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1.03140

Parteck® SI 400 (Sorbitol)

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

Synonym(s):

Parteck® Sorbitol, D-Glucitol

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About This Item

Empirical Formula (Hill Notation):
C6H14O6
CAS Number:
50-70-4
Molecular Weight:
182.17
UNSPSC Code:
12352201
E Number:
E420
EC Index Number:
200-061-5
MDL number:
MFCD00004708
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Quality Level

500

agency

BP, JSFA, NF, Ph. Eur.

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

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

SMILES string

OC(C(O)C(O)CO)C(O)CO

InChI

1S/C6H14O6/c7-1-3(9)5(11)6(12)4(10)2-8/h3-12H,1-2H2

InChI key

FBPFZTCFMRRESA-UHFFFAOYSA-N

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

WGK 1

flash_point_f

Not applicable

flash_point_c

Not applicable

Certificates of Analysis (COA)

Search for Certificates of Analysis (COA) by entering the products Lot/Batch Number. Lot and Batch Numbers can be found on a product’s label following the words ‘Lot’ or ‘Batch’.

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Articles

Active Pharmaceutical Ingredient (API) Stability in Solid Dose Formulation

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

Global Trade Item Number

SKUGTIN
103140902604022536583501
103140902804022536936437
103140905304054839032981
103140950104022536864600
103140250004022536961354
103140905004022536040233
103140950004022536531366