Description

Pregabalin Impurity 11 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 availability 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: Essential for developing and validating HPLC, UPLC, or GC methods for impurity detection and separation.
• Quality Control & Assurance: Employed in routine QC testing of pregabalin batches to monitor and control impurity levels as per ICH guidelines.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity data for drug master files (DMFs) and dossiers.
• Stability Studies: Used to identify and track degradation products formed during the stability testing of pregabalin under various conditions.
• Research & Development: Serves as a key intermediate or impurity marker in synthetic chemistry and pharmaceutical R&D programs.

Basic Information

Item	Details
Product Name	Pregabalin Impurity 11
CAS No.	2375259-86-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Pregabalin Related Compound 11; Pregabalin EP Impurity J; Pregabalin USP Impurity; (S)-3-(Aminomethyl)-5-methylhexanoic acid impurity; Lyrica Impurity 11; Pregabalin Process Impurity; Pregabalin Degradant
EINECS	Contact for details

Quality Control

Our Pregabalin Impurity 11 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation by spectroscopic methods (NMR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. Certificates of Analysis (COA) with detailed chromatographic data are provided and traceable to primary standards.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and should be handled under anhydrous conditions to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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