Description

D 517-D7 Hydrochloride (Verapamil Impurity) is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the calcium channel blocker drug, Verapamil. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling studies. The material is supplied with comprehensive analytical data to support rigorous quality control protocols.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference standard for the identification and quantification of specific impurities in Verapamil hydrochloride active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing and validating chromatographic methods (HPLC, UPLC) to ensure specificity, accuracy, and precision in impurity detection.
• Quality Control & Assurance (QC/QA): Serves as a system suitability standard and for routine batch release testing in pharmaceutical manufacturing to comply with ICH Q3A/B guidelines.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., ANDA, NDA) by providing characterized impurity data for health authorities like the US FDA and EMA.
• Stability Studies: Employed in forced degradation and long-term stability studies of Verapamil to monitor impurity formation over time and under various stress conditions.
• Research & Development: Used in pharmaceutical R&D for studying the degradation pathways, metabolism, and synthesis of Verapamil and related compounds.

Basic Information

Product Name	D 517-D7 Hydrochloride (Verapamil Impurity)
CAS No.	1330173-18-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Verapamil Impurity D 517-D7 HCl; D517-D7 Hydrochloride; Verapamil Related Compound D 517-D7; 5-[(3,4-Dimethoxyphenethyl)methylamino]-2-(3,4-dimethoxyphenyl)-2-isopropylvaleronitrile Hydrochloride (Deuterated); Verapamil-d7 Hydrochloride Impurity; Norverapamil Impurity (deuterated analog); (RS)-Verapamil-d7 Impurity Hydrochloride
EINECS	Contact for details

Quality Control

Every batch of D 517-D7 Hydrochloride (Verapamil Impurity) is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity assay, and impurity profiling using advanced techniques like HPLC, MS, and NMR to ensure it meets the exacting standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming compliance with relevant pharmacopeial guidelines.

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 nature, the container should be kept in a desiccated environment to prevent moisture uptake. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%
Heavy Metals	≤ 20 ppm
Isotopic Purity (Deuteration)	≥ 98 atom % D

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