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100490 Parteck® ODT

EMPROVE® ESSENTIAL

Parteck® ODT MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.
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100490
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Overview

Replacement Information

Products

Catalogue NumberPackaging Qty/Pack
1.00490.9025 Fibre carton 25 kg
Description
Catalogue Number100490
References
Product Information
HS Code3824 99 89
Quality LevelMQ500
Applications
Biological Information
Physicochemical Information
Dimensions
Materials Information
Toxicological Information
Safety Information according to GHS
Storage class10 - 13 Other liquids and solids
WGKWGK 1 slightly hazardous to water
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
Identitypasses test
Appearance (description)fine powder
Appearance (color)white
Assay (mannitol)90.0 - 95.0 %
Assay (Croscarmellose-Sodium)3.0 - 7.0 %
Ni (Nickel)*≤ 0.0001 %
Heavy metals (as Pb)≤ 0.0005 %
Ethanol (HS-GC)≤ 5000 ppm
Other residual solvents (ICH Q3C)excluded by manufacturing process
Water (according to Karl Fischer)≤ 2 %
Microbiological purity (Total aerobic microbial count (TAMC))≤ 2000 CFU/g
Microbiological purity (Total yeast and mould count (TYMC))≤ 200 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
Particle size (laser diffraction) (d10)30 - 90 µm
Particle size (laser diffraction) (d50)80 - 220 µm
Particle size (laser diffraction) (d90)170 - 520 µm
The Mannit and Croscarmellose-Na used for the production correspond to Ph Eur, USP/NF and JP.
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 (*).
Global Trade Item Number
Catalogue Number GTIN
1.00490.9025 04027269144548

Documentation

Material Qualification Dossier

TitleVersion
9.0

Quality Management Dossier (Open Access)

Title

Operational Excellence Dossier

Title

Parteck® ODT SDS

Title

Safety Data Sheet (SDS) 

Parteck® ODT Certificates of Analysis

Product Number PackagingSpecificationLot Number
1.00490.9025 Fibre cartonPDF Specification Document

Certificates

Title