcium And Tri calcium Phosphate | Complies | To Pass test limit 0.5% |
| Tri Calcium Phosphate | Complies | |
| Water Soluble | Complies | |
| Substances | Complies | |
| Assay | 100.75% | 90% to 100.5% |
CALCIUM HYDROGEN PHOSPAHTE DIHYDRATE IP/BP/USP
| Total Aerobic microbial count Total yeast and mold count Escherichia Coli Salmonella | In House | Cfu/gm Cfu/gm Absent/g Absent/g | — — — — | 1,000 100 Absent/g Absent/g | Complies Complies Complies Complies |
CALCIUM HYDROGEN PHOSPAHTE DIHYDRATE IP/BP/USP
| Total Aerobic microbial count Total yeast and mold count Escherichia Coli Salmonella | In House | Cfu/gm Cfu/gm Absent/g Absent/g | — — — — | 1,000 100 Absent/g Absent/g | Complies Complies Complies Complies |
CALCIUM CARBONATE IP/BP/USP
| Properties | Specification | Result |
| Description | Fine, white, or colorless, microcrystalline powder. | Complies |
| Solubility | Practically insoluble in water and in ethanol (95%). It is soluble with effervescence in dilute acids. | Complies |
| Foreign Particles | Free from any foreign particle. | Complies |
| Identification | Test A: The sample dissolves with effervescence in each case. Test B (Calcium): Each solution passes tests. | Complies Complies |
| Acid Insoluble Substance | Not more than 0.2%. | 0.1% |
| Inorganic Impurities | Arsenic: Not more than 3 mg/kg Fluoride: Not more than 0.005%. Lead: note more than 3 mg/kg. | 2.5 mg/kg 0.003% 2.7 mg/kg |
| Magnesium & Alkali Metals | Residue not more than 1%. | 0.8% |
| Loss on Drying (200OC for 4 hrs.) | Not more than 2.0%. | 1.6% |
| % Assay as (CaCO3) | 98.0% to 100.5% of CaCO3, on dried basis | 99.5 |
| Particle Size | 100% passes through 80# | Complies |
| Additional Test | ||
| Bulk Density | 0.700 to 0.900 gm/ml | 0.850 gm/ml |
| Tapped Density | 0.900 to 1.400 gm/ml | 0.990 gm/ml |
CALCIUM CARBONATE OYSTERSHELL (JP)
| Total Aerobic microbial count Total yeast and mold count Escherichia Coli Salmonella Pseudomonas Aeruginosa Salmonella Staphylococcus aureus | 1,000 cfu/g 100 cfu/g Absent/g Absent/ 10g Absent/g Absent/g | Complies Complies Complies Complies Complies Complies |
MAGNESIUM STEARATE IP/BP
| TESTS | RESULTS | SPECIFICATION |
| Description | Complies | A Very Fine, Light, White Powder, Odorless or with a faint odor of stearic acid; unctuous and free from grittiness |
| Solubility | Complies | Practically insoluble in water, in ethanol & in ether |
| Identification: | ||
| (A) Freezing Point | 56O C | Not Less Than 53O C |
| (B)Acid Value | Complies | The Acid Value of the fatty acid is 195 to 210 |
| (C)Fatty Acid Composition | Complies | As Per IP |
| (D)Reaction on Magnesium | Complies | Solution A gives the reaction of magnesium |
| Appearance of solution | Complies | Solution A is not more intensely colored than reference solution YS6 |
| Appearance of solution of the fatty acids. | Complies | The solution is clear, and not more intensely colored than reference solution YS5 |
| Acidity of Alkalinity | 0.004 ml of 0.1 M HCI is Required | NMT 0.05 ml of 0.1M HCI or 0.1 M NaOH is required to change the color of the solution |
| Acid value of the fatty acids | 208.2 | 195 to 210 |
| Free Stearic acid | 1.41% | NMT 3 % |
| Zinc Stearate | Complies | No violet Precipitate is formed |
| Heavy Metals | Complies | Max 20 ppm |
| Chlorides | Complies | Max 250 ppm |
| Sulphates | Complies | Max 0.6% |
| Loss on Drying at 105OC,1.0 g | 2.86% | NMT 6.0% |
| Bulk Density (In House) | 0.22 g/cc | 0.15-0.3 g/cc |
| Assay | 4.75% | 3.8% -5.0% Mg on the Dried Basis |
| The Fatty acid Fraction Stearic Acid | Complies | NLT 40.0% |
| Sum of stearic acid and palmitic acid | Complies | NLT 90.0% |
| TAMC | <1000 cfu/g | Acceptance criterion 103 cfu/g |
| TYMC | <100 cfu/g | Acceptance criterion 102 cfu/g |
| Escherichia coli | Absent | Absent |
| Salmonella | Absent | Absent |
ZINC OXIDE IP/BP
| Total Aerobic microbial count Total yeast and mold count Escherichia Coli Salmonella | In House | Cfu/gm Cfu/gm Absent/g Absent/g | 1,000 100 Absent/g Absent/g | Complies Complies Complies Complies | |
| Pathogens | Absent | Absent | Complies | ||
| O V I (ORGANIC VOLATILE IMPURITES) | Meets the requirement | Meets | Complies | ||
| B S E/ TSE | Absent | Absent | Complies |
DI CALCIUM PHOSPHATE – DENTAL GRADE
| Sr.No. | Parameters | Specifications | |
| 01 | Appearance | White fine Crystalline Powder | |
| 02 | Assay | Min 98.5 % | |
| 03 | P2O5 | 40.5 – 42.0 % | |
| 04 | CaO | Min 32.0% | |
| 05 | Whiteness | Min 95.0% | |
| 06 | Particle Size (325 Mesh) | Min 99.0% | |
| 07 | Apparent Density | 0.8 -1.0 g/ml | |
| 08 | Water Absorption | 5.0 – 6.0 ml / 20g | |
| 09 | Stability | Shall Pass | |
| 10 | pH 20% w/v | 7.0 – 8.1 | |
| 11 | Loss on Ignition | 25.0 – 26.5 % | |
| 12 | Loss on Drying | Max 0.60% | |
| 13 | Heavy Metal as Pb | Max 0.002% | |
| 14 | Fluoride | Max 0.005% | |
| 15 | Chloride | Max 0.03 % | |
| 16 | Sulfate | Shall Pass | |
| 17 | Arsenic | Max 0.0002% | |
| 18 | Iron | Max 50 ppm | |
| 19 | Insoluble in HCL | Max 0.2 % | |
| 20 | Total Bacterial Count | <100 cfu / g | |
| Total Fungal Count | <10 cfu/ g |