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安全信息

PHR1809

Supelco

他克莫司

Pharmaceutical Secondary Standard; Certified Reference Material

别名:

FK-506 一水合物, 他克莫司

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About This Item

经验公式（希尔记法）:
C44H69NO12 · H2O
CAS号:
109581-93-3
分子量:
822.03
MDL编号:
MFCD11045918
UNSPSC代码:
41116107
PubChem化学物质编号:
329823627
NACRES:
NA.24

等级

certified reference material
pharmaceutical secondary standard

质量水平

300

Agency

traceable to USP 1642802

API类

tacrolimus

表单

powder

CofA

current certificate can be downloaded

包装

pkg of 150 mg

技术

HPLC: suitable
gas chromatography (GC): suitable

应用

pharmaceutical (small molecule)

储存温度

-10 to -25°C

SMILES字符串

O.CO[C@@H]1C[C@@H](CC[C@H]1O)\C=C(/C)[C@H]2OC(=O)[C@@H]3CCCCN3C(=O)C(=O)[C@]4(O)O[C@H]([C@H](C[C@@H](C)C\C(C)=C\[C@@H](CC=C)C(=O)C[C@H](O)[C@H]2C)OC)[C@H](C[C@H]4C)OC

InChI

1S/C44H69NO12.H2O/c1-10-13-31-19-25(2)18-26(3)20-37(54-8)40-38(55-9)22-28(5)44(52,57-40)41(49)42(50)45-17-12-11-14-32(45)43(51)56-39(29(6)34(47)24-35(31)48)27(4)21-30-15-16-33(46)36(23-30)53-7;/h10,19,21,26,28-34,36-40,46-47,52H,1,11-18,20,22-24H2,2-9H3;1H2/b25-19+,27-21+;/t26-,28+,29+,30-,31+,32-,33+,34-,36+,37-,38-,39+,40+,44+;/m0./s1

InChI key

NWJQLQGQZSIBAF-MLAUYUEBSA-N

基因信息

human ... FKBP1A(2280)

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相关类别

一般描述

This Certified Reference Material (CRM) is produced and certified in accordance with ISO 17034 and ISO/IEC 17025. All information regarding the use of this CRM can be found on the certificate of analysis.

Pharmaceutical secondary standards for application in quality control provide pharma laboratories and manufacturers with a convenient and cost-effective alternative to the preparation of in-house working standards.

Tacrolimus belongs to the class II drugs of the biopharmaceutics classification system (BCS). Also known as FK-506, it is isolated from Streptomyces tsukubaensis. It is used for its immunosuppressive properties to prevent rejection after organ transplantations. It is a 23-membered macrolide lactone and contains tricarbonyl and l-pipecolic acid moieties.

应用

This pharmaceutical secondary standard can also be used as follows:

  • Evaluation of a Bio-solid phase microextraction-tandem mass spectrometry (SPME-MS/MS) method to determine four immunosuppressive drugs in whole human blood
  • High-performance liquid chromatographic (HPLC) analysis of tacrolimus tablet samples, prepared by freeze-drying
  • Development and validation of a reversed phase-high performance liquid chromatographic (RP-HPLC) for the determination of tacrolimus in its capsule formulations
  • Stability analysis of tacrolimus and simultaneous determination of its important impurities by reversed phase-ultra-high performance liquid chromatography (RP-UHPLC)

生化/生理作用

FK-506是一种有效的免疫抑制剂，神经保护和神经再生剂，以及 体外 T细胞增殖阻滞剂。FK-506可破坏T淋巴细胞中钙调神经磷酸酶介导的信号转导，并与FK-506结合蛋白-12（FKBP12）相互作用。
FK-506是一种有效的免疫抑制剂；神经保护和神经再生； 体外 T细胞增殖阻滞剂。

分析说明

These secondary standards offer multi-traceability to the USP, EP and BP primary standards, where they are available.

附注

To see an example of a Certificate of Analysis for this material enter LRAC1117 in the Documents slot below. This is an example certificate only and may not be the lot that you receive.

象形图

Skull and crossbones
GHS06

警示用语：

Danger

危险声明

H301

危险分类

Acute Tox. 3 Oral

储存分类代码

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

WGK

WGK 3

闪点(°F)

Not applicable

闪点(°C)

Not applicable

法规信息

监管及禁止进口产品

分析证书(COA)

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Reversed-phase high performance liquid chromatographic (RP-HPLC) method for determination of tacrolimus in bulk and pharmaceutical formulation
Patel P, et al.
International Journal of Pharmacy and Pharmaceutical Sciences, 3, 220-222 (2011)

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