1.12635
Parteck® Delta M (Mannitol)
EMPROVE® ESSENTIAL, Ph. Eur., BP, ChP, JP, USP, E 421
Synonym(s):
D-Mannitol
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About This Item
Empirical Formula (Hill Notation):
C6H14O6
CAS Number:
Molecular Weight:
182.17
UNSPSC Code:
12352201
E Number:
E421
EC Index Number:
200-711-8
MDL number:
Quality Level
agency
BP, ChP, JP, Ph. Eur., USP
description
EMPROVE® ESSENTIAL Ph Eur,BP,USP,JP,E 421
product line
EMPROVE® ESSENTIAL
form
fine powder
autoignition temp.
410 °C
potency
13500 mg/kg LD50, oral (Rat)
pH
5-7 (20 °C, 100 g/L in H2O)
bp
290-295 °C/4 hPa
mp
164-169 °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
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.
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® Delta M excipient is a convertible mannitol specifically designed to handle wet granulation. Its delta-polymorphic crystals make it extremely adaptable. While it is monographed as a standard mannitol, this exceptional excipient changes its structure and converts into a beta-polymorph when it comes into contact with water. This creates a porous structure, thereby increasing the surface area, which leads to the ability to produce exceptionally hard tablets with fast disintegration.
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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Global Trade Item Number
| SKU | GTIN |
|---|---|
| 1126359025 | 04027269210076 |
| 1126351000 | 04022536961415 |