1.06143

N-メチル-D-グルカミン

low in endotoxins, EMPROVE^® API, Ph. Eur., ChP, JP, USP

• 別名: 1-デオキシ-1-（メチルアミノ）-D-グルシトール, メグルミン
• 実験式（ヒル表記法）: C₇H₁₇NO₅
• CAS番号: 6284-40-8
• 分子量: 195.21
• Beilstein: 385906
• MDL番号: MFCD00004707
• UNSPSCコード: 12352104
• EC Index Number: 228-506-9

特性

• 認証: ChP; JP; Ph. Eur.; USP
• 品質水準: 600
• 製品種目: EMPROVE^® API
• 形状: extra fine powder; solid
• 自己発火温度: ~662 °F
• 有効性: >5000 mg/kg LD₅₀, oral (Rat)
• テクニック: 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.)
• アプリケーション: liquid formulation; parenterals; pharma/biopharma processes; pharmaceutical; solid formulation; solubility enhancement
• 保管温度: no temp limit
• SMILES記法: 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

詳細

詳細

When working on a pharmaceutical formulation, there are specific considerations to make and challenging hurdles to take before you can successfully launch your final drug product - formulation stability, release kinetics and bioavailability limitations just to name a few. 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.

アプリケーション

Meglumine API grade is a high-quality advanced intermediate that can be directly incorporated as a co-former in API formulations.
Meglumine Emprove^® API is manufactured according to ICH Q7 guidelines.

法的情報

Emprove is a registered trademark of Merck KGaA, Darmstadt, Germany

SAFC is a registered trademark of Merck KGaA, Darmstadt, Germany

免責事項

The substance 1.06143 has no REACH registration because the only supported use is the use in medicinal products for human or veterinary use or in food or feedingstuffs according to article 2 of the REACH Regulation (EC) No 1907/2006.

安全性情報

• 保管分類コード: 11 - Combustible Solids
• WGK: WGK 1
• 引火点(°F): Not applicable
• 引火点(℃): Not applicable