サイズを選択してください
この商品について
Quality Level
agency
ChP, JP, Ph. Eur., USP
product line
EMPROVE® API
form
extra fine powder, solid
autoignition temp.
~662 °F
potency
>5000 mg/kg LD50, oral (Rat)
technique(s)
API processing | salt formation: suitable
pH
11 (20 °C, 10 g/L in H2O)
bp
210 °C/1013 hPa (decomposes)
mp
129-131.5 °C (lit.)
application(s)
liquid formulation
parenterals
pharma/biopharma processes
pharmaceutical
solid formulation
solubility enhancement
storage temp.
no temp limit
SMILES string
CNC[C@H](O)[C@@H](O)[C@H](O)[C@H](O)CO
InChI
1S/C7H17NO5/c1-8-2-4(10)6(12)7(13)5(11)3-9/h4-13H,2-3H2,1H3/t4-,5+,6+,7+/m0/s1
InChI key
MBBZMMPHUWSWHV-BDVNFPICSA-N
General description
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
Meglumine Emprove® API is manufactured according to ICH Q7 guidelines.
Legal Information
Still not finding the right product?
Explore all of our products under N-メチル-D-グルカミン
保管分類
11 - Combustible Solids
wgk
WGK 1
flash_point_f
Not applicable
flash_point_c
Not applicable
Emprove®プログラムを使用してGMPを遵守します。
Emprove® Dossiersで資格認定を加速し、コンプライアンスを維持し、時間を節約しましょう。
注意: EmproveSuite.comに移動します。ユーザー名とパスワードはSigmaAldrich.comとは別のもので、異なる場合があります。
無料会員登録すると、数分でEmprove® Dossiersにアクセスできます。 購読プランをアップグレードして、Emprove® Suiteの高度でカスタマイズされたコンテンツをアンロックしてください。
お探しのものが見つかりませんか?Emprove® プログラムのヘルプページをご覧ください。.
資料
Discover strategies to enhance solubility in injectable formulations using excipients, including cyclodextrins, meglumine, and polyethylene glycols.
Instead of addressing API solubility during formulation, tackle it early during development. Read about the various methods for API processing.
関連コンテンツ
This page summarizes key considerations related to regulatory expectations for biomanufacturing including chemicals and polymeric materials. For chemicals, topics include nitrosamines and elemental impurities, and for polymeric materials such as filters and single-use assemblies, the focus is qualification and extractable and leachable testing.
グローバルトレードアイテム番号
| カタログ番号 | GTIN |
|---|---|
| 1.06143.1000 | 04022536073262 |
| 1.06143.9025 | 04022536073279 |