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%
19.821694671690171692091687931685651690100.21
29.841684141689491686820.23
单位质量响应值RSD%判断
17210.7917142.480.29数据可信
长期24月-供试品溶液-2023120823批-依折麦布-pH6.8(内含0.2%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min150811-5081126.55730.3423.3826.5630.3423.38
266159-6615934.57934.58
377532-7753240.52340.52
437701-3770119.70519.70
555975-5597529.25629.26
660086-6008631.40531.40
10min1149422-14942278.09774.256.2778.2474.426.30
2138233-13823372.24972.44
3154263-15426380.62780.85
4128907-12890767.37467.48
5139681-13968173.00673.17
6141841-14184174.13574.31
15min1169703-16970388.69788.932.0589.2889.512.08
2167668-16766887.63388.23
3177065-17706592.54593.22
4169532-16953288.60889.09
5168517-16851788.07788.65
6168401-16840188.01688.60
20min1181330-18133094.77495.191.0795.8596.271.10
2181735-18173594.98696.07
3185776-18577697.09898.28
4182198-18219895.22896.20
5181781-18178195.01096.07
6179972-17997294.06495.14
30min1183488-18348895.90297.521.0297.5099.131.00
2187829-18782998.17199.78
3187758-18775898.13499.86
4188547-18854798.546100.05
5186532-18653297.49399.08
6185391-18539196.89698.49
45min1184126-18412696.23598.951.5598.37101.101.50
2190403-19040399.516101.67
3188394-18839498.466100.74
4192012-192012100.357102.41
5191869-191869100.282102.41
6189093-18909398.831100.97
60min1184238-18423896.29497.610.9898.96100.300.92
2188012-18801298.266100.97
3185416-18541696.90999.73
4189274-18927498.926101.54
5187212-18721297.848100.53
6186345-18634597.395100.08
极限1183130-18313095.71596.460.5898.9299.700.55
2185034-18503496.71099.96
3184451-18445196.40599.76
4186144-18614497.290100.45
5183708-18370896.01799.24
6184856-18485696.61799.84
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%
110.981589061581491573801586961588051583870.41
210.891551181553871552520.13
单位质量响应值RSD%判断
14425.0514256.380.84数据可信
长期24月-供试品溶液-2023120823批-阿托伐他汀钙-pH6.8(内含0.2%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min197348-9734856.19176.3613.8256.1976.3613.82
2130515-13051575.33575.34
3136287-13628778.66778.67
4136974-13697479.06479.06
5143573-14357382.87382.87
6149023-14902386.01986.02
10min1149826-14982686.48294.164.4786.7994.594.52
2162873-16287394.01394.43
3161385-16138593.15493.59
4166598-16659896.16396.60
5170327-17032798.31698.78
6167801-16780196.85797.34
15min1157068-15706890.66296.683.4891.4597.623.52
2168861-16886197.46998.41
3165723-16572395.65896.61
4172983-17298399.849100.82
5172545-17254599.596100.60
6167754-16775496.83097.85
20min1164693-16469395.06498.172.1896.3699.652.23
2170703-17070398.533100.01
3167480-16748096.67298.16
4173703-173703100.264101.79
5174431-174431100.684102.24
6169425-16942597.79599.35
30min1164819-16481995.13697.201.6796.9699.231.72
2168842-16884297.45899.49
3165927-16592795.77697.80
4172043-17204399.306101.39
5170954-17095498.677100.80
6167751-16775196.82998.93
45min1165428-16542895.48897.762.1497.84100.332.18
2169058-16905897.583100.15
3165290-16529095.40897.96
4172751-17275199.715102.35
5174021-174021100.448103.12
6169607-16960797.900100.54
60min1165132-16513295.31796.291.4998.2099.401.53
2166593-16659396.16099.27
3163226-16322694.21797.30
4169942-16994298.093101.28
5169101-16910197.608100.83
6166947-16694796.36599.54
极限1164101-16410194.72295.021.1198.1398.661.15
2163841-16384194.57298.22
3161786-16178693.38696.99
4166880-16688096.326100.06
5166175-16617595.91999.69
6164885-16488595.17498.89
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%
19.821684171690881690361688291688181688380.16
29.841682841684451683640.07
单位质量响应值RSD%判断
17193.2817110.160.35数据可信
长期24月-供试品溶液-2023120823批-依折麦布-pH6.8(内含0.2%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min157444-5744430.06724.6334.2830.0724.6434.28
253319-5331927.90827.91
371331-7133137.33637.34
434302-3430217.95417.95
531234-3123416.34816.35
634753-3475318.19018.19
10min1134120-13412070.20167.1012.2070.3767.2412.24
2134440-13444070.36970.52
3151779-15177979.44479.65
4109902-10990257.52557.62
5112213-11221358.73558.83
6126763-12676366.35066.45
15min1160479-16047983.99884.285.8884.5584.795.94
2165473-16547386.61287.16
3175046-17504691.62392.27
4149074-14907478.02878.45
5152100-15210079.61280.03
6163905-16390585.79186.26
20min1175428-17542891.82392.003.0292.8592.983.10
2178845-17884593.61194.64
3182142-18214295.33796.49
4170104-17010489.03689.89
5168941-16894188.42789.29
6179188-17918893.79194.74
30min1180249-18024994.34696.841.7695.8898.321.79
2186264-18626497.49499.04
3188762-18876298.802100.49
4186822-18682297.78699.13
5181828-18182895.17296.52
6186107-18610797.41298.88
45min1189681-18968199.28399.581.41101.34101.611.48
2188976-18897698.914101.00
3194496-194496101.803104.04
4190286-19028699.599101.49
5186521-18652197.62999.51
6191545-191545100.258102.27
60min1182575-18257595.56397.751.2598.17100.331.22
2186456-18645697.595100.23
3188396-18839698.610101.41
4189300-18930099.083101.53
5186533-18653397.635100.06
6187237-18723798.004100.57
极限1184350-18435096.49297.741.4399.63100.861.48
2186235-18623597.479100.66
3190630-19063099.780103.13
4188315-18831598.568101.56
5183348-18334895.96898.93
6187468-18746898.124101.23
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%
110.981552321557581558951554481555321555730.17
210.891550791553741552260.14
单位质量响应值RSD%判断
14168.7614253.990.43数据可信
长期24月-供试品溶液-2023120823批-阿托伐他汀钙-pH6.8(内含0.2%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1142686-14268683.10867.8816.7183.1167.8816.71
292877-9287754.09754.10
399313-9931357.84557.85
4111172-11117264.75364.75
5118677-11867769.12469.12
6134495-13449578.33778.34
10min1163869-16386995.44693.623.2595.9194.003.29
2154724-15472490.12090.42
3159300-15930092.78593.11
4155068-15506890.32090.68
5164017-16401795.53295.92
6167463-16746397.54097.97
15min1164483-16448395.80497.481.8296.8098.381.82
2167385-16738597.49498.30
3167243-16724397.41198.25
4163524-16352495.24596.11
5171095-17109599.655100.57
6170407-17040799.254100.23
20min1167657-16765797.65398.641.7399.18100.081.73
2170368-17036899.232100.57
3167004-16700497.27298.65
4165902-16590296.63098.02
5172911-172911100.713102.18
6172263-172263100.335101.86
30min1164579-16457995.86098.351.5597.93100.331.51
2170464-17046499.288101.18
3168083-16808397.90199.82
4167768-16776897.71799.64
5171899-171899100.123102.15
6170295-17029599.189101.28
45min1170116-17011699.08599.181.17101.68101.711.18
2170394-17039499.247101.69
3171223-17122399.730102.19
4166527-16652796.99499.46
5171262-17126299.752102.34
6172168-172168100.280102.92
60min1163921-16392195.47797.191.3798.63100.281.34
2168445-16844598.112101.11
3165822-16582296.58499.60
4165156-16515696.19699.21
5169985-16998599.009102.15
6167866-16786697.774100.97
极限1164073-16407395.56596.681.0399.25100.311.00
2167537-16753797.583101.12
3167051-16705197.300100.85
4163737-16373795.36998.91
5166125-16612596.760100.45
6167432-16743297.522101.26
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%
19.821683321688431693251696541697101691730.35
29.841671751679241675500.32
单位质量响应值RSD%判断
17227.3917027.440.83数据可信
长期24月-供试品溶液-2023121221批-依折麦布-pH6.8(内含0.2%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min125519-2551913.37621.8619.3213.3821.8619.31
244233-4423323.18623.19
344647-4464723.40323.40
444373-4437323.25923.26
543764-4376422.94022.94
647703-4770325.00525.00
10min1104096-10409654.56566.149.6954.6466.269.70
2129469-12946967.86567.99
3130909-13090968.62068.75
4141182-14118274.00474.13
5125506-12550665.78765.91
6125889-12588965.98866.13
15min1145351-14535176.19085.686.6176.5786.166.63
2171492-17149289.89290.40
3167701-16770187.90588.42
4175740-17574092.11992.66
5160292-16029284.02184.51
6160113-16011383.92884.43
20min1164151-16415186.04491.693.7286.8492.653.78
2180195-18019594.45495.46
3179001-17900193.82894.83
4181115-18111594.93695.99
5171757-17175790.03190.99
6173300-17330090.84091.81
30min1182505-18250595.66598.161.5396.9499.631.59
2186676-18667697.85199.38
3186933-18693397.98699.51
4189722-18972299.448101.03
5187053-18705398.04999.51
6190647-19064799.933101.41
45min1185897-18589797.44399.081.0499.25101.101.11
2188182-18818298.641100.71
3190695-19069599.958102.02
4190428-19042899.818101.95
5188088-18808898.591100.60
6190801-190801100.014102.05
60min1184423-18442396.67097.540.5999.02100.110.65
2186864-18686497.950100.57
3185087-18508797.01899.64
4186397-18639797.705100.39
5187146-18714698.098100.65
6186621-18662197.823100.41
极限1187572-18757298.32198.281.26101.21101.391.21
2184990-18499096.968100.13
3185872-18587297.430100.59
4186843-18684397.939101.17
5187934-18793498.511101.61
6191767-191767100.520103.65
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100590-202406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%
110.983084283093333104233106683108303099360.34
210.893058353069243063800.26
单位质量响应值RSD%判断
28227.3228134.070.24数据可信
长期24月-供试品溶液-2023121221批-阿托伐他汀钙-pH6.8(内含0.2%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1210980-21098061.97165.7721.2161.9765.7821.21
2177062-17706252.00852.01
3161528-16152847.44547.45
4261966-26196676.94676.95
5262216-26221677.02077.02
6269833-26983379.25779.26
10min1304320-30432089.38789.486.5589.7389.856.61
2288574-28857484.76285.05
3273963-27396380.47080.73
4324693-32469395.37195.80
5314847-31484792.47992.91
6321453-32145394.41994.86
15min1321813-32181394.52594.743.5995.3795.603.67
2311856-31185691.60192.36
3305619-30561989.76990.48
4331960-33196097.50698.46
5330985-33098597.21998.16
6332992-33299297.80998.77
20min1325916-32591695.73095.081.6497.1096.471.74
2315904-31590492.79094.06
3318146-31814693.44894.66
4325934-32593495.73697.23
5328247-32824796.41597.90
6327990-32799096.34097.85
30min1330978-33097897.21797.601.5599.1299.521.63
2324134-32413495.20796.99
3330172-33017296.98098.71
4333738-33373898.028100.06
5335598-33559898.574100.59
6339091-33909199.600101.64
45min1331047-33104797.23797.691.1099.68100.151.07
2327351-32735196.15298.46
3338311-33831199.371101.64
4332178-33217897.570100.15
5332228-33222897.584100.15
6334320-33432098.199100.80
60min1327604-32760496.22696.761.0399.2099.760.88
2332387-33238797.631100.48
3334090-33409098.131100.95
4325642-32564295.65098.77
5330209-33020996.991100.10
6326540-32654095.91499.06
极限1331550-33155097.38597.110.84100.90100.650.82
2328864-32886496.59699.99
3332065-33206597.536100.90
4326277-32627795.83699.49
5330735-33073597.146100.79
6334210-33421098.167101.84
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%
19.821686621694861703921706531705781699540.51
29.841679081685191682140.26
单位质量响应值RSD%判断
17306.9217094.920.88数据可信
长期24月-供试品溶液-2023121221批-依折麦布-pH6.8(内含0.2%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min136183-3618318.88520.0625.9218.8920.0625.91
245298-4529823.64323.64
320209-2020910.54810.55
448718-4871825.42825.43
539651-3965120.69520.70
640534-4053421.15621.16
10min1114816-11481659.92758.1614.2060.0358.2714.21
2135416-13541670.67970.81
394804-9480449.48249.54
4123079-12307964.24064.38
599546-9954651.95752.07
6100916-10091652.67252.79
15min1155637-15563781.23379.638.2481.6780.068.26
2168897-16889788.15488.68
3147358-14735876.91277.25
4164285-16428585.74786.24
5141957-14195774.09374.50
6137213-13721371.61772.03
20min1173875-17387590.75289.874.6891.6490.744.74
2182099-18209995.04596.06
3168856-16885688.13388.89
4180364-18036494.13995.11
5166148-16614886.71987.53
6161746-16174684.42285.23
30min1183037-18303795.53497.251.5796.9398.631.60
2186415-18641597.29798.84
3184976-18497696.54697.80
4191053-19105399.718101.22
5184308-18430896.19897.49
6188206-18820698.23299.51
45min1186685-18668597.43898.370.9099.36100.290.87
2186644-18664497.41799.50
3187663-18766397.94999.74
4190360-19036099.356101.41
5189374-18937498.842100.67
6190105-19010599.223101.05
60min1183288-18328895.66597.221.3098.1399.681.26
2185977-18597797.06999.69
3187475-18747597.851100.18
4187360-18736097.791100.39
5183847-18384795.95798.34
6189675-18967598.999101.37
极限1186799-18679997.49897.840.66100.49100.840.61
2185327-18532796.72999.89
3187680-18768097.958100.83
4188759-18875998.521101.67
5188211-18821198.235101.15
6187962-18796298.105101.03
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%
110.983095103103683122173128463122363114350.46
210.893075033082343078680.17
单位质量响应值RSD%判断
28363.8428270.710.24数据可信
长期24月-供试品溶液-2023121221批-阿托伐他汀钙-pH6.8(内含0.2%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1192134-19213456.16362.8226.7556.1662.8226.74
2275693-27569380.58880.59
3229053-22905366.95566.95
4279605-27960581.73181.73
5133062-13306238.89538.90
6180002-18000252.61652.62
10min1299297-29929787.48890.444.8187.8090.794.88
2317660-31766092.85593.30
3315525-31552592.23192.60
4332219-33221997.11197.57
5293668-29366885.84286.06
6298085-29808587.13387.43
15min1320570-32057093.70696.302.2494.5097.152.28
2326548-32654895.45396.42
3328839-32883996.12397.01
4342711-342711100.178101.17
5327216-32721695.64996.34
6330745-33074596.68097.46
20min1334723-33472397.84398.541.8199.1699.931.84
2332337-33233797.14698.64
3333898-33389897.60299.02
4346999-346999101.431102.98
5332417-33241797.16998.39
6342281-342281100.052101.37
30min1328209-32820995.93999.423.2197.80101.363.18
2330911-33091196.72998.76
3338906-33890699.066101.03
4350273-350273102.388104.50
5336497-33649798.362100.13
6355932-355932104.043105.91
45min1329755-32975596.39198.642.2298.79101.122.19
2328740-32874096.09498.67
3336853-33685398.466100.98
4344163-344163100.602103.28
5337678-33767898.707101.02
6347420-347420101.554104.00
60min1323955-32395594.69597.392.4797.63100.432.47
2327881-32788195.84398.95
3334900-33490097.895100.95
4339875-33987599.349102.59
5327373-32737395.69598.55
6345141-345141100.888103.90
极限1331238-33123896.82497.821.80100.28101.401.79
2325904-32590495.26598.90
3333435-33343597.466101.07
4341770-34177099.903103.70
5334592-33459297.805101.20
6340980-34098099.672103.24
点击查看处理图标(自动生成)
 
原始图谱下载图谱(谢鑫慧 于 2026-01-06 17:00:05 完成)
生成报告数据部分(等待生成报告)
Current page cost:4.133 s