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Merck - 1.08195.9029 - Lactose monohydrate

  • MFR SKU: 1.08195.9029
  • ITEM #: 11565479
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ITEM #: 11565479
(milk sugar) special grade for tabletting EMPROVE® ESSENTIAL Ph Eur, BP, NF, JP
This listing is for 25 kg Double PE Sack

Merck - 1.08195.9029 - Lactose monohydrate

  • Item #: 11565479
  • MFR SKU: 1.08195.9029
  • Catalogue Number 108195
  • Synonyms Milk sugar, Lactobiose
  • CAS number 10039-26-6
  • EC number 200-559-2
  • Grade Ph Eur, BP, NF, JP
  • Hill Formula CHO * HO
  • Molar Mass 360.32 g/mol
  • HS Code 1702 11 00
  • Structure formula Image
  • Quality Level MQ500
  • Ignition temperature 390 ° C
  • Melting Point 202 ° C
  • pH value 4.0 - 6.5 (100 g/l, HO, 20 ° C)
  • Bulk density 500 kg/m3
  • Solubility 161 g/l
  • LD 50 oral LD50 Rat > 10000 mg/kg
  • RTECS OD9625000
  • Storage class 10 - 13 Other liquids and solids
  • WGK WGK 2 obviously hazardous to water
  • Disposal 3
  • 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.
  • Storage Store at +15° C to +25° C.
  • Declaration (railroad and road) ADR, RID Kein Gefahrgut
  • Declaration (transport by air) IATA-DGR No Dangerous Good
  • Declaration (transport by sea) IMDG-Code No Dangerous Good
  • Identity (IR) passes test
  • Identity (TLC) passes test
  • Identity (water) passes test
  • Appearance of solution (10%; water) passes test
  • Clarity and color of solution passes test
  • Acidity or alkalinity passes test
  • Spec. rotation (α 20/D; 10%; water; calc. on anhydrous substance) +54.4 - +55.9 °
  • Heavy metals (as Pb) ≤ 5 ppm
  • Residual solvents (ICH Q3C) excluded by the production process
  • Proteins and UV-absorbing impurities passes test
  • Sulfated ash ≤ 0.1 %
  • Loss on drying (80° C, 2h) ≤ 0.5 %
  • Water 4.5 - 5.5 %
  • Particle size ( 250µm) ≤ 2 %
  • Microbiological purity (Total aerobic microbial count (TAMC)) ≤ 100 CFU/g
  • Microbiological purity (Total yeast and mould count (TYMC)) ≤ 50 CFU/g
  • Bile tolerant Gram negative Bacteria (absent in 1 g) conforms
  • Escherichia coli (absent in 1 g) conforms
  • Pseudomonas aeruginosa (absent in 1 g) conforms
  • Staphylococcus aureus (absent in 1 g) conforms
  • Candida albicans (absent in 1 g) conforms
  • Salmonella ssp (absent in 10 g) conforms
  • 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, NF, JP

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