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1.08195 SAFC

Lactose monohydrate

(milk sugar) special grade for tabletting EMPROVE® ESSENTIAL Ph Eur,BP,NF,JP

Synonym: Lactose monohydrate, Milk sugar, Lactobiose

  • CAS Number 10039-26-6

  • Empirical Formula (Hill Notation) C12H22O11 · xH2O

  • Molecular Weight 342.30 (anhydrous basis)

  •  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
bulk density   500 kg/m3
storage conditions   Store at +15°C to +25°C.

Description

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 test
Identity (TLC): passes test
Identity (water): passes test
Appearance of solution (10 %; water): 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): ≤ 0.0005 %
As (Arsenic): ≤ 0.0001 %
Cu (Copper): ≤ 0.0025 %
Pb (Lead): ≤ 0.00005 %
Zn (Zinc): ≤ 0.0025 %
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, 2 h): ≤ 0.5 %
Water: 4.5 - 5.5 %
Particle size (< 100 µm): ≤ 50 %
Particle size (> 250 µm): ≤ 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

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.

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