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1.00494 SAFC

Parteck® M 100 (Mannitol)

Emprove® Essential, Ph. Eur., BP, JP, USP, E 421

Synonym: Parteck® Mannitol

  • CAS Number 69-65-8

  • Empirical Formula (Hill Notation) C6H14O6

  • Molecular Weight 182.17

  •  MDL number MFCD00064287

  •  E Number E421

  •  EC Index Number 200-711-8

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Properties

Related Categories APIs (Active Pharmaceutical Ingredients) and Excipients, Binders & Fillers, Biopharmaceutical Process Development and Manufacturing, Controlled Release, Excipients,
Agency/Method   BP
  JP
  Ph. Eur.
  USP
Quality Level   500
product line   Emprove® Essential
autoignition temp.   410 °C
potency   13500 mg/kg LD50, oral (Rat)
quality   E 421
particle size   212 μm
pH   5-7 (20 °C, 100 g/L in H2O)
bp   290-295 °C/4 hPa
mp   164-169 °C
solubility   213 g/L
bulk density   400‑500 kg/m3
InChI   1S/C6H14O6/c7-1-3(9)5(11)6(12)4(10)2-8/h3-12H,1-2H2
InChI key   FBPFZTCFMRRESA-UHFFFAOYSA-N
storage conditions   no restrictions.

Description

General description

With formulation challenges in mind, we have used particle engineering technologies to develop functional excipients specifically for solid oral dosage forms. The products in our Parteck® portfolio feature unique particle properties tailored for excellent performance in tableting processes, for specific drug delivery technologies, or for solubility enhancement.
As part of our Emprove® Program, our raw materials are offered with extensive documentation facilitating compliance of your pharma and biopharma product, full supply chain transparency and risk mitigation. Our SAFC® portfolio of high-quality products for biopharmaceutical and pharmaceutical formulation and production withstands strict quality control procedures and is produced according to applicable cGMP guidelines.

Application

Parteck® M excipient achieves excellent compressibility while keeping the APIstable throughout your manufacturing process and beyond. Based on directlycompressible mannitol, it does not require further processing or highcompression forces. The unique and large surface area of Parteck® M excipientenables rapid disintegration and quick release regardless of the dosage. Parteck® M is available in different particle sizes.
The specification of the product is part of the Emprove® Material Qualification Dossier and can be found under "General Properties".

Analysis Note

Assay (HPLC, calc. on dried substance): 98.0 - 101.0 %
Identity (NIR): passes test
Appearance of solution (10 %; water): passes test
pH-value (10 %; water): 4.5 - 7.5
Melting point: 165 - 169
Conductivity (25°C) (20 %; water): ≤ 20
Heavy metals (as Pb): ≤ 5 ppm
Ni (Nickel) (#): ≤ 1 ppm
Pb (Lead): ≤ 0.5 ppm
Related substances (HPLC) (Sorbitol (Impurity A)): ≤ 2.0 %
Related substances (HPLC) (Sum of Maltitol and Isomalt(Impurities B and C)): ≤ 2.0
Related substances (HPLC) (Major unspecified impurity): ≤ 0.10 %
Related substances (HPLC)(Sum of all impurities): ≤ 2.0 %
Reducing sugars (as glucose): ≤ 0.05
Reducing sugars after hydrolysis/total sugar (as glucose): ≤ 1
Sulfated ash: ≤ 0.1
Water: ≤ 0.5 %
Loss on Drying (105 °C): ≤ 0.30 %
Particle size (> 212 µm): ≤ 20 %
Residual solvents (ICH Q3C): excluded by manufacturing process
Microbiological test: passes test
Colony count (aerobic bacteria (TAMC)): ≤ 10³
Colony count (Yeasts and moulds (TYMC)): ≤ 10²
Salmonella spp.: in 10g Substance not detectable
E.coli: in 1g Substance not detectable
Staphylococcus aureus: in 1g Substance not detectable
Pseudomonas aeruginosa: in 1g Substance not detectable
Candida albicans: In 1g Substance not detectable
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, JP, USP, E 421
Conforms to the purity criteria on food additives according to the current European Commission Regulation.

Legal Information

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

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

SAFC 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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The Emprove® Program is a system providing comprehensive and thorough documentation of our filters and single-use components, pharma raw materials, and starting materials. Three document types are included with an Emprove® Program subscription:

  • Material Qualification Dossiers
  • Quality Management Dossiers
  • Operational Excellence Dossiers

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Protocols & Articles

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