1.06143
葡甲胺
low in endotoxins, EMPROVE® API, Ph. Eur., ChP, JP, USP
别名:
N -甲基- D -葡胺, 1-脱氧-1-甲基氨基山梨醇, 1-去氧-1-(甲胺)-D-山梨醇, 葡甲胺
选择尺寸
关于此项目
Quality Level
agency
ChP, JP, Ph. Eur., USP
product line
EMPROVE® API
form
extra fine powder, solid
autoignition temp.
~662 °F
potency
>5000 mg/kg LD50, oral (Rat)
technique(s)
API processing | salt formation: suitable
pH
11 (20 °C, 10 g/L in H2O)
bp
210 °C/1013 hPa (decomposes)
mp
129-131.5 °C (lit.)
application(s)
liquid formulation
parenterals
pharma/biopharma processes
pharmaceutical
solid formulation
solubility enhancement
storage temp.
no temp limit
SMILES string
CNC[C@H](O)[C@@H](O)[C@H](O)[C@H](O)CO
InChI
1S/C7H17NO5/c1-8-2-4(10)6(12)7(13)5(11)3-9/h4-13H,2-3H2,1H3/t4-,5+,6+,7+/m0/s1
InChI key
MBBZMMPHUWSWHV-BDVNFPICSA-N
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。
Application
Emprove® API级葡甲胺根据ICH Q7指南要求生产。
Legal Information
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存储类别
11 - Combustible Solids
wgk
WGK 1
flash_point_f
Not applicable
flash_point_c
Not applicable
商品
Discover strategies to enhance solubility in injectable formulations using excipients, including cyclodextrins, meglumine, and polyethylene glycols.
相关内容
This page summarizes key considerations related to regulatory expectations for biomanufacturing including chemicals and polymeric materials. For chemicals, topics include nitrosamines and elemental impurities, and for polymeric materials such as filters and single-use assemblies, the focus is qualification and extractable and leachable testing.
全球贸易项目编号
| 货号 | GTIN |
|---|---|
| 1061431000 | 04022536073262 |
| 1061439025 | 04022536073279 |
| 1061439029 | 04022536556796 |
| 1061439030 | 04022536631479 |
| 1061430001 | 04054839016783 |
| 1061439026 | 04022536938639 |
| 1061439050 | 04022536585086 |