1.03140

Parteck^® SI 400 (Sorbitol)

EMPROVE^® ESSENTIAL, Ph. Eur., BP, NF, FCC, E 420, JSFA

• Synonym(s): Parteck^® Sorbitol, D-Glucitol
• Empirical Formula (Hill Notation): C₆H₁₄O₆
• CAS Number: 50-70-4
• Molecular Weight: 182.17
• MDL number: MFCD00004708
• UNSPSC Code: 12352201
• E Number: E420
• EC Index Number: 200-061-5

Properties

• Agency: BP; JSFA; NF; Ph. Eur.
• Quality Level: 500
• reg. compliance: FCC
• product line: EMPROVE^® ESSENTIAL
• form: coarse powder
• autoignition temp.: 420 °C
• quality: E 420
• particle size: (see specification)
• pH: 6-7 (20 °C, 100 g/L in H₂O)
• mp: 94-96 °C
• transition temp: flash point >100 °C
• solubility: 2350 g/L
• density: 1.49 g/cm³ at 20 °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^® SI excipient is a directly compressible sorbitol which combines excellent tableting behavior, resulting in very robust and shiny tablets, with a pleasant mouthfeel and taste. The unique and large surface area allows for a fast disintegration and dissolution, even at high tablet hardnesses and supports a good content uniformity of low dose API formulations. Parteck^® SI excipient comes in a variety of particle sizes and qualities to meet the needs of a very wide range of applications.

Features and Benefits

• Excellent direct compression properties
• High dilution and adsorption capacity
• Larger and highly structured surface area
• Low hygroscopicity
• Low amount of reducing sugars

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
• Flash Point(F): Not applicable
• Flash Point(C): Not applicable