Description

Creatine Phosphate Impurity 1 is a specified impurity of creatine phosphate, a critical biomolecule involved in cellular energy metabolism. This high-purity reference standard is essential for pharmaceutical research and development, particularly in the analysis and quality control of creatine phosphate-based drug substances and products. It is primarily used by analytical chemists and quality assurance professionals in the pharmaceutical and biotechnology industries to ensure product safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of related substances in creatine phosphate active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Used as a critical component in developing and validating HPLC, UPLC, or LC-MS methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to monitor impurity levels and ensure compliance with ICH Q3A/B guidelines and pharmacopeial standards (e.g., USP, EP).
• Stability Studies: Acts as a marker compound in forced degradation and long-term stability studies to understand the degradation pathways of creatine phosphate.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., CMC sections of IND/NDA/ANDA) to demonstrate thorough impurity characterization.
• Biochemical Research: Used in metabolic research to study the pathways and by-products of creatine phosphate metabolism.

Basic Information

Item	Detail
Product Name	Creatine Phosphate Impurity 1
CAS No.	98924-69-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Phosphocreatine Impurity 1; Creatine Phosphate Related Compound 1; N-Methylguanidinoethyl Phosphoric Acid (potential structural synonym); CP Impurity 1; Phosphorylcreatine Impurity A; 98924-69-7; PCr Impurity 1
EINECS	Contact for details

Quality Control

Every batch of Creatine Phosphate Impurity 1 is manufactured and controlled under a strict quality management system. The material undergoes comprehensive analytical testing, including chromatographic purity (HPLC), identity confirmation (IR, MS), and residual solvent analysis, to ensure it meets the stringent requirements for use as a reference standard. A comprehensive Certificate of Analysis (COA) with batch-specific data is provided, supporting compliance with current Good Manufacturing Practice (cGMP) principles and ICH guidelines.

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 product is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity. Avoid repeated opening of the primary container.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unspecified impurity ≤ 1.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

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