Alcool benzylique, EMPROVE® EXPERT NF, JP, Ph. Eur., BP, qualité Spéciale suitable for use as excipient (max. 0,05% benzaldéhyde), SAFC®
Marques : MERCK PRODUCTION CHEMICALS
Ratings:
Ecrire un avis
Total Evaluation: 0
Moyenne des Notes : 0.0 sur 5
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Attention
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Synonyme(s):
Phénylcarbinol
1.00987.2500
1.00987.6025
1.00987.2500EA
522
EUR
1.00987.2500
1.00987.6025
Alcool benzylique, EMPROVE® EXPERT NF, JP, Ph. Eur., BP, qualité Spéciale suitable for use as excipient (max. 0,05% benzaldéhyde), SAFC®
Alcool benzylique
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: Conforms to Ph Eur, BP, JP, NF
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Formule:
C₆H₅CH₂OH Point d'ébullition: 205 °C (1013 hPa) Point de fusion: –15,3 °C Densité: 1,05 g/cm³ (20 °C) Point éclair: 101 °C Température de stockage: Température ambiante |
Numéro MDL:
MFCD00004599 Numéro CAS: 100-51-6 EINECS: 202-859-9 Indice Merck: 13,01126 |
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Résultats des tests de spécification
| 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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