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104078 Gelatina

pulbere, adecvat pentru utilizare ca excipient EMPROVE® ESSENTIAL Ph Eur,BP,NF

Gelatina MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.
CAS #: 9000-70-8 EC Number: 232-554-6 Grade: Ph Eur,BP,NF
104078
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Overview

Replacement Information

Key Spec Table

CAS #EC NumberGrade Value
9000-70-8232-554-6Ph Eur,BP,NF

Pricing & Availability

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1040781000
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      		 Plastic bottle 1 kg
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      1040789029
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          		 Double PE Sack 25 kg
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          Description
          Catalogue Number104078
          References
          Product Information
          CAS number9000-70-8
          EC number232-554-6
          GradePh Eur,BP,NF
          HS Code3503 00 19
          Quality LevelMQ500
          Applications
          Biological Information
          Physicochemical Information
          pH value3.8 - 7.6 (10 g/l, H₂O, 25 °C)
          Dimensions
          Materials Information
          Toxicological Information
          LD 50 oralLD50 Rat > 5000 mg/kg
          Safety Information according to GHS
          Storage class10 - 13 Alte lichide sau solide
          WGKNWG nu prezintă pericol pentru apă
          Disposal3
          Reactivii organici relativ cu reactivitate relativ redusa trebuie colectati in containerul A. Daca sunt halogenati, ei trebuie colectati in containerul B. Pentru reziduurile solide utilizati containerul C.
          Safety Information
          Product Usage Statements
          Storage and Shipping Information
          StorageA se depozita între +15°C la +25°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
          Appearancefaintly yellow to light yellowish-brown granular powder
          Identity (IR-spectrum)passes test
          Identity (coloring)passes test
          Identity (gelatinizing property)passes test
          pH (10 g/l, CO₂-free water)3.8 - 7.6
          Conductivity (1.0 %, 30 °C)≤ 1 mS/cm
          Sulfur dioxide (SO₂)≤ 50 ppm
          Al (Aluminium)≤ 5 ppm
          Cr (Chromium)≤ 10 ppm
          Fe (Iron)≤ 30 ppm
          Zn (Zinc)≤ 30 ppm
          Peroxide (as H₂O₂)≤ 10 ppm
          Residual solvents (ICH (Q3C))excluded by manufacturing process
          Bloom value (about 110)90 - 130
          Loss on drying (105 °C, 16h)≤ 15.0 %
          Total aerobic microbial count (TAMC)≤ 10³
          Total combined yeasts/moulds count (TYMC)≤ 10²
          Bile-tolerant gram-negative bacteria (absent in 1 g)passes test
          Candida albicans (absent in 1 g)passes test
          Escherichia coli (absent in 1 g)passes test
          Pseudomonas aeruginosa (absent in 1 g)passes test
          Salmonella (absent in 10 g)passes test
          Staphylococcus aureus (absent in 1 g)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 the Ph. Eur., BP and NF. The sulfite contentconforms to the requirements according to European directive 95/2/EC.

          Corresponds to the Ph. Eur., BP and NF. The sulfite contentconforms to the requirements according to European directive 95/2/EC.
          Global Trade Item Number
          Catalogue Number GTIN
          1040781000 04022536047218
          1040789029 04022536938561

          Documentation

          Emprove Dossier

          TitleVersion
          7.0

          Quality Management Dossier (Open Access)

          Title

          Operational Excellence Dossier

          Title

          Gelatina MSDS

          Title

          Safety Data Sheet (SDS) 

          Gelatina Certificates of Analysis

          Product Number PackagingSpecificationLot Number
          1040781000 Plastic bottlePDF Specification Document
          1040789029 Double PE SackPDF Specification Document

          Certificates

          Title