Description

p-Hydroxy Atorvastatin-D5 Calcium Salt is a high-purity, deuterated isotopologue of the active pharmaceutical ingredient atorvastatin, specifically labeled at five positions. This compound is essential for use as an internal standard in quantitative bioanalytical methods, ensuring unparalleled accuracy and reliability in pharmacokinetic and metabolic studies. It is primarily required by pharmaceutical R&D laboratories, contract research organizations (CROs), and analytical testing facilities engaged in the development and quality control of statin-based therapeutics.

Application

• Internal Standard for LC-MS/MS: Critical for the precise quantification of atorvastatin and its metabolites in complex biological matrices like plasma, serum, and tissue homogenates.
• Drug Metabolism and Pharmacokinetics (DMPK): Enables accurate tracking of drug absorption, distribution, metabolism, and excretion (ADME) profiles in preclinical and clinical studies.
• Bioequivalence and Bioanalytical Testing: Supports regulatory submissions by providing robust data for bioequivalence studies of generic atorvastatin formulations.
• Metabolite Identification and Profiling: Aids in the structural elucidation and quantification of hydroxylated and other oxidative metabolites of atorvastatin.
• Quality Control in API Manufacturing: Serves as a reference standard for the analytical validation of atorvastatin calcium active pharmaceutical ingredient (API) batches.
• Stability-Indicating Methods: Used in the development and execution of HPLC and UPLC assays to monitor the stability and degradation products of atorvastatin formulations.

Basic Information

Item	Details
Product Name	p-Hydroxy Atorvastatin-D5 Calcium Salt
CAS No.	214217-88-6
Molecular Formula	C66H68D5CaF2N4O10
Molecular Weight	Contact for details
Synonyms	Atorvastatin-d5 Hydroxy Calcium Salt; [R-(R*,R*)]-2-(4-Fluorophenyl)-β,δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic Acid-d5 Calcium Salt (2:1); Deuterated Atorvastatin Hydroxy Metabolite Calcium Salt; Atorvastatin-d5 p-Hydroxy Analog Calcium; p-Hydroxy Atorvastatin-d5 Ca Salt; Internal Standard for Atorvastatin Analysis; Atorvastatin Metabolite-d5 Standard
EINECS	Contact for details

Quality Control

Our p-Hydroxy Atorvastatin-D5 Calcium Salt is manufactured under strict quality systems to ensure it meets the exacting requirements for analytical reference standards. Each batch undergoes rigorous testing, including identity confirmation by spectroscopic methods and purity assessment by advanced chromatographic techniques. Certificates of Analysis (COA) are provided, detailing batch-specific results for isotopic purity, chemical purity, and residual solvents, ensuring full traceability and compliance with relevant pharmacopeial guidelines for reference standards.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept under anhydrous conditions. For long-term storage, consider storing under an inert atmosphere in a desiccator.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (NMR)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Purity (LC-MS)	≥ 98.0 atom % D
Chemical Purity (HPLC)	≥ 95.0%
Water Content (KF)	≤ 2.0%
Residual Solvents (GC)	Complies with ICH limits

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