阿齐沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号68522100802对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.70对照品水分(%)0对照品稀释倍数1000
标示量(mg)20供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.562849732845732848162838442831782842770.27
210.622851552837942844740.34
单位质量响应值RSD%判断
26920.1726786.630.36数据可信
长期3月-供试品溶液-2023101221批-阿齐沙坦-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1108750-10875036.33931.8625.0636.3431.8625.05
2114422-11442238.23438.23
348620-4862016.24616.25
493971-9397131.40031.40
5102138-10213834.12934.13
6104098-10409834.78434.78
10min1260845-26084587.16182.4210.1787.3682.5910.20
2259492-25949286.70986.92
3201636-20163667.37767.47
4232435-23243577.66877.84
5258599-25859986.41186.60
6266861-26686189.17289.36
15min1277649-27764992.77691.395.0693.4692.035.10
2274384-27438491.68592.38
3257894-25789486.17586.64
4256159-25615985.59586.20
5288937-28893796.54897.22
6286000-28600095.56796.26
20min1283163-28316394.61993.303.9095.8294.443.93
2278334-27833493.00594.21
3273301-27330191.32392.27
4262208-26220887.61788.70
5294390-29439098.37099.58
6283889-28388994.86196.08
30min1283747-28374794.81494.752.0296.5496.412.08
2280360-28036093.68295.40
3280110-28011093.59995.05
4276618-27661892.43294.00
5291647-29164797.45499.21
6288802-28880296.50398.25
45min1284762-28476295.15396.211.7197.4198.401.74
2283987-28398794.89497.13
3282223-28222394.30596.28
4290537-29053797.08399.16
5294529-29452998.417100.71
6291482-29148297.39999.68
60min1279863-27986393.51696.602.0696.3099.322.03
2285448-28544895.38298.15
3288130-28813096.27998.77
4290676-29067697.12999.75
5295539-29553998.754101.59
6294892-29489298.538101.36
极限1289917-28991796.87698.182.44100.18101.442.34
2296838-29683899.188102.49
3299983-299983100.239103.27
4289575-28957596.76199.92
5302711-302711101.151104.54
6283976-28397694.89098.26
阿齐沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数4000
标示量(mg)5供试品稀释倍数2系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.837089471044711917082770778709470.24
214.957201271611718120.40
单位质量响应值RSD%判断
4784.024803.480.29数据可信
长期3月-供试品溶液-2023101221批-氨氯地平-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min155121-5512174.55071.108.0974.5571.108.09
249826-4982667.38967.39
346447-4644762.81962.82
451339-5133969.43569.43
558450-5845079.05279.05
654216-5421673.32673.33
10min163811-6381186.30387.132.8086.7287.522.77
266616-6661690.09790.47
364232-6423286.87287.22
465928-6592889.16689.55
564475-6447587.20187.64
661478-6147883.14883.55
15min164258-6425886.90789.583.5587.8090.463.52
268589-6858992.76593.64
367056-6705690.69291.52
467925-6792591.86792.75
567084-6708490.73091.65
662503-6250384.53485.40
20min166333-6633389.71490.713.8891.0992.093.84
269507-6950794.00795.40
369460-6946093.94395.28
467315-6731591.04292.43
567381-6738191.13192.56
662438-6243884.44685.78
30min166061-6606189.34692.294.0391.2294.173.98
270402-7040295.21797.13
370770-7077095.71597.57
470093-7009394.79996.70
568175-6817592.20594.14
663939-6393986.47688.28
45min167006-6700690.62493.773.8993.0096.173.85
271280-7128096.40598.85
371413-7141396.58498.97
470886-7088695.87298.30
570462-7046295.29897.74
664960-6496087.85790.15
60min163739-6373986.20694.105.5589.0897.015.45
271996-7199697.373100.35
372345-7234597.845100.77
472209-7220997.661100.62
571571-7157196.79899.77
665583-6558388.70091.48
极限167447-6744791.22194.295.9294.5797.725.81
272448-7244897.984101.50
374105-74105100.225103.69
470705-7070595.62799.13
570975-7097595.99299.51
662601-6260184.66687.94
阿齐沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号68522100802对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.70对照品水分(%)0对照品稀释倍数1000
标示量(mg)20供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.562857692850392844452857932859572854010.23
210.622863432861762862600.05
单位质量响应值RSD%判断
27026.6126954.800.19数据可信
长期3月-供试品溶液-2024010621批-阿齐沙坦-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1187932-18793262.47844.6838.5562.4844.6838.56
253071-5307117.64317.64
3100923-10092333.55233.55
4178940-17894059.48859.49
5161344-16134453.63953.64
6124102-12410241.25841.26
10min1291395-29139596.87484.1711.7397.2284.4111.81
2212583-21258370.67370.77
3230245-23024576.54576.73
4278759-27875992.67393.00
5260640-26064086.64986.95
6245407-24540781.58581.81
15min1288646-28864695.96089.356.7896.8590.076.89
2245644-24564481.66482.15
3248705-24870582.68283.29
4284084-28408494.44395.29
5278235-27823592.49993.28
6267308-26730888.86689.55
20min1289312-28931296.18191.704.3897.6092.924.52
2257729-25772985.68286.63
3265256-26525688.18489.25
4284478-28447894.57495.94
5281584-28158493.61294.91
6276676-27667691.98093.16
30min1292915-29291597.37994.622.5999.3396.342.74
2273622-27362290.96592.39
3277823-27782392.36293.92
4285982-28598295.07496.97
5288997-28899796.07797.89
6288393-28839395.87697.56
45min1282888-28288894.04693.612.1396.5495.862.10
2282815-28281594.02195.95
3274301-27430191.19193.26
4278569-27856992.61095.03
5278982-27898292.74795.09
6291933-29193397.05399.27
60min1283158-28315894.13594.202.2297.1596.972.19
2283271-28327194.17396.62
3276554-27655491.94094.52
4277095-27709592.12095.06
5286653-28665395.29798.16
6293430-29343097.550100.31
极限1285652-28565294.96596.391.2398.5099.681.01
2292478-29247897.234100.21
3293276-29327697.499100.59
4285506-28550694.91698.37
5290041-29004196.42499.82
6292645-29264597.289100.59
阿齐沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数4000
标示量(mg)5供试品稀释倍数2系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.837111671166710007072870892709800.25
214.957002070138700790.12
单位质量响应值RSD%判断
4786.244687.561.48数据可信
长期3月-供试品溶液-2024010621批-氨氯地平-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min161114-6111483.65669.8526.4983.6669.8526.50
229456-2945640.32140.32
339393-3939353.92353.92
461211-6121183.78983.79
560932-6093283.40783.41
654053-5405373.99173.99
10min168890-6889094.30088.716.1294.7689.106.17
263647-6364787.12387.35
357588-5758878.82979.13
467369-6736992.21892.68
565999-6599990.34390.81
665342-6534289.44389.85
15min168340-6834093.54791.164.5494.5492.044.60
266961-6696191.66092.37
360672-6067283.05183.79
469021-6902194.47995.46
567828-6782892.84693.81
666736-6673691.35292.26
20min170419-7041996.39393.143.4797.9094.533.54
268106-6810693.22794.44
363672-6367287.15888.36
469797-6979795.54297.04
568105-6810593.22694.71
668176-6817693.32394.74
30min171808-7180898.29495.502.11100.3497.402.21
269346-6934694.92496.66
367502-6750292.40094.08
470881-7088197.02699.06
569539-6953995.18997.19
669522-6952295.16597.10
45min169620-6962095.29993.881.7197.8996.321.71
269870-6987095.64297.90
367099-6709991.84994.05
468381-6838193.60396.18
567344-6734492.18494.71
669177-6917794.69397.16
60min170936-7093697.10195.081.57100.2298.041.64
269492-6949295.12497.92
367785-6778592.78895.49
468745-6874594.10297.19
569781-6978195.52098.56
670017-7001795.84398.83
极限170489-7048996.48996.151.17100.1599.641.17
270946-7094697.115100.44
369245-6924594.78698.01
469688-6968895.39399.01
569730-6973095.45099.02
671346-7134697.662101.18
阿齐沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号68522100802对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.70对照品水分(%)0对照品稀释倍数1000
标示量(mg)20供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.562863592855942863292859892858152860170.12
210.622861932858972860450.08
单位质量响应值RSD%判断
27084.9426934.560.40数据可信
长期3月-供试品溶液-2024010721批-阿齐沙坦-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1175664-17566458.35843.6838.2158.3643.6838.21
2158280-15828052.58352.58
3182152-18215260.51460.51
452686-5268617.50317.50
598792-9879232.82032.82
6121323-12132340.30540.31
10min1274789-27478991.28982.6712.0391.6182.9212.11
2260162-26016286.43086.72
3286551-28655195.19795.53
4208854-20885469.38569.48
5226400-22640075.21475.40
6236388-23638878.53278.76
15min1282909-28290993.98788.347.7094.8289.047.81
2273779-27377990.95491.73
3291441-29144196.82197.69
4240288-24028879.82880.31
5245469-24546981.54982.15
6261590-26159086.90487.56
20min1280619-28061993.22690.624.3994.5891.824.53
2277949-27794992.33993.62
3286632-28663295.22496.63
4253995-25399584.38185.31
5263786-26378687.63488.69
6273704-27370490.92992.07
30min1280664-28066493.24193.502.1995.1195.202.33
2287004-28700495.34797.14
3288339-28833995.79197.72
4273774-27377490.95292.35
5274779-27477991.28692.83
6284086-28408694.37896.03
45min1281969-28196993.67594.452.4396.0696.672.46
2283192-28319294.08196.40
3289455-28945596.16298.63
4282886-28288693.97995.88
5274095-27409591.05993.11
6294259-29425997.75899.93
60min1285005-28500594.68395.171.7797.5997.911.73
2289022-28902296.01898.86
3282297-28229793.78496.78
4286051-28605195.03197.45
5281335-28133593.46496.02
6295152-29515298.054100.77
极限1285866-28586694.96996.480.9798.4199.750.77
2290370-29037096.46699.84
3289809-28980996.27999.80
4294244-29424497.753100.70
5292173-29217397.065100.14
6289989-28998996.33999.60
阿齐沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数4000
标示量(mg)5供试品稀释倍数2系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.837194371934715547181271237716960.42
214.957202071806719130.22
单位质量响应值RSD%判断
4834.524810.230.36数据可信
长期3月-供试品溶液-2024010721批-氨氯地平-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min159821-5982180.42666.5326.5680.4366.5326.57
258960-5896079.26979.27
359072-5907279.41979.42
428541-2854138.37238.37
538158-3815851.30251.30
652349-5234970.38170.38
10min166649-6664989.60685.406.5390.0585.776.59
265659-6565988.27588.72
367304-6730490.48790.93
461542-6154282.74082.95
556224-5622475.59075.88
663746-6374685.70386.09
15min168667-6866792.31988.475.5593.2689.315.60
265974-6597488.69989.63
370159-7015994.32595.27
465428-6542887.96588.64
559598-5959880.12780.83
664976-6497687.35788.22
20min168295-6829591.81990.123.2193.2891.453.27
266644-6664489.60091.02
369526-6952693.47494.94
467373-6737390.58091.74
563168-6316884.92686.08
667162-6716290.29691.65
30min168890-6889092.61992.192.3994.5994.032.46
268303-6830391.83093.75
371088-7108895.57497.56
469068-6906892.85994.52
566055-6605588.80890.43
668042-6804291.47993.33
45min169435-6943593.35293.092.1095.8395.442.17
268131-6813191.59994.03
371736-7173696.44698.96
468933-6893392.67794.86
567572-6757290.84792.96
669649-6964993.64096.00
60min170852-7085295.25793.891.3198.2696.761.43
269841-6984193.89896.84
370503-7050394.78897.84
468567-6856792.18594.88
568928-6892892.67095.29
670314-7031494.53497.42
极限169866-6986693.93195.281.8497.4698.661.76
269065-6906592.85496.32
372669-7266997.700101.28
471776-7177696.49999.71
571121-7112195.61998.75
670704-7070495.05898.47
阿齐沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号68522100802对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.70对照品水分(%)0对照品稀释倍数1000
标示量(mg)20供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.562857482864582849312870632865482861500.29
210.622861262863402862330.06
单位质量响应值RSD%判断
27097.5426952.260.39数据可信
长期3月-供试品溶液-2024010921批-阿齐沙坦-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1172876-17287657.40043.5738.5157.4043.5738.51
2184704-18470461.32761.33
3157255-15725552.21352.21
452004-5200417.26717.27
5123118-12311840.87940.88
697304-9730432.30832.31
10min1269648-26964889.53181.8911.6589.8582.1411.73
2284210-28421094.36694.71
3255330-25533084.77785.07
4206754-20675468.64868.74
5238543-23854379.20379.43
6225412-22541274.84375.02
15min1278422-27842292.44488.057.0693.2688.747.17
2286411-28641195.09795.96
3277357-27735792.09192.85
4240452-24045279.83780.31
5262140-26214087.03887.71
6246297-24629781.77882.37
20min1281326-28132693.40990.654.5694.7491.844.70
2288577-28857795.81697.21
3279110-27911092.67393.95
4256025-25602585.00885.93
5271622-27162290.18791.34
6261436-26143686.80487.85
30min1281322-28132293.40793.342.4295.2695.022.52
2287226-28722695.36897.29
3280908-28090893.27095.06
4273649-27364990.86092.25
5290027-29002796.29897.95
6273507-27350790.81292.34
45min1283042-28304293.97894.591.6996.3596.801.74
2285637-28563794.84097.30
3285663-28566394.84997.15
4281215-28121593.37295.27
5293561-29356197.47199.66
6280170-28017093.02595.06
60min1281752-28175293.55094.772.0096.4497.511.98
2286601-28660195.16098.14
3284122-28412294.33797.17
4285675-28567594.85397.27
5295580-29558098.141100.87
6278910-27891092.60695.16
极限1288514-28851495.79596.610.4399.2099.870.38
2291201-29120196.687100.20
3291152-29115296.671100.03
4291237-29123796.69999.64
5291691-29169196.850100.12
6291975-29197596.944100.01
阿齐沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数4000
标示量(mg)5供试品稀释倍数2系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.837151071378716077144871587715060.14
214.957193172172720520.24
单位质量响应值RSD%判断
4821.714819.530.04数据可信
长期3月-供试品溶液-2024010921批-氨氯地平-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min159316-5931679.77666.4927.2279.7866.4927.22
259684-5968480.27180.27
358735-5873578.99578.99
428040-2804037.71237.71
553366-5336671.77471.77
637490-3749050.42250.42
10min165102-6510287.55884.666.5688.0085.036.62
267333-6733390.55891.00
364635-6463586.93087.37
461062-6106282.12482.33
563953-6395386.01286.41
655607-5560774.78875.07
15min167450-6745090.71687.954.7791.6588.794.84
268193-6819391.71592.66
367012-6701290.12791.05
464508-6450886.75987.42
565564-6556488.17989.06
659642-5964280.21480.91
20min168771-6877192.49290.083.6693.9391.413.73
269862-6986293.96095.42
366804-6680489.84791.27
467288-6728890.49891.65
566408-6640889.31490.68
662732-6273284.37085.51
30min169043-6904392.85891.502.5094.8193.322.56
269387-6938793.32195.30
367125-6712590.27992.20
468729-6872992.43694.09
568930-6893092.70694.57
664966-6496687.37588.98
45min168973-6897392.76493.271.4695.2395.611.53
271249-7124995.82598.32
368630-6863092.30394.73
468714-6871492.41694.58
569730-6973093.78296.16
668811-6881192.54694.64
60min169570-6957093.56794.051.5396.5596.911.56
271424-7142496.06099.09
368661-6866192.34495.28
469898-6989894.00896.69
570924-7092495.38898.29
669097-6909792.93195.54
极限169670-6967093.70195.131.5097.2098.511.47
272587-7258797.625101.19
369818-6981893.90097.35
470827-7082795.25898.46
570440-7044094.73798.17
671052-7105295.56098.69
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