Description

Ritonavir Ep Impurity C is a specified impurity used in the quality control and analytical profiling of the active pharmaceutical ingredient (API) Ritonavir. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure the purity, safety, and efficacy of the final drug product in compliance with stringent pharmacopeial standards. It is primarily utilized by professionals in pharmaceutical R&D, quality assurance, and regulatory affairs for method development, validation, and batch release testing.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of Ritonavir Ep Impurity C in Ritonavir API and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods in accordance with ICH guidelines.
• Quality Control & Batch Release: Used in routine QC testing to monitor impurity levels and ensure API batches meet specifications set by EP, USP, or other pharmacopeias.
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions (e.g., heat, humidity, light) during drug stability testing.
• Regulatory Submissions: Provides necessary impurity characterization data for regulatory filings (e.g., ANDA, NDA, CTA) with agencies like the FDA and EMA.
• Process Chemistry Research: Aids in understanding and optimizing the Ritonavir synthesis pathway to minimize the formation of this impurity.

Basic Information

Product Name	Ritonavir Ep Impurity C
CAS No.	1010808-43-1
Molecular Formula	C37H48N6O5S2
Molecular Weight	720.94 g/mol
Synonyms	Ritonavir Impurity C; Ritonavir Related Compound C; 5-Thiazolylmethyl [(1S,2S,4S)-4-[[(2S)-2-[[(2S,3S,5S)-3-Hydroxy-5-[[(2S)-3-Methyl-2-[[methyl[(2-propan-2-yl-1,3-thiazol-4-yl)methyl]carbamoyl]amino]butanoyl]amino]-1,6-diphenylhexan-2-yl]carbamoyl]-4-methylpentanoyl]amino]-2-hydroxy-5-phenyl-1-(phenylmethyl)pentyl]carbamate; Lopinavir Impurity (related); Norvir Impurity C
EINECS	Contact for details

Quality Control

Every batch of Ritonavir Ep Impurity C is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing, including advanced chromatographic and spectroscopic techniques, to ensure compliance with pharmacopeial standards and customer specifications. A comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profile 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 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%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
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.