PHR1809

Tacrolimus

Pharmaceutical Secondary Standard; Certified Reference Material

• 동의어(들): FK-506 monohydrate, Tacrolimus
• 실험식(Hill 표기법): C₄₄H₆₉NO₁₂ · H₂O
• CAS Number: 109581-93-3
• Molecular Weight: 822.03
• MDL number: MFCD11045918
• UNSPSC 코드: 41116107
• PubChem Substance ID: 329823627
• NACRES: NA.24

속성

• Grade: certified reference material; pharmaceutical secondary standard
• Quality Level: 300
• Agency: traceable to USP 1642802
• API family: tacrolimus
• 형태: powder
• CofA: current certificate can be downloaded
• 포장: pkg of 150 mg
• 기술: HPLC: suitable; gas chromatography (GC): suitable
• 응용 분야: pharmaceutical (small molecule)
• 저장 온도: -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
• 유전자 정보: human ... FKBP1A(2280)

설명

일반 설명

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.

애플리케이션

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)

생화학적/생리학적 작용

FK-506 is a potent immunosuppressant, neuroprotective and neuroregenerative, and in vitro T cell proliferation blocker. FK-506 disrupts calcineurin-mediated signal transduction in T lymphocytes and interacts with its FK-506-binding protein-12 (FKBP12).

분석 메모

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

각주

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.

안전성 정보

• 픽토그램: GHS06
• 신호어: Danger
• 유해 및 위험 성명서: H301
• 예방조치 성명서: P264 - P270 - P301 + P310 - P405 - P501
• Hazard Classifications: Acute Tox. 3 Oral
• Storage Class Code: 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