Citronsyra 99.5-100.5%, pulver USP, Multi-Compendial, GMP, J.T.Baker®
Leverantör: Avantor
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Varning
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Synonyms:
2-Hydroxypropane-1,2,3-tricarboxylic acid, Hydroxytricarballylic acid
0127-07EA
10325
SEK
0127-07
0127-05
Citronsyra 99.5-100.5%, pulver USP, Multi-Compendial, GMP, J.T.Baker®
Citronsyra
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Formel:
HOC(COOH)(CH₂COOH)₂ MW: 192,13 g/mol Kokpunkt: 310 °C (1013 hPa) Smältpunkt: 149…151 °C Densitet: 1,67 g/cm³ Storage Temperature: Omgivande |
MDL Number:
MFCD00011669 CAS nummer: 77-92-9 EINECS: 201-069-1 REACH: 01-2119457026-42-0000 Merck Index: 13,02350 |
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Specifikation testresultat
| 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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