Description

Risedronic Acid D4 CAS NO 1035438-80-2 is a deuterated isotopologue of the active pharmaceutical ingredient risedronic acid, a potent bisphosphonate. This stable isotope-labeled compound is essential for use as an internal standard in quantitative mass spectrometry-based bioanalytical methods, ensuring the highest accuracy and reliability in pharmacokinetic and metabolic studies. It is a critical tool for pharmaceutical R&D laboratories, contract research organizations (CROs), and academic institutions engaged in drug development and clinical research for bone metabolism disorders.

Application

• Internal Standard for LC-MS/MS Analysis: Primary application for quantifying risedronic acid in complex biological matrices like plasma, serum, and urine.
• Pharmacokinetic (PK) and Bioequivalence Studies: Enables precise measurement of drug concentration over time to determine absorption, distribution, metabolism, and excretion profiles.
• Metabolite Identification and Profiling: Used in high-resolution mass spectrometry to aid in the structural elucidation of drug metabolites.
• Method Development and Validation: Serves as a critical reference material for developing and validating robust, GLP-compliant analytical methods.
• Drug Metabolism and Pharmacokinetics (DMPK) Research: Fundamental for in-vitro and in-vivo studies to understand the drug's metabolic fate.
• Clinical Trial Support: Provides reliable data for patient monitoring and efficacy assessment during clinical phases of drug development.
• Quality Control in API Manufacturing: Can be utilized in analytical procedures to monitor process-related impurities.

Basic Information

Product Name	Risedronic Acid D4
CAS No.	1035438-80-2
Molecular Formula	C7H6D4NO7P2
Molecular Weight	286.12 g/mol (for monohydrate form)
Synonyms	[1-Hydroxy-2-(3-pyridinyl)ethylidene]bisphosphonic Acid-d4; (1-Hydroxy-1-phosphono-2-pyridin-3-ylethane-1,1-diyl)bisphosphonic Acid-d4; Risedronate-d4; Risedronate Sodium-d4 (salt form); Risedronic Acid Deuterated; Risedronate-d4 Internal Standard; 2-(3-Pyridinyl)-1-hydroxyethylidene-1,1-bisphosphonic Acid-d4; Actonel-d4
EINECS	Contact for details

Quality Control

Our Risedronic Acid D4 is manufactured under strict quality control protocols to ensure it meets the exacting standards required for analytical reference materials. Each batch is characterized by advanced spectroscopic and chromatographic techniques, including NMR, HPLC, and MS, to confirm chemical identity, isotopic purity (D-enrichment ≥98%), and chemical purity (typically ≥95%). A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment to support your regulatory and quality documentation needs.

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) and must be kept in a dry environment. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 95.0%
Isotopic Purity (D-enrichment)	≥ 98.0 atom % D
Chemical Purity (NMR)	Conforms
Water Content (KF)	≤ 5.0%
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.