D-(+)-Galactose ≥97.0% NF, Ph. Eur. for bioprocessing, suitable for use as excipient endotoxin tested
VWRC3441-1KG
:
- Pack type:Plastic container
- Pk:1 kg
- Seq:4024
- Environmentally Preferable:
- Appearance:Conforms (see CoA/CoS)
- Bacterial endotoxins:Max. 10 EU/g
- Residual solvents:Passes test
- Conforms to Ph.Eur./NF:Passes test
- Ph.Eur. specifications:Passes test NF
- Assay (calculated on anhydrous)[Ph.Eur.]:97.0 - 102.0 %
- Identification A:Passes test Ph.Eur.
- Appearance of solution:Passes test Ph.Eur.
- Acidity or alkalinity:Passes test Ph.Eur.
- Proteins [Ph.Eur.]:≤ 0.1 mg/ml
- Related substances:Passes test Ph.Eur.
- Sum of impurties A and B [Ph.Eur.]:≤ 1.0 %
- Unspecified impurities [Ph.Eur.]:≤ 0.3 %
- Total impurities [Ph.Eur.]:≤ 2.0 %
- Reporting threshold [Ph.Eur.]:≤ 0.2 %
- Water [Ph.Eur.]:≤ 1.0 %
- Sulphated ash [Ph.Eur.]:≤ 0.1 %
- Microbial contamination (TAMC) [Ph.Eur.]:Max. 10² CFU/g
- NF specifications:Max. 0.1 %
- Assay (calculated on anhydrous) [NF]:98.0 - 102.0 %
- Identification B:Passes test NF
- Identification C:Passes test NF
- Lactose and 1,6-galactosylgalactose [NF]:≤ 0.6 %
- Galacturonic acid [NF]:≤ 0.6 %
- Dextrose [NF]:≤ 0.6 %
- Tagatose [NF]:≤ 0.6 %
- Dulcitol [NF]:≤ 0.6 %
- Arabinose [NF]:≤ 0.6 %
- Any unspecified impurity [NF]:≤ 0.2 %
- Total impurities [NF]:≤ 1.0 %
- Residue on ignition [NF]:≤ 0.1 %
- Limit of lead [NF]:≤ 0.5 μg/g
- Ba (Barium):Passes test NF
- Microbial enumeration (TAMC) [NF]:Max. 10³ CFU/g
- Microbial enumeration (TYMC) [NF]:Max. 10² CFU/g
- Salmonella [NF]:Absent
- Escherichia coli [NF]:Absent
- Staphylococcus aureus [NF]:Absent
- Pseudomonas aeruginosa [NF]:Absent
- Spec.opt.rot.(20°C)(on anhydrous) [NF]:78.0 - 81.5 °
- Acidity:Passes test NF
- Water determination [NF]:≤ 1.0 %
: D-Galactose, (2R,3S,4S,5R)-2,3,4,5,6-Pentahydroxyhexanal, (2R,3S,4S,5R)-Pentahydroxyhexanal
:
:180.16 g/mol
:13,04356
:527 °C (1013 hPa)
:163…169 °C
:1.5 g/cm³ (20 °C)
:Ambient
:200-416-4
:59-23-4
:C₆H₁₂O₆
:MFCD00151230