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Key Documents

Safety Information

1.05980

SAFC

D-Mannitol

EMPROVE® ESSENTIAL, Ph. Eur., BP, ChP, JP, USP, FCC, E 421

Pharma Manufacturing

Synonym(s):

Mannite

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About This Item

Empirical Formula (Hill Notation):
C6H14O6
CAS Number:
Molecular Weight:
182.17
Beilstein:
1721898
MDL number:
UNSPSC Code:
12352201
E Number:
E421
EC Index Number:
200-711-8

Agency

BP
ChP
JP
Ph. Eur.
USP

Quality Level

reg. compliance

FCC

product line

EMPROVE® ESSENTIAL

form

fine powder

autoignition temp.

410 °C

potency

13500 mg/kg LD50, oral (Rat)

quality

E 421

particle size

(see specification)

pH

5-7 (20 °C, 100 g/L in H2O)

bp

290-295 °C/4 hPa

solubility

213 g/L

application(s)

liquid formulation
pharmaceutical
semi-solid formulation
solid formulation

storage temp.

2-25°C

SMILES string

OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO

InChI

1S/C6H14O6/c7-1-3(9)5(11)6(12)4(10)2-8/h3-12H,1-2H2/t3-,4-,5-,6-/m1/s1

InChI key

FBPFZTCFMRRESA-KVTDHHQDSA-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

Mannitol is widely used in pharmaceutical formulations and food applications, mainly as diluent and bulking agent in solid oral formulations such as tablets. For mannitols with DC properties or for a product specifically developed for wet granulation, please explore the Parteck® range of products.

Biochem/physiol Actions

A sugar alcohol sweet tastant. Used in sweetness inhibition studies.

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


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

MX11059802500:
CO1E1059809050:
1059802500:
1059809500:
1059800000:
1059809024:
1059809053:
1059809999:
1059809050:


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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