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107130 Pancreatin

Overview

Key Spec Table

Grade Value
USP

Products

Catalogue NumberPackaging Qty/Pack
1.07130.1000 Plastic bottle 1 kg
Description
Catalogue Number107130
Product Information
GradeUSP
HS Code3507 90 19
Quality LevelMQ500
Safety Information according to GHS
Hazard Pictogram(s) Hazard Pictogram(s)
Hazard Pictogram(s)
Hazard Statement(s)H315: Causes skin irritation.
H317: May cause an allergic skin reaction.
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.
P280: Wear protective gloves/ eye protection/ face protection.
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
Safety Information
Categories of dangerirritant, sensitizing
Storage and Shipping Information
StorageStore at +2°C to +8°C.
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
Specifications
Activity/FIP (Protease)min. 350 (activated)
Activity/Ph Eur (Protease)min.0.35 (activated)
Activity/USP (Protease)min. 25 (not activated)
Activity/FIP (Amylase)min 7500
Activity/Ph Eur (Amylase)min 7.5
Activity/USP (Amylase)min 25
Activity/FIP (Lipase)min 6000
Activity/Ph Eur (Lipase)min 6.0
Activity/USP (Lipase)min 6.0
AppearancePale yellow to light brown powder
Al (Aluminium)≤ 50 ppm
Cd (Cadmium)*≤ 0.2 ppm
Fatsmax 3.0
Loss on drying (60 °C; 4 h; vacuum < 670 Pa)max 5.0
Microbiological test≤ 10000 CFU/g; EP/USP indicator microorganisms absent
Acetone (GC)max 0.5
Residual solvents (Ph Eur/USP/ICH) class 3max 0.5
Other residual solvents (Ph Eur/USP/ICH)excluded by production process
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
1.07130.1000 04022536086873