Description

Hydrocodone Bitartrate Related Compound A Cii (70 Mg) (Morphinan-6-One, 4-Hydroxy-3-Methoxy-17-Methyl) is a high-purity analytical reference standard, essential for pharmaceutical research and quality control. This compound, with CAS number 847-86-9, is critical for ensuring the accuracy and reliability of analytical methods used in the development and testing of active pharmaceutical ingredients (APIs). It is primarily utilized by analytical laboratories, pharmaceutical manufacturers, and regulatory bodies for method validation, impurity profiling, and compliance testing.

Application

• Pharmaceutical Impurity Profiling and Identification: Serves as a certified reference material (CRM) for the identification and quantification of specific impurities or degradation products in Hydrocodone Bitartrate drug substances and finished dosage forms.
• Analytical Method Development and Validation: Used as a critical standard to develop, optimize, and validate chromatographic methods (e.g., HPLC, UPLC) for potency and purity assays.
• Quality Control (QC) Testing: Employed in routine QC laboratories to calibrate instruments and ensure the specificity and accuracy of tests for pharmaceutical raw materials and products.
• Stability Studies: Acts as a marker compound in forced degradation and shelf-life studies to monitor the stability of pharmaceutical formulations under various stress conditions.
• Regulatory Compliance and Documentation: Provides essential data for regulatory submissions (e.g., to FDA, EMA) to demonstrate control over the manufacturing process and product quality.
• Research and Development (R&D): Used in pharmaceutical R&D for metabolic studies, pharmacokinetic research, and the synthesis of novel derivatives.

Basic Information

Product Name	Hydrocodone Bitartrate Related Compound A Cii (70 Mg) (Morphinan-6-One, 4-Hydroxy-3-Methoxy-17-Methyl)
CAS No.	847-86-9
Molecular Formula	C18H21NO3
Molecular Weight	299.36 g/mol
Synonyms	Hydrocodone Related Compound A; 4,5α-Epoxy-3-methoxy-17-methylmorphinan-6-one; Norhydrocodone; Dihydrocodeinone Impurity A; 10-Hydroxycodeinone; Morphinan-6-one, 4-hydroxy-3-methoxy-17-methyl-; Hydrocodone EP Impurity A; Hydrocodone Bitartrate Impurity A
EINECS	Contact for details

Quality Control

Our reference standards are produced under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity and identity confirmation against qualified primary standards. We provide a comprehensive Certificate of Analysis (COA) that includes batch-specific data on purity, impurities, and chromatographic profiles, supporting compliance with ICH guidelines and pharmacopeial requirements. Certificates are available upon request and with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F). This material is hygroscopic (moisture-sensitive) and should be kept in a dry environment. After opening, ensure the container is resealed tightly to minimize exposure to atmospheric moisture.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0%
Assay (on dried basis)	97.0% - 103.0%

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