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Merck
CN

1.00563

正磷酸

85%, EMPROVE® EXPERT, Ph. Eur., BP, ChP, JPE, NF

别名:

磷酸, 正磷酸

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关于此项目

线性分子式:
H3PO4
化学文摘社编号:
分子量:
98.00
E Number:
E338
UNSPSC Code:
12352301
Beilstein/REAXYS Number:
1921286
MDL number:
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Quality Level

agency

BP, ChP, JPE, NF, Ph. Eur.

vapor density

3.4 (vs air)

vapor pressure

5 mmHg ( 25 °C), 2.2 mmHg ( 20 °C)

product line

EMPROVE® EXPERT

form

liquid

concentration

85%

technique(s)

API processing | salt formation: suitable

pH

<0.5 (20 °C, 100 g/L in H2O)

kinematic viscosity

30.5 cSt(20 °C)

bp

158 °C (lit.)

mp

~40 °C (lit.)

density

1.685 g/mL at 25 °C (lit.)

application(s)

liquid formulation
ophthalmics
pharma/biopharma processes
pharmaceutical
semi-solid formulation

storage temp.

2-30°C

SMILES string

OP(O)(O)=O

InChI

1S/H3O4P/c1-5(2,3)4/h(H3,1,2,3,4)

InChI key

NBIIXXVUZAFLBC-UHFFFAOYSA-N

General description

在制剂中,寻找既能满足您的应用需求同时又符合监管要求的合适辅料是一项复杂棘手的难题。凭借应用技巧和监管专业知识,我们可为您开发、放大和生产中的每一步骤提供支持。
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。

Application

磷酸可用作多种药物制剂和工艺中的酸化剂。

Analysis Note

The following cations are harmonized with the ICH Q3D limits:
  • Cadmium (Cd): from <= 0.0001% to <= 0.000020%
  • Mercury (Hg): from <= 0.0001% to <= 0.000030%
  • Lead (Pb): from <= 0.0001% to <= 0.000050%
  • Copper (Cu) gets 1 NKS more: from <= 0.002% to <= 0.0020%
The batch values are set to 30% of the Option 1 limit in each case. The MiBio parameters TAMC and TYMC are set to statistical testing and analyzed only once a year (periodic testing).

Other Notes

浓磷酸大约为 85% H3PO4(水溶液)。

Legal Information

Emprove is a registered trademark of Merck KGaA, Darmstadt, Germany
SAFC is a registered trademark of Merck KGaA, Darmstadt, Germany


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pictograms

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Danger

Hazard Classifications

Acute Tox. 4 Oral - Eye Dam. 1 - Met. Corr. 1 - Skin Corr. 1B

存储类别

8B - Non-combustible corrosive hazardous materials

flash_point_f

does not flash

flash_point_c

does not flash

法规信息

危险化学品

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Instead of addressing API solubility during formulation, tackle it early during development. Read about the various methods for API processing.





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