Description

Oxonic Acid Impurity 1 CAS NO 60301-55-5 is a high-purity chemical reference standard used for analytical and quality control purposes. This compound is critical for ensuring the purity and safety profile of pharmaceutical products and fine chemicals where oxonic acid or its derivatives are involved. It is primarily utilized by research and development laboratories, quality assurance departments in pharmaceutical manufacturing, and analytical service providers for method development and validation.

Application

• Pharmaceutical Impurity Profiling: Serves as a certified reference material for the identification and quantification of specific impurities in oxonic acid active pharmaceutical ingredients (APIs) and drug products.
• Analytical Method Development: Used as a standard to develop and validate HPLC, UPLC, or GC methods for impurity detection in compliance with ICH Q3A/B guidelines.
• Quality Control & Assurance: Essential for routine batch testing in pharmaceutical manufacturing to monitor and control impurity levels, ensuring product consistency and regulatory compliance.
• Stability Studies: Employed as a marker compound in forced degradation and shelf-life studies to understand the degradation pathways of oxonic acid-containing formulations.
• Chemical Research: Used as a building block or intermediate in synthetic organic chemistry research for developing new compounds or studying reaction mechanisms.
• Regulatory Submissions: Provides necessary impurity data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).

Basic Information

Product Name	Oxonic Acid Impurity 1
CAS No.	60301-55-5
Molecular Formula	C5H4N4O3
Molecular Weight	168.11 g/mol
Synonyms	1,2,3,6-Tetrahydro-3,6-dioxopyrazino[2,3-d]pyridazine; 1,2,3,6-Tetrahydro-3,6-dioxopyridazino[2,3-d]pyridazine; 3,6-Dioxo-1,2,3,6-tetrahydropyridazino[2,3-d]pyridazine; Oxonate Impurity 1; Oxonic Acid Related Compound A; Pyridazino[2,3-d]pyridazine-1,4(2H,3H)-dione, 5,8-dihydro-; 5,8-Dihydro-1,4-dioxopyridazino[2,3-d]pyridazine
EINECS	Contact for details

Quality Control

Every batch of Oxonic Acid Impurity 1 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing, including advanced chromatographic techniques, to ensure identity, purity, and consistency in line with industry standards for reference materials. Certificates of Analysis (COA) detailing batch-specific results are provided and can be tailored to meet specific pharmacopeial (e.g., USP, EP) or customer requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept 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 structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Individual 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.