Tris(Hydroxymethyl) Aminomethane 1Kg
suitable for biopharmaceutical production EMPROVE® bio
Manufacturer: Merck
Catalog ID: 108219.1000
Stock: In Stock
Description
| Catalogue Number | 108219 |
| Synonyms | Trometamol, Aminomethylidine trimethanol, 2-Amino-2-hydroxymethyl-1.3-propanediol, TRIS-buffer |
| Description | Tris(hydroxymethyl)aminomethane hydrochloride |
Product Information
| CAS number | 1185-53-1 |
| EC number | 214-684-5 |
| Hill Formula | C₄H₁₂ClNO₃ |
| Chemical formula | C₄H₁₁NO₃*ClH |
| Molar Mass | 157.60 g/mol |
| HS Code | 2922 19 00 |
Physicochemical Information
| Density | 1.28 g/cm3 (20.2 °C) |
| Melting Point | 150.7 °C |
| pH value | 4.2 (100 g/l, H₂O, 20 °C) |
| Vapor pressure | <1 Pa (50 °C) |
| Solubility | 561 g/l soluble |
Storage and Shipping Information
| Storage | Store at +15°C to +25°C. |
Specifications
| Appearance (color) | white to almost white |
| Appearance (description) | crystalline powder |
| Assay (Perchloric acid titration, calc. on anhydrous substance) | ≥ 99.0 % |
| Identity (IR-spectrum) | conforms |
| pH-value (0.5 mol/l, water) | 3.5 - 5.0 |
| Melting range | 147 - 153 °C |
| UV-Absorption (230 nm; 10 %; 1 cm; water) | ≤ 0.1 |
| UV-Absorption (260 nm; 10 %, 1 cm; water) | ≤ 0.06 |
| UV-Absorption (280 nm; 10 %; 1 cm; water) | ≤ 0.06 |
| UV-Absorption (300 nm; 10 %; 1 cm; water) | ≤ 0.02 |
| UV-Absorption (400 nm; 10 %; 1 cm; water) | ≤ 0.01 |
| As (Arsenic) | ≤ 0.0001 % |
| Ca (Calcium) | ≤ 0.0010 % |
| Cd (Cadmium) | ≤ 0.0001 % |
| Cu (Copper) | ≤ 0.0001 % |
| Fe (Iron) | ≤ 0.0001 % |
| Mg (Magnesium) | ≤ 0.0010 % |
| Ni (Nickel) | ≤ 0.00025 % |
| Pb (Lead) | ≤ 0.0001 % |
| Zn (Zinc) | ≤ 0.0002 % |
| Residual solvents (ICHQ3C) of class 2 (Methanol) | ≤ 3000 ppm |
| Residual solvents (ICHQ3C) of class 2 (Nitromethane) | ≤ 50 ppm |
| Residual solvents (ICHQ3C) of class 3 (Ethanol) | ≤ 5000 ppm |
| Residual solvents (ICHQ3C) of class 3 (Ethylmethylketon) | ≤ 5000 ppm |
| Other residual solvents (ICH Q3C) | excluded by manufacturing process |
| Sulfated ash | ≤ 0.03 |
| Loss on Drying (105°C) | ≤ 0.5 |
| Water (according to Karl Fischer) | ≤ 0.5 |
| Endotoxins | < 2.5 |
| Total aerobic microbial count | ≤ 10² |
| Total yeast and mould count | ≤ 10² |
| Salmonella spp. | absent in 10 g |
| E.coli | absent in 1 g |
| Staphylococcus aureus | absent in 1 g |
| Pseudomonas aeruginosa | absent in 1 g |
| Candida albicans | absent in 1 g |
| Bile tolerante gram negative bacteria | absent in 1 g |
| DNases (Exo- and endonucleases) | not detected |
| Proteases | not detected |
| RNases | not detected |
| Elemental impurity specifications have been set considering ICH Q3D (Guideline for Elemental Impurities). Class 1-3 elements are not likely to be present above the ICH Q3D option 1 limit, unless specified and indicated (*). |
