依折麦布阿托伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DSMF-387-240606对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.75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%
110.391800271803771801281800941800071801270.09
210.431798781796571797680.09
单位质量响应值RSD%判断
17336.5717235.670.42数据可信
供试品溶液-25012201批-依折麦布-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min16417-64173.3333.4522.563.333.4522.55
29166-91664.7604.76
35794-57943.0093.01
47350-73503.8173.82
56361-63613.3043.30
64770-47702.4772.48
10min114469-144697.5157.623.957.537.644.00
214942-149427.7607.79
314852-148527.7137.73
415432-154328.0158.04
513702-137027.1167.13
614607-146077.5867.60
15min114491-144917.5267.793.017.597.852.94
214782-147827.6777.75
314836-148367.7057.76
414879-148797.7277.79
515178-151787.8837.94
615796-157968.2048.26
20min115330-153307.9627.961.598.068.061.56
215457-154578.0288.14
315132-151327.8597.96
414996-149967.7887.90
515356-153567.9758.08
615689-156898.1488.25
30min114427-144277.4937.662.667.647.822.63
214597-145977.5817.74
315087-150877.8357.98
415392-153927.9948.15
514443-144437.5017.65
614597-145977.5817.73
45min114303-143037.4287.482.207.627.672.20
214685-146857.6277.83
314443-144437.5017.69
414362-143627.4597.66
513857-138577.1977.38
614732-147327.6517.84
60min113707-137077.1197.412.607.357.642.53
214510-145107.5367.78
314772-147727.6727.90
414318-143187.4367.67
514034-140347.2897.52
614282-142827.4177.65
极限113676-136767.1037.345.257.377.625.12
214604-146047.5857.87
314670-146707.6197.89
414636-146367.6017.88
512828-128286.6626.93
614399-143997.4787.75
依折麦布阿托伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100590-202005对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.9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0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.211590351591691590441590191591411590820.05
211.221590391589981590180.02
单位质量响应值RSD%判断
14191.0814172.730.10数据可信
供试品溶液-25012201批-阿托伐他汀钙-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min184747-8474749.35943.0711.2149.3643.0711.21
278271-7827145.58845.59
359652-5965234.74334.74
474785-7478543.55743.56
573897-7389743.04043.04
672328-7232842.12642.13
10min1134231-13423178.18178.364.9578.4578.604.96
2142372-14237282.92283.18
3124546-12454672.54072.73
4139454-13945481.22381.46
5129287-12928775.30175.54
6137376-13737680.01280.25
15min1143171-14317183.38787.464.9784.1088.144.95
2152561-15256188.85789.57
3139602-13960281.30981.90
4150465-15046587.63688.33
5158087-15808792.07592.73
6157130-15713091.51892.20
20min1156698-15669891.26693.945.4192.4495.105.39
2167243-16724397.40898.62
3147859-14785986.11887.17
4157866-15786691.94693.13
5171445-17144599.855101.02
6166638-16663897.05598.24
30min1156754-15675491.29995.834.9292.9897.524.90
2166018-16601896.69498.44
3153994-15399489.69191.22
4165405-16540596.33798.03
5176023-176023102.522104.25
6169034-16903498.451100.18
45min1160877-16087793.70097.854.8795.89100.064.86
2172716-172716100.595102.88
3156018-15601890.87092.89
4167264-16726497.42099.65
5174372-174372101.560103.85
6176766-176766102.954105.23
60min1161248-16124893.91698.734.3596.62101.494.34
2171493-17149399.883102.73
3159545-15954592.92495.45
4172244-172244100.321103.09
5175665-175665102.313105.17
6176878-176878103.020105.86
极限1162902-16290294.87998.854.2798.11102.164.24
2174747-174747101.778105.18
3159747-15974793.04296.09
4177337-177337103.287106.61
5168376-16837698.068101.49
6175230-175230102.060105.48
依折麦布阿托伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DSMF-387-240606对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.75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%
110.391793171794311792151793381792931793190.05
210.431807461805201806330.09
单位质量响应值RSD%判断
17258.8117318.600.25数据可信
供试品溶液-25012202批-依折麦布-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min17706-77064.0024.294.584.004.304.61
28010-80104.1594.16
38661-86614.4974.50
48429-84294.3774.38
58644-86444.4894.49
68163-81634.2394.24
10min115197-151977.8917.625.597.917.645.57
214097-140977.3207.34
315549-155498.0748.10
413833-138337.1837.21
515492-154928.0458.07
613891-138917.2137.24
15min115811-158118.2108.272.238.288.342.20
216613-166138.6278.69
315927-159278.2708.34
415572-155728.0868.15
515865-158658.2388.31
615805-158058.2078.27
20min115845-158458.2288.172.688.348.282.63
216150-161508.3868.50
315860-158608.2368.35
415688-156888.1468.26
514938-149387.7577.87
615953-159538.2848.39
30min116047-160478.3337.953.138.498.103.08
215739-157398.1738.33
315104-151047.8438.00
414885-148857.7297.88
514924-149247.7507.91
615108-151087.8458.00
45min114377-143777.4667.481.567.677.681.49
214216-142167.3827.59
314253-142537.4017.61
414768-147687.6697.87
514230-142307.3897.59
614573-145737.5677.77
60min114229-142297.3897.451.347.637.701.29
214475-144757.5167.76
314425-144257.4907.74
414377-143777.4667.71
514025-140257.2837.53
614554-145547.5577.80
极限114514-145147.5377.542.347.827.822.25
214495-144957.5277.81
314327-143277.4407.73
414549-145497.5557.84
514117-141177.3317.61
615130-151307.8578.14
依折麦布阿托伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100590-202005对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.9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0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.213149193148153145733146473145883147080.05
211.223172713170073171390.06
单位质量响应值RSD%判断
28073.8628265.510.49数据可信
供试品溶液-25012202批-阿托伐他汀钙-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min164421-6442118.89023.0721.5418.8923.0721.54
279679-7967923.36423.36
3107379-10737931.48631.49
466369-6636919.46119.46
588336-8833625.90225.90
665920-6592019.32919.33
10min1216890-21689063.59866.735.9763.7066.866.00
2235384-23538469.02169.15
3250361-25036173.41273.59
4226485-22648566.41166.52
5223123-22312365.42665.57
6213197-21319762.51562.62
15min1283372-28337283.09281.302.8783.5581.802.89
2281578-28157882.56683.08
3287328-28732884.25284.83
4273934-27393480.32580.80
5268992-26899278.87679.38
6268377-26837778.69579.15
20min1311969-31196991.47887.124.0992.4088.074.07
2290078-29007885.05986.03
3311786-31178691.42492.47
4292974-29297485.90886.83
5282303-28230382.77983.72
6293483-29348386.05786.95
30min1334011-33401197.94192.803.1699.3794.233.15
2313434-31343491.90793.35
3322494-32249494.56496.12
4307822-30782290.26291.66
5309773-30977390.83492.24
6311288-31128891.27892.65
45min1329667-32966796.66792.973.6698.6494.923.61
2297164-29716487.13689.09
3326419-32641995.71597.80
4314450-31445092.20594.11
5314084-31408492.09894.01
6320521-32052193.98595.86
60min1333702-33370297.85094.742.67100.3697.212.66
2310757-31075791.12293.56
3332397-33239797.468100.08
4320423-32042393.95696.37
5320932-32093294.10696.53
6320354-32035493.93696.34
极限1348638-348638102.23096.753.52105.2899.753.48
2316563-31656392.82595.77
3338558-33855899.274102.43
4327427-32742796.01098.95
5324033-32403395.01597.96
6324547-32454795.16698.09
依折麦布阿托伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DSMF-387-240606对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.75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%
110.391806521808641805061804131805991806070.10
210.431796311794561795440.07
单位质量响应值RSD%判断
17382.7717214.190.69数据可信
供试品溶液-25012201批-依折麦布-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min16664-66643.4593.587.833.463.587.81
26210-62103.2233.22
37176-71763.7243.72
46665-66653.4593.46
56887-68873.5743.57
67792-77924.0444.04
10min113306-133066.9066.923.056.926.943.04
213115-131156.8076.82
313346-133466.9266.95
412923-129236.7076.73
513232-132326.8676.89
614109-141097.3227.34
15min113476-134766.9947.162.587.057.222.58
213716-137167.1187.17
313325-133256.9166.97
414178-141787.3587.41
514146-141467.3427.40
613976-139767.2537.32
20min113791-137917.1577.251.567.257.351.58
214007-140077.2697.36
313698-136987.1097.21
413954-139547.2427.34
514020-140207.2767.38
614324-143247.4347.54
30min113068-130686.7826.831.396.926.971.38
213242-132426.8727.01
313329-133296.9187.05
413206-132066.8546.99
512843-128436.6656.80
613297-132976.9017.05
45min112752-127526.6186.791.656.796.971.64
213179-131796.8407.01
313180-131806.8407.02
413016-130166.7556.93
513005-130056.7496.93
613390-133906.9497.13
60min112677-126776.5796.783.346.797.003.30
213251-132516.8777.09
313018-130186.7566.97
412958-129586.7256.94
512654-126546.5676.78
613826-138267.1767.40
极限113307-133076.9066.905.497.157.155.35
213532-135327.0237.27
313216-132166.8597.11
412818-128186.6526.90
512367-123676.4186.67
614520-145207.5367.80
依折麦布阿托伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100590-202005对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.9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0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.211592771594811593971591611594441593520.09
211.221585141584701584920.02
单位质量响应值RSD%判断
14215.1714125.850.45数据可信
供试品溶液-25012201批-阿托伐他汀钙-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min194112-9411254.85959.9210.5754.8659.9210.57
2113380-11338066.09066.09
3110662-11066264.50664.51
4113849-11384966.36366.36
592651-9265154.00754.01
692068-9206853.66753.67
10min1152897-15289789.12588.551.8289.4388.881.80
2149591-14959187.19887.56
3147783-14778386.14486.50
4153467-15346789.45789.83
5155408-15540890.58890.89
6152305-15230588.78089.08
15min1153854-15385489.68390.422.9990.4891.242.94
2153306-15330689.36390.21
3148341-14834186.46987.31
4155899-15589990.87591.74
5162325-16232594.62095.42
6157008-15700891.52192.31
20min1157448-15744891.77792.092.8293.0893.422.77
2154421-15442190.01391.36
3152821-15282189.08090.40
4157179-15717991.62192.99
5164964-16496496.15997.49
6161096-16109693.90495.20
30min1156481-15648191.21490.512.5793.0292.352.55
2154665-15466590.15592.00
3148806-14880686.74088.55
4158983-15898392.67294.55
5159514-15951492.98294.84
6153227-15322789.31791.14
45min1163759-16375995.45694.672.9797.7797.012.91
2160664-16066493.65296.00
3157666-15766691.90594.20
4160424-16042493.51295.91
5171392-17139299.906102.29
6160522-16052293.56995.89
60min1161794-16179494.31194.762.7397.1697.632.66
2161793-16179394.31097.18
3156497-15649791.22394.03
4160236-16023693.40396.32
5165936-16593696.72599.66
6169130-16913098.587101.42
极限1180749-180749105.360102.102.16108.73105.502.10
2177233-177233103.310106.70
3169846-16984699.004102.32
4173005-173005100.846104.28
5173818-173818101.320104.79
6176303-176303102.768106.15
依折麦布阿托伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DSMF-387-240606对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.75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%
110.391790671790341793001791451791051791300.06
210.431802131809201805660.28
单位质量响应值RSD%判断
17240.6217312.180.30数据可信
供试品溶液-25012202批-依折麦布-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min17971-79714.1424.294.484.144.284.51
28064-80644.1904.19
38429-84294.3804.38
48909-89094.6294.63
58181-81814.2514.25
67935-79354.1234.12
10min113510-135107.0207.252.607.047.272.61
213785-137857.1637.19
314026-140267.2887.31
414594-145947.5847.61
513887-138877.2167.24
613870-138707.2077.23
15min114074-140747.3137.291.517.387.351.48
213678-136787.1087.17
313958-139587.2537.32
413979-139797.2647.33
514239-142397.3997.46
614243-142437.4017.46
20min113845-138457.1947.141.567.307.251.54
213457-134576.9937.10
313571-135717.0527.16
414069-140697.3117.42
513747-137477.1447.25
613764-137647.1527.26
30min113574-135747.0546.882.437.207.022.41
212992-129926.7516.89
313430-134306.9797.12
413493-134937.0127.16
513181-131816.8496.99
612753-127536.6276.77
45min113775-137757.1586.882.597.347.062.53
213003-130036.7576.94
312945-129456.7276.91
413358-133586.9417.13
512908-129086.7086.89
613422-134226.9757.16
60min114625-146257.6006.865.477.827.085.29
212623-126236.5596.78
312814-128146.6596.88
413040-130406.7767.00
512996-129966.7536.97
613081-130816.7977.02
极限115944-159448.2857.138.608.557.398.33
213280-132806.9017.15
313057-130576.7857.04
412888-128886.6976.96
513006-130066.7587.02
614130-141307.3437.60
依折麦布阿托伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100590-202005对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.9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0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.213141353140213142603140203141113141090.04
211.223165153171983168560.16
单位质量响应值RSD%判断
28020.4328240.290.56数据可信
供试品溶液-25012202批-阿托伐他汀钙-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1103379-10337930.35640.9039.1230.3640.9039.11
2184214-18421454.09254.09
3192222-19222256.44456.44
4188986-18898655.49355.49
587789-8778925.77825.78
679206-7920623.25823.26
10min1255630-25563075.06378.965.6775.2379.185.75
2292108-29210885.77486.07
3281060-28106082.53082.84
4270586-27058679.45479.76
5259446-25944676.18376.33
6254525-25452574.73874.87
15min1287366-28736684.38185.462.5184.9786.122.56
2303044-30304488.98589.76
3294445-29444586.46087.23
4283271-28327183.17983.93
5292830-29283085.98686.55
6285214-28521483.75084.29
20min1296967-29696787.20186.652.5688.2687.792.57
2306985-30698590.14291.41
3294120-29412086.36587.62
4286805-28680584.21785.43
5298253-29825387.57888.62
6287398-28739884.39185.40
30min1300342-30034288.19287.243.8989.7388.863.92
2312353-31235391.71993.49
3306360-30636089.95991.69
4286787-28678784.21185.89
5294639-29463986.51788.05
6282067-28206782.82584.30
45min1306031-30603189.86289.782.6891.8991.882.71
2312215-31221591.67893.96
3318186-31818693.43195.66
4296766-29676687.14289.29
5299242-29924287.86989.88
6301965-30196588.66890.61
60min1315605-31560592.67390.524.1695.2093.124.11
2313094-31309491.93694.73
3325426-32542695.55798.31
4288075-28807584.59087.22
5303514-30351489.12391.62
6303813-30381389.21191.64
极限1358573-358573105.290100.154.89108.33103.264.74
2351536-351536103.224106.53
3337189-33718999.011102.29
4313152-31315291.95395.05
5333777-33377798.009101.00
6352270-352270103.440106.37
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