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100663 PARTECK LUB MST

100663
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Tabulka spec. kláve

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

Products

Katalogové čísloBalení ks/bal.
1006630250 Plastová láhev 250 g
1006639020 Lepenková bedna 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) (kal)
Bulk density250 kg/m3
Dimensions
Materials Information
Toxicological Information
LD 50 oralLD50 Potkan > 2000 mg/kg
Safety Information according to GHS
RTECSWI4390000
Storage class10 - 13 Ostatní kapalné a tuhé látky
WGKNWG neohrožující vody
Disposal3
Relativně nereaktivní organické reagencie mohou být shromažďovány v kontejneru A. Pokud jsou halogenované, musí být umístěny v kontejneru B. U pevných reziduí použijte kontejner C.
Safety Information
Product Usage Statements
Storage and Shipping Information
StorageSkladovat od +2°C až +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
Katalogové číslo GTIN
1006630250 04027269027919
1006639020 04022536742151

Documentation

Material Qualification Dossier

TitleVersion
9.0

Quality Management Dossier (Open Access)

Title

Operational Excellence Dossier

Title

PARTECK LUB MST MSDS

Title

Safety Data Sheet (SDS) 

PARTECK LUB MST Certificates of Analysis

Katalogové číslo BaleníSpecifikaceČíslo šarže
1006630250 Plastová láhevSpecifikující dokument ve formátu PDF
1006639020 Lepenková bednaSpecifikující dokument ve formátu PDF

Certificates

Title

Brochure

Title
Brochure: Parteck® LUB Excipient - A smooth operation