Description

Calcium Dobesilate Impurity 5 is a specified impurity and reference standard used in the quality control of the active pharmaceutical ingredient, Calcium Dobesilate. This compound is critical for ensuring the purity, safety, and efficacy of pharmaceutical formulations through precise analytical methods. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for research, development, and quality assurance processes.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Calcium Dobesilate API batches.
• Analytical Method Development & Validation: Essential for developing and validating HPLC, UPLC, or other chromatographic methods in quality control laboratories.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing necessary impurity profiles and stability data.
• Pharmaceutical R&D: Employed in research to study degradation pathways and establish stability-indicating methods for Calcium Dobesilate.
• Quality Control & Batch Release: A critical component in the routine QC testing of raw materials and finished pharmaceutical products to ensure they meet pharmacopeial specifications.

Basic Information

Product Name	Calcium Dobesilate Impurity 5
CAS No.	81010-88-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Dobesilate Impurity 5; Calcium Dobesilate Related Compound 5; 2,5-Dihydroxybenzenesulfonic Acid Calcium Salt Impurity; Calcium 2,5-Dihydroxybenzenesulfonate Impurity 5; Dobesilate Calcium Impurity C; Dobesilic Acid Impurity 5; Calcium Dobesilate EP Impurity 5
EINECS	Contact for details

Quality Control

Our Calcium Dobesilate Impurity 5 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity and identity confirmation (IR, NMR), to ensure it meets the stringent requirements for use as a pharmaceutical reference standard. A detailed Certificate of Analysis (COA) is provided with every shipment, confirming compliance with in-house specifications aligned with ICH guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). The product is light-sensitive and should be handled under appropriate conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Complies
Residual Solvents (GC)	Complies with ICH limits

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