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Safety Information

1.11597

SAFC

Parteck® SI 400 LEX (Sorbitol)

EMPROVE® EXPERT, Ph. Eur., BP, NF, JP

Pharma Manufacturing

Synonym(s):

Parteck® Sorbitol, D-Glucitol

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About This Item

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

Agency

BP
JP
NF
Ph. Eur.

Quality Level

product line

EMPROVE® EXPERT

form

solid

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
ophthalmics
parenterals
pharmaceutical

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

Finding the right excipient that matches your needs as well as regulatory demands can be a complicated challenge in formulation. With our application know-how and regulatory expertise, we support you in every step of development, scale-up, and production.
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

Sorbitol is a sugar alcohol which is widely used in biomolecule formulations as a stabilizer and tonicity agent.

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 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

1115979500:
1115979250:
1115979029:
1115979251:
1115979024:
1115979051:
1115970200:
MX11115972500:
1115970000:
1115979075:
1115979050:
1115979027:
1115972500:
1115979503:
1115979750:
1115979012:
CO1E1115979028:
1.11597.1000:
1.11597.1000DISC:
1115979011:
1115979023:
1115979999:
1.11597.9024:
1115979028:
1115971003:
1.11597.9028:


Certificates of Analysis (COA)

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