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107147 Papain 6000 USP-U/mg

Overview

Replacement Information
Description
Catalogue Number107147
References
Product Information
HS Code3507 90 26
Quality LevelMQ500
Applications
Biological Information
Physicochemical Information
pH value4 - 7 (1 g/l, H₂O, 25 °C)
Bulk density800 kg/m3
Dimensions
Materials Information
Toxicological Information
Safety Information according to GHS
Hazard Pictogram(s) Hazard Pictogram(s)
Hazard Statement(s)H315: Causes skin irritation.
H319: Causes serious eye irritation.
H334: May cause allergy or asthma symptoms or breathing difficulties if inhaled.
Precautionary Statement(s)P261: Avoid breathing dust/ fume/ gas/ mist/ vapours/ spray.
P264: Wash skin thoroughly after handling.
P280: Wear protective gloves/ eye protection/ face protection.
P284: Wear respiratory protection.
P302 + P352: IF ON SKIN: Wash with plenty of water.
P305 + P351 + P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
Signal WordDanger
Safety Information
Product Usage Statements
Storage and Shipping Information
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
Activity (Casein, pH 6.0, 40 °C)≥ 6000 USP-U/mg
AppearanceAlmost white, fine powder
Loss on drying (60 °C; 4 h; vacuum)≤ 7.0 % (w/w)
pH-value (1 in 50; water)4.8 - 6.2
Al (Aluminium)≤ 50 ppm
V (Vanadium)*≤ 1 ppm
Water (according to Karl Fischer)≤ 6 %
Microbiological test≤ 500 CFU/g; EP/USP indicator microorganisms absent
Residual solvents (Ph Eur/USP/ICH)excluded by manufacturing process
Lot (USP reference standard)
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 USP

Documentation

Material Qualification Dossier

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6.2

Quality Management Dossier (Open Access)

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Operational Excellence Dossier

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Papain 6000 USP-U/mg SDS

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Safety Data Sheet (SDS) 

Papain 6000 USP-U/mg Certificates of Analysis

Product Number PackagingLot Number
107147

Certificates

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