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

EMPROVE® EXPERT Ph Eur,BP,USP

Sodium-(S)-lactate-solution about 50%: Malzeme Güvenlik Bilgi Formu (MSDS) veya SDS, Analiz Sertifikası (COA) ve Kalite Uygunluk Sertifikası (COQ), dosyalar, broşürler ve diğer dokümanlar.
Grade: Ph Eur,BP,USP
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106522
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Overview

Replacement Information

Key Spec Table

Grade Value
Ph Eur,BP,USP

Pricing & Availability

Catalogue Number AvailabilityPackaging Qty/Pack Price Quantity
1065222500
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      		 Plastic bottle 2.5 l
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      1065229019
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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
          Quality LevelMQ500
          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 +15°C to +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
          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
          Fe (Iron)#≤ 10 ppm
          K (Potassium)≤ 100 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
          #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
          Global Trade Item Number
          Catalogue Number GTIN
          1065222500 04022536078212
          1065229019 04022536532400

          Documentation

          Material Qualification Dossier

          TitleVersion
          9.0

          Quality Management Dossier (Open Access)

          Title

          Operational Excellence Dossier

          Title

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

          Title

          Safety Data Sheet (SDS) 

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

          Product Number PackagingSpecificationLot Number
          1065222500 Plastic bottlePDF Specification Document
          1065229019 Plastic containerPDF Specification Document

          Certificates

          Title