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%
110.011693381696871694951695341703771696860.24
210.101685511687341686420.08
单位质量响应值RSD%判断
16951.6516697.231.07数据可信
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%
5min163461-6346133.86528.8727.0833.8628.8727.08
267688-6768836.12036.12
348793-4879326.03726.04
428685-2868515.30715.31
564940-6494034.65434.65
651051-5105127.24227.24
10min1147729-14772978.83370.7215.1279.0270.8815.14
2137890-13789073.58273.78
3134715-13471571.88872.03
4100230-10023053.48653.57
5155388-15538882.92083.11
6119249-11924963.63563.79
15min1175062-17506293.41889.107.4194.0489.657.47
2171944-17194491.75492.36
3165892-16589288.52589.07
4144902-14490277.32477.71
5180239-18023996.18196.83
6163745-16374587.37987.88
20min1183208-18320897.76594.993.8798.9196.043.97
2182828-18282897.56298.68
3175189-17518993.48694.52
4166842-16684289.03289.84
5184782-18478298.60599.79
6175249-17524993.51894.51
30min1191053-191053101.95199.192.40103.64100.772.47
2186710-18671099.634101.30
3180185-18018596.15297.71
4180705-18070596.42997.74
5188717-188717100.705102.44
6187897-187897100.267101.78
45min1193251-193251103.124100.821.46105.38102.941.56
2188719-188719100.706102.92
3185950-18595099.228101.32
4186489-18648999.516101.36
5190883-190883101.861104.16
6188249-188249100.455102.52
60min1185508-18550898.99399.651.03101.82102.340.89
2186537-18653799.542102.32
3185179-18517998.817101.46
4190507-190507101.660104.06
5186462-18646299.502102.36
6186256-18625699.392102.02
极限1185942-18594299.22499.460.91102.60102.700.76
2185103-18510398.776102.10
3185656-18565699.071102.26
4189746-189746101.254104.21
5186011-18601199.261102.67
6185803-18580399.150102.33
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%
111.183108663099233098033107283092793101200.22
211.153075293074163074720.03
单位质量响应值RSD%判断
27738.8227575.960.42数据可信
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%
5min1286825-28682585.66267.7717.1485.6667.7617.15
2173690-17369051.87451.87
3244848-24484873.12673.13
4210234-21023462.78862.79
5206972-20697261.81461.81
6238828-23882871.32871.33
10min1329284-32928498.34394.333.7498.8294.703.79
2300569-30056989.76790.06
3329313-32931398.35298.76
4316804-31680494.61694.96
5306308-30630891.48191.82
6312725-31272593.39793.79
15min1339088-339088101.27199.051.88102.2999.951.93
2326005-32600597.36498.15
3337750-337750100.871101.82
4333386-33338699.568100.44
5323661-32366196.66497.52
6330077-33007798.58099.49
20min1342167-342167102.191100.282.14103.78101.742.17
2333769-33376999.682101.01
3342206-342206102.202103.72
4340731-340731101.762103.19
5324498-32449896.91498.30
6331326-33132698.953100.42
30min1343628-343628102.627101.121.34104.78103.131.37
2337891-337891100.914102.80
3337686-337686100.852102.93
4342705-342705102.351104.34
5330956-33095698.842100.77
6338703-338703101.156103.17
45min1342358-342358102.248101.690.70104.97104.260.74
2340708-340708101.755104.20
3341447-341447101.976104.62
4343138-343138102.481105.04
5337232-337232100.717103.19
6338068-338068100.966103.54
60min1332864-33286499.412100.351.79102.70103.481.77
2334962-334962100.039103.05
3341593-341593102.019105.23
4344378-344378102.851105.98
5327919-32791997.935100.97
6334259-33425999.829102.96
极限1331638-33163899.046100.140.97102.89103.830.95
2334721-33472199.967103.53
3338395-338395101.064104.84
4340034-340034101.554105.26
5333190-33319099.510103.09
6333814-33381499.696103.39
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%
110.011684231681901688051681911689941685210.22
210.101696161702081699120.25
单位质量响应值RSD%判断
16835.2616822.970.06数据可信
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%
5min146617-4661724.86824.4616.6424.8724.4616.65
251906-5190627.68927.69
350800-5080027.09927.10
452543-5254328.02928.03
539298-3929820.96420.96
633958-3395818.11518.11
10min1132721-13272170.80070.068.4270.9470.198.44
2134164-13416471.57071.72
3143374-14337476.48376.63
4141182-14118275.31475.47
5121271-12127164.69264.81
6115273-11527361.49261.59
15min1164488-16448887.74688.523.0488.2889.043.08
2165338-16533888.20088.75
3171726-17172691.60792.18
4172257-17225791.89192.46
5161212-16121285.99986.47
6160567-16056785.65586.10
20min1176555-17655594.18394.521.4795.2095.541.51
2179021-17902195.49996.54
3177872-17787294.88695.97
4180043-18004396.04497.13
5177066-17706694.45695.41
6172574-17257492.06092.98
30min1184582-18458298.46597.730.94100.0199.270.99
2183439-18343997.85699.43
3183856-18385698.07899.69
4185054-18505498.717100.34
5181462-18146296.80198.28
6180807-18080796.45297.88
45min1186450-18645099.46299.861.10101.55101.951.10
2189307-189307100.986103.10
3184372-18437298.353100.51
4189790-189790101.244103.41
5186014-18601499.229101.25
6187253-18725399.890101.86
60min1184483-18448398.41398.620.99101.05101.260.94
2187849-187849100.208102.88
3182349-18234997.27499.98
4183915-18391598.110100.84
5185133-18513398.759101.33
6185465-18546598.936101.46
极限1183568-18356897.92497.680.37101.11100.870.36
2182770-18277097.499100.73
3182401-18240197.302100.55
4183913-18391398.108101.38
5182419-18241997.312100.43
6183588-18358897.935101.01
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%
111.183075543075293078073073623097513080010.33
211.153094473094403094440.01
单位质量响应值RSD%判断
27549.2827752.830.53数据可信
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%
5min1256072-25607276.49670.9013.8276.5070.9013.81
2212455-21245563.46663.47
3265840-26584079.41479.41
4275812-27581282.39282.39
5218460-21846065.26065.26
6195448-19544858.38658.39
10min1320845-32084595.84594.472.7396.2794.862.77
2314367-31436793.91094.26
3324465-32446596.92697.37
4322201-32220196.25096.71
5314818-31481894.04594.41
6300702-30070289.82890.15
15min1330056-33005698.59797.901.9199.5598.811.96
2324605-32460596.96897.84
3333481-33348199.620100.60
4333586-33358699.651100.64
5327441-32744197.81598.70
6317088-31708894.72395.55
20min1334066-33406699.79498.741.76101.30100.201.79
2332773-33277399.408100.82
3332903-33290399.447100.98
4332306-33230699.269100.81
5332396-33239699.296100.72
6318775-31877595.22796.58
30min1335149-335149100.11898.601.50102.18100.621.55
2329375-32937598.393100.36
3332885-33288599.442101.53
4333267-33326799.556101.65
5328420-32842098.108100.09
6321397-32139796.01097.89
45min1339047-339047101.28299.621.50103.90102.181.54
2331860-33186099.135101.65
3335208-335208100.136102.77
4338427-338427101.097103.75
5329903-32990398.551101.08
6326416-32641697.50999.92
60min1332295-33229599.26598.670.80102.44101.780.80
2333799-33379999.715102.78
3330704-33070498.790101.98
4327874-32787497.945101.16
5330245-33024598.653101.73
6326831-32683197.633100.59
极限1330215-33021598.64497.631.12102.37101.301.15
2322866-32286696.449100.07
3331737-33173799.099102.84
4327757-32775797.910101.67
5324418-32441896.912100.53
6324005-32400596.789100.29
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%
110.011691821692491693091688221688961690920.13
210.101706421711661709040.22
单位质量响应值RSD%判断
16892.3116921.190.13数据可信
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%
5min149920-4992026.50825.1720.2626.5125.1720.26
230710-3071016.30716.31
352646-5264627.95527.96
447991-4799125.48325.48
544036-4403623.38323.38
659092-5909231.37831.38
10min1119607-11960763.51165.065.5863.6665.205.60
2113629-11362960.33760.43
3118200-11820062.76462.92
4122954-12295465.28965.43
5129191-12919168.60168.73
6131616-13161669.88870.06
15min1153029-15302981.25983.003.3081.7683.503.31
2155051-15505182.33282.76
3148638-14863878.92779.43
4157778-15777883.78084.28
5160697-16069785.33085.84
6162665-16266586.37586.94
20min1168072-16807289.24690.582.0590.2091.552.07
2166395-16639588.35689.24
3168168-16816889.29790.24
4172480-17248091.58792.56
5174985-17498592.91793.90
6173445-17344592.10093.14
30min1180974-18097496.09796.822.0197.5498.281.94
2188429-188429100.056101.43
3183288-18328897.32698.76
4177210-17721094.09995.58
5182387-18238796.84898.35
6181667-18166796.46598.02
45min1186036-18603698.78598.021.18100.77100.031.11
2187905-18790599.778101.71
3184822-18482298.141100.12
4184113-18411397.76499.77
5182068-18206896.67898.72
6182653-18265396.98999.08
60min1182567-18256796.94397.911.0899.47100.451.04
2187835-18783599.741102.22
3183081-18308197.21699.74
4182971-18297197.15899.70
5184951-18495198.209100.79
6184887-18488798.175100.80
极限1176993-17699393.98497.372.1597.05100.472.08
2187044-18704499.321102.36
3184334-18433497.882100.95
4182522-18252296.919100.00
5187696-18769699.667102.79
6181685-18168596.47599.65
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%
111.183084233090243080543079623107043088330.37
211.153111993120923116460.21
单位质量响应值RSD%判断
27623.7027950.310.84数据可信
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%
5min1161998-16199848.15756.3618.9748.1656.3618.97
2205181-20518160.99460.99
3172654-17265451.32551.33
4255141-25514175.84675.85
5161151-16115147.90647.91
6181383-18138353.92053.92
10min1281154-28115483.57987.925.3683.8588.245.39
2313129-31312993.08493.42
3291553-29155386.67086.96
4309558-30955892.02392.44
5274537-27453781.61281.88
6304689-30468990.57590.87
15min1323077-32307796.04296.081.9696.7796.892.00
2328296-32829697.59398.45
3322502-32250295.87196.64
4326651-32665197.10498.04
5311268-31126892.53193.25
6327535-32753597.36798.17
20min1330571-33057198.26996.901.2199.5398.241.13
2321149-32114995.46896.87
3329531-32953197.96099.26
4323608-32360896.19997.67
5328193-32819397.56298.80
6322802-32280295.96097.30
30min1329179-32917997.85698.282.2699.67100.162.19
2339969-339969101.063102.99
3337623-337623100.366102.21
4319944-31994495.11097.12
5331410-33141098.519100.29
6325554-32555496.77898.65
45min1331497-33149798.54597.781.71100.90100.201.69
2339064-339064100.794103.28
3327907-32790797.47799.88
4324749-32474996.53999.07
5325789-32578996.84899.17
6324474-32447496.45798.87
60min1323747-32374796.24197.411.7199.14100.371.68
2337061-337061100.199103.25
3322144-32214495.76498.71
4324688-32468896.52099.59
5331311-33131198.489101.35
6327063-32706397.227100.18
极限1312441-31244192.88096.932.8296.32100.432.72
2333320-33332099.087102.69
3326494-32649497.057100.53
4323515-32351596.17299.78
5338635-338635100.667104.07
6321909-32190995.69499.18
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