Alcol benzilico, EMPROVE® EXPERT Ph. Eur., BP, JP, NF, qualità speciale (max. 0,05% aldeide benzoica), SAFC®
Fornitore: MERCK PRODUCTION CHEMICALS
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Attenzione
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Synonyms:
Benzenemethanol, Phenylmethanol, Phenylcarbinol
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 (*).
Certificazioni: Conforms to Ph Eur, BP, JP, NF
Formula:
C₆H₅CH₂OH Peso molecolare: 108,14 g/mol Punto di ebollizione: 205 °C (1013 hPa) Punto di fusione: –15,3 °C Densità: 1,05 g/cm³ (20 °C) Flash Pt: 101 °C Temperatura di stoccaggio: Ambiente |
MDL Number:
MFCD00004599 CAS Number: 100-51-6 EINECS: 202-859-9 Merck Index: 13,01126 |
Risultati del test di specificazione
Assay (GC) | 98.0 - 100.5 % |
Identity (IR) | conforms |
Appearance of solution (nephelometric) | conforms |
Clarity of solution | conforms |
Color of solution | conforms |
Acidity | conforms |
Refractive index (n 20/D) | 1.538 - 1.541 |
Density (d 20 °C/20 °C) | 1.043 - 1.049 |
Peroxide value | ≤ 5.0 |
Related substances (GC) (Benzaldehyde (Impurity A)) | ≤ 0.05 % |
Related substances (GC) (Cyclohexylmethanol (Impurity B)) | ≤ 0.10 % |
Related substances (GC) (Sum of peaks with a relative retention less than that of benzyl alcohol) | ≤ 0.02 % |
Related substances (GC) (Sum of peaks with a relative retention greater than that of benzyl alcohol) | ≤ 0.20 % |
Related substances (GC) (disregard limit) | ≤ 0.0001 % |
Benzene (GC) | ≤ 0.0002 % |
Chlorobenzene (GC) | ≤ 0.01 % |
Toluene (GC) | ≤ 0.01 % |
Other residual solvents (ICH Q3C) | excluded by manufacturing process |
Evaporation residue | ≤ 0.050 % |
Water | ≤ 0.1 % |
Bacterial endotoxins | ≤ 2.5 I.U./ml |
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 |
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