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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 | |