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MilliporeSigma

1.03140

SAFC

Parteck® SI 400 (Sorbitol)

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

Pharma Manufacturing

Synonym(s):

Parteck® Sorbitol, D-Glucitol

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1 KIT
$1,480.00

$1,480.00


Estimated to ship onMay 25, 2025


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1 KIT
$1,480.00

About This Item

Empirical Formula (Hill Notation):
C6H14O6
CAS Number:
Molecular Weight:
182.17
MDL number:
UNSPSC Code:
12352201
E Number:
E420
EC Index Number:
200-061-5

$1,480.00


Estimated to ship onMay 25, 2025


Request a Bulk OrderRequest a Sample

agency

BP
JSFA
NF
Ph. Eur.

Quality Level

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

98-100 °C

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1 of 4

This Item
1.003181.0151413-1740
Quality Level

300

Quality Level

100

Quality Level

100

Quality Level

-

form

liquid

form

liquid

form

liquid

form

liquid

pH

<1 (20 °C in H2O)

pH

<1 (20 °C, 300 g/L in H2O)

pH

<1 (20 °C, 300 g/L in H2O)

pH

-

storage temp.

2-30°C

storage temp.

15-25°C

storage temp.

2-30°C

storage temp.

-

impurities

≤0.01 ppm As (Arsenic), ≤0.010 ppm Co (Cobalt), ≤0.010 ppm Mn (Manganese), ≤0.010 ppm V (Vanadium), ≤0.020 ppm Be (Beryllium), ≤0.020 ppm Cu (Copper), ≤0.020 ppm Ni (Nickel), ≤0.050 ppm Al (Aluminium), ≤0.050 ppm Tl (Thallium), ≤0.100 ppm Bi (Bismuth), ≤0.100 ppm Mg (Magnesium), ≤0.100 ppm Zr (Zirconium), ≤0.5 ppm Free chlorine (Cl), ≤0.500 ppm Na (Sodium), ≤1 ppm Sulfate (SO4), ≤50 ppm Bromide (Br), ≤0.010 ppm Cd (Cadmium), ≤0.010 ppm Sr (Strontium), ≤0.020 ppm Cr (Chromium), ≤0.020 ppm Pb (Lead), ≤0.050 ppm Zn (Zinc), ≤0.100 ppm Ti (Titanium), ≤0.500 ppm Ca (Calcium), ≤1 ppm Sulfite (SO3), ≤0.010 ppm Li (Lithium), ≤0.020 ppm Mo (Molybdenum), ≤0.100 ppm K (Potassium), ≤1 ppm NH4 (Ammonium), ≤0.020 ppm Ba (Barium), ≤0.200 ppm Fe (Iron), ≤0.050 ppm Ge (Germanium)

impurities

-

impurities

-

impurities

-

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

Storage Class

11 - Combustible Solids

wgk_germany

WGK 1

flash_point_f

Not applicable

flash_point_c

Not applicable


What is the Emprove® Program?

The Emprove® Program is a system providing comprehensive and thorough documentation of our filters and single-use components, pharma raw materials, and starting materials. Four document types are included with an Emprove® Program subscription:

Material Qualification Dossier

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Material Qualification Dossier

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Quality Management Dossier (Open Access)

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Operational Excellence Dossier

Available by subscription or for a fee

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Why are these documents unavailable?
Emprove® Dossiers contain information intended to support the registration process and risk assessment activities of pharmaceutical producers and contain confidential information. Please contact us if you would like access.

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Articles

This article describes the use of excipients to help address API stability issues.

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