Description

Bilastine Impurity 12 is a specified organic impurity associated with the antihistamine drug substance Bilastine. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development, validation, and quality control. It is primarily used by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure the purity, safety, and efficacy of Bilastine-based drug products. The availability of a well-characterized impurity standard is essential for meeting stringent global regulatory requirements for drug substance and drug product filings.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Bilastine Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC/UPLC methods to monitor impurity profiles during stability studies and forced degradation testing.
• Quality Control & Batch Release: Employed in routine QC testing to ensure Bilastine batches comply with established impurity limits as per ICH Q3A(R2) and Q3B(R2) guidelines.
• Regulatory Compliance & Filing: Supports the preparation of regulatory submission documents (e.g., CMC sections for FDA, EMA) by providing necessary impurity characterization data.
• Stability Studies: Acts as a marker to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity).
• Process Chemistry Research: Used to study and optimize the synthetic pathway of Bilastine to minimize the formation of this impurity.

Basic Information

Product Name	Bilastine Impurity 12
CAS No.	1638785-18-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Bilastine Related Compound 12; Bilastine Impurity; Bilastine EP Impurity 12; Bilastine USP Impurity; 2-[4-[(R)-(4-Chlorophenyl)(phenyl)methoxy]piperidin-1-yl]ethyl 3-aminopropanoate; UNII-0Q9K5VQ1R2
EINECS	Contact for details

Quality Control

Every batch of Bilastine Impurity 12 is manufactured and analyzed under strict quality management systems. The material undergoes comprehensive characterization and purity analysis using advanced techniques such as HPLC, GC, NMR, and MS to ensure identity, potency, and purity. A comprehensive Certificate of Analysis (COA) is provided with each batch, detailing all analytical results. Our quality standards align with the requirements for pharmaceutical reference standards and support compliance with ICH, USP, and EP guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F), in a dry environment. For long-term storage, consider storing desiccated at 2-8°C. Handle the material under appropriate conditions to prevent contamination or degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (NMR/IR)	Conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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