106522 Sodium-(S)-lactate-solution about 50%

106522
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      Overview

      Replacement Information

      Key Specifications Table

      Grade Value
      Ph Eur,BP,USP

      Pricing & Availability

      Catalog Number AvailabilityPackaging Qty/Pack Price Quantity
      1.06522.2500
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          Plastic bottle 2.5 l
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          1.06522.9019
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              Plastic container 19 l
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              Description
              Catalogue Number106522
              References
              Product Information
              GradePh Eur,BP,USP
              HS Code2918 11 00
              Structure formula ImageStructure formula Image
              Applications
              Biological Information
              Physicochemical Information
              Boiling point109 °C (1013 hPa)
              Density1.263 g/cm3 (20 °C)
              pH value6.5 - 9.0 (H₂O)
              Dimensions
              Materials Information
              Toxicological Information
              Safety Information according to GHS
              Storage class10 - 13 Other liquids and solids
              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
              Product Usage Statements
              Storage and Shipping Information
              StorageStore at +5°C to +30°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
              Assay (Perchloric acid titration)#50.0 - 51.0 %
              Assay (Stereochemical purity of Sodium-(S)-lactate)#≥ 95.0 %
              Identity (Sodium) passes test
              Identity (Lactat)passes test
              Appearance of solutionClear and not more intense in color than reference solution BY₇
              pH (in present substance)6.5 - 9.0
              Chloride (Cl)#≤ 50 ppm
              Sulfate (SO₄) (Ph Eur)#≤ 100 ppm
              Sulfate (SO₄) (USP)passes test
              Al (Aluminium)≤ 0.1 ppm
              As (Arsenic)#≤ 3 ppm
              Ba (Barium)passes test
              Fe (Iron)#≤ 10 ppm
              Hg (Mercury)≤ 1 ppm
              Pb (Lead)≤ 5 ppm
              Oxalate and Phosphate (Ph Eur)passes test
              Citrate, Oxalate, Phosphate or Tartrate (USP)passes test
              Methanol and Methyl Esters≤ 250 ppm
              Reducing sugars and sucrose (Ph Eur)passes test
              Sugar (USP)passes test
              Methanol#≤ 50 ppm
              Residual solvents (ICH Q3C)excluded by manufacturing process
              Total aerobic microbial count (TAMC)≤ 100 CFU/ml
              Total combined yeasts/moulds count (TYMC)≤ 10 CFU/ml
              Bile-tolerant gram-negative bacteria (absent in 1 ml)passes test
              Candida albicans (absent in 1 ml)passes test
              Escherichia coli (absent in 1 ml)passes test
              Pseudomonas aeruginosa (absent in 1 ml)passes test
              Salmonella (absent in 10 ml)passes test
              Staphylococcus aureus (absent in 1 ml)passes test
              Endotoxins< 5
              #calculated on sodium lactate
              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, USP

              Documentation

              Material Qualification Dossier

              Title

              Quality Management Dossier

              Title

              Operational Excellence Dossier

              Title

              Sodium-(S)-lactate-solution about 50% SDS

              Title

              Safety Data Sheet (SDS) 

              Sodium-(S)-lactate-solution about 50% Certificates of Analysis

              Product Number PackagingSpecificationLot Number
              1.06522.2500 Plastic bottlePDF Specification Document
              1.06522.9019 Plastic containerPDF Specification Document

              Certificates

              Title