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Merck
CN

D2975000

阿霉素 盐酸盐

European Pharmacopoeia (EP) Reference Standard

别名:

DOX, 多柔比星® 盐酸盐, 羟基柔红霉素 盐酸盐

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关于此项目

经验公式(希尔记法):
C27H29NO11 · HCl
化学文摘社编号:
分子量:
579.98
UNSPSC Code:
41116107
NACRES:
NA.24
PubChem Substance ID:
EC Number:
246-818-3
Beilstein/REAXYS Number:
4229251
MDL number:
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产品名称

阿霉素 盐酸盐, European Pharmacopoeia (EP) Reference Standard

InChI

1S/C27H29NO11.ClH/c1-10-22(31)13(28)6-17(38-10)39-15-8-27(36,16(30)9-29)7-12-19(15)26(35)21-20(24(12)33)23(32)11-4-3-5-14(37-2)18(11)25(21)34;/h3-5,10,13,15,17,22,29,31,33,35-36H,6-9,28H2,1-2H3;1H/t10-,13-,15-,17-,22+,27-;/m0./s1

InChI key

MWWSFMDVAYGXBV-RUELKSSGSA-N

SMILES string

Cl[H].COc1cccc2C(=O)c3c(O)c4C[C@](O)(C[C@H](O[C@H]5C[C@H](N)[C@H](O)[C@H](C)O5)c4c(O)c3C(=O)c12)C(=O)CO

grade

pharmaceutical primary standard

API family

doxorubicin

manufacturer/tradename

EDQM

mp

216 °C (dec.) (lit.)

application(s)

pharmaceutical (small molecule)

format

neat

Gene Information

human ... TOP2A(7153)

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Application

This European Pharmacopoeia reference standard is intended for use only as specifically prescribed in the European Pharmacopoeia. Their suitability for any other use is not guaranteed and is the sole responsibility of the user. This standard is not intended for human or animal use.
Established for the preparation of the below-given solutions as per European Pharmacopoeia:
  • Reference solutions (b) and (c) in the testing of related substances in daunorubicin hydrochloride using liquid chromatography (General text 2.2.29), according to the monograph 0662
  • Reference solutions (a) and (c) to test related substances in doxorubicin hydrochloride using liquid chromatography (General text 2.2.29), according to the monograph 0714
  • Reference solutions (b) and (c) in the testing of related substances in epirubicin hydrochloride using liquid chromatography (General text 2.2.29), according to the monograph 1590

General description

This product is provided as delivered and specified by the issuing Pharmacopoeia. All information provided in support of this product, including SDS and any product information leaflets, has been developed and issued under the Authority of the Issuing Pharmacopoeia.

For further information and support please go to the website of the issuing Pharmacopoeia.

Produced by certain strains of Streptomyces coeruleorubidus or Streptomyces peucetius or obtained by any other means.

Other Notes

Sales restrictions may apply.

Packaging

The product is delivered as supplied by the issuing Pharmacopoeia. For the current unit quantity, please visit the EDQM reference substance catalogue.

pictograms

Health hazardExclamation mark

signalword

Danger

Hazard Classifications

Acute Tox. 4 Oral - Carc. 1B - Muta. 1B - Repr. 1B

存储类别

6.1C - Combustible acute toxic Cat.3 / toxic compounds or compounds which causing chronic effects

wgk

WGK 3

flash_point_f

Not applicable

flash_point_c

Not applicable

法规信息

涉药品监管产品
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历史批次信息供参考:

分析证书(COA)

Lot/Batch Number

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Doxorubicin hydrochloride
European Pharmacopoeia Commission and European Directorate for the Quality of Medicines & Healthcare
European pharmacopoeia, 2471-2472 (2008)
Daunorubicin hydrochloride
European Pharmacopoeia Commission and European Directorate for the Quality of Medicines & Healthcare
European pharmacopoeia, 2343-2344 (2008)
Epirubicin hydrochloride
European Pharmacopoeia Commission and European Directorate for the Quality of Medicines & Healthcare
European pharmacopoeia, 4974-4975 (2021)
Maide Gökçe Bekaroğlu et al.
Materials science & engineering. C, Materials for biological applications, 103, 109838-109838 (2019-07-28)
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C Main et al.
Health technology assessment (Winchester, England), 10(9), 1-132 (2006-03-21)
To examine the clinical effectiveness and cost-effectiveness of intravenous formulations of topotecan monotherapy, pegylated liposomal doxorubicin hydorocholoride (PLDH) monotherapy and paclitaxel used alone or in combination with a platinum-based compound for the second-line or subsequent treatment of advanced ovarian cancer.

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