D-(+)-Galactose ≥97.0% Ph. Eur., NF for bioprocessing, suitable for use as excipient endotoxin tested

Leverancier: VWR Chemicals

3441.1000EA 725 EUR
3441.1000 VWRUVWRB3441-1KG 3441.5000 3441.9025
D-(+)-Galactose ≥97.0% Ph. Eur., NF for bioprocessing, suitable for use as excipient endotoxin tested
D-(+)-Galactose

Appearance: White or almost white, crystalline or finely granulated powder.


Opgelet: Not for use as Active Pharmaceutical Ingredient (API).

Formule: C₆H₁₂O₆
MW: 180,16 g/mol
Kookpunt: 527 °C (1013 hPa)
Smeltpunt: 163…169 °C
Dichtheid: 1,5 g/cm³ (20 °C)
Opslagtemperatuur: Kamertemperatuur
MDL-nummer: MFCD00151230
CAS-nummer: 59-23-4
EINECS: 200-416-4
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Specificaties testresultaten

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
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
Assay (calculated on anhydrous) [NF] 98.0 - 102.0 %
Identification A Passes test NF
Identification B Passes test NF
Identification C Passes test NF
Related substances 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
Appearance of solution 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 %

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