柠檬酸一水合物 99,5-100,5 alkalimetry on anhydrous substance, crystals, EMPROVE® EXPERT USP, JP, ACS, Ph. Eur., BP for biopharmaceutical production, SAFC®
供应商: MERCK PRODUCTION CHEMICALS
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Warning
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Synonyms:
一水柠檬酸
1.37003.5000
1.37003.9012
MERP1.37003.5000EA
0
CNY
MERP1.37003.5000
MERP1.37003.9012
柠檬酸一水合物 99,5-100,5 alkalimetry on anhydrous substance, crystals, EMPROVE® EXPERT USP, JP, ACS, Ph. Eur., BP for biopharmaceutical production, SAFC®
柠檬酸一水合物
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 (*).
Certifications: Corresponds to Ph. Eur., BP, JP, USP, ACS
分子式:
C₆H₈O₇.H₂O 分子量: 210.14 g/mol 溶点: 135…152 °C 密度: 1.552 g/cm³ (20 °C) 闪点: 173.9 °C (closed cup) 存储条件: Ambient |
MDL编号:
MFCD00149972 CAS号: 5949-29-1 EINECS: 201-069-1 Merck Index: 13,02350 |
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产品技术规格
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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