Description

Venlafaxine Related Compound A (10 Mg) (1-(1-(4-Methoxyphenyl)-2-(Methylamino)Ethyl)Cyclohexanol Hydrochloride) is a high-purity reference standard and pharmaceutical impurity critical for analytical research and quality control in drug development. This compound is essential for ensuring the safety and efficacy of Venlafaxine, a widely prescribed antidepressant, by enabling the accurate identification and quantification of related substances. It is primarily used by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method validation, stability studies, and compliance testing.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of related substances in Venlafaxine Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Serves as a critical standard for developing, calibrating, and validating HPLC, UPLC, and GC methods in quality control laboratories.
• Stability Indicating Studies: Employed to monitor the formation of degradation products in Venlafaxine formulations under various stress conditions (e.g., heat, light, humidity).
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing necessary data for impurity identification as per ICH Q3A(R2) and Q3B(R2) guidelines.
• Pharmacopoeial Testing: Used in testing to meet the specifications of pharmacopoeias such as USP (United States Pharmacopeia) and EP (European Pharmacopoeia).
• Research & Development: Aids in synthetic chemistry research, metabolic studies, and the development of generic versions of Venlafaxine.

Basic Information

Product Name	Venlafaxine Related Compound A (10 Mg) (1-(1-(4-Methoxyphenyl)-2-(Methylamino)Ethyl)Cyclohexanol Hydrochloride)
CAS No.	93413-90-2
Molecular Formula	C₁₇H₂₈ClNO₂
Molecular Weight	313.86 g/mol
Synonyms	1-(1-(4-Methoxyphenyl)-2-(methylamino)ethyl)cyclohexanol hydrochloride; Venlafaxine Impurity A; Venlafaxine Related Substance A; O-Desmethylvenlafaxine Impurity; Cyclohexanol, 1-[1-(4-methoxyphenyl)-2-(methylamino)ethyl]-, hydrochloride; UNII-7T1N6XK1WQ; 7T1N6XK1WQ
EINECS	Contact for details

Quality Control

Our Venlafaxine Related Compound A is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation, to ensure it meets the high standards required for pharmaceutical reference materials. Certificates of Analysis (COA) detailing batch-specific results are available upon request. Production adheres to relevant guidelines for the handling of pharmaceutical impurities.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (typically 15-25°C). This product is hygroscopic (moisture-sensitive); ensure the container is sealed tightly after each use to minimize exposure to atmospheric humidity. For long-term storage, consider desiccants.

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%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Single Unknown Impurity (HPLC)	≤ 0.5%
Total Impurities (HPLC)	≤ 2.0%

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