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この商品について
Quality Segment
agency
BP, ChP, JP, Ph. Eur., USP
vapor pressure
<0.1 hPa ( 20 °C)
product line
EMPROVE® EXPERT
assay
99.5-100.5% substance (anhydrous) basis (alkalimetric)
form
fine powder, solid
feature
RNase and DNase free
expl. lim.
8 %, 65 °F
technique(s)
API processing | cocrystal formation: suitable, API processing | salt formation: suitable
impurities
endotoxins, low
pH
1.7 (20 °C, 100 g/L in H2O)
pKa
(1) 3.13, (2) 4.76, (3) 6.4
bp
200 °C/1013 hPa (decomposition)
mp
153-159 °C (lit.)
solubility
water: 1330 g/L at 20 °C
density
1.665 g/cm3 at 18 °C
cation traces
Al: ≤0.2 ppm, Fe: ≤3 ppm, Pb: ≤2 ppm, heavy metals (as Pb): ≤10 ppm
SMILES string
OC(=O)CC(O)(CC(O)=O)C(O)=O
application(s)
liquid formulation
parenterals
pharma/biopharma processes
pharmaceutical
storage temp.
15-25°C
InChI
1S/C6H8O7/c7-3(8)1-6(13,5(11)12)2-4(9)10/h13H,1-2H2,(H,7,8)(H,9,10)(H,11,12)
InChI key
KRKNYBCHXYNGOX-UHFFFAOYSA-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
Due to its low microbial and endotoxin limits, Citric acid anhydrous Emprove® Expert is especially suitable for high-risk applications.
Legal Information
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signalword
Warning
hcodes
Hazard Classifications
Eye Irrit. 2 - STOT SE 3
target_organs
Respiratory system
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
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
Learn more on mAb subcutaneous or intravenous formulation, and the relevant associated products, including excipients.
グローバルトレードアイテム番号
| カタログ番号 | GTIN |
|---|---|
| 1.37002.9012 | 04027269077419 |
| 1.37002.1000 | 04027269358235 |
| 1.37002.5000 | 04027269061890 |
| 1.37002.9029 | 04027269061418 |
