BioHale® Trehalose Dihydrate

高純度・低エンドトキシントレハロース二水和物

Biopharma

製品情報

BioHale® トレハロース水和物は、バイオ医薬品製剤を安定化するための最高純度の添加剤です。BioHale® トレハロース水和物は、2つのα-グルコースユニット間の1,1-グリコシド結合により形成される2糖類です。酸で加水分解されにくい非還元糖であり、グリコシド結合はα-グルコシダーゼで切断されません。

BioHale® トレハロース水和物は、非経口、吸入、眼科など幅広い投与経路で使用することが可能です。特に、治療用タンパク質の凍結保護、凍結保存によく使用され、特に非経口投与に適しています。

その他の用途としては、リポソームの凍結融解や凍結乾燥時の安定化剤としての使用、血液細胞やモノクローナル抗体の安定化などがあります。当社の添加剤ポートフォリオに加え、当社の技術ソリューションと規制当局に対するサポートは、お客様の競争力を高めるために役立っています。

当社のBioHale®添加剤は、製薬業界のグローバルな規制要件（Ph.Eur.、USP-NF、JP、ChP）に準拠しており、中国医薬品マスターファイル（cDMF）を保有しています。

製品カタログのダウンロードはこちら

当社のバイオファーマの専門家にお問合せする方は、こちらをクリック

添加剤の機能性: 安定化剤
推奨プロセス: 凍結乾燥
剤形: 非経口剤

代表的な製品データ

CAS番号

CAS番号: 6138-23-4

モノグラフの遵守

モノグラフの遵守: Ph. Eur., USP-NF, JP, ChP

エンドトキシンレベル(EU/g)

エンドトキシンレベル(EU/g): ≤ 0.3

Tg (°C)

Tg (°C): ~107

ドキュメンテーション

Brochure Biohale® 表示
Product page Biohale Trehalose 表示
Absence of Melamine Pharmacel, SuperStarch, Disintegrants
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BSE statement BioHale (Sucrose, Trehalose)
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Collective statement Trehalose
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Contaminants Statement Trehalose
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COS Trehalose
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FDA UNI numbers
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Genotoxic impurities statement
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GMO statement Trehalose
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ICHQ3D - Elemental Impurities Starches
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Ingredient declaration Trehalose
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IPEC questionnaire on Nitrosamines
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Laboratories used for end product testing
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Nano materials
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Stability Summary Trehalose
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Process flow sheet Trehalose
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Production sites & warehouses
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Residual solvents
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Safety Information Trehalose
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Stability Summary Trehalose
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