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500299 Nicotinamide

Overview

Replacement Information

Key Spec Table

CAS #EC NumberHill FormulaMolar MassGrade Value
98-92-0202-713-4C₆H₆N₂O122.13 g/molPh Eur,BP,USP,JP,FCC

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5.00299.9020
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      Fibre carton 20 kg
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      Description
      Catalogue Number500299
      SynonymsNicotinamide, Niacinamide, 3-Pyridinecarboxamide
      References
      Product Information
      CAS number98-92-0
      EC number202-713-4
      GradePh Eur,BP,USP,JP,FCC
      Hill FormulaC₆H₆N₂O
      Molar Mass122.13 g/mol
      HS Code2936 29 00
      Quality LevelMQ500
      Applications
      Biological Information
      Physicochemical Information
      Boiling point150 - 160 °C (0.0007 hPa)
      Density1.40 g/cm3 (25 °C)
      Flash point150 °C
      Ignition temperature480 °C
      Melting Point130 °C (sublimed)
      pH value6.0 - 7.5 (50 g/l, H₂O, 20 °C)
      Bulk density360 kg/m3
      Solubility691 g/l
      Dimensions
      Materials Information
      Toxicological Information
      LD 50 oralLD50 Rat 3530 - 3540 mg/kg
      LD 50 dermalLD50 Rabbit > 2000 mg/kg
      Safety Information according to GHS
      Hazard Pictogram(s) Hazard Pictogram(s)
      Hazard Statement(s)H319: Causes serious eye irritation.
      Precautionary Statement(s)P264: Wash skin thoroughly after handling.
      P280: Wear eye protection/ face protection.
      P305 + P351 + P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
      P337 + P313: If eye irritation persists: Get medical advice/ attention.
      Signal WordWarning
      RTECSQS3675000
      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
      Categories of dangerirritant
      Product Usage Statements
      Storage and Shipping Information
      StorageStore at +15°C to +25°C.
      Packaging Information
      Transport Information
      Supplemental Information
      Specifications
      Assay (perchloric acid titration, calculated on dried substance)99.0 - 101.0 %
      Assay (HPLC, calc. on dried substance)98.5 - 101.0 %
      Identity (IR-spectrum) (Ph Eur)passes test
      Identity (IR-spectrum) (USP)passes test
      Identity (coloring 1)passes test
      Identity (coloring 2)passes test
      Identity (UV/VIS-Spectrum)passes test
      AppearanceWhite to almost white, crystalline powder
      Appearance of solution (50 g/l; water)Clear, colourless, not more intense in color than reference solution BY₇
      pH (50 g/l; water)6.0 - 7.5
      Melting range (lower value)≥ 128 °C
      Melting range (upper value)≤ 131 °C
      Absorption ratio (A 245 nm/A 262 nm)0.63 - 0.67
      Chloride (Cl)≤ 210 ppm
      Sulfate (SO₄)≤ 190 ppm
      Pb (Lead)≤ 2 ppm
      Residual solvents (ICH Q3C)excluded by production process
      Readily carbonisable substancepasses test
      Related substances (HPLC) (Major unspecified impurity)≤ 0.10 %
      Related substances (HPLC) (Sum of all impurities)≤ 0.2 %
      Sulfated ash (600 °C)
      ≤ 0.1 %
      Loss on drying (Vacuum; 18 h)
      ≤ 0.5 %
      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, FCC, JP.
      Sulfated ash (600 °C)
      ≤ 0.1 %
      Loss on drying (Vacuum; 18 h)
      ≤ 0.5 %
      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, FCC, JP.
      Global Trade Item Number
      Catalogue Number GTIN
      5.00299.9020 04022536722382

      Documentation

      Material Qualification Dossier

      TitleVersion
      5.0

      Quality Management Dossier (Open Access)

      Title

      Operational Excellence Dossier

      Title

      Nicotinamide SDS

      Title

      Safety Data Sheet (SDS) 

      Nicotinamide Certificates of Analysis

      Product Number PackagingSpecificationLot Number
      5.00299.9020 Fibre cartonPDF Specification Document

      Certificates

      Title

      Brochure

      Title
      バイオ医薬品製造用製品ガイド