Description

Simvastatin-D6 is a high-purity, stable isotope-labeled analog of the widely prescribed cholesterol-lowering agent, Simvastatin. This deuterated compound is an essential internal standard for the accurate quantification of Simvastatin and its metabolites in complex biological matrices using advanced analytical techniques. It is primarily utilized by pharmaceutical R&D laboratories, contract research organizations (CROs), and analytical testing facilities engaged in pharmacokinetic studies, bioequivalence testing, and drug metabolism research.

Application

• LC-MS/MS Internal Standard: Serves as a critical deuterated internal standard for the precise and accurate quantification of Simvastatin in bioanalytical methods, minimizing matrix effects and improving data reliability.
• Pharmacokinetic & Metabolism Studies: Enables detailed investigation of the absorption, distribution, metabolism, and excretion (ADME) profile of Simvastatin in preclinical and clinical research.
• Bioequivalence Testing: Used in the development and validation of robust analytical methods to compare the bioavailability of generic Simvastatin formulations against the branded product.
• Drug Impurity Profiling: Assists in the identification and quantification of potential deuterated impurities or related substances in Simvastatin drug substance and product manufacturing.
• Stable Isotope Labeling Experiments: Facilitates mechanistic studies in drug metabolism, allowing researchers to trace metabolic pathways with high specificity.
• Regulatory Submission Support: Provides essential data traceability and method validation required for submissions to regulatory bodies like the FDA and EMA.

Basic Information

Product Name	Simvastatin-D6
CAS No.	1002347-71-8
Molecular Formula	C₂₅H₃₂D₆O₅
Molecular Weight	424.60 g/mol
Synonyms	Simvastatin (hexadeuterated); Simvastatin-d6; (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-d6; 2,2-Dimethylbutyric acid-1,1,1,3,3,3-d6 8-ester with (4R,6R)-6-[2-[(1S,2S,6R,8S,8aR)-8-hydroxy-2,6-dimethyl-1,2,6,7,8,8a-hexahydronaphthalen-1-yl]ethyl]tetrahydro-2H-pyran-2-one; MK 733-d6; Zocor-d6 (labeled).
EINECS	Contact for details

Quality Control

Our Simvastatin-D6 is manufactured under strict quality-controlled conditions to ensure the highest standards of isotopic purity and chemical integrity. Each batch is comprehensively characterized using NMR (¹H, ¹³C), High-Resolution Mass Spectrometry (HRMS), and HPLC to confirm chemical structure, isotopic enrichment (≥98 atom % D), and chemical purity (typically ≥95%). Certificates of Analysis (COA) detailing all analytical results are provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. This material is hygroscopic (moisture-sensitive). Store under an inert atmosphere in a cool, dry place. Keep container tightly sealed when not in use.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HRMS)	Conforms to structure
Purity (HPLC)	≥ 95.0%
Isotopic Purity	≥ 98 atom % D
Chemical Purity (NMR)	Conforms
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH guidelines

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