Description

Pregabalin Impurity 22 is a high-purity reference standard used for analytical and research purposes. This compound is critical for the quality control and regulatory compliance of Pregabalin, a widely prescribed pharmaceutical. It is primarily needed by pharmaceutical manufacturers, analytical laboratories, and research institutions involved in drug development and impurity profiling. Ensuring the integrity of this impurity standard is fundamental to maintaining the safety and efficacy of the final drug product.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material for the identification and quantification of Pregabalin Impurity 22 in active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Used in HPLC, UPLC, and LC-MS methods to establish system suitability, specificity, and detection limits for impurity analysis.
• Quality Control & Assurance (QC/QA): Essential for routine batch testing of Pregabalin to ensure compliance with pharmacopeial monographs (USP, EP, ICH guidelines) and internal specifications.
• Stability Studies: Employed to monitor the formation and level of this specific impurity under various stress conditions (e.g., heat, light, humidity) during drug shelf-life studies.
• Regulatory Submissions: Provides necessary data for impurity identification and qualification reports required by regulatory bodies like the FDA and EMA.
• Research & Development: Used in synthetic chemistry research to study the formation pathways and chemical behavior of this impurity.

Basic Information

Item	Detail
Product Name	Pregabalin Impurity 22
CAS No.	1082077-24-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	(S)-3-(Aminomethyl)-5-methylhexanoic acid impurity 22; Pregabalin Related Compound 22; Lyrica Impurity 22; (3S)-3-(Aminomethyl)-5-methylhexanoic acid impurity; Pregabalin EP Impurity J; Pregabalin Process Impurity
EINECS	Contact for details

Quality Control

Our Pregabalin Impurity 22 is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods, to ensure it meets the high 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 standards.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. Keep the container in a dry, cool, and well-ventilated area.

Specification

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

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