Description

Benidipine Oxidation Impurities (Hydrochloride) are critical reference standards used in the analytical profiling of the active pharmaceutical ingredient Benidipine. These impurities are essential for ensuring the quality, safety, and efficacy of the final drug product by enabling accurate identification and quantification of potential oxidative degradation products. They are primarily required by pharmaceutical manufacturers, quality control laboratories, and regulatory bodies for method development, validation, and stability studies.

Application

• Pharmaceutical Quality Control (QC): Used as certified reference standards for the identification and quantification of oxidative degradation products in Benidipine API and finished dosage forms.
• Analytical Method Development & Validation: Critical for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods to monitor impurity profiles.
• Stability Studies: Employed to assess the forced degradation and long-term stability of Benidipine under various environmental conditions (e.g., heat, humidity, light).
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., ANDA, NDA) by providing necessary impurity data to meet ICH Q3A(R2) and Q3B(R2) guidelines.
• Research & Development: Aids in understanding the degradation pathways of Benidipine to improve formulation strategies and shelf-life predictions.
• Pharmacopoeial Standards: Serves as a potential impurity standard for compliance with pharmacopoeial monographs (e.g., USP, EP, JP).

Basic Information

Product Name	Benidipine Oxidation Impurities (Hydrochloride)
CAS No.	121138-34-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Benidipine Related Compound; Benidipine Oxidative Degradant; Benidipine Hydrochloride Oxidation Impurity; Benidipine Impurity; Benidipine Degradation Product; 1,4-Dihydropyridine Oxidation Impurity; Calcium Channel Blocker Impurity; Coniel® Related Substance
EINECS	Contact for details

Quality Control

Our Benidipine Oxidation Impurities (Hydrochloride) are manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods (NMR, MS). Certificates of Analysis (COA) with detailed chromatographic data are provided to ensure compliance with ICH guidelines and support your regulatory requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a desiccated environment to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (MS)	Consistent with molecular structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single specified impurity
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

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