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1.01615 SAFC

Agar

extra pure, EMPROVE® ESSENTIAL Ph Eur,BP

Synonym: Agar-agar, Gum agar

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Properties

Agency/Method   BP
  Ph. Eur.
Quality Level   500
product line   Emprove® Essential
potency   11000 mg/kg LD50, oral (Rat)
particle size   315 μm
pH   6.8 (20 °C, 100 g/L in H2O)
mp   90 °C
bulk density   550 kg/m3
storage conditions   Store at +5°C to +30°C.

Description

Analysis Note

Identity (A: Microscopic test): passes test
Identity (B: Reaktion with iodine-solution): passes test
Identity (C: Turbidity): passes test
Identity (D: Gelatinization): passes test
Swelling value: 10 - 15
Insoluble matter: ≤ 1.0 %
Gelatin: passes test
Al (Aluminium): ≤ 100 ppm
As (Arsenic)*: ≤ 1.5 ppm
Fe (Iron): ≤ 130 ppm
Mn (Manganese): ≤ 25 ppm
Pb (Lead)*: ≤ 0.5 ppm
V (Vanadium)*: ≤ 1 ppm
Residual solvents (ICH (Q3C)): excluded by manufacturing process
Ash (600 °C): ≤ 5.0 %
Loss on Drying (105 °C): ≤ 20.0 %
Particle size (< 315 µm): ≥ 97 %
Total aerobic microbial count (TAMC): ≤ 1000 CFU/g
Total combined yeasts/moulds count (TYMC): ≤ 100 CFU/g
Bile-tolerant gram-negative bacteria(absent in 1 g): passes test
Candida albicans (absent in 1 g): passes test
Escherichia coli (absent in 1 g): passes test
Pseudomonas aeruginosa(absent in 1 g): passes test
Salmonella (absent in 10 g): passes test
Staphylococcus aureus(absent in 1 g): passes test
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

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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