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The efficacy and safety of pharmaceutical products are intrinsically linked to the quality of their Active Pharmaceutical Ingredients (APIs). Vilazodone Hydrochloride (CAS: 163521-08-2) is no exception, and understanding its precise chemical properties and the stringent quality standards it must meet is crucial for anyone involved in its production or use.
Vilazodone Hydrochloride is typically supplied as a white to off-white solid powder. Its chemical identification is critical, and standard analytical methods such as Infrared Spectroscopy (IR) and High-Performance Liquid Chromatography (HPLC) are employed to confirm its identity and purity. The assay specification for pharmaceutical-grade Vilazodone Hydrochloride API commonly requires a purity level of greater than 99%. This high level of purity ensures that the active compound is potent and free from significant impurities that could affect its therapeutic action or patient safety.
Water content is another important specification, often limited to 1.00% or less. Heavy metals are also carefully controlled, with limits typically set to comply with international pharmacopoeial standards, ensuring the absence of toxic metallic contaminants. Residue on ignition, which indicates the amount of inorganic impurities, is also monitored, usually with a strict limit of 0.10% or less.
The specification for related substances is particularly important, as it quantifies any impurities that may arise during synthesis or degradation. Limits are set for both individual impurities (e.g., not more than 0.50%) and total impurities (e.g., not more than 1.00%). These specifications are vital for ensuring the stability and safety profile of the final drug product.
Manufacturers of Vilazodone Hydrochloride API adhere to these rigorous standards to guarantee that the product meets the exacting requirements of the pharmaceutical industry. These detailed specifications, verified through thorough analytical testing, underscore the commitment to quality that is essential for APIs used in medications for treating conditions like Major Depressive Disorder.
Manufacturing Facilities
Professional Export Experience
to Global Customers
1. 20 years of R&D, manufacturing and sales experience, serving customers in 60 countries and regions around the world;
2. Own R&D laboratory, pilot platform and large-scale production workshop, which can meet the audit requirements of global customers;
3. We can satisfy customers' perfect transition from small scale lab requirements (gram level) to commercialization requirements (hundred tons level).
A: We don't have Minimum Order Quantity, exact quantity should be provided before quotation for us to calculate the exact cost.
A: We don't provide free samples due to lots of request and expensive international courier's cost, we can deduct the sample charge after commercial order placed.
A: Our payment terms: Small or sample order: T/T IN ADVANCE. Commercial order: First order should be by T/T IN ADVANCE or L/C at sight, and following orders T/T 30~90days is acceptable subject to approval of credit application.
