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1.04078 SAFC

Gelatin

powder, EMPROVE® ESSENTIAL Ph Eur,BP,NF

Synonym: Gelatin

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Properties

Related Categories APIs (Active Pharmaceutical Ingredients) and Excipients, Binders & Fillers, Biopharmaceutical Process Development and Manufacturing, Excipients, Semisolid Dosage Forms,
Agency/Method   BP
  NF
  Ph. Eur.
Quality Level   500
product line   Emprove® Essential
form   powder or granules
potency   >5000 mg/kg LD50, oral (Rat)
particle size   800 μm
pH   3.8-7.6 (25 °C, 10 g/L in H2O)
storage conditions   Store at +5°C to +30°C.

Description

General description

powder, EMPROVE® ESSENTIAL Ph Eur,BP,NF

Application

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

Analysis Note

Appearancefaintly yellow to light yellowish-brown granular powderIdentity (IR-spectrum)passes testIdentity (coloring)passes testIdentity (gelatinizing property)passes testpH (10 g/l, CO₂-free water)3.8 - 7.6Conductivity (1.0 %, 30 °C)≤ 1 mS/cmSulfur dioxide (SO₂)≤ 50 ppmAl (Aluminium)≤ 5 ppmCr (Chromium)≤ 10 ppmFe (Iron)≤ 30 ppmZn (Zinc)≤ 30 ppmPeroxide (as H₂O₂)≤ 10 ppmResidual solvents (ICH (Q3C))excluded by manufacturing processBloom value (about 110)90 - 130Loss on drying (105 °C, 16h)≤ 15.0 %Particle size (< 800 µm)≥ 99 %Total aerobic microbial count (TAMC)≤ 10³Total combined yeasts/moulds count (TYMC)≤ 10²Bile-tolerant gram-negative bacteria(absent in 1 g)passes testCandida albicans (absent in 1 g)passes testEscherichia coli (absent in 1 g)passes testPseudomonas aeruginosa(absent in 1 g)passes testSalmonella (absent in 10 g)passes testStaphylococcus aureus(absent in 1 g)passes testElemental 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 the Ph. Eur., BP and NF. The sulfite contentconforms to the requirements according to European directive 95/2/EC.

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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