Description

Lamivudine Impurity 7 is a designated pharmaceutical reference standard used for analytical and quality control purposes. This compound is critical for ensuring the purity, safety, and efficacy of the active pharmaceutical ingredient (API) Lamivudine, an essential antiviral medication. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in drug development and quality assurance. The use of this well-characterized impurity standard is fundamental for compliance with stringent pharmacopeial guidelines.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of Lamivudine Impurity 7 in Lamivudine API and finished drug products.
• Analytical Method Development & Validation: Used in HPLC, UPLC, and LC-MS methods to establish system suitability, specificity, and detection limits.
• Quality Control & Batch Release Testing: Essential for routine impurity profiling to ensure Lamivudine batches meet ICH Q3A(R2) and pharmacopeial (USP, EP) specifications.
• Stability Studies: Employed to monitor the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Provides necessary data for Drug Master Files (DMFs), Investigational New Drug (IND), and New Drug Application (NDA) filings to health authorities like the FDA and EMA.
• Research & Development: Used in synthetic chemistry research to study the formation pathways and chemical behavior of this impurity.

Basic Information

Product Name	Lamivudine Impurity 7
CAS No.	147126-63-4
Molecular Formula	C8H11N3O3S
Molecular Weight	229.26 g/mol
Synonyms	Lamivudine Related Compound C; (2R,5S)-5-(Cytosin-1-yl)-1,3-oxathiolane-2-carboxamide; 1,3-Oxathiolane-2-carboxamide, 5-(4-amino-2-oxo-1(2H)-pyrimidinyl)-, (2R,5S)-; Lamivudine EP Impurity C; Lamivudine USP Related Compound C; 3TC Impurity 7; (-)-2',3'-Dideoxy-3'-thiacytidine Impurity 7
EINECS	Contact for details

Quality Control

Our Lamivudine Impurity 7 is manufactured and handled under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity confirmation and structural elucidation via spectroscopic methods (NMR, MS). We provide a comprehensive Certificate of Analysis (COA) with each shipment, detailing batch-specific results against established specifications. Our quality commitment aligns with the standards expected for pharmaceutical reference materials.

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 product is hygroscopic (moisture-sensitive) and must be kept under anhydrous conditions. 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%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm

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