D(-)-Mannitol 98.0-101.0% (by HPLC on dried basis), EMPROVE® ESSENTIAL USP, JP, Ph. Eur., BP, E421 suitable for use as excipient, SAFC®

Supplier: MERCK PRODUCTION CHEMICALS

Certificates

Supplier: MERCK PRODUCTION CHEMICALS

About this item

Synonyms: Mannitol, (2R,3R,4R,5R)-Hexane-1,2,3,4,5,6-hexaol

CAS Number:69-65-8

Formula:HOH₂C(CH(OH))₄CH₂OH

MDL Number:MFCD00064287

:182.17 g/mol

Merck Index:13,05769

Boiling Pt:290…295 °C (4 hPa)

Melting Pt:164…169 °C

Density:1.49 g/cm³ (20 °C)

Storage Temperature:Kamertemperatuur

EINECS:200-711-8

Specifications

Environmentally Preferable:

Specifications

Specification Test Results

Assay (HPLC, calc. on dried substance):
98.0 - 101.0 %
Identity (NIR):
passes test
Identity (IR-spectrum):
passes test
Identity (wet chemistry):
passes test
Appearance of solution (13 %; water):
passes test
Free acid:
passes test
pH-value (10 %; water):
4.5 - 7.5
Melting point:
166 - 169
Spec. rotation (α 25/D; 1 %; molybdate complex, calc. on anhydrous substance):
137 - 145 °
Conductivity (25°C) (20 %; water):
≤ 20
Arsenic (As):
≤ 2
Ni (Nickel) (#):
≤ 1
Pb (Lead):
≤ 0.5
Chloride (Cl):
≤ 0.003 %
Sulfate (SO₄):
≤ 0.01 %
Heavy metals (as Pb):
≤ 5 ppm
Oxalate (C₂O₄):
≤ 0.02 %
Related substances (HPLC) (Sorbitol (Impurity A)):
≤ 2.0 %
Related substances (HPLC) (Sum of Maltitol and Isomalt (Impurities B and C)):
≤ 2.0
Related substances (HPLC) (Major unspecified impurity):
≤ 0.10 %
Residual solvents (ICH Q3C):
excluded by manufacturing process
Related substances (HPLC) (Sum of all impurities):
≤ 2.0 %
Reducing sugars after hydrolysis/total sugar (as glucose):
≤ 1
Reducing sugars (as glucose):
≤ 0.05
Sulfated ash:
≤ 0.1
Loss on Drying (105 °C):
≤ 0.30 %
Water:
≤ 0.5 %
Particle size (< 53 µm):
≤ 15 %
Particle size (> 500 µm):
≤ 15 %
Microbiological test:
passes test
Colony count (aerobic bacteria (TAMC)):
≤ 10³
Colony count (Yeasts and moulds (TYMC)):
≤ 10²
Salmonella spp.:
in 10 g Substance not detectable
E.coli:
in 1 g Substance not detectable
Staphylococcus aureus:
in 1g Substance not detectable
Pseudomonas aeruginosa:
in 1g Substance not detectable
Candida albicans:
In 1g Substance not detectable