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%
111.101882751881971883141881611879651881820.08
211.181888251884621886440.14
单位质量响应值RSD%判断
16953.3316873.350.34数据可信
中间条件12月-供试品溶液-2024011621批-依折麦布-pH6.8(内含0.2%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min141870-4187022.22421.1031.7122.2221.1031.72
223045-2304512.23212.23
326509-2650914.07114.07
451447-5144727.30827.31
553671-5367128.48828.49
641977-4197722.28122.28
10min1117855-11785562.55763.2115.2662.6863.3215.29
292044-9204448.85748.92
3104780-10478055.61755.70
4141635-14163575.17975.33
5130563-13056369.30269.46
6127605-12760567.73267.86
15min1160553-16055385.22183.537.1285.6984.007.17
2138656-13865673.59873.94
3155598-15559882.59182.98
4173185-17318591.92692.50
5155633-15563382.61083.15
6160598-16059885.24585.75
20min1173164-17316491.91590.534.3892.8691.474.42
2159881-15988184.86485.61
3172306-17230691.46092.31
4181149-18114996.15397.23
5164366-16436687.24588.25
6172508-17250891.56792.54
30min1178916-17891694.96894.612.3796.4296.042.45
2171638-17163891.10592.32
3179703-17970395.38696.74
4184052-18405297.69499.31
5175560-17556093.18794.67
6179596-17959695.32996.81
45min1180681-18068195.90596.371.9697.8998.331.99
2178692-17869294.84996.58
3184300-18430097.82699.71
4186034-18603498.746100.90
5176612-17661293.74595.75
6183036-18303697.15599.17
60min1179454-17945495.25496.821.6897.7799.321.66
2182790-18279097.02499.28
3184599-18459997.985100.41
4186048-18604898.754101.46
5178110-17811094.54097.07
6183409-18340997.35399.90
极限1180754-18075495.94497.381.8098.99100.421.70
2186702-18670299.101101.89
3184632-18463298.002100.97
4183264-18326497.276100.53
5178590-17859094.79597.85
6186830-18683099.169102.26
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100590-202406对照品来源中检院对照品使用方法直接使用
对照品含量(%)95.1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%
111.323147033145903145163144603142493145040.06
211.273145403144103144750.03
单位质量响应值RSD%判断
27783.0427903.730.31数据可信
中间条件12月-供试品溶液-2024011621批-阿托伐他汀钙-pH6.8(内含0.2%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1182462-18246254.24362.6620.0954.2462.6620.09
2178343-17834353.01953.02
3195756-19575658.19658.20
4178525-17852553.07353.07
5263007-26300778.18878.19
6266562-26656279.24579.25
10min1278596-27859682.82388.255.0583.1288.605.09
2299225-29922588.95589.25
3302135-30213589.82190.14
4278893-27889382.91183.21
5307550-30755091.43091.86
6314668-31466893.54693.99
15min1308891-30889191.82992.731.7492.5993.561.79
2314810-31481093.58994.38
3314204-31420493.40894.23
4303012-30301290.08190.84
5311997-31199792.75293.69
6318551-31855194.70195.66
20min1315770-31577093.87494.232.0095.1595.581.99
2325111-32511196.65197.96
3320292-32029295.21896.56
4309548-30954892.02493.28
5309909-30990992.13293.59
6321089-32108995.45596.94
30min1315000-31500093.64594.511.3695.4496.391.39
2323774-32377496.25398.10
3319422-31942294.96096.83
4311263-31126392.53494.30
5318369-31836994.64796.62
6319682-31968295.03797.05
45min1315456-31545693.78194.851.5096.0997.251.50
2323453-32345396.15898.54
3324646-32464696.51398.91
4314211-31421193.41195.69
5314664-31466493.54596.04
6321793-32179395.66598.21
60min1312740-31274092.97394.991.8095.8197.921.78
2327572-32757297.383100.30
3323995-32399596.31999.25
4315982-31598293.93796.74
5315432-31543293.77496.79
6321393-32139395.54698.62
极限1318383-31838394.65195.031.8998.0098.491.85
2327993-32799397.508100.96
3323290-32329096.11099.58
4314680-31468093.55096.87
5311499-31149992.60496.14
6322185-32218595.78199.39
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%
111.101885931887061878641880841883601883210.19
211.181885321889281887300.15
单位质量响应值RSD%判断
16965.8616881.040.36数据可信
中间条件12月-供试品溶液-2024011821批-依折麦布-pH6.8(内含0.2%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min157380-5738030.43920.6128.2630.4420.6128.28
229114-2911415.44415.44
340631-4063121.55421.55
426248-2624813.92413.92
539378-3937820.88920.89
640364-4036421.41221.41
10min1130095-13009569.01362.9714.3169.1863.0814.32
2108129-10812957.36057.45
3141126-14112674.86574.98
496184-9618451.02451.10
5128086-12808667.94768.06
6108560-10856057.58957.71
15min1157625-15762583.61782.508.4784.1782.978.49
2153032-15303281.18081.58
3175289-17528992.98793.52
4139641-13964174.07774.44
5163950-16395086.97287.47
6143599-14359976.17676.62
20min1169628-16962889.98490.474.6491.0091.394.68
2175581-17558193.14294.00
3179337-17933795.13596.19
4159478-15947884.60085.37
5176115-17611593.42694.40
6163125-16312586.53587.40
30min1177909-17790994.37795.622.8595.8997.042.91
2181446-18144696.25497.63
3189064-189064100.295101.88
4175369-17536993.03094.27
5181960-18196096.52698.02
6175739-17573993.22694.57
45min1178701-17870194.79797.341.6796.8499.301.68
2182563-18256396.84698.75
3186827-18682799.108101.25
4181832-18183296.45898.22
5186155-18615598.752100.78
6184872-18487298.07199.93
60min1179370-17937095.15297.141.4997.7299.641.50
2183779-18377997.49199.94
3185373-18537398.337101.03
4180172-18017295.57897.87
5184197-18419797.713100.29
6185839-18583998.584100.99
极限1183034-18303497.09697.630.66100.19100.670.59
2182950-18295097.051100.04
3182972-18297297.063100.30
4184602-18460297.928100.75
5185110-18511098.197101.32
6185579-18557998.446101.40
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100590-202406对照品来源中检院对照品使用方法直接使用
对照品含量(%)95.1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%
111.323155463155973146393145733144663149640.18
211.273158453158953158700.02
单位质量响应值RSD%判断
27823.6728027.510.52数据可信
中间条件12月-供试品溶液-2024011821批-阿托伐他汀钙-pH6.8(内含0.2%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1262855-26285577.91465.2314.4877.9165.2314.48
2205086-20508660.79060.79
3201784-20178459.81159.81
4229665-22966568.07668.08
5175802-17580252.11052.11
6245199-24519972.68072.68
10min1313472-31347292.91790.503.0793.3590.863.11
2302959-30295989.80190.14
3303262-30326289.89190.22
4307284-30728491.08391.46
5289345-28934585.76686.06
6315479-31547993.51293.92
15min1321129-32112995.18793.572.0596.1494.442.10
2312410-31241092.60393.44
3314405-31440593.19494.03
4317625-31762594.14895.03
5305314-30531490.49991.27
6323141-32314195.78396.71
20min1326378-32637896.74394.842.6398.2296.222.66
2325322-32532296.43097.78
3308941-30894191.57492.92
4320879-32087995.11396.52
5310168-31016891.93893.21
6328078-32807897.24798.70
30min1327134-32713496.96795.431.8498.9897.341.89
2321290-32129095.23597.12
3319452-31945294.69096.55
4326218-32621896.69598.63
5311612-31161292.36694.15
6325914-32591496.60598.60
45min1322319-32231995.54095.411.8698.0997.861.89
2318756-31875694.48496.90
3315357-31535793.47695.86
4327222-32722296.99399.47
5317143-31714394.00596.30
6330571-33057197.986100.52
60min1322126-32212695.48294.761.8198.5797.731.85
2319948-31994894.83797.78
3311690-31169092.38995.29
4320743-32074395.07398.08
5315241-31524193.44296.26
6328389-32838997.339100.42
极限1323154-32315495.78795.391.0899.4098.881.07
2318797-31879794.49697.96
3316283-31628393.75197.17
4323816-32381695.98399.52
5324963-32496396.32399.66
6323790-32379095.97699.59
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%
111.101881381883291882091881001881221881800.05
211.181888221890511889360.09
单位质量响应值RSD%判断
16953.1516899.460.23数据可信
中间条件12月-供试品溶液-2024012021批-依折麦布-pH6.8(内含0.2%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min148952-4895225.96424.6811.2725.9624.6811.28
238334-3833420.33220.33
343087-4308722.85322.85
450118-5011826.58226.58
552801-5280128.00528.01
645930-4593024.36124.36
10min1120891-12089164.11964.9510.8964.2665.0810.88
2106336-10633656.39956.51
3128413-12841368.10968.24
4127347-12734767.54367.69
5142340-14234075.49675.65
6109387-10938758.01858.15
15min1153104-15310481.20581.717.2281.7182.217.23
2143787-14378776.26376.69
3154337-15433781.85982.36
4160219-16021984.97885.50
5171636-17163691.03491.61
6141252-14125274.91875.38
20min1169057-16905789.66689.153.4890.6290.103.54
2161564-16156485.69286.54
3167292-16729288.73089.69
4173058-17305891.78892.78
5175861-17586193.27594.36
6161630-16163085.72786.60
30min1178220-17822094.52694.841.5095.9896.291.55
2175932-17593293.31294.64
3179878-17987895.40596.86
4183054-18305497.09098.59
5179658-17965895.28996.89
6176109-17610993.40694.76
45min1181278-18127896.14896.321.2698.1298.301.32
2180930-18093095.96397.81
3183217-18321797.17699.16
4183502-18350297.32799.37
5183218-18321897.17799.31
6177526-17752694.15896.03
60min1180653-18065395.81695.820.6498.3398.340.69
2179003-17900394.94197.32
3180814-18081495.90298.42
4182585-18258596.84199.43
5180491-18049195.73098.40
6180459-18045995.71398.11
极限1180472-18047295.72095.220.4298.7698.270.47
2178722-17872294.79297.70
3179963-17996395.45098.51
4180099-18009995.52298.65
5179194-17919495.04298.24
6178764-17876494.81497.74
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100590-202406对照品来源中检院对照品使用方法直接使用
对照品含量(%)95.1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%
111.323148203149713148423147203147373148180.04
211.273135443138663137050.08
单位质量响应值RSD%判断
27810.7827835.400.07数据可信
中间条件12月-供试品溶液-2024012021批-阿托伐他汀钙-pH6.8(内含0.2%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1208454-20845462.01566.0617.3562.0266.0617.35
2230113-23011368.45968.46
3190051-19005156.54056.54
4261971-26197177.93777.94
5268544-26854479.89279.89
6173199-17319951.52751.53
10min1299524-29952489.10988.903.2689.4589.263.31
2301961-30196189.83490.21
3286049-28604985.10085.41
4303503-30350390.29390.73
5312491-31249192.96793.41
6289302-28930286.06886.35
15min1314622-31462293.60193.921.9194.4494.781.97
2316457-31645794.14695.03
3309388-30938892.04392.83
4318543-31854394.76795.70
5325485-32548596.83297.79
6309698-30969892.13692.90
20min1321834-32183495.74695.150.5697.1196.540.62
2319813-31981395.14596.55
3318129-31812994.64495.94
4319641-31964195.09496.55
5321878-32187895.75997.26
6317721-31772194.52295.80
30min1322627-32262795.98295.700.2897.8797.620.33
2322539-32253995.95697.89
3321025-32102595.50597.33
4322249-32224995.87097.86
5321212-32121295.56197.59
6320492-32049295.34797.15
45min1321470-32147095.63895.321.3098.0697.761.33
2322269-32226995.87698.34
3321138-32113895.53997.89
4318220-31822094.67197.19
5325804-32580496.92799.49
6313583-31358393.29195.62
60min1319278-31927894.98694.730.5897.9497.700.58
2317754-31775494.53297.53
3319104-31910494.93497.82
4315524-31552493.86996.92
5320929-32092995.47798.58
6317902-31790294.57697.43
极限1318535-31853594.76593.910.9298.2597.410.92
2316751-31675194.23497.76
3314631-31463193.60397.02
4311459-31145992.66096.23
5318822-31882294.85098.48
6313789-31378993.35396.73
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