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对照品来源自制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%
111.221926281927571928511927681927681927540.05
211.351923421926121924770.10
单位质量响应值RSD%判断
17179.5016958.330.92数据可信
中间条件6月-供试品溶液-2024011621批-依折麦布-pH6.8(内含0.2%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min162279-6227932.75725.6217.4532.7625.6217.45
249284-4928425.92225.92
353647-5364728.21728.22
446205-4620524.30324.30
538463-3846320.23120.23
642331-4233122.26522.27
10min1144573-14457376.04268.537.2876.2268.677.29
2134433-13443370.70970.85
3123311-12331164.85965.02
4124107-12410765.27865.41
5119649-11964962.93363.05
6135614-13561471.33071.45
15min1168664-16866488.71485.204.6189.3285.724.62
2169290-16929089.04389.58
3154050-15405081.02781.54
4159096-15909683.68184.18
5153193-15319380.57681.04
6167552-16755288.12988.65
20min1175916-17591692.52891.583.7393.6392.573.74
2180718-18071895.05496.09
3165870-16587087.24488.21
4171364-17136490.13491.10
5168851-16885188.81289.72
6181906-18190695.67996.69
30min1174563-17456391.81693.932.5393.4395.442.52
2185345-18534597.48799.05
3173917-17391791.47792.93
4178484-17848493.87995.34
5176766-17676692.97594.38
6182429-18242995.95497.49
45min1178067-17806793.65995.432.0095.7897.461.99
2187906-18790698.834100.94
3178579-17857993.92995.89
4180586-18058694.98496.97
5180531-18053194.95596.87
6182958-18295896.23298.31
60min1175578-17557892.35094.991.8794.9997.541.82
2183413-18341396.47199.12
3179950-17995094.65097.13
4185195-18519597.40999.92
5179122-17912294.21496.66
6180315-18031594.84297.45
极限1178846-17884694.06995.561.6297.2298.641.54
2183073-18307396.29299.48
3181182-18118295.29898.31
4178584-17858493.93196.99
5186506-18650698.098101.07
6181884-18188495.66798.80
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2500
标示量(mg)20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%
111.243117283118903120033118613117293118420.04
211.243114283116083115180.05
单位质量响应值RSD%判断
27743.9527715.120.08数据可信
中间条件6月-供试品溶液-2024011621批-阿托伐他汀钙-pH6.8(内含0.2%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1271505-27150580.87568.3112.2680.8868.3112.26
2202104-20210460.20260.20
3225077-22507767.04567.05
4239293-23929371.28071.28
5242385-24238572.20172.20
6195567-19556758.25558.25
10min1314288-31428893.61991.223.6094.0791.603.63
2287798-28779885.72986.06
3300727-30072789.58089.95
4313602-31360293.41593.81
5316863-31686394.38694.79
6304137-30413790.59690.92
15min1323026-32302696.22294.353.0897.1995.233.11
2300050-30005089.37890.19
3315810-31581094.07394.94
4324907-32490796.78297.70
5324799-32479996.75097.68
6311784-31178492.87393.70
20min1326271-32627197.18995.972.5798.6997.382.59
2306152-30615291.19692.50
3321394-32139495.73697.13
4325517-32551796.96498.42
5329220-32922098.06799.53
6324544-32454496.67498.02
30min1317529-31752994.58595.142.1296.6397.092.13
2307664-30766491.64693.46
3325428-32542896.93898.86
4322394-32239496.03498.03
5325584-32558496.98498.99
6317831-31783194.67596.55
45min1321402-32140295.73895.261.8998.3197.731.92
2310091-31009192.36994.69
3325158-32515896.85799.32
4320230-32023095.38997.91
5326071-32607197.12999.68
6315822-31582294.07696.48
60min1316438-31643894.26094.452.5797.3697.452.57
2304460-30446090.69293.53
3321381-32138195.73298.73
4327274-32727497.488100.54
5321301-32130195.70898.79
6311590-31159092.81695.74
极限1320493-32049395.46895.641.7899.0999.171.71
2321711-32171195.83099.17
3319172-31917295.07498.61
4312343-31234393.04096.64
5329944-32994498.283101.90
6322763-32276396.14499.59
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对照品来源自制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%
111.221931491932961932111933011932521932420.04
211.351923681927131925400.13
单位质量响应值RSD%判断
17222.9916963.881.08数据可信
中间条件6月-供试品溶液-2024011821批-依折麦布-pH6.8(内含0.2%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min132494-3249417.06722.9524.7717.0722.9524.76
250670-5067026.61326.61
330956-3095616.25916.26
459417-5941731.20831.21
545043-4504323.65823.66
643612-4361222.90622.91
10min1111683-11168358.65964.676.8258.7564.796.86
2130354-13035468.46668.61
3115051-11505160.42860.52
4132023-13202369.34369.52
5121721-12172163.93264.06
6127887-12788767.17067.30
15min1164272-16427286.28183.552.2786.7084.032.23
2159863-15986383.96584.49
3157012-15701282.46882.89
4156801-15680182.35782.92
5154595-15459581.19881.68
6161840-16184085.00485.50
20min1176931-17693192.93090.462.2293.8391.412.19
2172858-17285890.79191.79
3169066-16906688.79989.68
4168517-16851788.51089.53
5169436-16943688.99389.93
6176510-17651092.70993.68
30min1180406-18040694.75595.272.1296.1796.722.10
2181413-18141395.28496.78
3180371-18037194.73796.11
4177675-17767593.32194.83
5179661-17966194.36495.80
6188781-18878199.154100.64
45min1188359-18835998.93297.531.11100.8799.521.06
2185379-18537997.36799.40
3187687-18768798.579100.48
4184318-18431896.81098.84
5182862-18286296.04598.00
6185569-18556997.46799.51
60min1182802-18280296.01395.820.4298.5198.350.42
2182170-18217095.68198.25
3182896-18289696.06398.51
4183268-18326896.25898.82
5181118-18111895.12997.62
6182407-18240795.80698.39
极限1183503-18350396.38297.290.8999.41100.340.87
2187436-18743698.447101.55
3184891-18489197.111100.10
4185607-18560797.487100.59
5186550-18655097.982101.00
6183360-18336096.30799.42
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2500
标示量(mg)20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%
111.243125103125213123913125083124493124760.02
211.243111713113803112760.05
单位质量响应值RSD%判断
27800.3627693.590.28数据可信
中间条件6月-供试品溶液-2024011821批-阿托伐他汀钙-pH6.8(内含0.2%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1234321-23432169.75563.7116.6069.7663.7116.60
2178542-17854253.15053.15
3196086-19608658.37358.37
4199708-19970859.45159.45
5276369-27636982.27382.27
6199035-19903559.25159.25
10min1306427-30642791.22190.903.3091.6191.263.34
2300851-30085189.56189.86
3312745-31274593.10193.43
4296246-29624688.19088.52
5320878-32087895.52395.98
6295048-29504887.83388.16
15min1321000-32100095.55995.212.9796.4596.072.98
2324544-32454496.61497.41
3328134-32813497.68398.52
4313812-31381293.41994.24
5327764-32776497.57298.56
6303729-30372990.41791.23
20min1322514-32251496.01096.512.4497.4397.902.43
2332635-33263599.023100.35
3328849-32884997.89599.28
4322012-32201295.86097.20
5328764-32876497.87099.40
6310439-31043992.41593.73
30min1316766-31676694.29896.911.7796.2698.841.74
2333027-33302799.139101.02
3328621-32862197.82899.76
4325508-32550896.90198.77
5327866-32786697.60399.68
6321414-32141495.68297.52
45min1327814-32781497.58797.622.36100.07100.082.33
2333781-33378199.364101.79
3335453-33545399.861102.33
4329833-32983398.188100.60
5326988-32698897.34199.96
6313697-31369793.38595.75
60min1318670-31867094.86595.742.1497.8998.742.12
2326950-32695097.330100.31
3325926-32592697.025100.05
4326494-32649497.194100.15
5322484-32248496.00199.16
6309121-30912192.02394.91
极限1321115-32111595.59396.971.4799.14100.511.46
2333449-33344999.265102.79
3325210-32521096.812100.38
4323531-32353196.31299.81
5329276-32927698.023101.71
6321852-32185295.81399.21
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对照品来源自制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%
111.221922861923631923661924191924981923860.05
211.351943611946541945080.11
单位质量响应值RSD%判断
17146.7017137.270.04数据可信
中间条件6月-供试品溶液-2024012021批-依折麦布-pH6.8(内含0.2%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min167233-6723335.21128.4517.2935.2128.4517.29
241429-4142921.69721.70
361154-6115432.02732.03
449126-4912625.72825.73
557546-5754630.13830.14
649424-4942425.88425.88
10min1143900-14390075.36270.096.0075.5670.256.02
2120078-12007862.88763.01
3131331-13133168.78068.96
4133040-13304069.67569.82
5137806-13780672.17172.34
6136800-13680071.64471.79
15min1165114-16511486.47386.312.9287.0986.852.92
2158957-15895783.24883.72
3159107-15910783.32783.89
4170571-17057189.33089.86
5168192-16819288.08588.65
6166823-16682387.36887.91
20min1172427-17242790.30291.622.2991.4092.652.28
2169123-16912388.57289.50
3174450-17445091.36292.38
4180608-18060894.58795.61
5175540-17554091.93392.99
6177534-17753492.97794.00
30min1174116-17411691.18793.532.3892.7895.072.34
2175444-17544491.88393.31
3181910-18191095.26996.80
4183086-18308695.88597.44
5174708-17470891.49793.07
6182289-18228995.46797.01
45min1181841-18184195.23396.731.4797.3498.781.46
2182055-18205595.34597.28
3185608-18560897.20699.27
4185551-18555197.17699.26
5184026-18402696.37798.45
6189111-18911199.040101.11
60min1175804-17580492.07194.401.7094.7096.991.64
2180919-18091994.75097.21
3183720-18372096.21798.82
4182806-18280695.73898.36
5177512-17751292.96695.58
6180713-18071394.64297.27
极限1176382-17638292.37494.332.3295.5297.442.26
2179358-17935893.93296.92
3180926-18092694.75497.89
4183572-18357296.13999.30
5174745-17474591.51694.65
6185675-18567597.241100.39
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2500
标示量(mg)20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%
111.243102813103703102753102803103303103070.02
211.243137083139373138220.06
单位质量响应值RSD%判断
27607.3827920.110.80数据可信
中间条件6月-供试品溶液-2024012021批-阿托伐他汀钙-pH6.8(内含0.2%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1256688-25668876.37070.1517.7476.3770.1517.74
2185945-18594555.32255.32
3222009-22200966.05266.05
4193047-19304757.43557.44
5269668-26966880.23280.23
6287308-28730885.48085.48
10min1311530-31153092.68692.594.2493.1192.984.28
2290463-29046386.41886.73
3305177-30517790.79691.16
4316767-31676794.24494.56
5312889-31288993.09193.54
6330421-33042198.30798.78
15min1323935-32393596.37796.333.2097.3297.233.23
2309779-30977992.16592.95
3315541-31554193.88094.75
4329681-32968198.08798.93
5324576-32457696.56897.53
6339076-339076100.882101.90
20min1325058-32505896.71197.302.9698.1998.742.98
2313764-31376493.35194.65
3323637-32363796.28897.68
4334918-33491899.645101.03
5323664-32366496.29697.80
6341222-341222101.520103.10
30min1318570-31857094.78196.142.7396.7998.122.73
2316206-31620694.07895.90
3325211-32521196.75798.68
4330161-33016198.229100.17
5312872-31287293.08695.12
6335828-33582899.915102.06
45min1329286-32928697.96998.362.03100.51100.872.09
2324081-32408196.42198.76
3328071-32807197.608100.07
4331289-33128998.565101.05
5327400-32740097.40899.96
6343397-343397102.167104.87
60min1316774-31677494.24795.761.4697.3398.821.45
2321598-32159895.68298.56
3323563-32356396.26699.27
4326082-32608297.016100.05
5315948-31594894.00197.09
6327199-32719997.348100.62
极限1314643-31464393.61395.462.6797.2299.052.65
2316807-31680794.25697.66
3318561-31856194.77898.32
4328901-32890197.855101.43
5312410-31241092.94896.56
6333832-33383299.322103.13
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对照品来源自制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%
111.221927471934111938061943691946621937990.40
211.351935181938611936900.13
单位质量响应值RSD%判断
17272.6417065.200.86数据可信
长期6月-供试品溶液-2024012021批-依折麦布-pH6.8(内含0.2%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min122695-2269511.86723.7131.7311.8723.7131.73
257445-5744530.03930.04
334412-3441217.99417.99
451525-5152526.94326.94
545930-4593024.01724.02
660090-6009031.42231.42
10min1107152-10715256.03167.8411.5256.1067.9811.56
2145999-14599976.34576.51
3115773-11577360.53960.64
4137850-13785072.08372.23
5134039-13403970.09170.22
6137648-13764871.97872.15
15min1152073-15207379.52185.794.4779.9086.304.53
2168640-16864088.18488.77
3159623-15962383.46983.91
4166277-16627786.94887.50
5164926-16492686.24286.76
6172881-17288190.40190.98
20min1168555-16855588.13991.782.7588.9692.762.83
2177352-17735292.73993.82
3171619-17161989.74290.64
4180465-18046594.36795.40
5174688-17468891.34692.35
6180427-18042794.34795.42
30min1177494-17749492.81496.062.2194.1297.552.26
2183573-18357395.99297.59
3186101-18610197.31498.71
4184885-18488596.67998.24
5181024-18102494.66096.17
6189121-18912198.894100.49
45min1185013-18501396.74596.950.6098.5798.970.66
2184394-18439496.42298.55
3184023-18402396.22898.17
4186552-18655297.55099.64
5185684-18568497.09699.13
6186706-18670697.63199.78
60min1182288-18228895.32196.821.0397.6899.391.11
2184957-18495796.71699.38
3184436-18443696.44498.92
4187964-18796498.289100.93
5185025-18502596.75299.33
6186273-18627397.404100.10
极限1181247-18124794.77695.980.9097.6799.090.95
2182202-18220295.27698.48
3184296-18429696.37199.38
4183271-18327195.83599.02
5184588-18458896.52399.64
6185741-18574197.126100.36
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2500
标示量(mg)20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%
111.243115073124453128913135963139433128760.31
211.243118593121283119940.07
单位质量响应值RSD%判断
27835.9427757.470.20数据可信
长期6月-供试品溶液-2024012021批-阿托伐他汀钙-pH6.8(内含0.2%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1222407-22240766.09070.7311.1966.0970.7311.19
2273902-27390281.39281.39
3237186-23718670.48270.48
4237902-23790270.69570.69
5258598-25859876.84476.84
6198175-19817558.88958.89
10min1304743-30474390.55791.383.8690.9291.773.89
2324301-32430196.36996.82
3300765-30076589.37589.77
4305769-30576990.86291.25
5317952-31795294.48294.91
6291542-29154286.63486.96
15min1322739-32273995.90595.171.4296.7796.071.43
2324114-32411496.31397.30
3320199-32019995.15096.04
4311623-31162392.60193.50
5322984-32298495.97796.93
6319906-31990695.06395.87
20min1324290-32429096.36596.050.9497.7797.480.96
2327556-32755697.33698.86
3318208-31820894.55895.97
4322603-32260395.86497.28
5322984-32298495.97797.46
6323654-32365496.17697.51
30min1321904-32190495.65697.241.6097.5999.201.56
2330473-33047398.203100.27
3331329-33132998.457100.40
4322475-32247595.82697.77
5323426-32342696.10998.13
6333825-33382599.199101.07
45min1329345-32934597.86897.150.83100.3499.650.84
2329214-32921497.829100.44
3323124-32312496.01998.51
4323961-32396196.26898.74
5328260-32826097.545100.10
6327627-32762797.35799.78
60min1322819-32281995.92896.890.8198.9499.930.83
2329777-32977797.996101.15
3323183-32318396.03699.06
4326694-32669497.080100.09
5326449-32644997.007100.10
6327330-32733097.269100.23
极限1319931-31993195.07096.441.4798.62100.021.39
2323688-32368896.18799.88
3323016-32301695.98799.54
4322988-32298895.97999.53
5323895-32389596.24899.88
6333782-33378299.186102.69
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