比索洛尔左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100711-202203对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.528521385528853048546785308853640.16
210.358504985160851040.10
单位质量响应值RSD%判断
8114.458222.610.94数据可信
供试品溶液-G01RY4批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min169552-6955276.48272.0210.3676.4872.0210.36
257953-5795363.72763.73
369340-6934076.24976.25
468331-6833175.13975.14
555869-5586961.43561.44
671905-7190579.06979.07
10min179155-7915587.04287.935.1087.1788.045.11
274558-7455881.98782.09
383079-8307991.35791.48
480960-8096089.02689.15
576507-7650784.13084.23
685496-8549694.01494.15
15min182378-8237890.58694.243.5990.8694.513.59
282089-8208990.26890.51
388883-8888397.73998.02
485769-8576994.31594.59
585812-8581294.36294.60
689300-8930098.19798.49
20min183238-8323891.53196.883.2291.9597.303.22
287040-8704095.71296.11
390563-9056399.586100.03
487603-8760396.33196.76
589306-8930698.20498.60
690863-9086399.916100.37
30min183253-8325391.54898.273.6592.1298.863.64
291227-91227100.316100.87
391311-91311100.409101.02
488017-8801796.78797.38
591351-91351100.453101.02
691044-91044100.115100.73
45min182852-8285291.10797.973.8091.8498.723.77
291829-91829100.978101.70
390660-9066099.693100.47
487656-8765696.39097.14
591214-91214100.302101.03
690352-9035299.354100.14
极限182397-8239790.60797.423.7991.4998.333.76
291303-91303100.400101.29
390235-9023599.225100.17
487173-8717395.85896.77
590697-9069799.734100.63
689734-8973498.67599.63
比索洛尔左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100711-202203对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.528528985316852008531185536853300.15
210.358507585051850630.02
单位质量响应值RSD%判断
8111.228218.650.94数据可信
供试品溶液-G01RY4批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min145433-4543349.98268.6916.8549.9868.6916.85
254291-5429159.72759.73
373646-7364681.01981.02
467880-6788074.67674.68
564870-6487071.36571.36
668494-6849475.35175.35
10min162034-6203468.24584.2212.1268.3384.3412.12
269035-6903575.94776.05
386457-8645795.11395.25
479768-7976887.75487.88
583686-8368692.06492.18
678380-7838086.22786.35
15min170795-7079577.88390.529.1178.0890.789.12
276237-7623783.87084.10
391164-91164100.291100.58
484735-8473593.21893.49
587372-8737296.12096.39
683415-8341591.76692.04
20min177852-7785285.64693.956.2885.9794.366.30
280896-8089688.99589.36
392777-92777102.066102.53
487093-8709395.81396.24
588380-8838097.22897.66
685424-8542493.97694.40
30min184379-8437992.82797.223.6393.3097.793.65
286984-8698495.69396.21
393619-93619102.992103.62
489169-8916998.09698.68
589625-8962598.59899.19
686479-8647995.13795.72
45min188646-8864697.52198.262.5698.1598.982.56
290378-9037899.426100.10
392982-92982102.291103.09
488485-8848597.34498.09
589323-8932398.26699.02
686097-8609794.71795.45
极限190148-9014899.17398.022.6499.9698.912.63
288969-8896997.87698.72
392543-92543101.808102.78
488174-8817497.00297.91
589368-8936898.31599.24
685402-8540293.95294.85
比索洛尔左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100711-202203对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.528526985454853108525685194852970.12
210.358538185691855360.26
单位质量响应值RSD%判断
8108.088264.351.35数据可信
供试品溶液-G01RY4批-0.005HCL
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min170068-7006876.88676.106.2176.8976.106.21
270756-7075677.64177.64
369003-6900375.71875.72
466877-6687773.38573.38
563227-6322769.38069.38
676168-7616883.58083.58
10min178255-7825585.87085.394.8086.0085.524.80
278318-7831885.93986.07
377252-7725284.76984.90
476178-7617883.59183.71
572738-7273879.81679.93
684163-8416392.35392.49
15min182807-8280790.86589.844.2891.1490.114.28
282299-8229990.30890.58
380768-8076888.62888.90
479536-7953687.27687.54
577847-7784785.42285.67
687970-8797096.53096.82
20min183923-8392392.09092.083.6392.5192.503.63
284031-8403192.20892.63
382644-8264490.68691.10
481342-8134289.25789.66
581836-8183689.80090.19
689712-8971298.44298.90
30min184986-8498693.25694.653.5193.8395.233.51
286607-8660795.03595.61
383731-8373191.87992.45
483621-8362191.75892.31
586855-8685595.30795.85
691759-91759100.688101.31
45min185960-8596094.32596.523.8495.0697.253.83
288775-8877597.41498.15
384504-8450492.72793.45
485356-8535693.66294.37
589703-8970398.43299.13
693472-93472102.568103.35
极限186506-8650694.92496.025.0695.8196.915.03
281524-8152489.45790.35
385365-8536593.67294.55
486651-8665195.08395.95
590775-9077599.608100.47
694215-94215103.383104.34
比索洛尔左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100711-202203对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.528534485339851958528485288852900.08
210.358531985412853660.08
单位质量响应值RSD%判断
8107.418247.921.22数据可信
供试品溶液-G01RY4批-0.005HCL
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min175633-7563383.07876.3716.4683.0876.3716.46
276567-7656784.10484.10
372605-7260579.75279.75
446535-4653551.11651.12
574708-7470882.06282.06
671122-7112278.12378.12
10min185114-8511493.49287.0014.8393.6387.1214.83
285561-8556193.98394.12
381523-8152389.54889.68
455477-5547760.93861.02
585149-8514993.53193.67
682385-8238590.49590.63
15min188109-8810996.78291.1913.4197.0891.4613.42
289621-8962198.44398.74
384907-8490793.26593.55
460619-6061966.58666.77
589093-8909397.86398.16
685765-8576594.20894.49
20min188877-8887797.62693.1912.1198.0893.6112.12
291722-91722100.751101.21
386716-8671695.25295.69
464229-6422970.55270.85
590258-9025899.14399.60
687225-8722595.81196.25
30min189774-8977498.61195.569.7999.2396.149.82
293697-93697102.920103.55
388091-8809196.76397.36
470169-7016977.07677.49
591847-91847100.888101.51
688389-8838997.09097.69
45min190390-9039099.28897.007.15100.0797.747.19
293858-93858103.097103.90
388305-8830596.99897.76
476138-7613883.63384.18
592231-92231101.310102.10
688918-8891897.67198.43
极限190902-9090299.85099.492.64100.80100.392.67
294227-94227103.503104.47
388092-8809296.76497.68
488794-8879497.53598.22
592387-92387101.481102.44
689043-8904397.80898.73
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