贝派度酸片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号BEMA-231010D对照品来源自制对照品使用方法直接使用
对照品含量(%)99.72对照品水分(%)0对照品稀释倍数50
标示量(mg)180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%
110.143046813050313055813051983054763051930.12
210.023066383060983063680.13
单位质量响应值RSD%判断
30097.9330575.651.12数据可信
供试品溶液-24061101批-pH6.6
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min176275-7627525.07423.875.1125.0723.875.11
272528-7252823.84223.84
376852-7685225.26425.26
467810-6781022.29122.29
573336-7333624.10824.11
668894-6889422.64822.65
10min1184245-18424560.56758.842.2060.8559.102.21
2177770-17777058.43858.70
3181721-18172159.73760.02
4172649-17264956.75557.00
5178488-17848858.67458.94
6179085-17908558.87159.12
15min1222745-22274573.22372.621.5674.1773.541.54
2219001-21900171.99272.91
3217172-21717271.39172.34
4218750-21875071.91072.79
5221172-22117272.70673.63
6226672-22667274.51475.42
20min1239288-23928878.66178.351.5580.4380.081.53
2237369-23736978.03079.74
3233638-23363876.80478.54
4236772-23677277.83479.51
5238241-23824178.31780.04
6244797-24479780.47282.21
30min1256991-25699184.48184.471.3887.1287.071.35
2256417-25641784.29286.87
3251811-25181182.77885.37
4256561-25656184.33986.88
5257151-25715184.53387.13
6262882-26288286.41789.05
45min1272228-27222889.49089.430.8493.0792.960.84
2272705-27270589.64693.16
3268129-26812988.14291.65
4272001-27200189.41592.89
5271954-27195489.39992.94
6275229-27522990.47694.06
60min1280144-28014492.09292.010.5896.6696.540.56
2282341-28234192.81497.33
3277649-27764991.27295.76
4280789-28078992.30496.78
5278873-27887391.67496.20
6279662-27966291.93396.53
极限1284744-28474493.60493.990.6799.2099.540.62
2287948-28794894.657100.20
3283808-28380893.29698.80
4288337-28833794.785100.28
5286346-28634694.13199.68
6284393-28439393.48999.10
贝派度酸片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号BEMA-231010D对照品来源自制对照品使用方法直接使用
对照品含量(%)99.72对照品水分(%)0对照品稀释倍数50
标示量(mg)180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%
110.143041093043203045293043173041843042920.06
210.023038103037933038020.01
单位质量响应值RSD%判断
30009.0730319.560.73数据可信
供试品溶液-24061101批-pH4.5(内含0.45%SDS)
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min114119-141194.6684.946.744.674.946.76
215747-157475.2065.21
316306-163065.3915.39
414748-147484.8764.88
515069-150694.9824.98
613595-135954.4944.49
10min145095-4509514.90814.643.0614.9614.703.05
243112-4311214.25314.31
344550-4455014.72814.79
446259-4625915.29315.35
542511-4251114.05414.11
644153-4415314.59714.65
15min162433-6243320.64020.882.0520.8621.102.03
263543-6354321.00721.22
362326-6232620.60520.83
464277-6427721.25021.47
561523-6152320.33920.55
664900-6490021.45621.67
20min172193-7219323.86724.171.8324.3124.621.82
273731-7373124.37524.82
373316-7331624.23824.69
473101-7310124.16724.63
571217-7121723.54423.98
675130-7513024.83825.29
30min182573-8257327.29828.352.1528.0129.062.10
285075-8507528.12628.85
385769-8576928.35529.08
486104-8610428.46629.19
587008-8700828.76529.46
687913-8791329.06429.79
45min196342-9634231.85033.022.3232.8734.052.26
2101484-10148433.55034.58
398400-9840032.53133.57
499353-9935332.84633.89
5100887-10088733.35334.37
6102728-10272833.96235.01
60min1101574-10157433.58035.552.9934.9536.952.91
2109511-10951136.20437.61
3106577-10657735.23436.63
4108047-10804735.72037.13
5110492-11049236.52837.92
6108955-10895536.02037.45
极限1115857-11585738.30238.542.0940.0440.332.02
2114220-11422037.76139.57
3114199-11419937.75439.54
4116254-11625438.43340.24
5120299-12029939.77141.57
6118546-11854639.19141.02
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