Description

7-Hydroxy Methotrexate-D3 is a deuterium-labeled internal standard critical for the precise quantification of its parent compound in complex biological matrices. This high-purity reference material is essential for ensuring accuracy and reproducibility in advanced analytical workflows. It is primarily utilized by pharmaceutical R&D laboratories, clinical research organizations, and bioanalytical service providers engaged in method development and validation for pharmacokinetic and metabolic studies.

Application

• Bioanalytical Method Development: Serves as a stable isotope-labeled internal standard for the quantification of 7-Hydroxy Methotrexate and Methotrexate in biological fluids (plasma, serum, urine) using LC-MS/MS.
• Pharmacokinetic (PK) and Pharmacodynamic (PD) Studies: Enables accurate tracking of drug metabolism and clearance rates in preclinical and clinical trial samples.
• Therapeutic Drug Monitoring (TDM): Supports the development of robust assays for monitoring methotrexate metabolite levels in patients undergoing treatment, aiding in dose optimization and toxicity management.
• Metabolite Identification and Quantification: Used in research to study the metabolic pathways of methotrexate, providing insights into its efficacy and safety profile.
• Regulatory Submission Support: Provides the traceable and consistent reference material required for generating data that meets stringent FDA, EMA, and ICH guidelines for bioanalytical method validation.
• Quality Control in Pharmaceutical Manufacturing: Can be employed in impurity profiling and stability testing of methotrexate-based drug products.

Basic Information

Product Name	7-Hydroxy Methotrexate-D3
CAS No.	432545-62-5
Molecular Formula	C₂₀H₂₀D₃N₈O₅
Molecular Weight	468.46 g/mol
Synonyms	7-Hydroxy Methotrexate-d3; (2S)-2-[[4-[(2,4-Diaminopteridin-6-yl)methyl-methylamino]benzoyl]amino]-5-[(3-hydroxy-2,3,3-trideuteriopentanoyl)amino]pentanedioic acid; 7-OH-MTX-D3; Deuterated 7-Hydroxy Methotrexate; Methotrexate Metabolite D3 Standard
EINECS	Contact for details

Quality Control

Our 7-Hydroxy Methotrexate-D3 is manufactured under strict quality systems to ensure the highest standards of purity and isotopic enrichment. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) detailing results for identity, purity (HPLC), chemical purity, isotopic purity (D-content), and residual solvents. Our quality commitment aligns with the principles of cGMP for reference standards, supporting data integrity for regulatory submissions.

Storage

Preserve in a tightly closed container, protected from light. Store at -20°C or below. For long-term storage, keep desiccated at -80°C. Allow the vial to equilibrate to room temperature in a dry environment before opening to minimize moisture absorption.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC/MS)	Conforms to reference standard
Purity (HPLC)	≥ 98.0%
Isotopic Purity (D-content)	≥ 98.0 atom % D
Chemical Purity	≥ 95.0%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Meets ICH guidelines

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