他克莫司，FK-506 monohydrate [Tacrolimus]；Pharmaceutical Secondary Standard; Certified Reference Material

别名：他克莫司标准品；FK506一水合物；大环哌喃；他克莫斯；泰克利马；富吉霉素；藤毒素；[3S-[3R[E(1S,3S,4S)],4S,5R,8S,9E,12R,14R,15S,16R, 18S,19S,26aR]]-5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-十六氢-5, 19-二羟基-3-[2-(4-羟基-3-甲氧基环已基)-1-甲基乙烯基]-14, 16-二甲氧基-4,10,12,18-四甲基-8-(2-丙烯基)-15,19-环氧-3H-吡啶并[2,1-c][1,4]氧杂氮杂环二十三碳烷-1,7,20,21(4H,23H)-四酮一水合物

Empirical Formula (Hill Notation): C44H69NO12 · H2O CAS号: 109581-93-3 分子量: 822.03 MDL编号: MFCD11045918 PubChem化学物质编号: 329823627 NACRES: NA.24

制造商品牌: 西格玛 Sigma-Aldrich , 色谱科 Supelco

货号（SKU）: PHR1809

CAS号: 109581-93-3

MDL号: MFCD11045918

签订合同 √ 正规发票 √ 技术支持 √ 质量保障 √ 全程可追溯 √

目录规格.SKU-Variant

150mg

说明

此认证参考材料（CRM）根据ISO 17034和ISO/IEC 17025进行生产和认证。有关使用此CRM的所有信息，请参阅分析证书。
用于质量控制的制药二级标准为制药实验室和制造商提供了一种方便且具有成本效益的替代方案，可用于制定内部工作标准。
他克莫司属于生物药剂学分类系统（BCS）的II类药物。也称为FK-506，它是从Streptomyces tsukubaensis中分离出来的。它用于其免疫抑制特性，以防止器官移植后的排斥反应。它是23元大环内酯内酯，含有三羰基和l-哌啶酸部分。

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。

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.

属性

等级

certified reference material
pharmaceutical secondary standard

质量水平

300

Agency

traceable to USP 1642802

形式

powder

CofA

current certificate can be downloaded

包装

pkg of 150 mg

technique(s)

HPLC: suitable
gas chromatography (GC): suitable

application(s)

pharmaceutical (small molecule)

储存温度

-10 to -25°C

SMILES string

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

Gene Information

human ... FKBP1A(2280)

安全信息

象形图

GHS06

警示用语：

Danger

危险声明

H301

预防措施声明

P301 + P310

危险分类

Acute Tox. 3 Oral

储存分类代码

6.1D - Non-combustible, acute toxic Cat.3 / toxic hazardous materials or hazardous materials causing chronic effects

WGK

WGK 3

个人防护装备

Eyeshields, Faceshields, Gloves, type P2 (EN 143) respirator cartridges

商品规格

属性名称	属性值
储存温度 Storage temp.	-20°C低温冷冻
全球实时库存 Availability √	美国St. Louis ≥ 20 \| 欧洲Eur. ≥ 16 \| 東京Tokyo ≥ 5 \| 香港与北京 ≥ 20

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