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100663 PARTECK LUB MST

(MAGNESIUM STEARATE VEGETABLE GRADE) EMPROVE® ESSENTIAL Ph Eur,BP,JP,NF,FCC

PARTECK LUB MST MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.
CAS #: 557-04-0 EC Number: 209-150-3 Molar Mass: 591.24 g/mol Hill Formula: C₃₆H₇₀Mg O₄ Grade: Ph Eur,BP,JP,NF,FCC
100663
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Overview

Replacement Information

Key Spec Table

CAS #EC NumberHill FormulaMolar MassGrade Value
557-04-0209-150-3C₃₆H₇₀Mg O₄591.24 g/molPh Eur,BP,JP,NF,FCC

Products

Catalogue NumberPackaging Qty/Pack
1006639020 Fibre carton 20 kg
Description
Catalogue Number100663
References
Product Information
CAS number557-04-0
EC number209-150-3
GradePh Eur,BP,JP,NF,FCC
Hill FormulaC₃₆H₇₀Mg O₄
Molar Mass591.24 g/mol
HS Code3824 99 89
Structure formula ImageStructure formula Image
Quality LevelMQ500
Applications
Biological Information
Physicochemical Information
Melting Point140 °C
pH value7 (H₂O) (slurry)
Bulk density250 kg/m3
Dimensions
Materials Information
Toxicological Information
LD 50 oralLD50 Rat > 2000 mg/kg
Safety Information according to GHS
RTECSWI4390000
Storage class10 - 13 Other liquids and solids
WGKNWG not water endangering
Disposal3
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.
Safety Information
Product Usage Statements
Storage and Shipping Information
StorageStore at +2°C to +30°C.
Packaging Information
Transport Information
Supplemental Information
Specifications
Assay (Mg; calculated on dried substance)4.0 - 5.0 %
Identity (GC)passes test
Identity (Solidification point)passes test
Identity (Magnesium)passes test
Identity (acid value)195 - 210
Palmitic- stearic acid components of fatty acids≥ 95 %
Stearic acid component of fatty acids60 - 70 %
Acidity or alkalinitypasses test
Chloride (Cl)≤ 0.1 %
Sulfate (SO₄)≤ 0.3 %
Heavy metals (as Pb)≤ 20 ppm
Al (Aluminium)≤ 50 ppm
Cd (Cadmium)≤ 0.2 ppm
Fe (Iron)≤ 100 ppm
Mn (Manganese)≤ 25 ppm
Ni (Nickel)*≤ 2 ppm
Pb (Lead)≤ 0.5 ppm
V (Vanadium)*≤ 2 ppm
Zn (Zinc)≤ 20 ppm
Residual solvents (ICH Q3C)excluded by the production process
Loss on Drying (105 °C)≤ 4.0 %
Particle Size (d10)≥ 1 µm
Particle Size (d50)3 - 7 µm
Particle Size (d90)≤ 30 µm
Specific surface area (BET, volumetric)5 - 12 m²/g
Microbiological purity (Total aerobic microbial count (TAMC))≤ 1E+03 CFU/g
Microbiological purity (Total yeast and mould count (TYMC))≤ 1E+02 CFU/g
Bile tolerant Gram negative Bacteria (absent in 1 g)passes test
Escherichia coli (absent in 1 g)passes test
Pseudomonas aeruginosa (absent in 1 g)passes test
Staphylococcus aureus (absent in 1 g)passes test
Candida albicans (absent in 1 g)passes test
Salmonella ssp (absent in 10 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 (*).
Corresponds to Ph Eur, BP, JP, NF, FCC
Global Trade Item Number
Catalogue Number GTIN
1006639020 04022536742151

Documentation

Material Qualification Dossier

TitleVersion
9.0

Quality Management Dossier (Open Access)

Title

Operational Excellence Dossier

Title

PARTECK LUB MST SDS

Title

Safety Data Sheet (SDS) 

PARTECK LUB MST Certificates of Analysis

Product Number PackagingSpecificationLot Number
1006639020 Fibre cartonPDF Specification Document

Certificates

Title

Brochure

Title
Brochure: Parteck® LUB Excipient - A smooth operation