Benzyl alcohol, EMPROVE® EXPERT NF, JP, Ph. Eur., BP, special quality suitable for use as excipient (max. 0.05% benzaldehyde), SAFC®

Synonyms: Benzenemethanol, Phenylmethanol, Phenylcarbinol

CAS Number:100-51-6

Formula:C₆H₅CH₂OH

MDL Number:MFCD00004599

:108.14 g/mol

Merck Index:13,01126

Boiling Pt:205 °C (1013 hPa)

Melting Pt:–15,3 °C

Density:1,05 g/cm³ (20 °C)

Flash Pt:101 °C

EINECS:202-859-9

:GHS07

Storage Temperature:Ambient

Specifications

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