Description

Calcitonin Impurity 4 is a defined chemical impurity used as a reference standard in the pharmaceutical development and quality control of Calcitonin-based drugs. This high-purity compound is critical for ensuring the safety and efficacy of peptide therapeutics by enabling accurate identification and quantification of process-related impurities. It is an essential material for analytical laboratories, quality assurance departments, and research institutions focused on peptide synthesis and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of Calcitonin Impurity 4 in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Critical for developing, optimizing, and validating HPLC, UPLC, and LC-MS methods for impurity profiling in compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control & Batch Release Testing: Used in routine QC testing to monitor impurity levels, ensuring batch-to-batch consistency and adherence to strict pharmacopeial specifications (e.g., USP, EP).
• Stability Studies: Employed as a marker to track impurity formation during forced degradation and long-term stability studies of Calcitonin drug substances and products.
• Regulatory Submissions: Supports the preparation of regulatory dossiers (e.g., for FDA, EMA) by providing definitive characterization data for specified impurities.
• Process Chemistry Research: Aids in understanding and optimizing the synthesis and purification processes for Calcitonin to minimize the formation of this specific impurity.

Basic Information

Product Name	Calcitonin Impurity 4
CAS No.	76240-86-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Calcitonin Related Compound 4; Salmon Calcitonin Impurity 4; Calcitonin (salmon) Impurity D; CAS 76240-86-3; Impurity 4 of Calcitonin; Calcitonin Process Impurity 4; Calcitonin Specified Impurity 4
EINECS	Contact for details

Quality Control

Every batch of Calcitonin Impurity 4 is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical characterization, including HPLC purity determination, LC-MS confirmation, and NMR spectroscopy, to ensure identity, strength, and composition. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming compliance with in-house specifications aligned with ICH guidelines for impurity standards.

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 Certificate of Analysis. This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Mass spectrum conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Report individual and total impurities
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.