Description

Calcitonin Impurity 7 is a specified impurity of the peptide hormone Calcitonin, identified by the CAS registry number 73547-10-1. This high-purity reference standard is critical for analytical method development, validation, and quality control in pharmaceutical manufacturing. It is primarily required by researchers and quality assurance professionals in the pharmaceutical and biotechnology sectors for ensuring the purity, safety, and efficacy of Calcitonin-based drug products and APIs.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of Calcitonin Impurity 7 in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Essential for developing and validating sensitive HPLC, UPLC, or LC-MS methods to monitor impurities in Calcitonin synthesis and purification processes.
• Quality Control & Assurance (QC/QA): Used in routine batch testing to ensure compliance with stringent pharmacopeial limits (e.g., ICH Q3A/B, USP, EP) for related substances.
• Stability Studies: Employed as a marker to track the formation of degradation products during forced degradation and long-term stability testing of Calcitonin formulations.
• Regulatory Submissions: Provides necessary impurity characterization data for regulatory filings (e.g., FDA, EMA) to support drug approval and market authorization.
• Process Chemistry Research: Aids in understanding synthetic pathways and optimizing manufacturing processes to minimize the formation of this specific impurity.

Basic Information

Product Name	Calcitonin Impurity 7
CAS No.	73547-10-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Calcitonin Related Compound 7; Calcitonin Impurity C; Calcitonin (salmon) Impurity 7; Calcitonin (human) Impurity 7; Calcitonin (synthetic) Impurity 7; Calcitonin peptide impurity; CAS 73547-10-1
EINECS	Contact for details

Quality Control

Our Calcitonin Impurity 7 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including chromatographic purity analysis and structural confirmation, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing identity, purity, and assay is provided with every shipment to support your regulatory and quality needs.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C) or as indicated on the label. Due to its hygroscopic nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Meets requirement
Water Content	≤ 5.0%

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