| Specifications | |
|---|---|
| Appearance | faintly yellow to light yellowish-brown granular powder |
| Identity (A: coloring) | passes test |
| Identity (B: gelatinizing property) | passes test |
| pH (10 g/l, CO₂-free water) | 3.8 - 7.6 |
| Conductivity (1.0 %, 30 °C) | ≤ 1 mS/cm |
| Sulfur dioxide (SO₂) | ≤ 50 ppm |
| Cr (Chromium) | ≤ 10 ppm |
| Fe (Iron) | ≤ 30 ppm |
| Zn (Zinc) | ≤ 30 ppm |
| Peroxide (as H₂O₂) | ≤ 10 ppm |
| Residual solvents (ICH (Q3C)) | excluded by manufacturing process |
| Bloom value (about 110) | 90 - 130 |
| Loss on drying (105 °C, 16h) | ≤ 15.0 % |
| Particle size (< 800 µm) | ≥ 99 % |
| 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 (absent in 1 g) | passes test |
| Salmonella (absent in 10 g) | passes test |
| Staphylococcus aureus (absent in 1 g) | passes test |
| Residues of metal catalysts or metal reagents acc. to EMEA/CHMP/SWP/4446/2000 are not likely to be present. |
|
| Corresponds to the Ph. Eur., BP and NF. The sulfite contentconforms to the requirements according to European directive 95/2/EC. | |
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Key Spec Table
| CAS # | EC Number | Grade Value |
|---|---|---|
| 9000-70-8 | 232-554-6 | Ph Eur,BP,NF |
| Description | |
|---|---|
| Catalogue Number | 104078 |
| Product Information | |
|---|---|
| CAS number | 9000-70-8 |
| EC number | 232-554-6 |
| Grade | Ph Eur,BP,NF |
| HS Code | 3503 00 10 |
| Applications | |
|---|---|
| Application | Gelatin powder, suitable for use as excipient EMPROVE® exp Ph Eur,BP,NF. CAS 9000-70-8, pH 3.8 - 7.6 (10 g/l, H₂O, 25 °C). MSDS and product info below. |
| Physicochemical Information | |
|---|---|
| pH value | 3.8 - 7.6 (10 g/l, H₂O, 25 °C) |
| Toxicological Information | |
|---|---|
| LD 50 oral | LD50 Rat > 5000 mg/kg |
| Safety Information according to GHS | |
|---|---|
| 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. |
| Storage and Shipping Information | |
|---|---|
| Storage | Store at +5°C to +30°C. |
| Transport Information | |
|---|---|
| Declaration (railroad and road) ADR, RID | Kein Gefahrgut |
| Declaration (transport by air) IATA-DGR | No Dangerous Good |
| Declaration (transport by sea) IMDG-Code | No Dangerous Good |
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