1.00987

SAFC

Benzyl alcohol

special grade (benzaldehyde ≤ 0.05%) EMPROVE® EXPERT Ph Eur,BP,JP,NF

Synonym(s):
Benzenemethanol
Linear Formula:
C6H5CH2OH
CAS Number:
Molecular Weight:
108.14
Beilstein/REAXYS Number:
878307
MDL number:
EC Index Number:
202-859-9
Pricing and availability is not currently available.

storage conditions

Store at +2°C to +25°C.

Quality Level

Agency/Method

BP
JP
NF
Ph. Eur.

vapor density

3.7 (vs air)

vapor pressure

0.07 hPa ( 20 °C)
13.3 mmHg ( 100 °C)
3.75 mmHg ( 77 °C)

product line

EMPROVE® Expert

assay

98.0-100.5% (GC)

form

liquid

autoignition temp.

435 °C (DIN 51794)
817 °F

potency

1620 mg/kg LD50, oral (Rat)

refractive index

n20/D 1.539 (lit.)

bp

203-205 °C (lit.)

mp

−16-−13 °C (lit.)

transition temp

flash point 101 °C (DIN 51758)

density

1.045 g/mL at 25 °C (lit.)

SMILES string

OCc1ccccc1

InChI

1S/C7H8O/c8-6-7-4-2-1-3-5-7/h1-5,8H,6H2

InChI key

WVDDGKGOMKODPV-UHFFFAOYSA-N

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General description

Finding the right excipient that matches your needs as well as regulatory demands can be a complicated challenge in formulation. With our application know-how and regulatory expertise, we support you in every step of development, scale-up, and production.As part of our Emprove® Program, our raw materials are offered with extensive documentation facilitating compliance of your pharma and biopharma product, full supply chain transparency and risk mitigation. Our SAFC® portfolio of high-quality products for biopharmaceutical and pharmaceutical formulation and production withstands strict quality control procedures and is produced according to applicable cGMP guidelines.

Application

Benzyl alcohol is typically used as a preservative in liquid formulations and is active against bacteria, yeast and mould. It can also serve as a solvent for poorly soluble drugs.

Benzyl Alcohol Special Grade Emprove® EXPERT is an extraordinary pure product with impurity specification thresholds even below current requirements of designated pharmacopoeias (e.g. benzaldehyde content < 0.05%). Therefore, this product is especially suitable for high-risk applications or any other purpose that requires superior quality.

The specification of the product is part of the Emprove® Material Qualification Dossier and can be found under "General Properties".

Analysis Note

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
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 (*).
Conforms to Ph Eur, BP, JP, NF

Legal Information

Emprove is a registered trademark of Merck KGaA, Darmstadt, Germany
SAFC is a registered trademark of Merck KGaA, Darmstadt, Germany

What is the Emprove® Program?

The Emprove® Program is a system providing comprehensive and thorough documentation of our filters and single-use components, pharma raw materials, and starting materials.

Material Qualification Dossier

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Quality Management Dossier

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Operational Excellence Dossier

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Learn more about the benefits an Emprove® Program subscription can provide
Why are these documents unavailable?
Emprove® Dossiers contain information intended to support the registration process and risk assessment activities of pharmaceutical producers and contain confidential information. Please contact us if you would like access.

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