依折麦布瑞舒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%
110.261713321701661704671702901704591705430.27
210.261694111696441695280.10
单位质量响应值RSD%判断
16622.1216523.200.43数据可信
供试品溶液-2023121621批-依折麦布-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min16810-68103.6865.0022.773.695.0022.73
210652-106525.7665.77
37681-76814.1584.16
411925-119256.4556.45
510654-106545.7675.77
67649-76494.1404.14
10min115512-155128.3969.236.628.429.266.66
218231-182319.8689.90
316552-165528.9598.98
418209-182099.8569.89
517615-176159.5359.57
616221-162218.7808.80
15min117961-179619.72210.001.879.7910.071.90
218820-1882010.18710.27
318678-1867810.11010.18
418463-184639.99410.08
518732-1873210.13910.22
618158-181589.8289.90
20min118357-183579.93610.032.4410.0610.172.42
218320-183209.91610.06
318739-1873910.14310.27
418101-181019.7989.94
519356-1935610.47710.62
618351-183519.93310.06
30min118793-1879310.1729.981.9410.3510.181.83
218273-182739.89110.09
318779-1877910.16510.35
418254-182549.88010.08
517912-179129.6959.89
618669-1866910.10510.29
45min117638-176389.5479.641.669.789.881.57
217570-175709.5109.76
318163-181639.83110.07
417483-174839.4639.72
517847-178479.6609.91
618151-181519.82510.06
60min117937-179379.7099.571.609.999.861.48
217418-174189.4289.73
317904-179049.6919.99
417279-172799.3539.66
517597-175979.5259.83
617894-178949.6869.98
极限117661-176619.5599.531.299.909.891.18
217526-175269.4869.85
317533-175339.4909.84
417353-173539.3939.75
517586-175869.5199.88
618028-180289.75810.10
依折麦布瑞舒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%
110.823180263166963167433166603167643169780.19
210.863147613152753150180.12
单位质量响应值RSD%判断
29295.5629007.180.70数据可信
供试品溶液-2023121621批-瑞舒伐他汀钙-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min196378-9637827.30930.8125.0727.3130.8025.07
286176-8617624.41824.42
380940-8094022.93522.93
4132744-13274437.61437.61
5149917-14991742.48042.48
6106171-10617130.08430.08
10min1219512-21951262.20061.6412.1462.3561.8112.17
2182074-18207451.59251.73
3193184-19318454.74054.87
4240255-24025568.07868.29
5250843-25084371.07871.31
6219264-21926462.13062.30
15min1279067-27906779.07576.426.9979.5776.937.04
2247892-24789270.24270.66
3244732-24473269.34669.78
4280565-28056579.50080.09
5290622-29062282.34982.98
6275212-27521277.98378.50
20min1297223-29722384.22082.685.2585.1683.625.31
2277800-27780078.71679.53
3268730-26873076.14676.96
4297188-29718884.21085.24
5309324-30932487.64988.74
6300470-30047085.14086.09
30min1322351-32235191.34089.293.7992.7490.693.85
2305461-30546186.55487.80
3295668-29566883.77985.02
4319398-31939890.50392.00
5321201-32120191.01492.59
6326647-32664792.55793.98
45min1317752-31775290.03790.422.5491.9592.322.61
2311346-31134688.22289.95
3309873-30987387.80489.51
4320139-32013990.71392.71
5324139-32413991.84793.93
6331467-33146793.92395.86
60min1329543-32954393.37891.912.3195.7994.312.38
2317271-31727189.90092.12
3314925-31492589.23691.43
4322014-32201491.24493.75
5328669-32866993.13095.72
6333752-33375294.57097.03
极限1334477-33447794.77694.631.6697.7197.531.62
2340703-34070396.54099.26
3326984-32698492.65395.34
4328604-32860493.11296.12
5333520-33352094.50597.61
6339409-33940996.17399.15
依折麦布瑞舒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%
110.261719631708701709491714881715651713670.27
210.261718881733211726040.59
单位质量响应值RSD%判断
16702.4416823.000.51数据可信
供试品溶液-2023121621批-依折麦布-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min19840-98405.2665.7012.565.275.7012.55
212915-129156.9116.91
38895-88954.7604.76
410600-106005.6725.67
510910-109105.8385.84
610792-107925.7755.78
10min117134-171349.1698.973.979.209.003.98
217227-172279.2199.26
317362-173629.2919.32
416762-167628.9709.00
515567-155678.3318.36
616504-165048.8328.86
15min118432-184329.8649.803.159.949.883.12
219011-1901110.17410.26
318711-1871110.01310.09
418493-184939.8969.98
517484-174849.3569.44
617786-177869.5189.60
20min118280-182809.7829.971.409.9210.111.39
218981-1898110.15810.30
318854-1885410.09010.22
418652-186529.98110.12
518440-184409.86810.00
618588-185889.94710.08
30min118306-183069.7969.802.319.999.992.30
219118-1911810.23110.43
318314-183149.8019.99
417977-179779.6209.81
517999-179999.6329.82
618145-181459.7109.90
45min118143-181439.7099.741.869.959.981.89
218816-1881610.06910.33
318301-183019.79410.04
418036-180369.6529.90
517881-178819.5699.81
617975-179759.6199.86
60min117960-179609.6119.601.859.919.901.84
218531-185319.91710.23
318014-180149.6409.94
417692-176929.4689.77
517815-178159.5349.83
617603-176039.4209.72
极限117506-175069.3689.492.119.729.852.13
218364-183649.82710.20
318001-180019.6339.99
417702-177029.4739.82
517472-174729.3509.70
617401-174019.3129.66
依折麦布瑞舒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%
110.823179793166283163953152693148183162180.40
210.863189273212333200800.51
单位质量响应值RSD%判断
29225.3229473.300.60数据可信
供试品溶液-2023121621批-瑞舒伐他汀钙-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1102053-10205328.72230.5216.0028.7230.5216.01
297580-9758027.46327.46
3133694-13369437.62737.63
4125420-12542035.29935.30
588631-8863124.94524.94
6103281-10328129.06829.07
10min1224140-22414063.08364.856.3263.2465.026.34
2236864-23686466.66466.82
3241947-24194768.09468.30
4243650-24365068.57468.77
5204572-20457257.57557.71
6231345-23134565.11065.27
15min1274302-27430277.20075.913.2577.7176.443.28
2259007-25900772.89673.42
3274992-27499277.39477.98
4281800-28180079.31179.89
5261675-26167573.64774.10
6266623-26662375.03975.56
20min1296387-29638783.41682.921.5084.3583.871.49
2291491-29149182.03882.97
3289043-28904381.34982.37
4301886-30188684.96485.98
5294683-29468382.93683.80
6294276-29427682.82283.76
30min1314218-31421888.43487.232.3589.8488.642.29
2314050-31405088.38789.77
3295533-29553383.17684.64
4311819-31181987.75989.25
5309955-30995587.23588.56
6314086-31408688.39789.80
45min1325037-32503791.47990.671.5893.3792.571.54
2325155-32515591.51293.39
3312306-31230687.89689.83
4325539-32553991.62193.60
5321503-32150390.48592.30
6323495-32349591.04592.94
60min1327122-32712292.06691.211.5494.4793.611.49
2326494-32649491.88994.27
3314738-31473888.58191.00
4326212-32621291.81094.30
5327785-32778592.25394.57
6322149-32214990.66693.06
极限1322654-32265490.80991.560.8493.7294.460.84
2327744-32774492.24195.13
3324399-32439991.30094.21
4329221-32922192.65795.65
5325278-32527891.54794.38
6322593-32259390.79193.69
依折麦布瑞舒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%
110.261721901717271717841719531721711719650.13
210.261692681716561704621.00
单位质量响应值RSD%判断
16760.7216614.230.63数据可信
供试品溶液-X013993批-依折麦布-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min112108-121086.5096.156.736.516.156.77
211958-119586.4286.43
311333-113336.0926.09
410184-101845.4745.47
510978-109785.9015.90
612104-121046.5076.51
10min118222-182229.7959.484.109.839.514.10
218368-183689.8749.91
316493-164938.8668.90
417046-170469.1639.19
517832-178329.5869.62
617810-178109.5749.61
15min118657-1865710.0299.703.0410.129.783.03
218623-1862310.01110.10
317238-172389.2669.35
417958-179589.6539.73
518096-180969.7289.81
617687-176879.5089.60
20min118644-1864410.0229.861.4010.1710.001.42
218530-185309.96110.11
318480-184809.93410.07
418245-182459.8089.94
517937-179379.6429.78
618252-182529.8119.95
30min118095-180959.7279.650.889.939.850.87
218028-180289.6919.89
318021-180219.6879.88
417910-179109.6289.82
517658-176589.4929.69
618021-180219.6879.88
45min118030-180309.6929.532.329.959.782.31
218066-180669.7129.97
317983-179839.6679.91
417618-176189.4719.71
516980-169809.1289.37
617711-177119.5219.77
60min117564-175649.4429.401.829.759.701.79
217714-177149.5229.83
317719-177199.5259.82
417348-173489.3269.62
516916-169169.0939.39
617699-176999.5149.82
极限116956-169569.1159.321.649.489.681.58
217425-174259.3679.73
317760-177609.5479.90
417229-172299.2629.61
517165-171659.2279.57
617509-175099.4129.77
依折麦布瑞舒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%
110.823180233178553177453181583182633180090.07
210.863137873174723156300.83
单位质量响应值RSD%判断
29390.8529063.540.80数据可信
供试品溶液-X013993批-瑞舒伐他汀钙-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min161657-6165717.42616.3848.6617.4316.3848.66
238880-3888010.98810.99
338486-3848610.87710.88
443323-4332312.24412.24
5112547-11254731.80831.81
652887-5288714.94714.95
10min1155248-15524843.87751.8712.8043.9751.9612.77
2211259-21125959.70759.77
3181969-18196951.42951.49
4163374-16337446.17346.24
5178337-17833750.40250.58
6211007-21100759.63559.72
15min1245487-24548769.38071.165.8969.7271.545.82
2260099-26009973.51073.90
3248081-24808170.11370.46
4266911-26691175.43575.76
5226949-22694964.14164.60
6263199-26319974.38674.80
20min1291241-29124182.31180.445.9583.0481.215.86
2279499-27949978.99379.79
3293455-29345582.93783.67
4301036-30103685.08085.82
5253136-25313671.54272.35
6289384-28938481.78682.61
30min1310098-31009887.64185.254.9288.8286.474.85
2302187-30218785.40586.64
3305616-30561686.37487.57
4314264-31426488.81890.03
5272655-27265577.05878.27
6305063-30506386.21887.50
45min1319676-31967690.34888.214.8692.0289.914.79
2316528-31652889.45891.17
3322019-32201991.01092.69
4321196-32119690.77792.49
5282317-28231779.78981.43
6310982-31098287.89089.65
60min1319070-31907090.17689.344.2892.3591.534.23
2319959-31995990.42892.64
3327241-32724192.48694.67
4324104-32410491.59993.81
5289630-28963081.85683.94
6316674-31667489.49991.75
极限1328735-32873592.90894.241.1995.5896.921.20
2337182-33718295.29598.01
3335804-33580494.90697.60
4330068-33006893.28596.01
5330990-33099093.54596.08
6337856-33785695.48698.23
依折麦布瑞舒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%
110.261712741719311727481730991733861724880.51
210.261707501712341709920.21
单位质量响应值RSD%判断
16811.7016665.890.62数据可信
供试品溶液-X013993批-依折麦布-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min113572-135727.2736.2710.717.276.2610.70
210903-109035.8435.84
311173-111735.9885.99
410020-100205.3705.37
512191-121916.5336.53
612304-123046.5946.59
10min118077-180779.6889.303.809.739.343.82
216518-165188.8528.88
316555-165558.8728.91
417686-176869.4789.51
517723-177239.4989.53
617612-176129.4389.48
15min118422-184229.8739.841.069.979.921.06
218549-185499.94110.02
318172-181729.7399.82
418424-184249.8749.96
518066-180669.6829.77
618506-185069.91810.01
20min118401-184019.8619.901.5410.0110.041.52
218826-1882610.08910.23
318398-183989.86010.00
418644-186449.99110.13
518531-185319.93110.07
617986-179869.6399.78
30min118294-182949.8049.943.7010.0110.143.61
219792-1979210.60710.80
318258-182589.7859.98
418874-1887410.11510.31
517921-179219.6049.80
618157-181579.7319.93
45min117734-177349.5049.591.839.769.841.75
218028-180289.6619.91
318039-180399.6679.91
418365-183659.84210.09
517749-177499.5129.76
617421-174219.3369.59
60min117679-176799.4749.543.869.799.853.71
218592-185929.96410.27
317895-178959.5909.89
418512-185129.92110.22
517320-173209.2829.59
616820-168209.0149.32
极限117440-174409.3469.442.609.719.802.54
218185-181859.74610.11
317629-176299.4489.80
417761-177619.5189.88
517826-178269.5539.91
616828-168289.0189.37
依折麦布瑞舒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%
110.823154193167753182643187273192923176950.50
210.863134763140213137480.13
单位质量响应值RSD%判断
29361.8328890.241.15数据可信
供试品溶液-X013993批-瑞舒伐他汀钙-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min134365-343659.74610.9817.589.7510.9817.57
236588-3658810.37710.38
351750-5175014.67714.68
432673-326739.2679.27
539162-3916211.10711.11
637644-3764410.67610.68
10min1164331-16433146.60743.0623.3546.6643.1223.31
2138678-13867839.33139.39
3117596-11759633.35233.43
4125755-12575535.66635.72
5215808-21580861.20661.27
6148850-14885042.21642.28
15min1246194-24619469.82465.3315.1970.1465.6315.18
2202143-20214357.33157.61
3184991-18499152.46652.73
4244175-24417569.25169.50
5282768-28276880.19780.60
6221837-22183762.91663.21
20min1280059-28005979.42976.3411.6280.1377.0011.64
2239003-23900367.78568.38
3230844-23084465.47166.03
4288162-28816281.72782.36
5313791-31379188.99589.84
6263128-26312874.62775.27
30min1301451-30145185.49688.615.5886.6489.705.57
2282182-28218280.03181.00
3325350-32535092.27493.20
4319041-31904190.48491.57
5327442-32744292.86794.21
6319164-31916490.51991.58
45min1313326-31332688.86492.014.3690.4893.594.37
2301383-30138385.47686.89
3328024-32802493.03294.47
4337981-33798195.85697.45
5333892-33389294.69696.55
6331988-33198894.15695.72
60min1324705-32470592.09194.852.8094.2096.942.78
2323529-32352991.75793.65
3338121-33812195.89697.85
4347879-34787998.663100.79
5332778-33277894.38096.76
6339509-33950996.28998.37
极限1336033-33603395.30496.371.0797.9398.991.04
2337249-33724995.64898.05
3346255-34625598.203100.69
4341217-34121796.77499.45
5339517-33951796.29299.20
6338535-33853596.01398.63
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