Description

Calcitonin Impurity 1 is a specified impurity of the peptide hormone Calcitonin, identified by the CAS registry number 28567-37-5. This compound is critical for pharmaceutical research and development, serving as a key reference standard for ensuring the purity, safety, and efficacy of Calcitonin-based drug products. It is primarily required by analytical laboratories and manufacturers in the pharmaceutical and biotechnology sectors for method development, validation, and rigorous quality control testing.

Application

• As a Pharmaceutical Reference Standard for the identification and quantification of impurities in Calcitonin Active Pharmaceutical Ingredients (APIs) and finished drug products.
• For Analytical Method Development and Validation (e.g., HPLC, UPLC) to establish specificity, accuracy, and detection limits for impurity profiling.
• In Stability Studies to monitor degradation pathways and establish shelf-life specifications for Calcitonin formulations.
• For Quality Control and Batch Release Testing to ensure compliance with pharmacopeial standards (USP, EP, ICH Q3A/B).
• As a critical material in Regulatory Submissions (e.g., CMC sections for FDA, EMA) to demonstrate control over the manufacturing process.
• Used in Research and Development to study the chemical and biological properties of Calcitonin-related compounds.

Basic Information

Product Name	Calcitonin Impurity 1
CAS No.	28567-37-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Calcitonin Related Compound 1; Calcitonin Impurity A; Calcitonin (salmon) impurity; (1,7-Dicarboxyheptyl)phosphonic acid (potential derivative/structure-related name); CAS 28567-37-5; Salmon Calcitonin Impurity
EINECS	Contact for details

Quality Control

Our Calcitonin Impurity 1 is produced and handled under strict quality management systems. Each batch undergoes comprehensive analytical testing, including chromatographic purity assays and spectroscopic identification, to ensure it meets the exacting standards required for use as a reference material. A detailed Certificate of Analysis (COA) providing batch-specific results is supplied with every shipment to support your quality and regulatory requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (typically 15-25°C). Due to its hygroscopic nature, the container should be kept in a desiccated environment to prevent moisture uptake. For long-term storage, consider conditions of 2-8°C.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity ≤ 1.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%

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