Isoniazid (CAS 54-85-3) is a critical pharmaceutical ingredient, renowned for its potent anti-tuberculosis properties. For procurement managers, R&D scientists, and formulators, understanding the nuances of its quality standards and manufacturing process is key to ensuring the success of their pharmaceutical products. This article provides insights into what makes high-quality Isoniazid and why sourcing from reputable Chinese manufacturers is advantageous.

At its core, Isoniazid is a highly specific compound, and its therapeutic effectiveness is directly tied to its purity. Pharmaceutical applications demand a minimum assay of 99.5% Isoniazid. This high level of purity is achieved through carefully controlled synthesis and purification processes. Manufacturers typically employ multi-step synthesis routes, often starting from precursors like 4-cyanopyridine and hydrazine hydrate. Subsequent crystallization and drying steps are crucial for achieving the desired purity and physical form, usually a white crystal powder.

Key to ensuring the quality and suitability of Isoniazid for pharmaceutical use are adherence to established pharmacopeial standards. Global buyers often look for compliance with USP (United States Pharmacopeia), BP (British Pharmacopoeia), EP (European Pharmacopoeia), and FCC (Food Chemicals Codex). These standards dictate stringent requirements for identity, purity, assay, and limits for impurities. A manufacturer that can demonstrate compliance with these pharmacopeias, often through independent testing and certifications like GMP, provides a significant advantage in the global market.

Manufacturing Isoniazid also involves meticulous attention to safety and environmental regulations. Good Manufacturing Practices (GMP) are not just a quality marker but a fundamental requirement for pharmaceutical ingredient production. GMP ensures that products are consistently produced and controlled according to quality standards appropriate to their intended use. When you decide to buy Isoniazid, confirming the manufacturer's GMP compliance is a critical step.

For buyers seeking competitive pricing without compromising on quality, China has emerged as a leading global supplier of pharmaceutical intermediates and APIs, including Isoniazid. Chinese manufacturers have invested heavily in advanced production facilities and quality control systems, enabling them to offer high-purity Isoniazid at competitive prices. These suppliers are well-versed in international trade and can facilitate direct purchase inquiries, providing detailed specifications, pricing, and logistical support.

When engaging with a potential Isoniazid manufacturer, it is advisable to request detailed technical documentation. This includes the Certificate of Analysis (CoA) for the specific batch, outlining assay results and impurity profiles, as well as the Material Safety Data Sheet (MSDS) or Safety Data Sheet (SDS) for safe handling. Understanding these documents will help procurement professionals make informed decisions about purchasing Isoniazid and ensure it meets all regulatory and application requirements.