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. |