Description

Cladribine Impurity D is a specified impurity of the active pharmaceutical ingredient Cladribine, a purine nucleoside analog used in chemotherapy. This high-purity reference standard is critical for analytical method development, validation, and quality control in pharmaceutical manufacturing. It is essential for researchers and quality assurance professionals in the pharmaceutical industry who require reliable materials for ensuring drug safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Cladribine Impurity D in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development: Used in developing and optimizing chromatographic methods, such as HPLC and UPLC, for impurity profiling.
• Quality Control & Assurance: Critical for routine batch testing in QC laboratories to monitor impurity levels and ensure they remain within specified limits (ICH guidelines).
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing characterized impurity data for drug master files (DMFs) and marketing authorization applications.
• Stability Studies: Employed as a marker in forced degradation and long-term stability studies of Cladribine to understand degradation pathways.
• Research & Development: Used in pharmacokinetic and metabolic studies to understand the fate of this impurity in biological systems.

Basic Information

Product Name	Cladribine Impurity D
CAS No.	5542-92-7
Molecular Formula	C10H12ClN5O3
Molecular Weight	285.69 g/mol
Synonyms	2-Chloro-2'-deoxyadenosine Impurity D; 2-CdA Impurity D; 2-Chlorodeoxyadenosine Related Compound D; 5'-O-Acetyl-2-chloro-2'-deoxyadenosine; 2-Chloro-9-(2-deoxy-5-O-acetyl-β-D-erythro-pentofuranosyl)adenine; 2-Cl-2'-deoxyadenosine 5'-acetate; Leustatin Impurity D
EINECS	Contact for details

Quality Control

Every batch of Cladribine Impurity D is manufactured and analyzed under strict quality management systems. We provide comprehensive analytical data to support its use as a reference standard, including characterization by HPLC, NMR, and MS. A detailed Certificate of Analysis (COA) is supplied with each shipment, confirming identity, purity, and impurity profile. Our quality systems are designed to meet the stringent requirements of pharmaceutical R&D and QC laboratories.

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 compound is hygroscopic (moisture-sensitive); therefore, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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