Description

Pregabalin Impurity 20 Hcl 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 active pharmaceutical ingredient (API) pregabalin. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling. The use of this well-characterized impurity standard is essential for maintaining stringent quality control in pharmaceutical production.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in pregabalin API and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing and validating HPLC, UPLC, or GC methods to monitor impurity levels during manufacturing and stability studies.
• Quality Control & Assurance (QC/QA): Serves as a system suitability standard in routine QC testing to ensure analytical procedures are performing as intended.
• Regulatory Compliance & Filings: Supports regulatory submissions (e.g., to FDA, EMA) by providing definitive impurity characterization data required for drug master files (DMFs).
• Stability Studies: Employed to track the formation and growth of specific impurities in pregabalin products under various storage conditions over time.
• Research & Development: Used in pharmaceutical R&D to study impurity formation pathways, degradation chemistry, and to establish appropriate specification limits.

Basic Information

Product Name	Pregabalin Impurity 20 Hcl
CAS No.	1464089-92-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Pregabalin Related Compound 20 Hydrochloride; Pregabalin EP Impurity H HCl; (3S)-3-(Aminomethyl)-5-methylhexanoic acid impurity 20 hydrochloride; Pregabalin Process Impurity 20 HCl; Lyrica Impurity 20 HCl; (S)-3-(Aminomethyl)-5-methylhexanoic Acid Related Substance 20 HCl
EINECS	Contact for details

Quality Control

Our Pregabalin Impurity 20 Hcl is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including chromatographic purity, identity confirmation, and residual solvent analysis, 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. Our quality commitment aligns with ICH guidelines and supports compliance with cGMP, USP, and EP monograph requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (typically 15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	≥ 95.0%
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Complies with specified limits
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.