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500936 Vitamin D₃ (kolekasiferol) kristal (1 g = 40 Mio.I.U.)

Overview

Replacement Information

Key Spec Table

CAS #EC NumberHill FormulaMolar MassGrade Value
67-97-0200-673-2C₂₇H₄₄O384.65 g/molPh Eur,BP,USP

Pricing & Availability

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5009360010
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      Botol kaca 10 g
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      5009360100
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          Botol kaca 100 g
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          Description
          Catalogue Number500936
          SynonymsColecalciferol, Cholecalciferol
          References
          Product Information
          CAS number67-97-0
          EC index number603-180-00-4
          EC number200-673-2
          GradePh Eur,BP,USP
          Hill FormulaC₂₇H₄₄O
          Molar Mass384.65 g/mol
          HS Code2936 29 21
          Structure formula ImageStructure formula Image
          Quality LevelMQ500
          Applications
          Biological Information
          Physicochemical Information
          Melting Point84 - 85 °C
          Solubility<0.1 g/l
          Dimensions
          Materials Information
          Toxicological Information
          LD 50 oralLD50 Tikus 5 - 50 mg/kg
          LD 50 dermalLD50 Tikus 61 mg/kg
          Safety Information according to GHS
          Hazard Pictogram(s) Hazard Pictogram(s)
          Hazard Pictogram(s)
          Hazard Statement(s)H300 + H310 + H330: Fatal bila tertelan, terkena kulit atau bila terhirup.
          H372: Menyebabkan kerusakan pada organ melalui paparan yang lama atau berulang jika tertelan.
          Precautionary Statement(s)P260: Jangan menghirup debu.
          P262: Jangan terkena mata, kulit atau pakaian.
          P280: Kenakan sarung tangan pelindung/ pakaian pelindung.
          P302 + P352 + P310: JIKA TERKENA KULIT: Cucilah dengan air yang banyak. Segera hubungi SENTRA INFORMASI KERACUNAN atau dokter/tenaga medis.
          P304 + P340 + P310: JIKA TERHIRUP: Pindahkan korban ke udara segar dan posisikan yang nyaman untuk bernapas. Segera hubungi SENTRA INFORMASI KERACUNAN atau dokter/tenaga medis.
          P314: Dapatkan nasehat/perhatian medis jika kamu merasa tidak sehat.
          Signal WordBahaya
          RTECSVS2900000
          Storage class6.1A Kat.1 dan 2 toksik akut, mudah terbakar/bahan berbahaya sangat toksik
          WGKWGK 2 membahayakan air secara signifikan
          Disposal9
          Senyawa karsinogenik dan senyawa yang dapat terbakar yang berlabel "Very Toxic" (Sangat beracun) atau "Toxic" (beracun) : kategori F. Alkil sulfat bersifat karsinogenik. Berhati-hatilah untuk menghindari penghirupan dan kontak dengan kulit. Untuk menghilangkan keaktifan alkil sulfat, tambahkan tetes per tetes (dari dalam corong tetes) ke dalam larutan amonia pekat dingin-es (Kat. No. 105426), dengan terus diaduk kuat. Sebelum ditempatkan di dalam kategori D, periksa pH dengan indikator pH universal (Kat. No. 105426).
          Safety Information
          Categories of dangersangat toksik
          Product Usage Statements
          Storage and Shipping Information
          StorageSimpan pada +2°C hingga +8°C.
          Packaging Information
          Transport Information
          Declaration (railroad and road) ADR, RIDUN 2811 , 6.1, I
          Declaration (transport by air) IATA-DGRUN 2811 , 6.1, I
          Declaration (transport by sea) IMDG-CodeUN 2811 , 6.1, I
          Supplemental Information
          Specifications
          Assay (HPLC)97.0 - 102.0 %
          Identity (IR-spectrum)passes test
          Identity (HPLC)passes test
          Identity (UV-spectrum (USP))passes test
          Spec. rotation [α²0/D (8 g/l; (aldehyde-free alcohol 96 %))+105 - +112 °
          Spec. rotation [α²5/D (5 g/l; ethanol)+105 - +112 °
          As (Arsenic)≤ 3 ppm
          Cu (Copper)≤ 25 ppm
          Pb (Lead)≤ 10 ppm
          Zn (Zinc)≤ 25 ppm
          Acetone (HS-GC)≤ 5000 ppm
          Hexane (HS-GC)≤ 290 ppm
          Methanol (HS-GC)≤ 3000 ppm
          Methylformate (HS-GC)≤ 1000 ppm
          Pyridine (HS-GC)≤ 200 ppm
          Other residual solvents (ICH Q3C)excluded by production process
          Related substances (HPLC) (trans-cholecalciferol)≤ 0.1 %
          Related substances (HPLC) (largest unspecified impurity)≤ 0.10 %
          Related substances (HPLC) (Sum of all impurities)≤ 1.0 %
          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
          5009360010 04022536257310
          5009360100 04022536257327

          Documentation

          Material Qualification Dossier

          TitleVersion
          8.0

          Quality Management Dossier (Open Access)

          Title

          Operational Excellence Dossier

          Title

          Vitamin D₃ (kolekasiferol) kristal (1 g = 40 Mio.I.U.) MSDS

          Title

          Safety Data Sheet (SDS) 

          Vitamin D₃ (kolekasiferol) kristal (1 g = 40 Mio.I.U.) Certificates of Analysis

          Product Number PackagingSpecificationLot Number
          5009360010 Botol kacaPDF Specification Document
          5009360100 Botol kacaPDF Specification Document

          Certificates

          Title