Benzylalkohol, EMPROVE® EXPERT NF, JP, Ph. Eur., ChP, Sigma-Aldrich®

Lieferant: Merck
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Synonyme: Benzenemethanol, Phenylmethanol, Phenylcarbinol

M-Clarity™ Qualitätsstufe = MQ500

1371201000 1371205000 1371209020
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SIAL1371201000 SIAL1371205000 SIAL1371209020
Benzylalkohol, EMPROVE® EXPERT NF, JP, Ph. Eur., ChP, Sigma-Aldrich®
Benzylalkohol

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 Emprove® Expert is an extraordinarily 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.

Formel: C₆H₅CH₂OH
Molekulargewicht: 108.14 g/mol
Siedepunkt: 203...205 °C (Lit.)
Schmelzpunkt: –16...–13 °C (Lit.)
Dichte: 1,045 g/ml (25 °C) (Lit.)
Flammpunkt: 101 °C
Lagerungstemperatur: Kühlschrank
MDL Number: MFCD00004599
CAS-Nummer: 100-51-6
EINECS: 202-859-9
Merck Index: 13,01126

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Spezifikation Testergebnisse

ASSAY (Ph.Eur/NF/JP) 98.0 - 100.5%
ASSAY BY GC (ChP) Anhydrous Basis
ID - IR (PhEur/NF/JP/ChP) Conforms to reference spectrum
APPEARANCE (PhEur/NF/JP) Clear, colourless, oily liquid
APPEARANCE – CLARITY (NF) The sample shows the same clarity as that of water, or its opalescence is not more pronounced than that of Reference suspension 1
APPEARANCE – COLOUR (NF) The sample solution has the colour of water
APPEARANCE - COLOUR (PhEur) The solution has the appearance of water and is not more intensely coloured than reference solution B9
APPEARANCE - CLARITY (PhEur) The sample shows the same clarity as that of water, or its opalescence is not more pronounced than that of Reference suspension 1
APPEARANCE - CLARITY (JP) The solution is clear and colourless
APPEARANCE - COLOUR (JP) The solution is colourless
APPEARANCE - CLARITY (ChP) Solution is clear
APPEARANCE - COLOUR (ChP) The solution is colourless
REFRACTIVE INDEX 1.538 - 1.541
BOILING RANGE (LOWER)(ChP) 203 - 206 °C
BOILING RANGE (UPPER)(ChP) 203 - 206 °C
SPECIFIC GRAVITY/REL DENSITY(Ph. Eur 1.043 - 1.049
SPECIFIC GRAVITY/REL DENSITY (ChP) 1.043 - 1.050
RELATED SUBTANCES - GC: Benzaldehyde ≤0.05%
RELATED SUBTANCES - GC: Cyclohexylmethanol ≤0.10%
RELATED SUBTANCES - GC: Individual peaks with RRT less than that of Benzyl Alcohol ≤0.02%
RELATED SUBST - GC (PhEur/JP): Individual peaks with RRT greater than that of Benzyl Alcohol ≤0.10%
RELATED SUBST - GC (USP/NF): Individual peaks with RRT greater than that of Benzyl Alcohol ≤0.05%
RELATED SUBTANCES - GC: Sum of other peaks with RRT less than that of Benzyl Alcohol ≤0.02%
RELATED SUBTANCES - GC: Sum of other peaks with RRT greater than that of Benzyl Alcohol ≤0.2%
RELATED SUBTANCES - GC: Total Impurities ≤0.37%
RELATED SUBST - GC (ChP): Total Impurities (except benzaldehyde) ≤0.01%
RELATED SUBST - GC (ChP): Total Impurities ≤0.05%
OTHER RELATED SUBSTANCES BY GC Benzene ≤0.0001%
OTHER RELATED SUBSTANCES BY GC: Benzyl Chloride ≤0.005%
OTHER RELATED SUBSTANCES BY GC: Dibenzyl Ether ≤0.05%
PEROXIDE VALUE (PhEur/NF/JP) ≤5
CHLORIDE (ChP) ≤0.003%
ACIDITY (PhEur/NF): 0.1M NaOH required to change the colour to pink ≤1 ml
ACIDITY (JP): 0.1 M sodium hydroxide required ≤1 ml
ACIDITY (ChP) ≤0.2 ml
RESIDUE ON EVAPORATION ≤0.05%
WATER CONTENT ≤0.1%
ENDOTOXINS (SAFC) ≤2.5 IU/ml
ENDOTOXINS (ChP): IU/mg. Limit of ≤0.04 set to align with ChP Chinese Language Version limit of <0.1IU/mg ≤0.04
TOTAL AEROBIC MICROBIAL COUNT ≤100 CFU/ml
TOTAL YEAST AND MOULD COUNT ≤10 CFU/ml
RESIDUAL SOLVENTS: No organic solvents are used in the process
ELEMENTAL IMPURITIES: No elemental impurities exceeded the control threshold of option 1 limit as stated in ICH Q3D


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