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この商品について
Quality Level
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
application(s)
liquid formulation
parenterals
pharma/biopharma processes
pharmaceutical
storage temp.
15-25°C
SMILES string
OC(=O)CC(O)(CC(O)=O)C(O)=O
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
試験成績書(COA)
製品のロット番号・バッチ番号を入力して、試験成績書(COA) を検索できます。ロット番号・バッチ番号は、製品ラベルに「Lot」または「Batch」に続いて記載されています。
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 |
