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LC2812 Gelatin(sheets) suitable for use as excipient EMPROVE exp Ph Eur,BP,NF |
| Order number | Packaging | Quantity | Price € |
| AC29812 | Fibre case | 1 kg | Inquire |
| Product information | |
| Grade | Ph Eur,BP,NF |
| HS Code | 3503 00 10 |
| EC number | 232-554-6 |
| CAS number | 9000-70-8 |
| Chemical and physical data | |
| Solubility | (20 °C) (swelling) |
| pH value | 3.8 – 7.6 (10 g/l, H2O, 25 °C) |
| Safety information | |
| Storage class | 10 – 13 Other liquids and solids |
| WGK | NWG not water endangering |
| Disposal | 3 Relatively unreactive organic reagents should be collected in container A. If halogenated, they should be collected in container B. For solid residues use container C. |
| Transport information | |
| Declaration (transport by sea) IMDG-Code | No Dangerous Good |
| Declaration (transport by air) IATA-DGR | No Dangerous Good |
| Toxicological data | |
| LD 50 oral | LD50 rat > 5000 mg/kg |
| Specifications | |
| Identity – A: coloring (Ph. Eur.) |
passes test |
| – B: gelatinizing property (Ph. Eur.) | passes test |
| – C: turbidity (NF) | passes test |
| – D: precipitate (NF) | passes test |
| Appearance | Colorless to yellowish-brownish, faint transparent plats. |
| Odor and water-insoluble substances | passes test |
| pH (10 g/l, CO2-free water) | 3.8 – 7.6 |
| Conductivity (1.0 %, 30 °C) | ≤ 1 mS/cm |
| Sulfur dioxide (SO2) | ≤ 40 ppm |
| Heavy metals (as Pb) | ≤ 10 ppm |
| As (Arsenic) | ≤ 0.8 ppm |
| Cr (Chromium) | ≤ 10.0 ppm |
| Fe (Iron) | ≤ 30.0 ppm |
| Zn (Zinc) | ≤ 30.0 ppm |
| Peroxide (as H2O2) | ≤ 10 ppm |
| Residual solvents (Ph. Eur./USP/ICH) | excluded by manufacturing process |
| Bloom value (about 200) | 160 – 240 |
| Ash (550 °C) | ≤ 2.0 % |
| Loss on drying (105 °C) | ≤ 15.0 % |
| plats | about 70 * 225 * 0.1 mm |
| Microbiological test – Total aerobic microbial count (TAMC) |
≤ 1000 CFU/g |
| – Total combined yeasts/moulds count (TYMC) | ≤ 100 CFU/g |
| – Bile-tolerant gram-negative bacteria (absent in 1 g) | passes test |
| – Candida albicans (absent in 1 g) | passes test |
| – Escherichia coli (absent in 1 g) | passes test |
| – Pseudomonas aeruginosa .br (absent in 1 g) | passes test |
| – Salmonella (absent in 10 g) | passes test |
| – Staphylococcus aureus .br (absent in 1 g) | passes test |