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产品名称
无水柠檬酸粉末, anhydrous powder, EMPROVE® EXPERT, Ph. Eur., BP, ChP, JP, USP
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
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
Quality Level
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Application
由于其微生物和内毒素限度低,Emprove® Expert无水柠檬酸特别适用于高风险应用。
General description
作为Emprove® 计划的一部分,我们的原料随附完备文件,以便助力您制药和生物制药产品合规性、完整供应链透明度以及风险规避。我们的SAFC®产品线经受严格的质控程序检验并遵照适用的cGMP指南生产,提供用于生物药物和药物制剂和生产的优质产品。
Legal Information
signalword
Warning
hcodes
Hazard Classifications
Eye Irrit. 2 - STOT SE 3
target_organs
Respiratory system
存储类别
11 - Combustible Solids
wgk
WGK 1
flash_point_f
Not applicable
flash_point_c
Not applicable
相关内容
Learn more on mAb subcutaneous or intravenous formulation, and the relevant associated products, including excipients.
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