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SAFC

Parteck® M DPI

EMPROVE® EXPERT, Ph. Eur., BP, JP, USP, E 421

Pharma Manufacturing

Synonym(s):

D-Mannitol

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About This Item

Empirical Formula (Hill Notation):
C6H14O6
CAS Number:
69-65-8
Molecular Weight:
182.17
MDL number:
MFCD00064287
UNSPSC Code:
12352107
E Number:
E421
EC Index Number:
200-711-8

agency

BP
JP
Ph. Eur.
USP

Quality Level

500

product line

EMPROVE® EXPERT

form

fine powder

particle size

145-200 μm (d50)

pH

5-7 (20 °C, 100 g/L in H2O)

mp

164-169 °C

solubility

213 g/L

application(s)

liquid formulation
pharmaceutical
solid formulation

storage temp.

2-25°C

InChI

1S/C6H14O6/c7-1-3(9)5(11)6(12)4(10)2-8/h3-12H,1-2H2

InChI key

FBPFZTCFMRRESA-UHFFFAOYSA-N

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General description

With formulation challenges in mind, we have used particle engineering technologies to develop functional excipients specifically for solid 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 DPI is a synthetic and versatile carrier option for your dry powder inhalation (DPI) formulation. Engineered from mannitol, Parteck® M DPI particles are designed to improve the flow and release characteristics of active pharmaceutical ingredients (APIs) in drugs delivered via dry, inhaled powders.
As Emprove® Expert product, Parteck® M DPI is specified with low low microbial and endotoxin limits, making is especially suitable for high-risk applications.

Features and Benefits

  • Particle distribution designed to improve flow and release characteristics in DPI application
  • Low water content & hygroscopicity
  • Synthesized from plant-based raw materials
  • 3-year shelf life
  • High API delivery to the lungs

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

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Storage Class

11 - Combustible Solids

wgk_germany

WGK 1

Certificates of Analysis (COA)

Search for Certificates of Analysis (COA) by entering the products Lot/Batch Number. Lot and Batch Numbers can be found on a product’s label following the words ‘Lot’ or ‘Batch’.

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