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101565 天冬酰胺酸;天门冬素

EMPROVE® EXPERT Ph Eur,ChP,NF

天冬酰胺酸;天门冬素 MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.

同义词: Asparaginic acid semiamide, Asn

CAS号: 5794-13-8 EC号: 200-735-9 摩尔质量: 150.14 g/mol Hill配方: C₄H₈N₂O₃ * H₂O 级别: Ph Eur,ChP,NF
101565
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概述

Replacement Information

重要规格表

CAS #EC号Hill配方摩尔质量级别值
5794-13-8200-735-9C₄H₈N₂O₃ * H₂O150.14 g/molPh Eur,ChP,NF

Products

产品目录编号包装 数量 / 包装
1.01565.1000 塑胶瓶 1 kg
1.01565.5000 塑胶滚桶;塑胶鼓桶 5 kg
1.01565.9010 塑胶滚桶;塑胶鼓桶 10 kg
描述
产品目录编号101565
同义词Asparaginic acid semiamide, Asn
参考
产品信息
CAS号5794-13-8
EC号200-735-9
级别Ph Eur,ChP,NF
Hill配方C₄H₈N₂O₃ * H₂O
Molar Mass150.14 g/mol
HS代码2924 19 00
结构配方图像结构配方图像
Quality LevelMQ500
应用
生物信息
理化信息
熔点215 - 217 °C 分解
pH值4.0 - 5.5 (20 g/l, H₂O, 20 °C)
容积密度530 kg/m3
溶解度22 g/l
尺寸
材料信息
毒性学信息
GHS安全信息
储存类别10 - 13 其它液体及固体
WGKWGK 1 轻度的水危害
一次性3
反应性相对较低的有机物必须被收集在第A类, 如果被卤化则在第B类, 如果为固体残留物则归在第C类.
安全信息
产品使用声明
储存和货运信息
储存于 +2°C 到 +30°C储存.
包装信息
运输信息
补充信息
规格
Assay (perchloric acid titration, calculated on dried substance)99.0 - 101.0 %
Assay (HPLC, calculated on dried substance)95.5 - 102.0 %
Identity (IR-spectrum)passes test
Identity (specific rotation)passes test
Identity (HPLC)passes test
Identity (loss on drying)passes test
Identity (wet chemistry)passes test
Identity (TLC)passes test
Appearancewhite to almost white crystalline powder or colorless crystals
Appearance of solution (20 g/l, CO₂-free water)clear and not more intense in color than reference solution B₉
Transmittance of solution (20 g/l, water)≥ 98.0 %
pH (20 g/l, CO₂-free water)4.0 - 6.0
Spec. rotation (α 20/D, 100 g/l, hydrochloric acid 3 mol/l, calc. on dried substance)+33.7 to +36.0
Spec. rotation (α 20/D, 20 g/l, hydrochloric acid 3 mol/l,calc. on dried substance)+31.0 to +35.0
Spec. rotation (α 20/D, 10 g/l, hydrochloric acid 6 mol/l, calc. on dried substance)+33.0 to +36.5
Chloride (Cl)≤ 50 ppm
Sulfate (SO₄)≤ 50 ppm
Heavy metals (as Pb)≤ 10 ppm
As (Arsenic)≤ 1 ppm
Fe (Iron)≤ 10 ppm
Pb (Lead)≤ 5 ppm
NH₄ (Ammonium)≤ 0.1 %
Other amino acids (TLC)≤ 0.5 %
Related substances (HPLC) (impurity A)≤ 0.5 %
Related substances (HPLC) (impurity C)≤ 0.1 %
Related substances (HPLC) (any unspecified impurity)≤ 0.05 %
Related substances (HPLC) (total impurities)≤ 0.8 %
Organic Impurities (HPLC) (Asparagine related compound A (2,2’-(3,6-Dioxopiperazine-2,5-diyl)diacetamide))≤ 1.0 %
Organic Impurities (HPLC) (Aspartic acid)≤ 1.0 %
Organic Impurities (HPLC) (any unspecified impurity)≤ 0.5 %
Organic Impurities (HPLC) (total impurities)≤ 3.0 %
Ethanol (HS-GC)≤ 5000 ppm
Other residual solvents (ICH Q3C)excluded by manufacturing process
Sulfated ash (600 °C)≤ 0.1 %
Loss on drying (105 °C; 3 h)11.5 - 12.5 %
Loss on drying (130 °C, 3 h)11.5 - 12.5 %
Bacterial endotoxins≤ 3.0 I.U./g
Microbiological test (total aerobic microbial count (TAMC))≤ 10²
Microbiological test (total yeast and mould count (TYMC))≤ 10²
Elemental impurity specifications have been set considering ICH Q3D (Guideline for Elemental Impurities). Class 1-3 elements are not likely to be present above the ICH Q3D option 1 limit, unless specified and indicated (*).
Corresponds to Ph. Eur., ChP, NF
Global Trade Item Number
产品目录编号 GTIN
1.01565.1000 04022536022819
1.01565.5000 04022536732602
1.01565.9010 04022536732619

Documentation

Material Qualification Dossier

标题版本
10.0

Quality Management Dossier (Open Access)

Title

Operational Excellence Dossier

Title

天冬酰胺酸;天门冬素 MSDS

职位

物料安全数据表 (MSDS) 

天冬酰胺酸;天门冬素 分析证书

产品货号 包装规格批号
1.01565.1000 塑胶瓶PDF文档规格
1.01565.5000 塑胶滚桶;塑胶鼓桶PDF文档规格
1.01565.9010 塑胶滚桶;塑胶鼓桶PDF文档规格

证书

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Small Molecule Pharmaceuticals > Formulation > Semisolid Dosage Form > Ingredients - Semi Solid
Biopharmaceutical Manufacturing > Upstream Processing > Cell Culture > Cell Culture Ingredients and Supplements > Cell Culture Ingredients > Amino Acids