PARTECH LUB Talc 25KG
suitable for use as excipient EMPROVE® exp Ph Eur,BP,JP,USP
Manufacturer: Merck
Catalog ID: 108070.9025
Stock: In Stock
Description
| Catalogue Number | 108070 |
| Synonyms | Soapstone, Talcum venetum |
| Description | PARTECK® LUB Talc |
Product Information
| CAS number | 14807-96-6 |
| EC number | 238-877-9 |
| Grade | Ph Eur,BP,JP,USP |
| Hill Formula | H₂Mg₃O₁₂Si₄ |
| Chemical formula | 3MgO*4SiO₂*H₂O |
| Molar Mass | 379.27 g/mol |
| HS Code | 2526 20 00 |
Physicochemical Information
| Density | 2.75 g/cm3 (20 °C) |
| Melting Point | >1300 °C |
| pH value | 7.0 - 9.0 (50 g/l, H₂O, 20 °C) (slurry) |
| Bulk density | 450 kg/m3 |
Storage and Shipping Information
| Storage | Store at +5°C to +30°C. |
Specifications
| Identity | passes test |
| Acid soluble matter | ≤ 2.0 % |
| Water-soluble substances | ≤ 0.1 % |
| Acidity or alkalinity | passes test |
| Al (Aluminium) | ≤ 2.0 % |
| As (Arsenic) | ≤ 0.0003 % |
| Ca (Calcium) | ≤ 0.9 % |
| Co (Cobalt)* | ≤ 0.0005 % |
| Fe (Iron) | ≤ 0.25 % |
| Mg (Magnesium) | 17.0 - 19.5 % |
| Ni (Nickel)* | ≤ 0.0020 % |
| Pb (Lead)* | ≤ 0.00005 % |
| V(Vanadium)* | ≤ 0.0010 % |
| Asbestos (IR spectroscopy) | passes test |
| Loss on ignition (1100 °C) | ≤ 6.5 % |
| Residual solvents (Ph Eur/USP/ICH) | excluded by the manufacturing process |
| Particle Size (d10) | ≥ 2 µm |
| Particle Size (d50) | about 30 µm |
| Particle Size (d90) | ≤ 65 µm |
| Specific surface area (BET) | 2.0 - 4.0 m²/g |
| Microbiological test (Total yeast and mould count (TYMC)) | ≤ 50 CFU/g |
| Microbiological test (Total aerobic microbial count (TAMC)) | ≤ 100 CFU/g |
| Microbiological test (Candida albicans (absent in 1 g)) | passes test |
| Microbiological test (Escherichia coli (absent in 1 g)) | passes test |
| Microbiological test (Pseudomonas aeruginosa (absent in 1 g)) | passes test |
| Microbiological test (Salmonella ssp (absent in 10 g)) | passes test |
| Microbiological test (Staphylococcus aureus (absent in 1 g)) | passes test |
| 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 (*). | |
| Conforms to Ph Eur, BP, JP, USP |
