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100366 (S)-Lactic acid about 90%

EMPROVE® EXPERT Ph Eur,BP,E 270

(S)-Lactic acid about 90% MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.

Synonyms: 2-Hydroxypropionic acid, Lactol

Grade: Ph Eur,BP,E 270
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100366
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Overview

Replacement Information

Key Specifications Table

Grade Value
Ph Eur,BP,E 270

Pricing & Availability

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1003662500
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      		 Plastic bottle 2.5 l
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      1003669025
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          		 Plastic container 25 l
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          Description
          Catalogue Number100366
          Synonyms2-Hydroxypropionic acid, Lactol
          References
          Product Information
          GradePh Eur,BP,E 270
          HS Code2918 11 00
          Quality LevelMQ500
          Applications
          Biological Information
          Physicochemical Information
          Boiling point122 °C (20 hPa)
          Density1.21 g/cm3 (20 °C)
          Melting Point18 °C
          pH value2.8 (10 g/l, H₂O, 20 °C)
          Vapor pressure0.1 hPa (25 °C)
          Dimensions
          Materials Information
          Toxicological Information
          Safety Information according to GHS
          Hazard Pictogram(s) Hazard Pictogram(s)
          Hazard Statement(s)H314: Causes severe skin burns and eye damage.
          EUH071: Corrosive to the respiratory tract.
          Precautionary Statement(s)P280: Wear protective gloves/ protective clothing/ eye protection/ face protection/ hearing protection.
          P303 + P361 + P353: IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water.
          P304 + P340 + P310: IF INHALED: Remove person to fresh air and keep comfortable for breathing. Immediately call a POISON CENTER/doctor.
          P305 + P351 + P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
          P363: Wash contaminated clothing before reuse.
          P405: Store locked up.
          Signal WordDanger
          Storage class8A Combustible, corrosive hazardous materials
          WGKWGK 1 slightly 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
          Product Usage Statements
          Storage and Shipping Information
          StorageStore at +2°C to +25°C.
          Packaging Information
          Transport Information
          Declaration (railroad and road) ADR, RIDUN 3265 , 8, III
          Declaration (transport by air) IATA-DGRUN 3265 , 8, III
          Declaration (transport by sea) IMDG-CodeUN 3265 , 8, III, Segregation Group: 1 (Acids)
          Supplemental Information
          Specifications
          Assay (alkalimetric)88.0 - 92.0 %
          Assay (stereochemical purity of (S)-lactic acid)≥ 95.0 %
          Identity (IR-spectrum)passes test
          Identity (pH)passes test
          Identity (Density)passes test
          Identity (Lactat)passes test
          Identity (assay)passes test
          Appearanceclear, oily liquid, not more intense in color than reference solution Y₆
          Ether-insoluble substancespasses test
          Citric, oxalic and Phosphoric acidspasses test
          Density (d 20/20)1.20 - 1.21
          Chloride (Cl)≤ 0.2 %
          Sulfate (SO₄)≤ 200 ppm
          As (Arsenic)≤ 3 ppm
          Ca (Calcium)≤ 200 ppm
          Fe (Iron)≤ 10 ppm
          Hg (Mercury)≤ 1 ppm
          Pb (Lead)≤ 2 ppm
          Ethanol≤ 5000 ppm
          Acetic acid≤ 5000 ppm
          Methanol≤ 50 ppm
          Other residual solvents (ICH Q3C)excluded by manufacturing process
          Sugars and other reducing substancespasses test
          Sulfated ash (600 °C)≤ 0.10 %
          Total aerobic microbial count (TAMC)≤ 10²
          Total combined yeasts/moulds count (TYMC)≤ 10²
          Bacterial endotoxins≤ 5 I.U./g
          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, E 270
          Conforms to the purity criteria on food additives according to European Commission directive 2008/84/EC.
          Global Trade Item Number
          Catalog Number GTIN
          1003662500 04022536005775
          1003669025 04027269142483

          Documentation

          Material Qualification Dossier

          TitleVersion
          9.0

          Quality Management Dossier (Open Access)

          Title

          Operational Excellence Dossier

          Title

          (S)-Lactic acid about 90% SDS

          Title

          Safety Data Sheet (SDS) 

          (S)-Lactic acid about 90% Certificates of Analysis

          Product Number PackagingSpecificationLot Number
          1003662500 Plastic bottlePDF Specification Document
          1003669025 Plastic containerPDF Specification Document

          Certificates

          Title
          KOSHER Certificate for 100366 (S)-Lactic acid about '0% suitable for use as excipient EMPROVE® exp Ph Eur,BP,E 270

          Technical Info

          Title
          Malt Extract Agar, 105398

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          Categories

          Small Molecule Pharmaceuticals > Formulation > Semisolid Dosage Form > Acidulants and pH Adjustments
          Small Molecule Pharmaceuticals > Formulation > Semisolid Dosage Form > Ingredients - Semi Solid
          IVD/OEM Materials & Reagents > Microscopy > Bacteriology > Auxiliaries for Bacteriology
          Biopharmaceutical Manufacturing > Formulation > Liquid Dosage > pH Adjustments and Isotonizers
          Small Molecule Pharmaceuticals > Formulation > Liquid Dosage Form > pH Adjustments and Isotonizers