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124069 Parteck® TA (Calcium carbonate)

Overview

Replacement Information

Key Specifications Table

CAS #Molar MassGrade Value
471-34-1100.09 g/molPh Eur,BP,USP,E 170,FCC

Products

Catalog NumberPackaging Qty/Pack
1240691000 Plastic bottle 1 kg
1240699025 Fibre carton 25 kg
Description
Catalogue Number124069
References
Product Information
CAS number471-34-1
GradePh Eur,BP,USP,E 170,FCC
Molar Mass100.09 g/mol
HS Code2836 50 00
Quality LevelMQ500
Applications
Biological Information
Physicochemical Information
Density2.8 g/cm3
pH value8.0 (H₂O)
Dimensions
Materials Information
Toxicological Information
Safety Information according to GHS
Storage class10 - 13 Other liquids and solids
WGKNWG not water endangering
Safety Information
Product Usage Statements
Storage and Shipping Information
StorageStore at +2°C to +30°C.
Packaging Information
Transport Information
Declaration (railroad and road) ADR, RIDKein Gefahrgut
Declaration (transport by air) IATA-DGRNo Dangerous Good
Declaration (transport by sea) IMDG-CodeNo Dangerous Good
Supplemental Information
Specifications
Assay (complexometric; calculated on dried substance)98.5 - 100.5 %
Identitypasses test
Substances insoluble in acetic acid≤ 0.2 %
Substances insoluble in hydrochloric acid≤ 0.2 %
Chloride (Cl)≤ 0.025 %
Fluoride (F)≤ 0.0050 %
Sulfate (SO₄)≤ 0.25 %
As (Arsenic)≤ 0.0003 %
Ba (Barium)passes test
Ba (Barium) (*)≤ 0.0100 %
Cd (Cadmium) (*)≤ 0.0001
Co (Cobalt)≤ 0.0001 %
Cr (Chromium)≤ 0.0100 %
Cu (Copper)≤ 0.0100 %
Fe (Iron)≤ 0.0200 %
Hg (Mercury)≤ 0.00005 %
Ni (Nickel)≤ 0.0002 %
Pb (Lead) (*)≤ 0.0003 %
Sb (Antimony)≤ 0.0100 %
V (Vanadium) (*)≤ 0.0005
Zn (Zinc)≤ 0.0100 %
Magnesium and alkali metals (Ph.Eur.)≤ 1.5 %
Magnesium and alkali salts (USP)≤ 1.0 %
Sb, Cu, Cr, Zn, Ba (combination)≤ 0.0100
Residual solvents (ICH Q3C)excluded by manufacturing process
Bulk density0.2 - 0.5 g/ml
Loss on drying (200 °C)≤ 2.0 %
Particle size (laser diffraction) (d50)2 - 6 µm
Particle size (laser diffraction) (d90)7 - 15 µm
Bile tolerant Gram negative Bacteria (absent in 1 g)passes test
Total aerobic microbial count (TAMC)≤ 500 CFU/g
Salmonella species (absent in 10g)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, USP, E 170, FCC
Conforms to the purity criteria on food additives according to the current European Commission Regulation.
Global Trade Item Number
Catalog Number GTIN
1240691000 04065269062516
1240699025 04065269122647

Documentation

Material Qualification Dossier

TitleVersion
7.0

Quality Management Dossier (Open Access)

Title

Operational Excellence Dossier

Title

Parteck® TA (Calcium carbonate) SDS

Title

Safety Data Sheet (SDS) 

Parteck® TA (Calcium carbonate) Certificates of Analysis

Product Number PackagingSpecificationLot Number
1240691000 Plastic bottlePDF Specification Document
1240699025 Fibre cartonPDF Specification Document

Certificates

Title