Description

Calcium Dobesilate Hydrate Impurity 2 is a specified impurity reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient, Calcium Dobesilate. This compound is critical for ensuring the purity, safety, and efficacy of pharmaceutical formulations. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and batch release testing.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of related substances in Calcium Dobesilate API and finished drug products.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC, UPLC, or GC methods to monitor impurity profiles.
• Quality Control & Batch Release: Employed in routine QC testing to ensure API batches comply with pharmacopeial (e.g., EP, USP) or internal purity specifications.
• Stability Studies: Used to track the formation and growth of this specific degradation product under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Provides necessary impurity characterization data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research & Development: Supports impurity isolation, identification, and toxicological studies during the drug development process.

Basic Information

Product Name	Calcium Dobesilate Hydrate Impurity 2
CAS No.	35857-70-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Calcium Dobesilate Related Compound B; Dobesilate Calcium Impurity 2; Calcium 2,5-Dihydroxybenzenesulfonate Impurity; 2,5-Dihydroxybenzenesulfonic Acid Calcium Salt Impurity; Calcium Hydroxy(methyl)benzenesulfonate Impurity; Dobesilate Impurity C (Calcium); 1,2-Dihydroxybenzene-4-sulfonic Acid Calcium Salt Derivative
EINECS	Contact for details

Quality Control

Our Calcium Dobesilate Hydrate Impurity 2 is manufactured under strict quality systems. Each batch is characterized and tested using advanced analytical techniques to ensure high purity and accurate certification. A comprehensive Certificate of Analysis (COA) is provided, detailing results for identity, purity, and assay by HPLC. Our quality commitment aligns with the standards required for pharmaceutical reference materials.

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 material is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and certified purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference
Assay (HPLC)	≥ 95.0%
Purity (HPLC)	≥ 98.0%
Water Content	≤ 5.0%
Residual Solvents	Complies with ICH guidelines

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