Description

Pregabalin Impurity D is a specified, structurally characterized impurity used in the quality control and analytical profiling of the active pharmaceutical ingredient (API) Pregabalin. This compound is critical for ensuring the purity, safety, and efficacy of Pregabalin formulations by serving as a reference standard in chromatographic analysis. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for research, method development, and compliance testing.

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, optimizing, and validating HPLC, UPLC, or GC methods to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): A critical component in routine batch release testing to ensure Pregabalin meets pharmacopeial specifications (e.g., USP, EP, ICH Q3A/B).
• Stability Studies: Employed to track the formation of degradation products in Pregabalin under various stress conditions.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., ANDA, NDA) by providing necessary impurity data for drug master files.
• Research & Development: Used in synthetic chemistry research to understand degradation pathways and to synthesize impurity markers.

Basic Information

Item	Details
Product Name	Pregabalin Impurity D
CAS No.	53439-96-6
Molecular Formula	C8H17NO2
Molecular Weight	159.23 g/mol
Synonyms	(3S)-3-(Aminomethyl)-5-methylhexanoic acid; (S)-3-(Aminomethyl)-5-methylhexanoic acid; Pregabalin Related Compound D; Pregabalin EP Impurity D; Pregabalin USP Impurity D; Lyrica Impurity D; (S)-3-Isobutyl GABA; CI-1008 Impurity D
EINECS	Contact for details

Quality Control

Every batch of Pregabalin Impurity D is manufactured and controlled under a strict quality management system. The product undergoes rigorous analytical testing, including chromatographic purity (HPLC), spectroscopic identification (IR, NMR), and residual solvent analysis, to ensure it meets the high standards required for use as a reference material. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept under dry conditions 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 reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
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.