| Food GMP Manufactured Product |
| GMP Manufactured Product |
| Meets B.P. Chemical Specifications |
| Meets E.P. Chemical Specifications |
| Meets F.C.C. Requirements |
| Meets J.P. Chemical Specifications |
| Meets U.S.P Requirements |
| CAUTION: For Manufacturing, processing or repackaging |
| Bulk Food Chemical |
| Bulk Pharmaceutical Chemical |
| USP - Assay (CaCl2 2H2O) | 99.0 - 107.0% |
| USP - Identification A | Passes Test |
| USP - Identification B | Passes Test |
| USP - pH of 5% Solution at 25°C | 4.5 - 9.2 |
| USP - Heavy Metals (as Pb) | <= 0.001 % |
| USP - Iron, Aluminum, and Phosphate | Passes Test |
| USP - Magnesium and Alkali Salts | <= 1.0 % |
| USP - Aluminum (Al)(µg/g) | <= 1 |
| Endotoxin Concentration (EU/g) | <= 10 |
| FCC - Assay (CaCl2 2H2O) | 99.0 - 107.0% |
| FCC - Identification A | Passes Test |
| FCC - Identification B | Passes Test |
| FCC - Arsenic (As) | <= 3 mg/kg |
| FCC - Magnesium and Alkali Salts | <= 1.0% |
| FCC - Lead (Pb) | <= 5 mg/kg |
| FCC - Fluoride (F) | <= 0.004% |
| Appearance (White crystals or granules) | Passes Test |
| EP/BP - Assay (CaCl2 2H2O) | 97.0 - 103.0% |
| EP/BP - Identification A | Passes Test |
| EP/BP - Identification B | Passes Test |
| EP/BP - Identification C | Passes Test |
| EP/BP - Appearance of Solution | Passes Test |
| EP/BP - Acidity or Alkalinity | Passes Test |
| EP/BP - Sulfate (SO4) | <= 300 ppm |
| EP/BP - Aluminum (Al) | Passes Test |
| EP/BP - Barium (Ba) | Passes Test |
| EP/BP - Heavy Metals (as Pb) | <= 20 ppm |
| EP/BP - Iron (Fe) | <= 10 ppm |
| EP/BP - Magnesium and Alkali Metals | <= 0.5% |
| JP - Assay (CaCl2 2H2O) | 96.7 - 103.3% |
| JP - Identification | Passes Test |
| JP - pH (1 in 20) | 4.5 - 9.2 |
| JP - Heavy Metals (as Pb) | <= 10 ppm |
| JP - Clarity and Color of Solution | Passes Test |
| JP - Sulfate (SO4) | <= 0.024% |
| JP - Hypochlorite | Passes Test |
| JP - Iron, Aluminum or Phosphate | Passes Test |
| JP - Barium (Ba) | Passes Test |
| JP - Arsenic (As) | <= 2 ppm |
| Appearance (white hygroscopic pellets) |
| No Class 1,2,3 or other solvents are used or produced in the manufacturing or purification of the product. |
| Metallic Residues: No metal catalysts or metal reagents, as defined by EMA Guideline EMEA/CHMP/SWP/4446/2000 , are used in the production of this material. |