1.00419

Parteck^® M 200 (Mannitol)

EMPROVE^® ESSENTIAL, Ph. Eur., ChP, 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: 12352201
• E Number: E421
• EC Index Number: 200-711-8

Properties

• agency: BP; ChP; JP; Ph. Eur.; USP
• Quality Level: 500
• product line: EMPROVE^® ESSENTIAL
• form: fine powder
• autoignition temp.: 410 °C
• quality: E 421
• particle size: (see specification)
• bp: 290-295 °C/4 hPa
• 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 excipient achieves excellent compressibility while keeping the API stable throughout your manufacturing process and beyond. Based on directly compressible mannitol, it does not require further processing or high compression forces. The unique and large surface area of Parteck^® M excipient enables rapid disintegration and quick release regardless of the dosage. It is well suitable for tableting processesusing direct compression or granulation techniques such as wet granulation androller compaction. 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".

Features and Benefits

• High compactibility at low compression forces
• Rapid disintegration and fast dissolution
• High dilution potential
• Non-hygroscopic, exceptionally low content of reducing sugars
• Uniform doses with homogenous distribution

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