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Safety Information

1.03557

SAFC

Parteck® SI 450 (Sorbitol)

EMPROVE® ESSENTIAL, NF, FCC, JSFA

Pharma Manufacturing

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
MDL number:
MFCD00004708
UNSPSC Code:
12352201
EC Index Number:
200-061-5

Agency

JSFA
NF

Quality Level

500

reg. compliance

FCC

product line

EMPROVE® ESSENTIAL

form

coarse powder

autoignition temp.

420 °C

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

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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.

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

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Description
Pricing

Storage Class Code

11 - Combustible Solids

WGK

WGK 1

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable

Regulatory Listings

Regulatory Listings are mainly provided for chemical products. Only limited information can be provided here for non-chemical products. No entry means none of the components are listed. It is the user’s obligation to ensure the safe and legal use of the product.

JAN Code

1035572503:
1035570000:
1035579999:
1035579028:
1035572500:
1035579027:
MX11035572500:

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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