TOC法测定清洁验证中盐酸林可霉素残留量
张友冬
摘 要 目的：验证总有机碳法测定盐酸林可霉素清洁残留物的准确性。方法：根据总有机碳法中测定值与浓度正相关的特性来判定林可霉素残留量。结果：该检验方法在0.5～2.0 μg/ml浓度范围有较好的线性关系，相关系数R2=0.998 6，检测限与定量限分别为0.504 9 和1.530 3 μg/ml，最低擦拭回收率为73.5%。结论：该方法简便、快捷、准确，适合林可霉素注射液生产结束清洁后残留量的检测。
关键词 总有机碳法 林可霉素 清洁残留 验证 方法学
中图分类号：R951 文献标志码：A 文章编号：1006-1533(2021)09-0067-04
Determination of lincomycin hydrochloride residue in cleaning verification by TOC method
ZHANG Youdong*
(Shanghai Sine-Jinzhu Pharmaceutical Co.， Ltd.， Shanghai 201506， China)
ABSTRACT Objective： To validate the accuracy of determination of lincomycin hydrochloride residue after cleaning by total organic carbon (TOC) method. Methods： The residue concentrations were determined based on the positive correlation between the measured value and the concentration in the TOC method. Results： A good linear relationship was shown when lincomycin hydrochloride concentrations were in the range of 0.5-2.0 mg/ml ......
您现在查看是摘要页，全文长 8246 字符。
闄愪簬鏈嶅姟鍣ㄥ帇鍔涳紝缃戠珯閮ㄥ垎淇℃伅鍙緵鐖卞績浼氬憳鎴栨湁涓€瀹氱Н鍒嗙殑娉ㄥ唽浼氬憳娴佽銆�
姝�淇℃伅闇€瑕� 2 绉垎锛堝厤璐规敞鍐岀櫥褰曞悗姣忓ぉ鍙互棰嗗彇10涓Н鍒�锛夈€�
娣団剝浼呮禒鍛返閸欏倽鈧喛绱濇稉宥嗙€幋鎰崲娴ｆ洑绠ｅ楦款唴閵嗕焦甯归懡鎰灗閹稿洤绱╅妴鍌涙瀮缁旂姷澧楅弶鍐ㄧ潣娴滃骸甯拋妞剧稊閺夊啩姹夐敍宀冨閹劏顓绘稉鐑橆劃閺傚洣绗夌€规粏顫﹂弨璺虹秿娓氭稑銇囩€硅泛鍘ょ拹褰掓鐠囦紮绱濈拠鐑藉仏娴犺埖鍨ㄩ悽浣冪樈闁氨鐓￠幋鎴滄粦閿涘本鍨滄禒顒佹暪閸掍即鈧氨鐓￠崥搴礉娴兼氨鐝涢崡鍐茬殺閹劎娈戞担婊冩惂娴犲孩婀扮純鎴犵彲閸掔娀娅庨妴锟�
|
瀵邦喕淇婇弬鍥╃彿
閸忚櫕鏁為惂鐐
鐠囧嫯顔戦崙鐘插綖
閹兼粎鍌ㄩ弴鏉戭樋
|