D-(+)-Galactose ≥97.0% Ph. Eur., NF for bioprocessing, suitable for use as excipient endotoxin tested
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3441.1000EA
800
EUR
3441.1000
VWRC3441-1KG
3441.9025
3441.5000
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) Bewaar temperatuur: Kamertemperatuur |
MDL Nummer:
MFCD00151230 CAS nummer: 59-23-4 EINECS: 200-416-4 |
Specification Test Results
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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