依折麦布阿托伐他汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DJ333-221017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(%)99.67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%
19.871628301631161630491627631625821628680.14
29.821638441651201644820.55
单位质量响应值RSD%判断
16501.3216749.691.06数据可信
供试品溶液-2023120821批-依折麦布-pH4.5(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%
5min175715-7571540.85445.0923.8740.8545.0923.88
2100241-10024154.08854.09
361237-6123733.04233.04
488645-8864547.83147.83
564453-6445334.77834.78
6111135-11113559.96659.97
10min1154625-15462583.43382.077.2483.6682.327.28
2159546-15954686.08886.39
3137869-13786974.39174.58
4149035-14903580.41680.68
5143398-14339877.37577.57
6168093-16809390.70091.03
15min1175941-17594194.93494.903.2095.6295.613.27
2182379-18237998.40899.19
3170411-17041191.95092.55
4174953-17495394.40195.11
5169282-16928291.34191.96
6182320-18232098.37699.21
20min1180737-18073797.52297.971.5698.7499.201.64
2184659-18465999.638100.96
3179003-17900396.58797.69
4180305-18030597.28998.53
5179186-17918696.68597.82
6185518-185518100.102101.49
30min1178303-17830396.20998.561.3897.97100.331.36
2184623-18462399.619101.50
3181862-18186298.12999.77
4183186-18318698.844100.62
5185420-185420100.049101.72
6182514-18251498.481100.42
45min1181812-18181298.10299.180.90100.40101.510.93
2185905-185905100.311102.74
3181991-18199198.199100.39
4184532-18453299.570101.90
5184976-18497699.809102.03
6183688-18368899.114101.60
60min1175793-17579394.85498.852.2997.69101.722.20
2182316-18231698.374101.36
3187119-187119100.966103.70
4183366-18336698.941101.82
5187291-187291101.059103.84
6183279-18327998.894101.93
极限1180598-18059897.44797.991.10100.81101.421.01
2182790-18279098.630102.17
3184236-18423699.410102.71
4179685-17968596.955100.38
5182953-18295398.718102.06
6179387-17938796.794100.38
依折麦布阿托伐他汀片项目信息
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%
110.851520451519671519541517041517731518890.10
210.841534221542971538600.41
单位质量响应值RSD%判断
13998.9914193.730.98数据可信
供试品溶液-2023120821批-阿托伐他汀-pH4.5(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%
5min1126252-12625273.98381.336.9973.9881.327.00
2142650-14265083.59283.59
3131059-13105976.80076.80
4153468-15346889.93189.93
5142933-14293383.75883.76
6136329-13632979.88879.89
10min1168175-16817598.55098.831.0298.9699.281.02
2166371-16637197.49397.96
3167651-16765198.24398.67
4169446-16944699.29599.79
5168878-16887898.96299.43
6171389-171389100.433100.88
15min1170452-17045299.884100.621.34100.84101.621.34
2171992-171992100.786101.79
3171408-171408100.444101.42
4172099-172099100.849101.90
5168676-16867698.84399.86
6175627-175627102.917103.92
20min1169847-16984799.53099.881.37101.04101.441.35
2168849-16884998.945100.51
3169774-16977499.487101.02
4170108-17010899.682101.29
5169022-16902299.046100.61
6175071-175071102.591104.16
30min1165934-16593497.23798.411.1099.30100.521.10
2165983-16598397.26599.38
3167095-16709597.917100.00
4168964-16896499.012101.18
5170020-17002099.631101.75
6169621-16962199.397101.54
45min1168697-16869798.85698.401.10101.46101.061.10
2166176-16617697.378100.03
3165199-16519996.80699.43
4168866-16886698.955101.67
5168444-16844498.707101.38
6170089-17008999.671102.37
60min1163644-16364495.89598.031.8199.05101.241.78
2163354-16335495.72598.92
3169797-16979799.500102.67
4167951-16795198.418101.68
5169028-16902899.050102.27
6169963-16996399.597102.85
极限1167474-16747498.13997.071.00101.83100.820.94
2163453-16345395.78399.51
3167008-16700897.866101.58
4163871-16387196.02899.84
5165905-16590597.220100.99
6166149-16614997.362101.17
依折麦布阿托伐他汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DJ333-221017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(%)99.67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%
19.871657701658551660411663011664411660820.18
29.821650341663561656950.57
单位质量响应值RSD%判断
16826.9516873.220.20数据可信
供试品溶液-2023120822批-依折麦布-pH4.5(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%
5min1124102-12410266.06739.2434.4466.0739.2434.44
259049-5904931.43531.44
356259-5625929.95029.95
464712-6471234.45034.45
564655-6465534.42034.42
673480-7348039.11839.12
10min1169449-16944990.20879.198.0790.5779.418.13
2138388-13838873.67273.85
3147533-14753378.54178.71
4148573-14857379.09479.29
5135861-13586172.32772.52
6152761-15276181.32481.54
15min1180929-18092996.31991.523.9297.1992.183.98
2170800-17080090.92791.51
3173450-17345092.33892.94
4172329-17232991.74192.37
5160184-16018485.27685.87
6173821-17382192.53593.20
20min1175311-17531193.32994.541.6494.7395.701.60
2176301-17630193.85694.94
3181642-18164296.69997.81
4178321-17832194.93196.07
5174007-17400792.63493.70
6179923-17992395.78496.97
30min1175549-17554993.45594.831.8595.3896.521.75
2176472-17647293.94795.56
3182545-18254597.18098.83
4176432-17643293.92595.59
5182132-18213296.96098.54
6175660-17566093.51495.23
45min1180760-18076096.22995.041.1098.6797.261.12
2177899-17789994.70696.84
3179879-17987995.76097.95
4175858-17585893.62095.81
5179929-17992995.78797.91
6176858-17685894.15296.39
60min1173361-17336192.29194.141.7195.2796.891.59
2177852-17785294.68197.34
3181700-18170096.73099.45
4177089-17708994.27596.98
5177160-17716094.31396.97
6173872-17387292.56395.32
极限1171114-17111491.09493.222.0394.5896.491.91
2175799-17579993.58896.77
3181500-18150096.62399.89
4172922-17292292.05795.29
5175024-17502493.17696.35
6174309-17430992.79596.07
依折麦布阿托伐他汀片项目信息
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%
110.851545171545981549441547631548051547250.11
210.841542491552241547360.45
单位质量响应值RSD%判断
14260.3714274.540.08数据可信
供试品溶液-2023120822批-阿托伐他汀-pH4.5(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%
5min1143021-14302182.80175.736.9682.8075.736.96
2129966-12996675.24375.24
3119193-11919369.00669.01
4124669-12466972.17672.18
5128043-12804374.12974.13
6139951-13995181.02381.02
10min1161549-16154993.52794.152.5893.9994.572.56
2161525-16152593.51393.93
3169183-16918397.94798.33
4156272-15627290.47290.87
5163691-16369194.76795.18
6163498-16349894.65695.11
15min1166648-16664896.47995.471.5597.4696.421.55
2165619-16561995.88496.82
3168015-16801597.27198.20
4161075-16107593.25394.16
5162770-16277094.23495.17
6165338-16533895.72196.70
20min1159175-15917592.15395.112.0493.6796.592.00
2163634-16363494.73496.20
3169155-16915597.93199.40
4162866-16286694.29095.71
5166092-16609296.15797.62
6164806-16480695.41396.92
30min1158756-15875691.91094.022.5193.9496.022.46
2161721-16172193.62795.62
3167154-16715496.77298.78
4160145-16014592.71494.66
5167800-16780097.14699.14
6158867-15886791.97494.01
45min1163764-16376494.81094.051.5697.3596.581.54
2162624-16262494.15096.67
3165178-16517895.62898.18
4159135-15913592.13094.59
5164372-16437295.16297.70
6159652-15965292.42994.98
60min1156800-15680090.77892.852.2193.8495.902.15
2162692-16269294.18997.23
3165747-16574795.95899.04
4158425-15842591.71994.69
5161473-16147393.48396.55
6157175-15717590.99594.06
极限1155407-15540789.97192.122.3093.5495.682.24
2160515-16051592.92996.49
3165405-16540595.76099.37
4156435-15643590.56794.05
5159683-15968392.44796.03
6157219-15721991.02094.59
依折麦布阿托伐他汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DJ333-221017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(%)99.67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%
19.871635211642221651581660201664111650660.74
29.821639381649001644190.42
单位质量响应值RSD%判断
16724.0116743.280.09数据可信
供试品溶液-2023120823批-依折麦布-pH4.5(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%
5min148615-4861526.06130.0019.4326.0630.0019.42
245164-4516424.21124.21
345081-4508124.16624.17
463170-6317033.86333.86
564396-6439634.52034.52
669327-6932737.16437.16
10min1137968-13796873.96073.616.9874.1073.786.99
2119059-11905963.82363.96
3138072-13807274.01574.15
4138859-13885974.43774.63
5143618-14361876.98877.18
6146375-14637578.46678.67
15min1170058-17005891.16287.824.2391.7288.404.24
2152942-15294281.98782.48
3161576-16157686.61587.16
4160407-16040785.98886.59
5171438-17143891.90292.52
6166569-16656989.29289.93
20min1170735-17073591.52592.231.7792.5993.301.82
2168324-16832490.23291.18
3171109-17110991.72592.75
4171019-17101991.67792.76
5176957-17695794.86095.99
6174189-17418993.37694.51
30min1171754-17175492.07193.552.1193.6495.122.14
2169851-16985191.05192.50
3174600-17460093.59795.13
4174611-17461193.60395.19
5180590-18059096.80898.46
6175632-17563294.15095.81
45min1176787-17678794.76994.050.9696.8596.140.94
2174414-17441493.49795.45
3177475-17747595.13897.19
4173887-17388793.21595.32
5176524-17652494.62896.82
6173582-17358293.05195.23
60min1170250-17025091.26594.321.6593.8796.941.62
2176050-17605094.37496.85
3177736-17773695.27897.86
4177059-17705994.91597.54
5176523-17652394.62897.35
6178088-17808895.46798.16
极限1171343-17134391.85193.471.7294.9796.611.70
2172994-17299492.73695.73
3175809-17580994.24597.36
4175598-17559894.13297.29
5178979-17897995.94499.19
6171421-17142191.89395.12
依折麦布阿托伐他汀片项目信息
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%
110.851529221536051542841549471553261542170.64
210.841531401540801536100.44
单位质量响应值RSD%判断
14213.5514170.660.22数据可信
供试品溶液-2023120823批-阿托伐他汀-pH4.5(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%
5min189602-8960252.15064.3020.6852.1564.3020.68
2108070-10807062.89862.90
3120465-12046570.11270.11
481772-8177247.59347.59
5144920-14492084.34684.35
6118033-11803368.69768.70
10min1141291-14129182.23390.935.6982.5291.285.73
2151931-15193188.42688.78
3164001-16400195.45195.84
4155628-15562890.57890.84
5165359-16535996.24196.71
6159153-15915392.62993.01
15min1156744-15674491.22793.992.8191.9794.862.87
2158203-15820392.07792.92
3164697-16469795.85696.78
4159813-15981393.01493.78
5168910-16891098.30899.31
6160614-16061493.48094.38
20min1152659-15265988.85093.792.9290.1095.182.98
2160945-16094593.67295.02
3165027-16502796.04897.50
4161849-16184994.19995.48
5165907-16590796.56098.11
6160517-16051793.42394.84
30min1152377-15237788.68692.433.0690.4394.343.11
2154717-15471790.04891.92
3162011-16201194.29396.28
4160105-16010593.18494.99
5165661-16566196.41798.50
6158023-15802391.97293.91
45min1156557-15655791.11992.051.7393.3694.471.78
2156402-15640291.02893.40
3162495-16249594.57597.08
4157759-15775991.81894.14
5160400-16040093.35595.98
6155379-15537990.43392.88
60min1152068-15206888.50692.492.3191.2595.422.35
2158061-15806191.99494.87
3162604-16260494.63897.67
4160681-16068193.51996.35
5160530-16053093.43196.57
6159518-15951892.84295.79
极限1153531-15353189.35791.612.4992.5995.052.52
2154745-15474590.06493.45
3160311-16031193.30396.86
4159327-15932792.73196.09
5162749-16274994.72298.38
6153706-15370689.45992.92
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