在医药原料药、精细化工合成领域，钯碳催化加氢、偶联反应是常用工艺，反应后体系中残留的**零价钯、钯碳颗粒一直是行业纯化痛点。相较于离子态钯，零价钯化学性质稳定、分散性极强，还易夹杂细微炭黑杂质，传统活性炭吸附、过滤、重结晶等手段难以彻底清除，极易导致原料药钯残留超标，无法满足ICH Q3D指南及各国药典≤10ppm的严苛限值，甚至影响产品纯度、晶型与稳定性，阻碍药企申报与规模化投产。
针对零价钯、钯碳残留的去除难题，宁波巯晟新材料推出QSM-102单齿巯基硅胶**，专为医药合成体系深度除钯打造，成为解决零价钯、钯碳残留的专属解决方案。该产品以高比表面积多孔硅胶为载体，通过稳定化学键合技术，接枝高活性单齿巯基官能团，对零价钯、胶体钯、钯碳微粒均具备极强的靶向吸附与螯合能力，精准捕捉体系中各类形态钯杂质，彻底告别传统工艺除钯不彻底、批次不稳定的弊端。
QSM-102单齿巯基硅胶机械强度高，耐酸碱腐蚀、不溶胀、无官能团溶出，不会引入新杂质污染原料药，兼容甲醇、乙醇、四氢呋喃、二氯甲烷等各类常用制药溶剂，适配常温常压温和操作，无需改动原有生产工艺，可直接用于搅拌吸附或柱层析纯化。经药企实际应用验证，该产品可将零价钯、钯碳残留从数百ppm稳定降至1ppm以下，同步可截留细微炭黑悬浮物，让原料药纯度达标、晶型规整，大幅提升工艺收率与批次稳定性。
此外，QSM-102工艺绿色环保，符合GMP制药规范，完美适配实验室小试、中试及工业化大生产，助力药企轻松攻克零价钯/钯碳残留难关，顺利通过药监核查与国际认证，赋能高端原料药绿色合规生产。
n the field of pharmaceutical APIs and fine chemical synthesis, palladium-carbon catalytic hydrogenation and coupling reactions are commonly used processes. The residual **zero-valent palladium and palladium-carbon particles** in the system after reactions have long been an industry purification pain point. Compared with ionic palladium, zero-valent palladium has stable chemical properties and strong dispersibility, and is easily mixed with fine carbon black impurities. Traditional methods such as activated carbon adsorption, filtration and recrystallization are difficult to completely remove it, which can easily lead to excessive palladium residue in APIs, failing to meet the strict limit of ≤10ppm in the ICH Q3D guidelines and national pharmacopoeias. It even affects product purity, crystal form and stability, hindering the declaration and large-scale production of pharmaceutical enterprises.
To solve the problem of removing zero-valent palladium and palladium-carbon residues, Ningbo Qiusheng New Materials launches **QSM-102 Single-tooth Mercapto Silica Gel**, specially developed for deep palladium removal in pharmaceutical synthesis systems, becoming an exclusive solution to eliminate zero-valent palladium and palladium-carbon residues. Using porous silica gel with high specific surface area as the carrier, this product is grafted with highly active single-tooth mercapto functional groups through stable chemical bonding technology. It has strong targeted adsorption and chelation capabilities for zero-valent palladium, colloidal palladium and palladium-carbon particles, accurately capturing various forms of palladium impurities in the system, and completely eliminating the disadvantages of incomplete palladium removal and unstable batches in traditional processes.
QSM-102 Single-tooth Mercapto Silica Gel has high mechanical strength, acid and alkali resistance, no swelling, and no functional group dissolution. It will not introduce new impurities to pollute APIs, and is compatible with various common pharmaceutical solvents such as methanol, ethanol, tetrahydrofuran, and dichloromethane. It is suitable for mild operation at normal temperature and pressure, without changing the original production process, and can be directly used for stirring adsorption or column chromatography purification. Verified by practical application of pharmaceutical enterprises, this product can stably reduce zero-valent palladium and palladium-carbon residues from hundreds of ppm to **less than 1ppm**, and simultaneously intercept fine carbon black suspensions, making API purity up to standard and crystal form regular, greatly improving process yield and batch stability.
In addition, QSM-102 can be regenerated and reused with specific eluents, effectively reducing material costs. The process is green and environmentally friendly, in line with GMP pharmaceutical standards, and perfectly adapts to laboratory pilot tests, pilot scale-up and industrial mass production. It helps pharmaceutical enterprises easily overcome the problem of zero-valent palladium/palladium-carbon residues, smoothly pass drug administration inspections and international certifications, and empower the green and compliant production of high-end APIs.
