Citronsyra monohydrat 99.5-100.5%, kristaller, EMPROVE® EXPERT Ph. Eur., BP, JP, USP, ACS, SAFC®
Leverantör: MERCK PRODUCTION CHEMICALS
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Varning
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Synonyms:
2-Hydroxypropane-1,2,3-tricarboxylic acid, Hydroxytricarballylic acid, 2-Hydroxy-1,2,3-propanetricarboxilic acid
1.37003.5000
1.37003.9012
1.37003.9029
1.37003.5000EA
9625
SEK
1.37003.5000
1.37003.9012
1.37003.9029
Citronsyra monohydrat 99.5-100.5%, kristaller, EMPROVE® EXPERT Ph. Eur., BP, JP, USP, ACS, SAFC®
Citronsyra monohydrat
Elemental impurity specifications have been set considering ICH Q3D (Guideline for Elemental Impurities). Class 1-3 elements are not likely to be present above the ICH Q3D option 1 limit, unless specified and indicated (*).
Certifikat: Corresponds to Ph. Eur., BP, JP, USP, ACS
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Formel:
C₆H₈O₇.H₂O MW: 210,14 g/mol Smältpunkt: 135…152 °C Densitet: 1,552 g/cm³ (20 °C) Flampunkt: 173,9 °C (closed cup) Storage Temperature: Omgivande |
MDL Number:
MFCD00149972 CAS nummer: 5949-29-1 EINECS: 201-069-1 Merck Index: 13,02350 |
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Specifikation testresultat
| Assay (alkalimetric, calculated on anhydrous substance) | 99.5 - 100.5 % |
| Identity (IR-spectrum) | passes test |
| Appearance | white to almost white or colorless crystals |
| Appearance of solution (200 g/l; water) | clear (≤ 3 NTU) and not more intense in color than reference solution Y₇, BY₇ or GY₇ |
| In water insoluble matter # | ≤ 0.005 % |
| Chlorid (Cl) # | ≤ 0.001 % |
| Phosphat (PO4) # | ≤ 0.001 % |
| Sulfate (SO₄) | ≤ 20 ppm |
| Heavy metals (as Pb) | ≤ 10 ppm |
| Al (Aluminium) | ≤ 0.2 ppm |
| Fe (Iron) # | ≤ 3 ppm |
| Pb (Lead) # | ≤ 2 ppm |
| Oxalates (as C₂H₂O₄) | ≤ 360 ppm |
| Residual solvents (ICH (Q3C)) | excluded by manufacturing process |
| Readily carbonisable substance | passes test |
| Sulfated ash (600 °C) | ≤ 0.02 % |
| Water (according to Karl Fischer) | 7.5 - 9.0 % |
| Total aerobic microbial count (TAMC) | ≤ 100 CFU/g |
| Total combined yeasts/moulds count (TYMC) | ≤ 10 CFU/g |
| Bile-tolerant gram-negative bacteria (absent in 1 g) | passes test |
| Candida albicans (absent in 1 g) | passes test |
| Escherichia coli (absent in 1 g) | passes test |
| Pseudomonas aeruginosa (absent in 1 g) | passes test |
| Salmonella (absent in 10 g) | passes test |
| Staphylococcus aureus (absent in 1 g) | passes test |
| Bacterial endotoxins | < 10 |
| # Additional requirements by ACS |
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