瑞德西韦

产品名

Product name

Remdesivir

CAS No.

1809249-37-3

Structure：

检测日期

Test Date

2020-05-13

批次：

Batch No.:

HTP2020051201

Batch Quantity

2.55kg

分子式:

Molecular formula：

C27H35N6O8P

分子量：

Molecular weight：

602.58

检验项目

Test Items

检验指标

Specification

检验结果

Test Results

性状

Appearance

White to off-white powder

Withe powder

鉴别

Identification (HNMR)

Conforms to structure

Conforms to structure

溶解性

Solubility

Freely soluble in dimethylsulfoxide,practically insoluble in water.

Conforms

鉴别

Identification

UV has characteristic absorption at wavelengths of 245nm and 275nm.

Conforms

The retention time of the major peak of the sample solution corresponds to that of the standard solution,as obtained in the Assay.

Conforms

IR spectrum conform to the standard.

Conforms

比旋度              Specific rotation

-19°～ -23°

-21.6°

水分            Water

≤1.0%

0.052%

溶液澄清度与颜色

Clarity and colour of

solution

Should be clear and colorless,If the olor,compared with yellow 1 standard liquid,color shall not be deeper.

Conforms

氯化物 Chlorides

≤0.05%

Conforms

硫酸盐 Sulfate

≤0.05%

Conforms

重金属 Heavy metals

≤10ppm

Conforms

有关物质

Related substances

ACS9087-10: ≤0.10%

0.0021%

ACS9087-5: ≤0.10%

0.041%

ACS9087-1101: ≤0.10%

0.057%

ACS9087-1103: ≤0.10%

Not detected

ACS9087-7: ≤0.10%

0.014%

ACS9087-1107: ≤0.10%

0.0026%

ACS9087-1108: ≤0.10%

Not detected

ACS9087-1109: ≤0.10%

Not detected

ACS9087-13: ≤0.10%

Not detected

Any individual unspecified impurity: ≤0.10%

0.025%

Total impurities: ≤0.50%

0.20%

残留溶剂 1

Residual solvents 1

Acetone: ≤0.5%

Not detected

Isopropanol: : ≤0.5%

0.048%

Dichloromethane: ≤0.06%

Not detected

MTBE: ≤0.5%

Not detected

Ethyl acetate: ≤0.5%

Not detected

THF: ≤0.072%

Not detected

IPAC: ≤0.5%

Not detected

Heptane: ≤0.5%

Not detected

MIBK: ≤0.45%

Not detected

2,2-methoxypropane: ≤0.5%

Not detected

残留溶剂 2

Residual solvents 2

TEA:≤0.5%

Not detected

DIPEA:≤0.1%

Not detected

含量                     Assay

≥98.0%(calculated on anhydrous substance)

100.5%

细菌内毒素

Bacterial endotoxins

<1.0EU/mg

<1.0EU/mg

微生物限度

Microbial contamination

Total amount of aerobe: ≤103 cfu/g

<10cfu/g

Yeast & Molds: ≤102 cfu/g

<10cfu/g

结论

Conclusion

本品按企业内控标准检验，结果符合规定。

Conforms to Enterprise Standard.