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LC1110 Bole whitepowder low bacterial content, for internal use, suitable for use as excipient exp Ph Eur,BP |
Order number | Packaging | Quantity | Price € |
AC28110 | Fibre carton | 25 kg | inquire |
Product information | |
Grade | Ph Eur,BP |
HS Code | 2507 00 20 |
EC number | 310-194-1 |
CAS number | 1332-58-7 |
Chemical and physical data | |
Solubility | (20 °C) insoluble |
Density | 2.6 g/cm3 (20 °C) |
Bulk density | 470 kg/m3 |
pH value | 6 – 7 (50 g/l, H2O) (slurry) |
Safety information | |
RTECS | GF1670500 |
Storage class | 10 – 13 Other liquids and solids |
WGK | NWG not water endangering |
Disposal | 14 Inorganic salts: Container I. Neutral solutions of the these salts: Container D. Before placing in Container D, check the pH with pH-Universal indicator strips (Item No. 109535). |
Transport information | |
Declaration (transport by sea) IMDG-Code | No Dangerous Good |
Declaration (transport by air) IATA-DGR | No Dangerous Good |
Specifications | |
Identity | passes test |
Substances soluble in hydrochloric acid | ≤ 1 % |
Acidic or alkaline impurities | passes test |
Chloride (Cl) | ≤ 0.0250 % |
Sulphate (SO4) | ≤ 0.1 % |
Heavy metals (as lead) | ≤ 0.0025 % |
Ca (Calcium) | ≤ 0.0250 % |
Organic impurities | passes test |
Adsorption power | passes test |
Loss on ignition (600 °C) | ≤ 15 % |
Lumps | passes test |
Microbiological purity – Total aerobic microbial count (TAMC) |
≤ 1E+03 CFU/g |
– Total yeast and mould count (TYMC) | ≤ 1E+02 CFU/g |
– Bile tolerant Gram negative Bacteria (absent in 1 g) | conforms |
– Escherichia coli (absent in 1 g) | conforms |
– Pseudomonas aeruginosa (absent in 1 g) | conforms |
– Staphylococcus aureus (absent in 1 g) | conforms |
– Candida albicans (absent in 1 g) | conforms |
– Salmonella ssp (absent in 10 g) | conforms |
Swelling power | passes test |
Residual solvents (Ph. Eur./ICH) | Excluded by production process |
Residues of metal catalysts or metal reagents acc. to EMEA/C HMP/SWP/4446/2000 are not likely to be present. | |
conforms to Ph Eur, BP |