Description

Codeine Impurity C is a high-purity reference standard critical for pharmaceutical research and development. This compound is essential for the accurate identification, quantification, and control of related substances in Codeine and its formulations, ensuring drug safety and efficacy. It is primarily utilized by analytical laboratories, quality control units, and regulatory bodies involved in pharmaceutical manufacturing and compliance testing.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for method development, validation, and routine quality control testing of Codeine API and finished drug products.
• Analytical Research: Serves as a critical marker in HPLC, UPLC, and GC analyses for impurity profiling and stability studies.
• Regulatory Compliance: Supports regulatory filings (e.g., ANDA, NDA) by providing necessary impurity data for submission to agencies like the FDA and EMA.
• Method Development: Aids scientists in developing and optimizing chromatographic separation methods for Codeine and related compounds.
• Stability Testing: Employed in forced degradation studies to understand the degradation pathways and stability profile of Codeine.
• Pharmacopoeial Testing: Used for testing against monographs in pharmacopoeias such as USP, EP, and BP where control of related substances is specified.

Basic Information

Product Name	Codeine Impurity C
CAS No.	121395-47-9
Molecular Formula	C18H21NO3
Molecular Weight	299.37 g/mol
Synonyms	Codeine Imp C; Codeine Related Compound C; 7,8-Didehydro-4,5α-epoxy-3-methoxy-17-methylmorphinan-6α-ol; 3-Methoxy-17-methyl-7,8-didehydro-4,5α-epoxymorphinan-6α-ol; Codeine EP Impurity C; Codeine USP Related Compound C; Neopine; β-Codeine
EINECS	Contact for details

Quality Control

Every batch of Codeine Impurity C (CAS 121395-47-9) is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC purity determination and spectroscopic identification, to ensure compliance with the high standards required for pharmaceutical reference materials. 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 at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing at 2-8°C to ensure maximum stability.

Specification

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

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