伐度司他，单杂不得过0.1%，总杂不得过0.5%

北京睿琪生物医药科技有限公司集食品新原料、医药原料及中间体、新药用辅料等研发、商务推广于一体的高新技术企业，倡导绿色环保、差异化的大健康理念；注重工艺开发的RSM研究和QbD过程研究，突出工艺的经济、环保、安全和质量可控性。 公司在北京市亦庄经济技术开发区拥有上千平米的研发中心，下设工艺开发、中试转化、商业化生产、质量研究及商务推广等部门。中心团队由多名拥有二十多年原料药商业化生产经验的化学专业博士、硕士组成，配套多台50/100L玻璃反应釜、20L旋转蒸发仪、高效液相色谱仪、红外光谱仪、液质联用仪（HPLC -MS）、气质联用仪（GC-MS）等仪器设备，并在天津、河北、山东及内蒙古等地拥有多个稳定合作的商业化生产基地。 公司可进行各种高端原料药、医药中间体、食品新原料和药用新辅料等相关化合物的研究开发、商业化生产。同时可承接原辅料的备案登记业务，以及已有药用原辅料生产工艺的优化与改进，为药企“原料+制剂”一体化战略贡献力量。 公司获授权发明专利3项，申请专利8项，其中ICP申请２项。 Beijing Ruqueen Biotech.，Co., Ltd.?is a high-tech enterprise integrating the R&D and business promotion of novel food ingredients, APIs and intermediates, and novel pharmaceutical excipients. The company advocates a green, eco-friendly, and differentiated approach to health and wellness, emphasizing RSM(Regulatory Starting Material) research and QbD (Quality by Design) process development to ensure economical, environmentally friendly, safe, and quality-controllable manufacturing processes. The company operates a?1,000+ square meter R&D center?in the Beijing Economic-Technological Development Area (BDA), housing departments for process development, pilot-scale conversion, commercial production, quality research, and business promotion. The center's team comprises?Ph.D. and M.S. holders in chemistry?with over 20 years of commercial production experience in APIs. It is equipped with multiple advanced instruments including: 50/100L glass reactors, 20L rotary evaporators, HPLC, IR, LC-MS, GC-MS. Additionally, the company maintains?stable cooperative manufacturing bases?in Tianjin City, Hebei Province, Shandong Province, Inner Mongolia Autonomous Region, and other regions, enabling scaled commercial production. The company conducts R&D and commercial manufacturing of: Complex active pharmaceutical ingredients (APIs), Pharmaceutical intermediates, Novel food ingredients and Advanced pharmaceutical excipients The company provides comprehensive services including: ? Registration filing support for APIs/excipients (e.g., DMF/CEP preparation) ? Process optimization for existing pharmaceutical materials ? Enabling "API + Formulation" integration strategies for pharmaceutical partners Intellectual Property Achievements: ? 3 authorized invention patents ? 8 pending patent applications (including 2 PCT international filings)