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tri-Sodio citrato diidrato 99.0-100.5%, granular USP, Multi-Compendial, J.T. Baker®

Fornitore: Avantor


Management of Change (MOC) category = R

CH07-20EA 0 CHF
CH07-20 CH07-05 CH07-01
tri-Sodio citrato diidrato 99.0-100.5%, granular USP, Multi-Compendial, J.T. Baker®
tri-Sodio citrato diidrato
Formula: Na₃C₆H₅O₇·2H₂O
Peso molecolare: 294,1 g/mol
Punto di fusione: 150 °C
Temperatura di stoccaggio: Ambiente
MDL Number: MFCD00150031
CAS Number: 6132-04-3
EINECS: 200-675-3

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Risultati del test di specificazione

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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