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100661 Parteck® LUB STA 50

(Kyselina stearová 50 rastlinného pôvodu) EMPROVE® ESSENTIAL Ph Eur,BP,JP,NF

Parteck® LUB STA 50 MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.
CAS #: 67701-03-5 Molar Mass: 284.48 g/mol Grade: Ph Eur,BP,JP,NF
100661
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Overview

Replacement Information

Key Spec Table

CAS #Molar MassGrade Value
67701-03-5284.48 g/molPh Eur,BP,JP,NF

Products

Catalogue NumberPackaging Qty/Pack
1006610250 Plastová flaša 250 g
1006619020 Kartónová krabica 20 kg
Description
Catalogue Number100661
DescriptionParteck® LUB STA 50
References
Product Information
CAS number67701-03-5
GradePh Eur,BP,JP,NF
Molar Mass284.48 g/mol
HS Code3823 11 00
Structure formula ImageStructure formula Image
Quality LevelMQ500
Applications
Biological Information
Physicochemical Information
Boiling point370 °C (1013 hPa)
Ignition temperature395 °C
Vapor pressure<0.01 hPa (20 °C)
Bulk density400 - 500 kg/m3
Dimensions
Materials Information
Toxicological Information
LD 50 oralLD50 Potkan > 5000 mg/kg
LD 50 dermalLD50 Králik > 5000 mg/kg
Safety Information according to GHS
Storage class10 - 13 Iné kvapaliny a tuhé látky
WGKNWG neohrozuje vodné prostredie
Safety Information
Product Usage Statements
Storage and Shipping Information
StorageSkladujte pri +15°C až +25°C.
Packaging Information
Transport Information
Supplemental Information
Specifications
Stearic acid (GC)40.0 - 60.0 %
Assay (Stearic acid and palmitinic acid) (GC)≥ 90.0 %
Identity (IR)passes test
Identity (Solidification point)passes test
Identity (acid value)passes test
Identity (GC)passes test
Appearance of melt (Ph Eur, BP)passes test
Color of solution (NF)passes test
Aciditypasses test
Solidification point53 - 59 °C
Heavy metals (as Pb)≤ 20 ppm
Ni (Nickel)*≤ 1 ppm
Residual solvents (ICH Q3C)excluded by production process
Iodine number≤ 4.0
Acid value194 - 212
Sulfated ash≤ 0.1 %
Particle Size (d10)≥ 5 µm
Particle Size (d50)15 - 45 µm
Particle Size (d90)≤ 200 µm
Specific surface area (BET, volumetric)0.90 - 1.40 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)conforms
Escherichia coli (absent in 1 g)conforms
Pseudomonas aeruginosa (absent in 1 g)conforms
Staphylococcus aureus (absent in 1 g)conforms
Candida albicans (absent in 1 g)conforms
Salmonella ssp (absent in 10 g)conforms
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
Global Trade Item Number
Catalogue Number GTIN
1006610250 04027269028299
1006619020 04022536757650

Documentation

Material Qualification Dossier

TitleVersion
9.0

Quality Management Dossier (Open Access)

Title

Operational Excellence Dossier

Title

Parteck® LUB STA 50 MSDS

Title

Safety Data Sheet (SDS) 

Parteck® LUB STA 50 Certificates of Analysis

Product Number PackagingSpecificationLot Number
1006610250 Plastová flašaPDF Specification Document
1006619020 Kartónová krabicaPDF Specification Document

Certificates

Title

Brochure

Title
Brochure: Parteck® LUB Excipient - A smooth operation