Description

Pregabalin Impurity 11/(S)-4,5-Dehydro Pregabalin/(3S)-3-(Aminomethyl)-5-Methyl-4-Hexenoic Acid is a high-purity chemical reference standard, specifically a structural analog and impurity of the active pharmaceutical ingredient pregabalin. This compound is critical for pharmaceutical research and development, serving as a key marker for analytical method development, stability studies, and quality control in API manufacturing. It is primarily required by pharmaceutical companies, contract research organizations (CROs), and analytical laboratories engaged in the synthesis, purification, and regulatory compliance of pregabalin-based therapeutics.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of related substances in pregabalin active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing and validating HPLC, UPLC, and LC-MS methods to ensure specificity, accuracy, and precision in impurity profiling.
• Stability Indicating Studies: Employed in forced degradation and long-term stability studies of pregabalin to monitor the formation of this specific degradation product.
• Quality Control & Batch Release: A critical component in the quality control workflow for pharmaceutical manufacturers to confirm batch-to-batch consistency and compliance with ICH guidelines.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to establish impurity thresholds and control strategies as per ICH Q3A(R2) and Q3B(R2).
• Research into Metabolic Pathways: Used in research settings to study the metabolism and pharmacokinetics of pregabalin and its analogs.

Basic Information

Product Name	Pregabalin Impurity 11/(S)-4,5-Dehydro Pregabalin/(3S)-3-(Aminomethyl)-5-Methyl-4-Hexenoic Acid
CAS No.	1141362-54-0
Molecular Formula	C9H17NO2
Molecular Weight	171.24 g/mol
Synonyms	(3S)-3-(Aminomethyl)-5-methyl-4-hexenoic acid; (S)-4,5-Dehydro Pregabalin; Pregabalin Related Compound H; Pregabalin Impurity H; Pregabalin EP Impurity H; (S)-3-(Aminomethyl)-5-methylhex-4-enoic acid; Lyrica Impurity 11; (3S)-3-(Aminomethyl)-5-methyl-4-hexenoic Acid Hydrochloride (salt form)
EINECS	Contact for details

Quality Control

Every batch of Pregabalin Impurity 11 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity, purity, and impurity profile testing using advanced analytical techniques including HPLC, GC, and NMR to ensure it meets the stringent requirements for pharmaceutical reference standards. A comprehensive Certificate of Analysis (COA) is supplied with each batch, detailing the results against predefined specifications. Our quality processes are designed to support compliance with ICH, USP, and EP guidelines for impurity 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. This product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. 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)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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