S-015

Sirolimus solution

1.0 mg/mL in acetonitrile, ampule of 1 mL, certified reference material, Cerilliant^®

• Synonym(s): Rapamycin
• Empirical Formula (Hill Notation): C₅₁H₇₉NO₁₃
• CAS Number: 53123-88-9
• Molecular Weight: 914.17
• EC Number: 200-835-2
• MDL number: MFCD00867594
• UNSPSC Code: 41116107
• PubChem Substance ID: 329824414

Properties

• grade: certified reference material
• Quality Level: 300
• form: liquid
• feature: Snap-N-Spike^®/Snap-N-Shoot^®
• packaging: ampule of 1 mL
• manufacturer/tradename: Cerilliant^®
• concentration: 1.0 mg/mL in acetonitrile
• technique(s): gas chromatography (GC): suitable; liquid chromatography (LC): suitable
• application(s): clinical testing
• format: single component solution
• storage temp.: −70°C
• SMILES string: CO[C@@H]1C[C@@H](CC[C@H]1O)C[C@H](C)[C@@H]2CC(=O)[C@H](C)C=C(C)[C@@H](O)[C@@H](OC)C(=O)[C@H](C)C[C@H](C)\C=C\C=C\C=C(C)[C@H](C[C@@H]3CC[C@@H](C)[C@@](O)(O3)C(=O)C(=O)N4CCCC[C@H]4C(=O)O2)OC
• InChI: 1S/C51H79NO13/c1-30-16-12-11-13-17-31(2)42(61-8)28-38-21-19-36(7)51(60,65-38)48(57)49(58)52-23-15-14-18-39(52)50(59)64-43(33(4)26-37-20-22-40(53)44(27-37)62-9)29-41(54)32(3)25-35(6)46(56)47(63-10)45(55)34(5)24-30/h11-13,16-17,25,30,32-34,36-40,42-44,46-47,53,56,60H,14-15,18-24,26-29H2,1-10H3/b13-11+,16-12+,31-17+,35-25+/t30-,32-,33-,34-,36-,37+,38+,39+,40-,42+,43+,44-,46-,47+,51-/m1/s1
• InChI key: QFJCIRLUMZQUOT-HPLJOQBZSA-N
• Gene Information: human ... FKBP1A(2280)

Description

General description

This Certified Spiking Solution^® is suitable for critical quantitative applications in clinical and diagnostic testing such as therapeutic drug monitoring assays to ensure patients remain within the drug’s narrow therapeutic range. The Snap-N-Spike^® format allows laboratories to eliminate weighing operations of hazardous substances such as sirolimus, significantly reducing occupational exposure hazards related to the handling of acutely toxic powders, and provides the ability to spike into their matrix of choice just before use.

Sirolimus, also known as rapamycin, belongs to the group of natural hydrophobic macrolides and is used widely as an immunosuppressive drug. It also shows anti-fungal, anti-candidal, anti-tumor, and anti-proliferative, in addition to immunosuppressive activities. Sirolimus is produced by Streptomyces hygroscopicus bacterium and works as a mammalian Target of Rapamycin (mTOR)inhibitor. It acts by blocking the activation and proliferation of T-lymphocytes, in response to the cytokines and antigens.

Application

The certified reference solution (CRM) in solution can also be used as follows:

• Multi-residue analysis of sirolimus, tacrolimus, everolimus, and cyclosporine A in whole blood samples by combining Bio-solid phase microextraction with mass spectrometry through a microfluidic open interface (Bio-SPME-MOI-MS/MS)
• Development and validation of a high-performance liquid chromatography-tandem mass spectrometry (HPLC-MS/MS) to determine immunosuppressive drugs― cyclosporine A, tacrolimus, sirolimus, and everolimus in whole blood samples
• Determination of sirolimus in both pig whole blood and lung tissue samples by liquid chromatography-tandem mass spectrometry (LC-MS/MS) and using a single protein precipitation step for sample preparation
• Analysis of blood samples collected from former transplant patients for the quantification of sirolimus, cyclosporine A, tacrolimus, and everolimus by liquid chromatography and tandem mass spectrometryEstimation of sirolimus, cyclosporine A, and everolimus in the dried matrix on paper discs (DMPD) by liquid chromatography along with tandem mass spectrometry (LC-MS/MS)

Features and Benefits

• Fully characterized under ISO/IEC 17025 and ISO 17034 accreditation
• Accompanied with a comprehensive Certificate of Analysis (CoA) with data on stability, homogeneity, accuracy of concentration, uncertainty, and traceability
• Rigorously tested through real-time stability studies to ensure accuracy and shelf life
• Gravimetrically prepared using qualified precision balances to ensure minimal uncertainty
• Flame sealed under argon into ampoules for long-term shelf life
• Offered in a convenient, DEA-exempt format to improve laboratory efficiency

Legal Information

CERILLIANT is a registered trademark of Merck KGaA, Darmstadt, Germany

CERTIFIED SPIKING SOLUTION is a registered trademark of Cerilliant Corporation

Snap-N-Shoot is a registered trademark of Cerilliant Corporation

Snap-N-Spike is a registered trademark of Merck KGaA, Darmstadt, Germany

Safety Information

• Pictograms: GHS02,GHS07
• Signal Word: Danger
• Hazard Statements: H225 - H302 + H312 + H332 - H319
• Precautionary Statements: P210 - P280 - P301 + P312 - P303 + P361 + P353 - P304 + P340 + P312 - P305 + P351 + P338
• Hazard Classifications: Acute Tox. 4 Dermal - Acute Tox. 4 Inhalation - Acute Tox. 4 Oral - Eye Irrit. 2 - Flam. Liq. 2
• Storage Class Code: 3 - Flammable liquids
• WGK: WGK 2
• Flash Point(F): 35.6 °F - closed cup
• Flash Point(C): 2 °C - closed cup