tri-Sodium citrate dihydrate 99.0-100.5% (by anhydrous basis), granular USP, Multi-Compendial, J.T.Baker®
Supplier: Avantor
Management of Change (MOC) category = R
CH07-20EA
0
EUR
CH07-20
CH07-05
CH07-01
tri-Sodium citrate dihydrate 99.0-100.5% (by anhydrous basis), granular USP, Multi-Compendial, J.T.Baker®
tri-Sodium citrate dihydrate
Formula:
Na₃C₆H₅O₇·2H₂O MW: 294,1 g/mol Melting Pt: 150 °C Storage Temperature: Ambient |
MDL Number:
MFCD00150031 CAS Number: 6132-04-3 EINECS: 200-675-3 |
Specification Test Results
Meets J.P. Chemical Specifications | |
Meets E.P. Chemical Specifications | |
Meets U.S.P Requirements | |
Meets B.P. Chemical Specifications | |
Meets ChP Chemical Specifications | |
GMP Manufactured Product | |
CAUTION: For Manufacturing, processing or repackaging | |
Bulk Pharmaceutical Chemical | |
USP - Identification A | Passes Test |
USP - Identification B | Passes Test |
USP - Identification C | Passes Test |
USP - Alkalinity | Passes Test |
USP - Water (H₂O) | 10.0 - 13.0 % |
USP - Tartrate | Passes Test |
USP - Assay (C₆H₅Na₃O₇) (calculated on the anhydrous basis) | 99.0 - 100.5 % |
EP/BP - Identification A | Passes Test |
EP/BP - Identification B | Passes Test |
EP/BP - Appearance of Solution | Passes Test |
EP/BP - Acidity or Alkalinity | Passes Test |
EP/BP - Readily Carbonizable Substances | Passes Test |
EP/BP - Chloride (Cl) | ≤ 50 ppm |
EP/BP - Oxalate (C₂O₄) | ≤ 300 ppm |
EP/BP - Sulfate (SO₄) | ≤ 150 ppm |
EP/BP - Water (H₂O) | 11.0 - 13.0 % |
EP/BP - Assay (C₆H₅Na₃O₇) (calculated on the anhydrous basis) | 99.0 - 101.0 % |
EP/BP - Endotoxin Concentration (EU/g) | ≤ 2.5 |
JP - Assay (C₆H₅Na₃O₇) (calculated on the anhydrous basis) | 99.0 - 101.0 % |
JP - pH (1 in 20) | 7.5 - 8.5 |
JP - Clarity and Color of Solution | Passes Test |
JP - Chloride (Cl) | ≤ 0.015 % |
JP - Identification | Passes Test |
JP - Sulfate (SO₄) | ≤ 0.048 % |
JP - Heavy Metals (as Pb) | ≤ 10 ppm |
JP - Arsenic (As) | ≤ 2 ppm |
JP - Tartrate | Passes Test |
JP - Oxalate (C₂O₄) | Passes Test |
JP - Readily Carbonizable Substances | Passes Test |
JP - Loss on Drying at 180°C | 10.0 - 13.0 % |
Total Aerobic Microbial Count, For Information Only | |
Total Yeasts and Molds Count, For Information Only | |
E. coli | Negative |
P. aureginosa | Negative |
ChP - Assay (dried basis) | ≥ 99.0 % |
ChP - Identification | Passes Test |
ChP - Alkalinity | Passes Test |
ChP - Clarity and Color of Solution | Passes Test |
ChP - Chloride (Cl) | ≤ 0.005 % |
ChP - Sulfates (SO4) | ≤ 0.015 % |
ChP - Tartrate | Passes Test |
ChP - Readily Carbonizable Substances | Passes Test |
ChP - Loss on Drying, 180 °C | 10.0 - 13.0 % |
ChP - Calcium Salts or Oxalate | Passes Test |
ChP - Iron (Fe) | ≤ 0.001 |
ChP - Heavy Metals | ≤ 0.0005 % |
ChP - Arsenic (As) | ≤ 0.0001 % |
ChP-Bacterial Endotoxin, EU/mg | ≤ 0.25 |
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. |
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