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%
111.151883281883031880771881451883431882390.07
211.211880191886091883140.23
单位质量响应值RSD%判断
16882.4216798.750.36数据可信
中间条件12月-供试品溶液-2023121221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%
5min144479-4447923.71123.666.6523.7123.666.66
248265-4826525.73025.73
345037-4503724.00924.01
442342-4234222.57222.57
546328-4632824.69724.70
639899-3989921.27021.27
10min198883-9888352.71462.037.9252.8562.167.90
2117329-11732962.54762.69
3126404-12640467.38567.52
4119236-11923663.56463.69
5119246-11924663.56963.71
6117073-11707362.41062.53
15min1138442-13844273.80281.184.7474.2381.664.74
2153107-15310781.62082.11
3158617-15861784.55785.06
4156982-15698283.68684.16
5152059-15205981.06181.55
6154531-15453182.37982.84
20min1160861-16086185.75389.392.1786.5990.322.20
2166579-16657988.80289.75
3170404-17040490.84191.82
4170527-17052790.90691.85
5168591-16859189.87490.81
6169101-16910190.14691.07
30min1173145-17314592.30293.901.2693.6195.331.30
2174905-17490593.24094.68
3178645-17864595.23496.72
4177081-17708194.40095.85
5178353-17835395.07896.52
6174744-17474493.15494.58
45min1178678-17867895.25295.330.7797.0897.280.77
2178370-17837095.08797.04
3179785-17978595.84297.85
4179290-17929095.57897.55
5180363-18036396.15098.12
6176471-17647194.07596.02
60min1180839-18083996.40495.141.2498.7697.621.19
2175492-17549293.55396.04
3178773-17877395.30297.85
4180777-18077796.37098.87
5178560-17856095.18997.69
6176382-17638294.02896.49
极限1179699-17969995.79695.501.0898.6898.501.07
2178162-17816294.97697.98
3182346-18234697.207100.28
4177807-17780794.78797.83
5179897-17989795.90198.93
6176951-17695194.33197.32
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%
111.293123583128293120273127983123453124710.11
211.343114763130513122640.36
单位质量响应值RSD%判断
27676.7927536.510.36数据可信
中间条件12月-供试品溶液-2023121221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%
5min1179821-17982153.80358.2412.1953.8058.2412.20
2209692-20969262.74162.74
3182704-18270454.66654.67
4171156-17115651.21151.21
5189308-18930856.64256.64
6235216-23521670.37870.38
10min1294706-29470688.17887.264.7588.4887.594.77
2296820-29682088.81089.16
3302217-30221790.42590.73
4265201-26520179.35079.63
5289041-28904186.48386.80
6301919-30191990.33690.73
15min1320023-32002395.75392.923.3596.5493.733.36
2312424-31242493.47994.32
3315101-31510194.28095.09
4290578-29057886.94287.67
5309573-30957392.62693.42
6315735-31573594.47095.36
20min1326342-32634297.64394.892.7698.9696.212.77
2313939-31393993.93295.29
3319831-31983195.69597.02
4301705-30170590.27291.48
5317430-31743094.97796.29
6323523-32352396.80098.22
30min1319761-31976195.67495.071.4897.5496.921.51
2314852-31485294.20596.09
3323789-32378996.87998.74
4310320-31032092.84994.56
5317687-31768795.05496.89
6320096-32009695.77497.73
45min1321229-32122996.11395.300.9798.5197.681.02
2317145-31714594.89197.30
3321439-32143996.17698.58
4313654-31365493.84796.07
5317034-31703494.85897.22
6320538-32053895.90798.39
60min1323087-32308796.66995.081.3499.6097.991.31
2311543-31154393.21596.15
3320271-32027195.82798.76
4318195-31819595.20697.95
5314056-31405693.96796.86
6319444-31944495.57998.60
极限1319495-31949595.59595.411.4899.0698.851.48
2316224-31622494.61698.07
3327596-32759698.018101.48
4314341-31434194.05297.33
5316270-31627094.63098.04
6319341-31934195.54899.10
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%
111.151892481894211891731891261890601892060.08
211.211894501901181897840.25
单位质量响应值RSD%判断
16969.1516929.880.17数据可信
中间条件12月-供试品溶液-2023121421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%
5min147368-4736825.08922.148.3325.0922.148.33
242199-4219922.35122.35
343969-4396923.28923.29
439193-3919320.75920.76
537875-3787520.06120.06
640228-4022821.30721.31
10min1121749-12174964.48663.237.5364.6363.357.53
2121567-12156764.38964.51
3133384-13338470.64870.78
4116763-11676361.84561.96
5105789-10578956.03256.14
6117024-11702461.98362.10
15min1155186-15518682.19681.754.7782.6982.224.78
2157970-15797083.67184.15
3162396-16239686.01586.54
4156063-15606382.66183.12
5140624-14062474.48374.91
6153816-15381681.47081.93
20min1170190-17019090.14389.282.5591.1090.212.57
2171415-17141590.79291.74
3170590-17059090.35591.35
4170350-17035090.22891.15
5159977-15997784.73485.57
6168892-16889289.45690.37
30min1173036-17303691.65192.612.0593.1194.042.07
2175318-17531892.85994.31
3177384-17738493.95495.46
4175008-17500892.69594.11
5169027-16902789.52790.83
6179360-17936095.00096.41
45min1174543-17454392.44993.630.9694.4195.560.91
2176540-17654093.50795.47
3175473-17547392.94194.97
4177612-17761294.07496.01
5177094-17709493.80095.60
6179349-17934994.99496.93
60min1173701-17370192.00393.502.0094.4895.961.94
2176441-17644193.45495.94
3174239-17423992.28894.83
4174337-17433792.34094.80
5177364-17736493.94396.27
6183113-18311396.98899.46
极限1174622-17462292.49193.441.0195.4896.420.97
2175442-17544292.92595.93
3175100-17510092.74495.80
4177129-17712993.81896.79
5176804-17680493.64696.49
6179438-17943895.04198.05
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%
111.293145123145003147863141663141083144140.09
211.343126893138313132600.26
单位质量响应值RSD%判断
27848.8927624.340.58数据可信
中间条件12月-供试品溶液-2023121421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%
5min1223464-22346466.54965.7411.3766.5565.7411.37
2245394-24539473.08073.08
3251110-25111074.78274.78
4183194-18319454.55654.56
5210679-21067962.74262.74
6210677-21067762.74162.74
10min1292835-29283587.20886.182.2587.5886.542.28
2290552-29055286.52886.93
3295295-29529587.94188.36
4276774-27677482.42582.73
5289646-28964686.25886.61
6291121-29112186.69887.05
15min1300434-30043489.47189.951.2190.3390.801.22
2302750-30275090.16191.05
3303754-30375490.46091.36
4297288-29728888.53489.30
5300226-30022689.40990.24
6307874-30787491.68792.52
20min1310399-31039992.43992.120.6293.7993.470.63
2311421-31142192.74394.13
3307212-30721291.49092.90
4307324-30732491.52392.78
5308444-30844491.85793.18
6311203-31120392.67894.02
30min1306980-30698091.42192.511.2693.2994.371.25
2312133-31213392.95594.86
3313009-31300993.21695.13
4310457-31045792.45694.22
5305415-30541590.95492.79
6315847-31584794.06195.92
45min1307573-30757391.59792.490.8793.9794.860.80
2308713-30871391.93794.36
3308482-30848291.86894.30
4314288-31428893.59795.87
5312510-31251093.06795.41
6311768-31176892.84695.22
60min1306598-30659891.30792.681.2894.1995.561.26
2309510-30951092.17495.10
3311789-31178992.85395.80
4308204-30820491.78594.58
5313600-31360093.39296.25
6317503-31750394.55497.45
极限1311547-31154792.78192.950.5296.1796.350.53
2313582-31358293.38796.83
3313975-31397593.50496.96
4312260-31226092.99396.30
5309472-30947292.16395.54
6311827-31182792.86496.28
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%
111.151882641886641885851889701886261886220.14
211.211902901901801902350.05
单位质量响应值RSD%判断
16916.7716970.120.23数据可信
中间条件12月-供试品溶液-2023121621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%
5min143346-4334622.96719.4835.9222.9719.4835.92
240272-4027221.33821.34
338177-3817720.22820.23
420740-2074010.98910.99
522494-2249411.91811.92
655579-5557929.44929.45
10min1123183-12318365.26957.0512.8265.4057.1612.86
2113957-11395760.38060.50
3108682-10868257.58557.70
487172-8717246.18846.25
595390-9539050.54350.61
6117641-11764162.33262.50
15min1155976-15597682.64477.105.0183.1377.525.05
2144094-14409476.34976.80
3140345-14034574.36274.79
4143978-14397876.28776.60
5136543-13654372.34872.69
6152129-15212980.60681.12
20min1166672-16667288.31285.463.0989.2686.323.13
2160504-16050485.04385.92
3154398-15439881.80882.65
4161772-16177285.71586.46
5157499-15749983.45184.20
6166928-16692888.44789.40
30min1172663-17266391.48691.471.3592.9392.801.33
2170646-17064690.41791.77
3169731-16973189.93291.23
4175957-17595793.23194.45
5172292-17229291.28992.50
6174495-17449592.45793.91
45min1180317-18031795.54193.551.9997.4995.381.98
2171199-17119990.71092.56
3173415-17341591.88493.68
4178578-17857894.62096.36
5177193-17719393.88695.61
6178600-17860094.63296.59
60min1173950-17395092.16893.341.3994.6595.701.28
2173733-17373392.05394.41
3175596-17559693.04095.35
4179117-17911794.90697.17
5179210-17921094.95597.20
6175347-17534792.90895.40
极限1174492-17449292.45593.231.0795.4596.111.00
2176074-17607493.29396.16
3173352-17335291.85194.68
4177039-17703993.80596.59
5178700-17870094.68597.45
6176123-17612393.31996.32
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%
111.293123263122213125233127243121153123820.08
211.343143873140173142020.09
单位质量响应值RSD%判断
27668.9127707.410.10数据可信
中间条件12月-供试品溶液-2023121621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%
5min1170398-17039850.83454.1421.7750.8354.1421.76
2221009-22100965.93265.93
3232177-23217769.26469.26
4169022-16902250.42350.42
5172389-17238951.42851.43
6123983-12398336.98736.99
10min1277654-27765482.83085.692.4983.1185.992.53
2291396-29139686.93087.30
3295746-29574688.22888.61
4281994-28199484.12584.41
5292949-29294987.39387.68
6283642-28364284.61784.82
15min1309064-30906492.20192.310.8892.9493.090.85
2305289-30528991.07591.92
3310125-31012592.51793.39
4307919-30791991.85992.61
5313238-31323893.44694.22
6311022-31102292.78593.46
20min1316834-31683494.51993.780.7895.7795.070.75
2312272-31227293.15894.51
3312615-31261593.26094.65
4312717-31271793.29194.55
5317969-31796994.85796.15
6313741-31374193.59694.79
30min1317022-31702294.57594.421.1796.3596.231.13
2311174-31117492.83094.70
3316319-31631994.36596.27
4322069-32206996.08097.86
5318249-31824994.94196.76
6314258-31425893.75095.46
45min1327174-32717497.60394.632.5899.9196.972.49
2304890-30489090.95693.34
3311553-31155392.94395.37
4324052-32405296.67298.98
5319242-31924295.23797.58
6316407-31640794.39196.62
60min1315874-31587494.23294.092.1197.0896.962.06
2306575-30657591.45894.35
3313821-31382193.62096.57
4324349-32434996.76199.61
5321406-32140695.88398.76
6310446-31044692.61395.37
极限1315974-31597494.26293.831.6497.6397.211.58
2310290-31029092.56795.97
3308468-30846892.02395.49
4321210-32121095.82499.21
5319324-31932495.26298.67
6311788-31178893.01396.28
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%
111.151903041900991906901905231907101904650.14
211.211913491917181915340.14
单位质量响应值RSD%判断
17082.0617085.990.02数据可信
中间条件12月-供试品溶液-2023121221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%
5min146724-4672424.55319.4323.8524.5519.4323.83
242036-4203622.09022.09
339797-3979720.91320.91
441127-4112721.61221.61
527739-2773914.57714.58
624426-2442612.83612.84
10min1126552-12655266.50259.6513.3866.6459.7613.39
2132553-13255369.65569.78
3116512-11651261.22661.34
4112981-11298159.37059.49
593772-9377249.27649.36
698680-9868051.85551.93
15min1154330-15433081.09977.796.3181.6078.226.35
2160614-16061484.40184.91
3150421-15042179.04579.50
4145358-14535876.38476.83
5133686-13368670.25170.61
6143747-14374775.53875.90
20min1168689-16868988.64586.053.9589.6086.924.01
2172695-17269590.75091.73
3165248-16524886.83687.73
4161257-16125784.73985.61
5154744-15474481.31782.06
6159925-15992584.03984.82
30min1175873-17587392.42091.821.1093.8793.171.16
2176469-17646992.73394.22
3175576-17557692.26493.64
4172642-17264290.72292.07
5171951-17195190.35991.56
6175833-17583392.39993.64
45min1179112-17911294.12293.900.7696.0895.760.70
2178448-17844893.77395.77
3177973-17797393.52395.41
4176641-17664192.82394.67
5180645-18064594.92796.63
6179312-17931294.22795.99
60min1180063-18006394.62193.401.2397.1195.781.16
2174991-17499191.95694.48
3177882-17788293.47595.89
4175759-17575992.36094.72
5180347-18034794.77197.00
6177366-17736693.20495.49
极限1177076-17707693.05293.470.7196.0696.370.59
2175847-17584792.40695.44
3178167-17816793.62596.55
4177914-17791493.49296.37
5178963-17896394.04396.80
6179247-17924794.19396.99
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%
111.293146223142953157653156933156743152100.23
211.343180643171793176220.20
单位质量响应值RSD%判断
27919.4028008.990.23数据可信
中间条件12月-供试品溶液-2023121221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%
5min1251953-25195374.42165.8112.5474.4265.8112.54
2260082-26008276.82376.82
3206435-20643560.97660.98
4187105-18710555.26755.27
5218350-21835064.49664.50
6212814-21281462.86162.86
10min1307366-30736690.78988.342.6291.2088.712.65
2308964-30896491.26191.69
3288130-28813085.10785.45
4297699-29769987.93488.24
5295788-29578887.36987.73
6296510-29651087.58387.93
15min1309080-30908091.29691.461.9092.2192.321.88
2309407-30940791.39292.33
3298551-29855188.18689.00
4312978-31297892.44793.24
5314282-31428292.83293.68
6313604-31360492.63293.47
20min1314676-31467692.94992.951.0394.3794.321.04
2317670-31767093.83395.27
3308910-30891091.24592.55
4317703-31770393.84395.15
5315082-31508293.06894.43
6314070-31407092.77094.12
30min1313933-31393392.72993.640.9994.6795.520.97
2317146-31714693.67895.64
3314009-31400992.75294.56
4318658-31865894.12595.96
5316147-31614793.38395.26
6322217-32221795.17697.04
45min1316347-31634793.44294.180.9795.9096.580.94
2317351-31735193.73996.22
3314913-31491393.01995.34
4320126-32012694.55896.91
5321833-32183395.06397.46
6322431-32243195.23997.63
60min1319470-31947094.36593.500.9197.3496.420.88
2312048-31204892.17295.18
3315155-31515593.09095.93
4316404-31640493.45996.34
5319758-31975894.45097.37
6316431-31643193.46796.39
极限1312472-31247292.29893.470.9595.8096.920.88
2313344-31334492.55596.07
3316333-31633393.43896.80
4319654-31965494.41997.82
5317577-31757793.80597.25
6319286-31928694.31097.75
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%
111.151897621898531899451902681900751899810.11
211.211916521927931922220.42
单位质量响应值RSD%判断
17038.6517147.370.45数据可信
中间条件12月-供试品溶液-2023121421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%
5min137445-3744519.66717.2125.7019.6717.2225.70
233506-3350617.59817.60
323732-2373212.46512.46
440591-4059121.31921.32
521184-2118411.12611.13
640188-4018821.10821.11
10min1122443-12244364.31056.8011.9664.4256.8911.98
2106806-10680656.09756.19
395400-9540050.10650.18
4120673-12067363.38063.50
591058-9105847.82547.89
6112447-11244759.05959.18
15min1165707-16570787.03379.205.9087.5079.615.93
2144693-14469375.99676.41
3149548-14954878.54678.89
4155614-15561481.73282.20
5140481-14048173.78374.11
6148694-14869478.09778.54
20min1171985-17198590.33087.243.3691.2888.093.41
2162219-16221985.20186.03
3167472-16747287.96088.74
4170778-17077889.69690.62
5157106-15710682.51583.25
6167077-16707787.75288.63
30min1178570-17857093.78992.402.5195.2493.742.55
2171365-17136590.00491.31
3177917-17791793.44694.72
4178145-17814593.56594.99
5169401-16940188.97390.17
6180158-18015894.62395.99
45min1179333-17933394.18993.401.9396.1695.251.98
2175129-17512991.98193.79
3179667-17966794.36596.16
4179016-17901694.02395.97
5172271-17227190.48092.17
6181519-18151995.33797.23
60min1177360-17736093.15393.421.3695.6595.791.33
2173562-17356291.15893.47
3180154-18015494.62096.94
4177499-17749993.22695.69
5178822-17882293.92196.11
6179860-17986094.46696.89
极限1176160-17616092.52392.721.4895.5495.601.51
2173506-17350691.12993.95
3175514-17551492.18395.03
4178015-17801593.49796.48
5175037-17503791.93394.65
6180930-18093095.02897.97
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%
111.293138983138593147193133023148333141220.21
211.343178123190323184220.28
单位质量响应值RSD%判断
27823.0328079.540.65数据可信
中间条件12月-供试品溶液-2023121421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%
5min1225190-22519066.54861.1614.1466.5561.1614.14
2239376-23937670.74070.74
3182395-18239553.90153.90
4207155-20715561.21961.22
5162612-16261248.05548.06
6225024-22502466.49966.50
10min1299212-29921288.42387.113.3088.7987.453.33
2297268-29726887.84988.24
3281934-28193483.31783.62
4306610-30661090.61090.95
5283948-28394883.91284.18
6299643-29964388.55188.92
15min1321248-32124894.93593.032.0295.8093.862.02
2308045-30804591.03491.91
3306119-30611990.46491.23
4320483-32048394.70995.55
5317233-31723393.74994.48
6315696-31569693.29594.16
20min1313656-31365692.69293.102.3094.0894.442.29
2313655-31365592.69194.08
3302544-30254489.40890.67
4323587-32358795.62797.00
5319965-31996594.55695.81
6316879-31687993.64495.02
30min1316131-31613193.42393.861.5995.3395.721.55
2310096-31009691.64093.54
3314042-31404292.80694.57
4320955-32095594.84996.75
5323126-32312695.49097.27
6321283-32128394.94696.85
45min1315276-31527693.17093.110.8395.5995.480.80
2310041-31004191.62394.03
3315155-31515593.13595.41
4316007-31600793.38795.81
5316442-31644293.51595.82
6317420-31742093.80496.23
60min1311808-31180892.14692.283.1495.0995.182.99
2299116-29911688.39591.31
3319118-31911894.30697.10
4313550-31355092.66095.61
5326010-32601096.34399.17
6304040-30404089.85092.80
极限1309654-30965491.50992.321.6394.9695.731.56
2304532-30453289.99593.41
3312037-31203792.21395.53
4312662-31266292.39895.86
5318424-31842494.10197.47
6317117-31711793.71597.16
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%
111.151903871907171913911921561921111913520.42
211.211899511924161911840.92
单位质量响应值RSD%判断
17161.6117054.770.45数据可信
中间条件12月-供试品溶液-2023121621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%
5min135490-3549018.62421.0718.7918.6221.0718.79
229151-2915115.29715.30
351697-5169727.12827.13
440355-4035521.17621.18
541440-4144021.74621.75
642736-4273622.42622.43
10min1118911-11891162.39960.6013.4562.5060.7113.45
285754-8575445.00045.08
3122470-12247064.26764.42
4121328-12132863.66763.78
5113941-11394159.79159.91
6130439-13043968.44868.57
15min1158864-15886483.36478.568.0883.8179.028.11
2126434-12643466.34766.68
3153400-15340080.49781.00
4152501-15250180.02580.50
5148337-14833777.84078.29
6158770-15877083.31583.82
20min1171732-17173290.11785.604.5191.0386.494.56
2149602-14960278.50479.21
3165610-16561086.90487.86
4163918-16391886.01786.93
5162423-16242385.23286.12
6165449-16544986.82087.79
30min1184001-18400196.55591.882.8997.9793.242.92
2170077-17007789.24990.39
3175404-17540492.04493.48
4173582-17358291.08892.48
5170849-17084989.65491.01
6176626-17662692.68594.14
45min1180002-18000294.45792.641.2296.4194.521.28
2174622-17462291.63493.27
3176351-17635192.54194.49
4175410-17541092.04793.95
5174714-17471491.68293.54
6178138-17813893.47995.44
60min1176971-17697192.86691.761.2895.3494.151.29
2174782-17478291.71793.86
3177037-17703792.90195.36
4175121-17512191.89594.31
5170939-17093989.70192.07
6174319-17431991.47593.96
极限1173983-17398391.29890.561.1294.2993.461.17
2170967-17096789.71692.37
3174923-17492391.79194.77
4173751-17375191.17694.10
5170063-17006389.24192.11
6171716-17171690.10993.10
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%
111.293154453162463168763181233180923169560.37
211.343144763171503158130.60
单位质量响应值RSD%判断
28074.0527849.470.57数据可信
中间条件12月-供试品溶液-2023121621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%
5min1225148-22514866.51163.0517.8466.5163.0517.84
2166549-16654949.20049.20
3253344-25334474.84074.84
4225803-22580366.70466.70
5166050-16605049.05349.05
6243710-24371071.99471.99
10min1299657-29965788.52186.502.8588.8986.852.90
2286547-28654784.64884.92
3302364-30236489.32189.74
4287833-28783385.02885.40
5282137-28213783.34683.62
6298291-29829188.11888.52
15min1309665-30966591.47890.981.4992.3491.811.52
2311137-31113791.91292.66
3313856-31385692.71693.63
4305472-30547290.23991.08
5300916-30091688.89389.63
6306795-30679590.63091.52
20min1316373-31637393.45991.611.5894.8392.951.57
2312193-31219392.22493.48
3313593-31359392.63894.07
4309027-30902791.28992.63
5306319-30631990.48991.72
6303220-30322089.57490.97
30min1327362-32736296.70593.542.0198.5995.382.03
2314499-31449992.90694.67
3320429-32042994.65796.60
4315203-31520393.11494.97
5309473-30947391.42193.15
6312833-31283392.41394.30
45min1317580-31758093.81693.010.8696.2495.380.91
2313608-31360892.64294.93
3317699-31769993.85196.32
4316034-31603493.35995.73
5310999-31099991.87294.11
6313255-31325592.53894.94
60min1312571-31257192.33691.821.7795.2894.701.78
2311181-31118191.92594.72
3318182-31818293.99496.98
4313916-31391692.73395.62
5303201-30320189.56892.32
6305819-30581990.34193.26
极限1307200-30720090.74990.631.8594.2194.021.85
2304445-30444589.93693.24
3314651-31465192.95196.46
4312126-31212692.20595.61
5301164-30116488.96692.21
6301122-30112288.95492.37
点击查看处理图标(自动生成)
 
原始图谱下载图谱(谢鑫慧 于 2025-03-12 16:44:24 完成)
生成报告数据部分(等待生成报告)
Current page cost:741 ms