依折麦布辛伐他汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DJ333-221017对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.67对照品水分(%)0对照品稀释倍数5000
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.291851371851991849731849531849531850430.07
211.351854431863091858760.33
单位质量响应值RSD%判断
16389.9916376.740.06数据可信
供试品溶液-X024017批-依折麦布-pH7.0(内含0.5%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1117236-11723664.19056.978.5964.1956.978.59
296499-9649952.83652.84
3109299-10929959.84459.84
4105659-10565957.85157.85
592312-9231250.54350.54
6103302-10330256.56056.56
10min1159445-15944587.30084.734.8287.6685.054.83
2144914-14491479.34479.64
3164864-16486490.26790.60
4157482-15748286.22586.55
5147753-14775380.89881.18
6154088-15408884.36784.68
15min1172201-17220194.28494.962.1495.1395.742.16
2170462-17046293.33294.07
3179014-17901498.01598.85
4175521-17552196.10296.90
5168822-16882292.43493.16
6174569-17456995.58196.36
20min1177550-17755097.21397.991.8898.5899.301.90
2175791-17579196.25097.50
3181791-18179199.535100.91
4184364-184364100.944102.28
5176557-17655796.66997.91
6177718-17771897.30598.62
30min1180668-18066898.92099.591.91100.83101.461.84
2182972-182972100.182101.97
3180503-18050398.830100.76
4183542-183542100.494102.39
5186987-186987102.380104.16
6176726-17672696.76298.62
45min1177737-17773797.31599.341.2299.77101.751.18
2181590-18159099.425101.77
3183903-183903100.691103.17
4180109-18010998.614101.07
5182519-18251999.934102.28
6182758-182758100.065102.46
60min1182659-182659100.01099.671.45103.01102.641.45
2181077-18107799.144102.04
3183108-183108100.256103.30
4186175-186175101.935104.94
5180861-18086199.026101.93
6178332-17833297.641100.59
极限1175448-17544896.06296.514.1699.61100.034.05
2161858-16185888.62192.07
3179902-17990298.501102.10
4181334-18133499.285102.85
5179498-17949898.280101.73
6179597-17959798.334101.82
依折麦布辛伐他汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100601-201906对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.5对照品水分(%)0对照品稀释倍数2500
标示量(mg)20供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.014368274369094366194366604369294367890.04
211.054374404397284385840.37
单位质量响应值RSD%判断
39672.0339690.860.04数据可信
供试品溶液-X024017批-辛伐他汀-pH7.0(内含0.5%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1305933-30593369.04161.478.6969.0461.478.69
2253012-25301257.09857.10
3287524-28752464.88664.89
4280245-28024563.24463.24
5241227-24122754.43854.44
6266470-26647060.13560.13
10min1386655-38665587.25785.123.9187.6485.463.92
2358998-35899881.01681.33
3397653-39765389.73990.10
4382717-38271786.36986.72
5362846-36284681.88482.19
6374135-37413584.43284.77
15min1402808-40280890.90392.111.7991.7792.921.79
2410807-41080792.70893.48
3419636-41963694.70095.56
4407623-40762391.98992.82
5398372-39837289.90290.66
6409617-40961792.43993.24
20min1408865-40886592.26993.321.6593.6494.641.65
2410019-41001992.53093.81
3418521-41852194.44995.83
4425124-42512495.93997.28
5409275-40927592.36293.62
6409203-40920392.34693.66
30min1409606-40960692.43793.542.5294.3295.382.43
2420921-42092194.99096.79
3409996-40999692.52594.43
4412243-41224393.03294.91
5431885-43188597.46499.23
6402185-40218590.76292.59
45min1398751-39875189.98792.111.1692.3994.481.11
2408672-40867292.22694.55
3411226-41122692.80295.23
4409390-40939092.38894.78
5410515-41051592.64294.95
6410407-41040792.61794.95
60min1408404-40840492.16591.732.5995.0694.602.54
2398277-39827789.88092.72
3406785-40678591.80094.74
4425528-42552896.03098.94
5403678-40367891.09993.92
6396049-39604989.37792.23
极限1392324-39232488.53787.837.8491.9591.227.58
2328629-32862974.16277.50
3400110-40011090.29493.74
4414086-41408693.44896.89
5401286-40128690.55993.89
6398760-39876089.98993.33
依折麦布辛伐他汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DJ333-221017对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.67对照品水分(%)0对照品稀释倍数5000
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.291848481849671846911846081844961847220.11
211.351855221865401860310.39
单位质量响应值RSD%判断
16361.5616390.400.13数据可信
供试品溶液-X024017批-依折麦布-pH7.0(内含0.5%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min199622-9962254.57058.207.1654.5758.207.16
2117492-11749264.35964.36
3109411-10941159.93259.93
4111161-11116160.89160.89
598555-9855553.98653.99
6101226-10122655.44955.45
10min1156880-15688085.93587.334.7186.2487.664.71
2167180-16718091.57791.93
3159281-15928187.25087.58
4162913-16291389.23989.58
5146043-14604379.99880.30
6164280-16428089.98890.30
15min1173360-17336094.96295.991.8495.7496.801.85
2178053-17805397.53398.40
3174805-17480595.75396.57
4174631-17463195.65896.49
5170846-17084693.58594.33
6179737-17973798.45599.26
20min1179742-17974298.45899.290.7299.77100.630.74
2182424-18242499.927101.33
3182790-182790100.127101.48
4180012-18001298.60699.97
5180614-18061498.935100.20
6181978-18197899.683101.04
30min1184413-184413101.016101.031.09102.87102.921.12
2187306-187306102.601104.56
3184290-184290100.949102.85
4183628-183628100.586102.50
5181335-18133599.330101.14
6185692-185692101.717103.63
45min1181708-18170899.53599.901.39101.95102.351.39
2182325-18232599.873102.41
3186675-186675102.255104.72
4182613-182613100.030102.50
5178772-17877297.926100.29
6182127-18212799.764102.24
60min1179797-17979798.48899.271.21101.46102.281.23
2182530-18253099.985103.07
3183259-183259100.384103.42
4180905-18090599.095102.12
5177723-17772397.352100.26
6183101-183101100.298103.33
极限1179238-17923898.18298.661.40101.70102.221.41
2181857-18185799.616103.26
3181660-18166099.508103.10
4182233-18223399.822103.40
5175551-17555196.16299.61
6180181-18018198.698102.28
依折麦布辛伐他汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100601-201906对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.5对照品水分(%)0对照品稀释倍数2500
标示量(mg)20供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.014368144375534371584369424366314370200.09
211.054379934404634392280.40
单位质量响应值RSD%判断
39693.0139749.140.10数据可信
供试品溶液-X024017批-辛伐他汀-pH7.0(内含0.5%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1268597-26859760.55463.446.7360.5563.446.73
2308446-30844669.53869.54
3287601-28760164.83964.84
4295230-29523066.55966.56
5258187-25818758.20858.21
6270244-27024460.92660.93
10min1385559-38555986.92387.704.7787.2688.064.76
2406121-40612191.55991.95
3386147-38614787.05687.42
4396377-39637789.36289.73
5355622-35562280.17480.50
6404268-40426891.14191.48
15min1410959-41095992.65093.161.6493.4794.001.66
2417943-41794394.22495.12
3412026-41202692.89093.73
4410430-41043092.53093.40
5404227-40422791.13291.90
6423786-42378695.54196.39
20min1416111-41611193.81194.450.6895.1595.810.68
2420081-42008194.70696.12
3423226-42322695.41596.78
4415823-41582393.74695.13
5418216-41821694.28695.56
6420186-42018694.73096.11
30min1419051-41905194.47494.091.0096.3395.971.02
2422688-42268895.29497.24
3415858-41585893.75495.64
4415991-41599193.78495.69
5410658-41065892.58294.38
6419743-41974394.63096.53
45min1419195-41919594.50694.791.3996.8997.201.37
2418408-41840894.32996.80
3430622-43062297.08399.49
4420173-42017394.72797.15
5412851-41285193.07695.39
6421585-42158595.04597.47
60min1413313-41331393.18093.651.0096.0996.591.02
2417683-41768394.16597.16
3420345-42034594.76697.72
4413627-41362793.25196.20
5409147-40914792.24195.07
6418378-41837894.32297.28
极限1410598-41059892.56892.931.2295.9996.381.23
2415498-41549893.67397.19
3413886-41388693.30996.79
4417742-41774294.17997.65
5403347-40334790.93394.28
6412037-41203792.89396.37
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