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Merck

1.00419

Parteck® M 200 (Mannitol)

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

別名:

D-Mannitol

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この商品について

実験式(ヒル表記法):
C6H14O6
CAS番号:
分子量:
182.17
UNSPSC Code:
12352201
E Number:
E421
EC Index Number:
200-711-8
MDL number:
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製品名

Parteck® M 200 (Mannitol), EMPROVE® ESSENTIAL, Ph. Eur., ChP, JP, USP, E 421

agency

ChP
JP
BP
Ph. Eur.
USP

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

product line

EMPROVE® ESSENTIAL

form

fine powder

autoignition temp.

410 °C

quality

E 421

particle size

(see specification)

bp

290-295 °C/4 hPa

mp

164-169 °C

solubility

213 g/L

application(s)

liquid formulation
pharmaceutical
solid formulation

storage temp.

2-25°C

Quality Level

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Features and Benefits

  • High compactibility at low compression forces
  • Rapid disintegration and fast dissolution
  • High dilution potential
  • Non-hygroscopic, exceptionally low content of reducing sugars
  • Uniform doses with homogenous distribution

Application

Parteck® M excipient achieves excellent compressibility while keeping the API stable throughout your manufacturing process and beyond. Based on directly compressible mannitol, it does not require further processing or high compression forces. The unique and large surface area of Parteck® M excipient enables rapid disintegration and quick release regardless of the dosage. It is well suitable for tableting processesusing direct compression or granulation techniques such as wet granulation androller compaction. Parteck® M is available in different particle sizes.
The specification of the product is part of the Emprove® Material Qualification Dossier and can be found under "General Properties".

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.

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

保管分類

11 - Combustible Solids

wgk

WGK 1


試験成績書(COA)

製品のロット番号・バッチ番号を入力して、試験成績書(COA) を検索できます。ロット番号・バッチ番号は、製品ラベルに「Lot」または「Batch」に続いて記載されています。

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資料

Medicine for children poses unique formulation challenges compared to adults. Consider developmental physiology and age specifics when designing pharmaceuticals. Quality issues can severely impact patient safety. Therefore, excipient quality, supplier selection, and supply chain security are crucial, particularly for pediatric formulations.

Our overview of API solubility and dissolution enhancement methods can help you decide between the many options to take during formulation.

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

This article describes the advantages of mannitol when used as an excipient in solid drug formulation.

すべて表示

関連コンテンツ

Developing formulations specifically for infants and children is increasingly important. To help you master these challenges effectively, we offer an extensive portfolio of well-established high-quality excipients and APIs for pediatric pharmaceutical formulations that are proven in practice.

グローバルトレードアイテム番号

カタログ番号GTIN
1.00419.902504027269146825
1.00419.905004022536696652
1.00419.250004022536958125

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