Description

Alendronic-D6 Acid is a deuterated isotopologue of alendronic acid, a key bisphosphonate compound. This high-purity reference standard is essential for ensuring analytical accuracy and reliability in pharmaceutical research and development. It is primarily utilized by scientists and quality control laboratories in the pharmaceutical and biotechnology sectors for applications such as method validation, metabolism studies, and internal standard preparation.

Application

• Pharmaceutical Reference Standard: Serves as a certified internal standard for the precise quantification of alendronic acid in drug substances and finished products using LC-MS/MS and other analytical techniques.
• Metabolic Studies: Used in pharmacokinetic and drug metabolism research (ADME) to track and differentiate the parent compound from its metabolites in biological matrices.
• Method Development & Validation: Critical for developing and validating robust, sensitive, and specific analytical methods in compliance with ICH and GLP guidelines.
• Quality Control & Assurance: Employed in QC laboratories to ensure batch-to-batch consistency, purity, and potency of alendronate sodium active pharmaceutical ingredients (APIs) and formulations.
• Stability-Indicating Assays: Facilitates the development of assays to monitor the stability and degradation profiles of bisphosphonate drugs under various conditions.
• Biomedical Research: Used as a tracer in biochemical research to investigate bone resorption mechanisms and the pharmacodynamics of bisphosphonate therapies.

Basic Information

Product Name	Alendronic-D6 Acid
CAS No.	1035437-39-8
Molecular Formula	C4D6H6NO7P2
Molecular Weight	273.10 g/mol (deuterated form)
Synonyms	(4-Amino-1-hydroxy-1-phosphonobutyl)phosphonic-1,1,2,3,3,3-d6 Acid; Alendronate-d6; Alendronic Acid-d6; 4-Amino-1-hydroxybutylidene-1,1-bisphosphonic Acid-d6; Deuterated Alendronic Acid; [1,1,2,3,3,3-2H6]-4-Amino-1-hydroxy-1,1-butanediyldiphosphonic Acid; Alendronic Acid (Hexadeuterated); ALN-d6
EINECS	Contact for details

Quality Control

Every batch of Alendronic-D6 Acid CAS 1035437-39-8 is manufactured and analyzed under strict quality management systems. We guarantee high chemical purity and isotopic enrichment, supported by comprehensive analytical data including NMR, HPLC, and MS. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting identity, purity (by HPLC), isotopic purity, and other critical parameters to meet the stringent requirements of pharmaceutical reference standard applications.

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); ensure the container is sealed tightly after each use to prevent degradation due to moisture absorption.

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 (NMR)	Conforms
Water Content (KF)	≤ 2.0%

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