產(chǎn)品名

Product name

Remdesivir

CAS No.

1809249-37-3

Structure：

檢測日期

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

檢驗(yàn)項(xiàng)目

Test Items

檢驗(yàn)指標(biāo)

Specification

檢驗(yàn)結(jié)果

Test Results

性狀

Appearance

White to off-white powder

Withe powder

鑒別

Identification (HNMR)

Conforms to structure

Conforms to structure

溶解性

Solubility

Freely soluble in dimethylsulfoxide,practically insoluble in water.

Conforms

鑒別

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%

溶液澄清度與顏色

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

硫酸鹽 Sulfate

≤0.05%

Conforms

重金屬 Heavy metals

≤10ppm

Conforms

有關(guān)物質(zhì)

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%

殘留溶劑 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

殘留溶劑 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%

細(xì)菌內(nèi)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

結(jié)論

Conclusion

本品按企業(yè)內(nèi)控標(biāo)準(zhǔn)檢驗(yàn)，結(jié)果符合規(guī)定。

Conforms to Enterprise Standard.