1.12635

Parteck^® Delta M (Mannitol)

EMPROVE^® ESSENTIAL, Ph. Eur., BP, 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
• description: EMPROVE^® ESSENTIAL Ph Eur,BP,USP,JP,E 421
• product line: EMPROVE^® ESSENTIAL
• form: fine powder
• autoignition temp.: 410 °C
• potency: 13500 mg/kg LD₅₀, oral (Rat)
• pH: 5-7 (20 °C, 100 g/L in H₂O)
• bp: 290-295 °C/4 hPa
• mp: 164-169 °C
• 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^® Delta M excipient is a convertible mannitol specifically designed to handle wet granulation. Its delta-polymorphic crystals make it extremely adaptable. While it is monographed as a standard mannitol, this exceptional excipient changes its structure and converts into a beta-polymorph when it comes into contact with water. This creates a porous structure, thereby increasing the surface area, which leads to the ability to produce exceptionally hard tablets with fast disintegration.

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 Code: 11 - Combustible Solids
• WGK: WGK 1