Description

Inosine Impurity 1 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of pharmaceutical products containing inosine or its derivatives. It is primarily required by analytical chemists, quality control laboratories, and research scientists working in pharmaceutical development and manufacturing. The availability of a well-characterized impurity standard is essential for method validation, stability studies, and impurity profiling.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in inosine Active Pharmaceutical Ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Serves as a critical component in developing and validating HPLC, UPLC, or GC methods for impurity detection and assay.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to monitor impurity levels and ensure product specifications are met according to ICH Q3A/B guidelines.
• Stability Studies: Used to track the formation of degradation products in inosine formulations under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to demonstrate control over product impurities.
• Research & Development: Facilitates metabolic studies, pharmacokinetic research, and the synthesis of related compounds in medicinal chemistry.

Basic Information

Product Name	Inosine Impurity 1
CAS No.	146196-07-8
Molecular Formula	C10H12N4O5
Molecular Weight	268.23 g/mol
Synonyms	9-β-D-Ribofuranosylhypoxanthine Impurity 1; Inosine Related Compound A; 1,9-Dihydro-9-[(2R,3R,4S,5R)-3,4-dihydroxy-5-(hydroxymethyl)oxolan-2-yl]-6H-purin-6-one; Hypoxanthine riboside impurity; Inosine EP Impurity A; Inosine USP Related Substance; 6-Oxopurine riboside impurity
EINECS	Contact for details

Quality Control

Every batch of Inosine Impurity 1 is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC for purity and identity confirmation (IR, NMR), to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, assay, and impurity profile. We support compliance with ICH guidelines and can supply materials suitable for use in regulated environments.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. This material is hygroscopic (moisture-sensitive); keep the container tightly sealed in a dry environment. For long-term storage, consider storing under inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Assay	97.0% - 103.0% (on dried basis)
Water Content (KF)	≤ 2.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%

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