四百七十九章 碘佛醇路线变更(1 / 1)
小人物的医化三十年
王者近水
638 字
2022-04-26
国家标准的项目一般是参照国外标准检测项目的同时,对某几个指标进一步收紧,提出比国外更严格的标准要求,参与国家标准的制定,不仅仅是一种荣誉与企业影响力,更重要的是,我们对质量指标有建议权,打个比方,如果我们根据自个企业的优势,对某个杂质或残留溶剂指标提出修正的要求后被编入了国标,哪么,以后有企业要生产这个产品时,就得在这几个单项指标上达到我们企业的要求,不同的工艺路线生产出来的产品产生的杂质是不一样的,自然地就形成了技术壁垒。抢占质量制高点,对维护企业市场竞争力有的作用有如抗美援朝时抢占了上甘岭对战争胜负的作用一般,难怪在接受审计的关键时刻,公司还派卫诚到北京药物研究所呢。王近之、赵定岳等几人颇有兴趣地围着卫诚听他说起了故事。
“北京药物所这次碰到的难题是相关杂质的液相切割,碘海醇产品中,碘化物、水解物等两个杂质与主峰特接近或干脆被包在主峰中,氧烷基峰群多个峰连在一起无法分开,把他们都搞糊涂了,我们跟他们统一的主要是氧烷基峰群的斜率。”卫诚边说边笑嘻嘻地拿着笔在纸上画着,接着说道:“根据双方确定后的方法对进口的碘海醇制剂进行液相分析,结果检出的多批制剂氧烷基合格边缘或不合格。”
这意味着目前公司生产的碘海醇原料药在单项指标上要高于欧美国家,一但标准生效,不仅可以挡住其它企业的进入,欧美国家碘海鸸原料药进口到国内也同样得过这道质量关,公司的美誉度会提高一个档次。这相当于给企业加了一层防护罩,市场竞争力强了很多。
“这是大好事,得好好敲吴总的竹杠,叫他请客了。”王近之半开玩笑地说道。
“还是老地方小扁大排档,你再叫上碘佛醇课题组的几个人。”正说到吴总呢,他就出现了。
为什么要叫上碘佛醇课题组的人一起去,是因为由应华义、张朋袅与张亭婷负责的路线变更的小试完成了,下一步就是中试。路线变更的主要内容是仿碘帕醇路线,先进行羟基乙酰化保护,氯仿溶解后加水长时间搅拌分层除去大部分的DMAC,再用碳酸钠水溶液中和洗涤,分出氯仿层,再用乙酰氧基乙酰氯进行氨基酰化,然后醇解过滤水解精制得到碘佛醇水解物,其后的合成同原工艺。
热菜上来了,极少喝酒的吴总很意外地给自个倒上一杯啤酒开始敬大家说:“今天与大家聚在一起不容易啊,搬到新厂区后,企业大了工作多了制度多了人情也似乎淡了,很少有与大家相聚的机会,今天,第一杯酒我先干为敬了。”
两年前,大家几乎每周一次轮流在小扁大排档里做庄,相互大呼小叫地互以名字相称,亲如兄弟姐妹,现在在公司必以职务互称,聚个餐得东考虑西细量该请谁不该请谁,事事得小心谨慎,王近之等几位老员工都有颇多的感慨。
三杯酒敬后,吴总换了杯,加上白开水说:“今天请大家来有三个理由,一是庆贺日本官方碘海醇审计通过与国际的建立,二是给几位新人鼓鼓劲,到公司短短的几个月就能融入这个团队并作出贡献,三是请大家想一想,公司大了,下一步的技术部门考核将怎么办?”
这话虐心呀,在老厂区,考核以新产品个数及老产品技改带来的年创造效益的百分比计奖,到新厂区二年了,搞的都是文件与操作参数的完善,奖金只是年底由领导确定,意思一下,没有文件依据。
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