Description

Simvastatin-D11 (2,2-Dimethylbutyrate-D11) is a high-purity, deuterium-labeled internal standard critical for ensuring the accuracy and reliability of quantitative mass spectrometry analysis. This compound is specifically designed for use in pharmacokinetic studies, bioequivalence testing, and metabolic research, where precise measurement of the parent drug is paramount. It is an essential tool for pharmaceutical R&D laboratories, contract research organizations (CROs), and analytical service providers requiring the highest standards in method validation and regulatory compliance.

Application

• Quantitative Bioanalysis: Serves as a stable isotope-labeled internal standard in LC-MS/MS methods for the precise quantification of simvastatin and its active metabolite, simvastatin acid, in biological matrices like plasma, serum, and tissue homogenates.
• Pharmacokinetic & Metabolism Studies: Enables accurate tracking of drug absorption, distribution, metabolism, and excretion (ADME) in preclinical and clinical research, improving data reliability for regulatory submissions.
• Drug Impurity & Degradation Profiling: Used as a reference standard in analytical methods to identify and quantify process-related impurities and degradation products in drug substance and finished product formulations.
• Method Development & Validation: Critical for developing, optimizing, and validating robust analytical methods in compliance with ICH, FDA, and EMA guidelines for Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP).
• Clinical Trial Support: Provides the analytical foundation for reliable data in bioequivalence and therapeutic drug monitoring studies essential for drug development pipelines.

Basic Information

Product Name	Simvastatin-D11 (2,2-Dimethylbutyrate-D11)
CAS No.	1002347-74-1
Molecular Formula	C₂₅H₃₈D₁₁O₅
Molecular Weight	~419.7 g/mol
Synonyms	Simvastatin-d11; Deuterated Simvastatin; [D11]-Simvastatin; Simvastatin (2,2-dimethylbutyrate-d11); (1S,3R,7S,8S,8aR)-8-{2-[(2R,4R)-4-Hydroxy-6-oxotetrahydro-2H-pyran-2-yl]ethyl}-3,7-dimethyl-1,2,3,7,8,8a-hexahydronaphthalen-1-yl 2,2-dimethylbutanoate-d11; MK 733-d11; Zocor-d11 (labeled)
EINECS	Contact for details

Quality Control

Every batch of Simvastatin-D11 is manufactured and analyzed under strict quality systems to ensure it meets the exacting standards required for analytical reference materials. Our products undergo rigorous quality testing, including advanced chromatographic and spectroscopic techniques, to ensure compliance with industry standards for isotopic purity and chemical purity. Certificates of Analysis (COA) detailing batch-specific results for identity, purity (HPLC), isotopic enrichment, and related substances are available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store at 2-8°C. This product is hygroscopic (moisture-sensitive) and should be handled in a controlled, dry environment to maintain stability. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Purity	≥ 98.0 atom % D
Chemical Purity	≥ 95.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.