1.08070

SAFC

Parteck® LUB Talc

EMPROVE® ESSENTIAL Ph Eur,BP,JP,USP

Synonym(s):
Soapstone, Talcum venetum
Empirical Formula (Hill Notation):
H2Mg3O12Si4
CAS Number:
Molecular Weight:
379.27
MDL number:
EC Index Number:
238-877-9

storage conditions

Store at +5°C to +30°C.

Quality Level

Agency/Method

BP
JP
Ph. Eur.
USP

product line

EMPROVE® Essential

pH

7.0-9.0 (20 °C, 50 g/L in H2O, slurry)

mp

>1300 °C

density

2.75 g/cm3 at 20 °C

bulk density

450 kg/m3

InChI

1S/3Mg.2HO3Si.2O3Si/c;;;4*1-4(2)3/h;;;2*1H;;/q3*+2;2*-1;2*-2

InChI key

KNXVOGGZOFOROK-UHFFFAOYSA-N

Analysis Note

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): not detectable
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

Legal Information

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PARTECK is a registered trademark of Merck KGaA, Darmstadt, Germany

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