Pharmacel® 112

低水分 (LOD Max. 1.5% w/w)

水分感受性の高い原薬に適する

高保護梱包

Oral Solid Dose

製品情報

Pharmacel® 112は、低水分含量（LOD < 1.5% w/w）の直打用結晶セルロースで、特に水分に敏感な医薬品原薬（API）の製剤用に設計されたグレードです。

Pharmacel® 112は、結合剤、圧縮剤、希釈剤および/または崩壊補助剤として幅広い経口固形剤（OSD）に使用することができます。その低水分含量は、最終製品の性能を損なうことなく、薬物の安定性を向上させることができます。

高度に保護されたパッケージは、4年間の品質保証期間中、Pharmacel® 112を湿気から完全に保護することを保証しています。

包装形態

- 25kg PEライナー付き多層紙袋

- サンプルサイズ：500g

生産地

インドCuddalore

製品の種類: 結晶セルロース
添加剤の機能性: 充填剤・バインダー, 希釈剤, 結合剤, 崩壊剤
推奨プロセス: 直打法, ドライブレンド
剤形: 錠剤, カプセル剤（経口固形剤）, 口腔内崩壊錠

代表的な製品データ

粒度分布(μm)

X10: 40
X10: 90
X90: 180

嵩密度(g/L)

嵩密度(g/L): 330

ハウスナー比 (-)

ハウスナー比 (-): 1.39

LOD (% w/w)

LOD (% w/w): 1.3

ドキュメンテーション

ALBA Pharmacel
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Oral Solid Dose Brochure 表示
Contaminants Statement Pharmacel
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Ingredient declaration Pharmacel
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MSDS Pharmacel
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Nutritional information Pharmacel
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Product Specification Pharmacel 112
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DFE Pharma Leaflet Pharmacel 112 表示

Process Flow Sheet (PFS) Pharmacel® 112
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cGMP Statement
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Irradiation free
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Contaminants and residues lactose
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Residual solvent Pharmacel
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Shelf life statement Pharmacel
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Stability Summary Pharmacel®112
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Re-compaction properties of lactose and mcc 表示
Roller compaction of anhydrous lactose and mcc 表示
MCC Effect of Increasing Pharmacel Concentration on the Tableting Properties of DC Diluents 表示
Impact of excipient and blend properties on feeding consistency for continuous manufacturing 表示
Choosing the optimal lactose and MCC grade for formulating moisture sensitive drugs 表示

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