Description

Ibadronic Acid-D3 is a deuterated analog of ibandronic acid, a potent bisphosphonate used in bone metabolism research. This stable isotope-labeled compound is essential for precise pharmacokinetic and metabolic studies, providing critical internal standards for mass spectrometry. It is primarily utilized by pharmaceutical R&D laboratories, contract research organizations (CROs), and academic institutions focused on osteoporosis treatment development and bioanalytical method validation. The product is supplied as a high-purity reference material to ensure data accuracy and reproducibility.

Application

• Internal Standard for LC-MS/MS: Serves as a critical deuterated internal standard in the quantitative bioanalysis of ibandronic acid in biological matrices like plasma and serum.
• Drug Metabolism and Pharmacokinetics (DMPK): Used in absorption, distribution, metabolism, and excretion (ADME) studies to track the parent drug without interference from metabolites.
• Clinical Research Assay Development: Enables the development and validation of highly sensitive and specific analytical methods for clinical trial sample analysis.
• Pharmaceutical Impurity Profiling: Aids in the identification and quantification of process-related impurities or degradants in active pharmaceutical ingredient (API) batches.
• Stable Isotope Tracer Studies: Facilitates advanced metabolic pathway investigation in preclinical models to understand drug action mechanisms.
• Quality Control Reference Material: Acts as a certified reference standard for in-house quality control testing of ibandronate sodium APIs and finished dosage forms.

Basic Information

Product Name	Ibadronic Acid-D3
CAS No.	1130899-41-0
Molecular Formula	C9H20D3NO7P2
Molecular Weight	325.23 g/mol (approximate)
Synonyms	Ibandronic Acid-d3; [D3]-Ibandronic Acid; 1-Hydroxy-3-(methyl-d3-amino)-1,1-propylidenebisphosphonic Acid; (3-(Methyl-d3-amino)-1-hydroxy-1-phosphonopropyl)phosphonic Acid; Ibandronate-d3; Bondronat-d3; Bonviva-d3; BN-d3
EINECS	Contact for details

Quality Control

Every batch of Ibadronic Acid-D3 is manufactured and tested under strict quality management systems. We provide comprehensive analytical data to support its use as a reference standard, including confirmation of isotopic purity and chemical identity. A detailed Certificate of Analysis (COA) is supplied with each shipment, documenting purity (by HPLC), isotopic enrichment, and results from specific identification tests. Our quality commitment ensures compliance with the standards expected for pharmaceutical research and development.

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). Keep the container tightly sealed in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

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 (MS)	≥ 99.0 atom % D
Chemical Purity	≥ 95.0% (by HPLC, area %)
Water Content (KF)	≤ 2.0%
Residue on Ignition	≤ 0.5%

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