Description

Piracetam Impurity 1 is a designated reference standard used for the analytical profiling and quality control of the nootropic pharmaceutical agent, Piracetam. This compound is critical for ensuring the purity, safety, and efficacy of the final drug product by enabling the accurate identification and quantification of related substances. It is an essential material for pharmaceutical R&D laboratories, quality assurance departments, and regulatory bodies involved in method development, validation, and compliance testing.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for calibrating analytical instruments and validating testing methods.
• Quality Control & Assurance (QC/QA): Used in-house by API and finished dosage form manufacturers to monitor and control impurity levels during production.
• Regulatory Compliance & Filing: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) to demonstrate thorough impurity characterization.
• Method Development & Validation: Serves as a key component in developing and validating stability-indicating HPLC, UPLC, or GC methods for Piracetam.
• Stability Studies: Employed to identify and track degradation products formed under various stress conditions (heat, light, humidity).
• Academic & Contract Research: Used in research institutions and CROs for pharmacokinetic, metabolic, and toxicological studies related to Piracetam.

Basic Information

Product Name	Piracetam Impurity 1
CAS No.	33996-53-1
Molecular Formula	C6H10N2O2
Molecular Weight	142.16 g/mol
Synonyms	2-(2-Oxopyrrolidin-1-yl)acetamide; 1-Acetamido-2-pyrrolidinone; N-Acetyl-GABA lactam; 1-(Aminocarbonylmethyl)-2-pyrrolidinone; Piracetam Related Compound A; Piracetam EP Impurity A; UCB 6215 Impurity
EINECS	Contact for details

Quality Control

Every batch of Piracetam Impurity 1 is manufactured and handled under strict quality management systems. The material undergoes comprehensive analytical testing, including HPLC for purity confirmation and structural elucidation via NMR and MS, to ensure it meets the high standards required for use as a reference material. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting batch-specific results. Our quality protocols are designed to support compliance with ICH Q3A/B guidelines and relevant pharmacopoeial standards.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing under inert atmosphere to maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5%

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