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1.07656 SAFC

Lactose monohydrate

(milk sugar) powder EMPROVE® ESSENTIAL Ph Eur,BP,NF,JP

Synonym: Lactose monohydrate, Milk sugar, Lactobiose

  • CAS Number 10039-26-6

  • Molecular Weight 360.32

  •  EC Index Number 200-559-2

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Properties

Related Categories APIs (Active Pharmaceutical Ingredients) and Excipients, Binders & Fillers, Biopharmaceutical Process Development and Manufacturing, Excipients, Liquid Dosage Forms,
Agency/Method   BP
  JP
  NF
  Ph. Eur.
Quality Level   500
product line   Emprove® Essential
autoignition temp.   390 °C
potency   >10000 mg/kg LD50, oral (Rat)
pH   4.0-6.5 (20 °C, 100 g/L in H2O)
mp   202 °C
solubility   161 g/L
bulk density   500 kg/m3
storage conditions   Store at +15°C to +25°C.

Description

General description

(milk sugar) powder EMPROVE® ESSENTIAL Ph Eur,BP,NF,JP

Application

The specification of the product is part of the Emprove® Material Qualification Dossier and can be found under "General Properties".

Analysis Note

Identity (IR-spectrum)passes testIdentity (TLC)passes testIdentity (water)passes testAppearance of solution (10 %; water)passes testAcidity or alkalinitypasses testSpec. rotation (α 20/D; 10 %; water; calc. on anhydrous substance)+54.4 - +55.9 °Heavy metals (as Pb)≤ 0.0005 %As (Arsenic)≤ 0.0001 %Cu (Copper)≤ 0.0025 %Pb (Lead)≤ 0.00005 %Zn (Zinc)≤ 0.0025 %Residual solvents (ICH Q3C)excluded by manufacturing processProteins and UV-absorbing impuritiespasses testSulfated ash≤ 0.1 %Loss on drying (80 °C, 2 h)≤ 0.5 %Water4.5 - 5.5 %Microbiological purity(Total aerobic microbial count (TAMC))≤ 100 CFU/gMicrobiological purity(Total yeast and mould count (TYMC))≤ 50 CFU/gBile tolerant Gram negative Bacteria(absent in 1 g)conformsEscherichia coli (absent in 1 g)conformsPseudomonas aeruginosa (absent in 1 g)conformsStaphylococcus aureus (absent in 1 g)conformsCandida albicans (absent in 1 g)conformsSalmonella ssp (absent in 10 g)conformsElemental 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

Legal Information

Emprove is a registered trademark of Merck KGaA, Darmstadt, Germany

Safety & Documentation

Safety Information

Safety Information for this product is unavailable at this time.

Emprove® Dossiers

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