1.03668
Parteck® M DPI
EMPROVE® EXPERT, Ph. Eur., BP, 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:
12352107
E Number:
E421
EC Index Number:
200-711-8
MDL number:
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
agency
BP, JP, Ph. Eur., USP
product line
EMPROVE® EXPERT
form
fine powder
particle size
145-200 μm (d50)
pH
5-7 (20 °C, 100 g/L in H2O)
mp
164-169 °C
solubility
213 g/L
application(s)
liquid formulation
pharmaceutical
solid formulation
storage temp.
2-25°C
Quality Level
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® M DPI is a synthetic and versatile carrier option for your dry powder inhalation (DPI) formulation. Engineered from mannitol, Parteck® M DPI particles are designed to improve the flow and release characteristics of active pharmaceutical ingredients (APIs) in drugs delivered via dry, inhaled powders.
As Emprove® Expert product, Parteck® M DPI is specified with low low microbial and endotoxin limits, making is especially suitable for high-risk applications.
As Emprove® Expert product, Parteck® M DPI is specified with low low microbial and endotoxin limits, making is especially suitable for high-risk applications.
Features and Benefits
- Particle distribution designed to improve flow and release characteristics in DPI application
- Low water content & hygroscopicity
- Synthesized from plant-based raw materials
- 3-year shelf life
- High API delivery to the lungs
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
flash_point_f
Not applicable
flash_point_c
Not applicable
適用法令
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1036689025BWT: + 1036681000: + 1036689025:
jan
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。
グローバルトレードアイテム番号
| カタログ番号 | GTIN |
|---|---|
| 1.03668.1000 | 04054839194146 |
| 1.03668.9025 | 04054839194139 |
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