依折麦布匹伐他汀钙片项目信息
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101245-202102对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.3对照品水分(%)0对照品稀释倍数5000
标示量(mg)2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%
110.851295851297471298991297471297341297420.09
210.88 1310251313331311790.17
单位质量响应值RSD%判断
11957.7912056.890.59数据可信
供试品溶液-2024061321批-匹伐他汀钙-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%
5min1115190-11519083.14786.432.9283.1586.432.92
2118572-11857285.58885.59
3125279-12527990.42990.43
4120558-12055887.02187.02
5121356-12135687.59787.60
6117489-11748984.80684.81
10min1124709-12470990.01892.151.9490.1692.301.94
2126966-12696691.64791.79
3130422-13042294.14194.29
4126179-12617991.07991.22
5126782-12678291.51491.66
6130924-13092494.50494.65
15min1124774-12477490.06492.212.0390.3592.512.03
2127474-12747492.01392.31
3130626-13062694.28994.60
4125760-12576090.77691.07
5126752-12675291.49291.79
6131134-13113494.65594.95
20min1124674-12467489.99292.062.0590.4392.512.05
2127044-12704491.70392.15
3130241-13024194.01194.48
4126091-12609191.01591.46
5125948-12594890.91291.36
6131228-13122894.72395.18
30min1123367-12336789.04991.642.1989.6492.242.19
2126569-12656991.36091.96
3129721-12972193.63594.26
4125340-12534090.47391.07
5125988-12598890.94191.54
6130722-13072294.35894.97
45min1124718-12471890.02491.591.8490.7692.351.84
2126228-12622891.11491.87
3129058-12905893.15793.93
4124834-12483490.10890.86
5126088-12608891.01391.77
6130425-13042594.14394.92
60min1123099-12309988.85591.291.9489.7492.201.94
2125387-12538790.50791.41
3128558-12855892.79693.73
4125832-12583290.82891.73
5125996-12599690.94791.85
6129988-12998893.82894.76
极限1123319-12331989.01491.001.8890.0592.061.88
2125635-12563590.68691.74
3128209-12820992.54493.63
4124822-12482290.09991.15
5124828-12482890.10391.16
6129616-12961693.56094.64
依折麦布匹伐他汀钙片项目信息
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ZT-705-231101-1-D对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数1000
标示量(mg)10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%
110.933851463855153855573856673857713855310.07
211.003873303863813868560.18
单位质量响应值RSD%判断
35272.7435168.730.21数据可信
供试品溶液-2024061321批-依折麦布-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%
5min135026-350268.9509.105.978.959.105.94
237743-377439.6459.64
335156-351568.9838.98
438168-381689.7539.75
535368-353689.0389.04
632317-323178.2588.26
10min133990-339908.6868.774.778.708.784.77
235958-359589.1889.20
335234-352349.0039.02
434841-348418.9038.92
534670-346708.8598.87
631261-312617.9888.00
15min135867-358679.1658.981.779.199.011.75
235177-351778.9899.02
335691-356919.1209.15
434121-341218.7198.75
535150-351508.9829.01
634910-349108.9218.95
20min135243-352439.0068.763.229.058.803.23
235633-356339.1059.15
333493-334938.5598.60
434795-347958.8918.94
532857-328578.3968.44
633627-336278.5938.63
30min134799-347998.8928.882.868.958.942.85
236081-360819.2209.28
335587-355879.0949.15
433702-337028.6128.67
534770-347708.8858.94
633594-335948.5848.64
45min133598-335988.5858.772.818.668.852.78
235831-358319.1569.23
334945-349458.9309.00
433901-339018.6638.74
534529-345298.8238.90
633210-332108.4868.56
60min134404-344048.7918.493.438.888.583.37
231957-319578.1668.26
334187-341878.7368.83
431761-317618.1168.21
533274-332748.5038.59
633856-338568.6518.74
极限135557-355579.0868.891.199.199.001.17
234464-344648.8078.91
334839-348398.9029.01
434798-347988.8928.99
534415-344158.7948.90
634713-347138.8708.97
依折麦布匹伐他汀钙片项目信息
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101245-202102对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.3对照品水分(%)0对照品稀释倍数5000
标示量(mg)2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%
110.851296231291511295181296991294861294950.17
210.88 1301711303231302470.09
单位质量响应值RSD%判断
11935.0211971.230.22数据可信
供试品溶液-2024061321批-匹伐他汀钙-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%
5min1122486-12248688.81383.044.9788.8183.044.97
2108492-10849278.66678.67
3112853-11285381.82881.83
4110897-11089780.41080.41
5120698-12069887.51687.52
6111702-11170280.99380.99
10min1127452-12745292.41391.771.0092.5691.911.00
2127558-12755892.49092.62
3124638-12463890.37390.51
4127756-12775692.63492.77
5125534-12553491.02391.17
6126449-12644991.68691.82
15min1127495-12749592.44592.151.1792.7592.441.17
2129579-12957993.95694.24
3125787-12578791.20691.49
4127459-12745992.41892.71
5125460-12546090.96991.27
6126714-12671491.87892.17
20min1127452-12745292.41391.560.8592.8792.010.85
2127220-12722092.24592.69
3125145-12514590.74191.18
4126858-12685891.98392.43
5124962-12496290.60891.06
6126041-12604191.39091.83
30min1126898-12689892.01291.390.8892.6291.990.87
2126866-12686691.98892.58
3124589-12458990.33790.93
4127202-12720292.23292.83
5125033-12503390.65991.26
6125689-12568991.13591.73
45min1126373-12637391.63191.260.6092.3992.000.60
2126735-12673591.89492.64
3124887-12488790.55491.29
4126293-12629391.57392.32
5125045-12504590.66891.42
6125811-12581191.22491.97
60min1126358-12635891.62090.930.9792.5491.840.97
2126184-12618491.49492.40
3124052-12405289.94890.84
4126515-12651591.73492.64
5123752-12375289.73190.63
6125591-12559191.06491.96
极限1124981-12498190.62290.730.6291.6991.780.61
2126118-12611891.44692.50
3124223-12422390.07291.11
4125756-12575691.18492.24
5124322-12432290.14491.20
6125400-12540090.92691.97
依折麦布匹伐他汀钙片项目信息
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ZT-705-231101-1-D对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数1000
标示量(mg)10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%
110.933844633849103851623849133847403848380.07
211.003851153864343857740.25
单位质量响应值RSD%判断
35209.3335070.360.28数据可信
供试品溶液-2024061321批-依折麦布-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%
5min136516-365169.3528.725.009.358.724.98
234073-340738.7278.73
334094-340948.7328.73
431420-314208.0478.05
534979-349798.9598.96
633273-332738.5228.52
10min133600-336008.6068.453.888.628.463.87
233243-332438.5148.53
333724-337248.6378.65
430552-305527.8257.84
534070-340708.7268.74
632699-326998.3758.39
15min134290-342908.7828.782.148.818.812.15
233725-337258.6388.67
334788-347888.9108.94
434421-344218.8168.84
535247-352479.0279.06
633202-332028.5048.53
20min134303-343038.7868.633.258.838.673.25
232948-329488.4398.48
334844-348448.9248.97
434543-345438.8478.89
533501-335018.5808.62
631975-319758.1898.23
30min132907-329078.4288.622.198.498.682.13
234111-341118.7378.79
333586-335868.6028.66
434897-348978.9388.99
533063-330638.4688.53
633467-334678.5728.63
45min133427-334278.5618.651.018.638.721.00
233695-336958.6308.70
333877-338778.6778.75
434399-343998.8108.88
533603-336038.6068.68
633647-336478.6188.69
60min134290-342908.7828.672.918.878.762.88
234350-343508.7988.88
333658-336588.6218.71
431963-319638.1868.27
534608-346088.8648.95
634301-343018.7858.87
极限132047-320478.2088.414.048.318.513.97
234411-344118.8138.91
331412-314128.0458.15
431567-315678.0858.18
533487-334878.5778.68
634106-341068.7358.83
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