1.03668

Parteck^® M DPI

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

• Synonym(s): D-Mannitol
• 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

Properties

• 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

Description

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

Safety Information

• Storage Class: 11 - Combustible Solids
• wgk_germany: WGK 1