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107149 Papain 30000 USP-U/mg

Overview

Replacement Information

Products

Catalogue NumberPackaging Qty/Pack
1.07149.5000 Metal can 5 kg
1.07149.9025 Fibre carton 25 kg
Description
Catalogue Number107149
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 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.
H335: May cause respiratory irritation.
Precautionary Statement(s)P261: Avoid breathing dust/ fume/ gas/ mist/ vapours/ spray.
P264: Wash skin thoroughly after handling.
P271: Use only outdoors or in a well-ventilated area.
P302 + P352: IF ON SKIN: Wash with plenty of water.
P304 + P340 + P312: IF INHALED: Remove person to fresh air and keep comfortable for breathing. Call a POISON CENTER/doctor if you feel unwell.
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
Storage class10 - 13 Other liquids and solids
WGKWGK 2 obviously 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
Categories of dangerirritant, sensitizing
Product Usage Statements
Storage and Shipping Information
StorageStore at +2°C to +8°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
Activity (Casein, pH 6.0, 40 °C)≥ 30000 USP-U/mg
AppearanceAlmost white to brownish-yellow, 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
Global Trade Item Number
Catalogue Number GTIN
1.07149.5000 04022536087061
1.07149.9025 04022536087078

Documentation

Material Qualification Dossier

TitleVersion
5.0

Quality Management Dossier (Open Access)

Title

Operational Excellence Dossier

Title

Papain 30000 USP-U/mg SDS

Title

Safety Data Sheet (SDS) 

Papain 30000 USP-U/mg Certificates of Analysis

Product Number PackagingSpecificationLot Number
1.07149.5000 Metal canPDF Specification Document
1.07149.9025 Fibre cartonPDF Specification Document

Certificates

Title