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.
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".
Assay (GC): 98.0 - 100.5 %
Identity (IR): conforms
Appearance of solution (nephelometric): conforms
Clarity of solution: conforms
Color of solution: 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
Emprove is a registered trademark of Merck KGaA, Darmstadt, Germany
SAFC is a registered trademark of Merck KGaA, Darmstadt, Germany