Citronensäure 99,5-100,5%, Pulver USP, Multikompendial, GMP, J.T.Baker®

Lieferant: Avantor
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Synonyme: Hydroxytricarballylic acid

0127-07EA 930.02 EUR
0127-07 0127-05
Citronensäure 99,5-100,5%, Pulver USP, Multikompendial, GMP, J.T.Baker®
Citronensäure
Formel: HOC(COOH)(CH₂COOH)₂
Molekulargewicht: 192,13 g/mol
Siedepunkt: 310 °C (1013 hPa)
Schmelzpunkt: 149…151 °C
Dichte: 1,67 g/cm³
Lagerungstemperatur: Raumtemperatur
MDL Number: MFCD00011669
CAS-Nummer: 77-92-9
EINECS: 201-069-1
REACH-Nummer: 01-2119457026-42-0000
Merck Index: 13,02350
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Spezifikation Testergebnisse

GMP Manufactured Product 99.5 - 100.5%
Meets B.P. Chemical Specifications Passes Test
Meets E.P. Chemical Specifications Passes Test
Meets J.P. Chemical Specifications Passes Test
Meets U.S.P Requirements ≤0.1%
Preserve in Tight Containers ≤0.036%
CAUTION: For Manufacturing, processing or repackaging ≤0.015%
Bulk Pharmaceutical Chemical Passes Test
USP - Assay (HOC(COOH)(CH₂COOH)₂) (anhydrous basis) 99.5 - 100.5 %
USP - Clarity of Solution Passes Test
USP - Color of Solution Passes Test
USP - Identification Passes Test
USP - Residue on Ignition ≤ 0.1 %
USP - Oxalic Acid ≤ 0.036 %
USP - Sulfate (SO₄) ≤ 0.015 %
USP - Readily Carbonizable Substances Passes Test
USP - Identification C: Water (H₂O) ≤ 1.0 %
EP/BP - Assay (HOC(COOH)(CH₂COOH)₂) (anhydrous basis) 99.5 - 100.5 %
EP/BP - Identification B Passes Test
EP/BP - Identification E Passes Test
EP/BP - Appearance of Solution Passes Test
EP/BP - Readily Carbonizable Substances Passes Test
EP/BP - Oxalic Acid ≤ 360 ppm
EP/BP - Sulfate (SO₄) ≤ 150 ppm
EP/BP - Water (H₂O) ≤ 1.0 %
EP/BP - Ash (sulfated) ≤ 0.1 %
EP/BP - Endotoxin Concentration, <0.5 IU/mg Passes Test
JP - Assay (HOC(COOH)(CH₂COOH)₂) (anhydrous basis) 99.5 - 100.5 %
JP - Clarity and Color of Solution Passes Test
JP - Identification Passes Test
JP - Sulfate (SO₄) ≤ 150 ppm
JP - Oxalic Acid ≤ 360 ppm
JP - Heavy Metals (as Pb) ≤ 10 ppm
JP - Readily Carbonizable Substances Passes Test
JP - Residue on Ignition ≤ 0.10 %
JP - Water (H₂O) ≤ 1.0 %
Total Aerobic Microbial Count, For Information Only
Total Yeasts and Molds Count, For Information Only
E. coli Negative
P. aureginosa Negative
Must be subjected to further processing during the preparation of injectable dosage forms
No Class 1,2,3 or other solvents are used or produced in the manufacturing or purification of the product.

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