Résultats des tests de spécification
Meets JPE Specifications |
|
GMP Manufactured Product |
|
Meets U.S.P Requirements |
|
Meets E.P. Chemical Specifications |
|
CAUTION: For Manufacturing, processing or repackaging |
|
Bulk Pharmaceutical Chemical |
|
USP - Assay (Na₂HPO₄) (dried basis) |
98.0 - 100.5 % |
USP - Identification |
Passes Test |
USP - Loss on Drying at 130°C |
≤ 5.0 % |
USP - Insoluble Substances |
≤ 0.4 % |
USP - Chloride (Cl) |
≤ 0.06 % |
USP - Sulfate (SO₄) |
≤ 0.2 % |
USP - Arsenic (As) |
≤ 16 ppm |
JPE - Assay (dried basis) |
≥ 99.0 % |
JPE - Arsenic (As) |
≤ 2 ppm |
JPE - Carbonate |
Passes Test |
JPE - Chloride (Cl) |
≤ 0.011 % |
JPE - Clarity and Color of Solution |
Passes Test |
JPE - Heavy Metals |
≤ 10 ppm |
JPE - pH (1-100) |
9.0 - 9.4 |
JPE - Sulfate (SO₄) |
≤ 0.038 % |
JPE - Loss on Drying |
≤ 2.0 % |
EP - Assay (Na₂HPO₄) (dried basis) |
98.0 - 101.0 % |
EP - Appearance of Solution |
Passes Test |
EP - Identification A |
Passes Test |
EP - Identification B |
Passes Test |
EP - Identification C |
Passes Test |
EP - Identification D |
Passes Test |
EP - Reducing Substances |
Passes Test |
EP - Chloride (Cl) |
≤ 200 ppm |
EP - Iron (Fe) |
≤ 20 ppm |
EP - Loss on Drying |
≤ 1.0 % |
EP - Monosodium Phosphate |
≤ 2.5 % |
EP - Sulfate (SO₄) |
≤ 500 ppm |
Endotoxin Concentration (EU/g) |
≤ 2.5 |
Microbial Testing – Total Aerobic Microbial Count (USP) |
≤ 10 cfu/g |
Microbial Testing – Total Yeast and Mold Count (USP) |
≤ 10 cfu/g |
Microbial Testing - Salmonella (USP) |
Negative |
Microbial Testing - Escherichia coli (USP) |
Negative |
Microbial Testing - Staphylococcus aureus (USP) |
Negative |
Microbial Testing - Pseudomonas aeruginosa (USP) |
Negative |
Microbial Testing -Bile tolerant gram-negative bacteria |
Negative |
Microbial Testing – Clostridia |
Negative |
Microbial Testing - Candida albicans |
Negative |
Trace Impurities - Cadmium (Cd) |
≤ 200 ppb |
Trace Impurities - Lead (Pb) |
≤ 500 ppb |
Trace Impurities - Arsenic (As) |
≤ 1500 ppb |
Trace Impurities - Mercury (Hg) |
≤ 300 ppb |
Trace Impurities - Cobalt (Co) |
≤ 500 ppb |
Trace Impurities - Vanadium (V) |
≤ 1000 ppb |
Trace Impurities - Nickel (Ni) |
≤ 2000 ppb |
Trace Impurities - Thallium (Tl) |
≤ 800 ppb |
Trace Impurities - Gold (Au) |
≤ 10000 ppb |
Trace Impurities - Palladium (Pd) |
≤ 1000 ppb |
Trace Impurities - Iridium (Ir) |
≤ 1000 ppb |
Trace Impurities - Osmium (Os) |
≤ 1000 ppb |
Trace Impurities - Rhodium (Rh) |
≤ 1000 ppb |
Trace Impurities - Ruthenium (Ru) |
≤ 1000 ppb |
Trace Impurities - Selenium (Se) |
≤ 8000 ppb |
Trace Impurities - Silver (Ag) |
≤ 1000 ppb |
Trace Impurities - Platinum (Pt) |
≤ 1000 ppb |
Trace Impurities - Lithium (Li) |
≤ 25000 ppb |
Trace Impurities - Antimony (Sb) |
≤ 9000 ppb |
Trace Impurities - Barium (Ba) |
≤ 70000 ppb |
Trace Impurities - Molybdenum (Mo) |
≤ 150000 ppb |
Trace Impurities - Copper (Cu) |
≤ 30000 ppb |
Trace Impurities - Tin (Sn) |
≤ 60000 ppb |
Trace Impurities - Chromium (Cr) |
≤ 110000 ppb |
No Class 1,2,3 or other solvents are used or produced in the |
|
manufacturing or purification of the product. |
|
Elemental Impurities (USP 232, EP 5.20) - Information on elemental |
|
impurities for this product is available on the associated Product |
|
Regulatory Data Sheet and elemental impurity profile report. |
|