培哚普利吲达帕胺片项目信息
介质体积(ml)500取样体积(ml)2补液体积(ml)2
对照品批号101072-202303对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数4000
标示量(mg)2供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.411631131633021635661638561637761635230.20
216.471640491641561641020.05
单位质量响应值RSD%判断
9964.849963.690.01数据可信
加速6月-供试品溶液-2023110821批-培哚普利-pH4.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min158722-5872236.75949.2944.1036.7649.2944.10
259224-5922437.07337.07
3147990-14799092.64092.64
477746-7774648.66848.67
568726-6872643.02243.02
660055-6005537.59437.59
10min1154563-15456396.75497.480.7496.9097.680.72
2157435-15743598.55298.70
3154919-15491996.97797.35
4156855-15685598.18998.38
5155421-15542197.29297.46
6155182-15518297.14297.29
15min1157562-15756298.63298.831.1699.1799.421.09
2160876-160876100.706101.25
3155150-15515097.12297.88
4157869-15786998.82499.41
5157967-15796798.88599.45
6157895-15789598.84099.38
20min1157510-15751098.59998.901.4199.5399.881.34
2160197-160197100.281101.23
3154023-15402396.41697.56
4159472-15947299.827100.81
5159231-15923199.677100.63
6157533-15753398.61499.55
30min1159065-15906599.57399.051.25100.90100.431.18
2161275-161275100.956102.30
3155457-15545797.31498.85
4158557-15855799.255100.64
5158040-15804098.931100.29
6156950-15695098.24999.58
45min1157600-15760098.65698.751.11100.38100.521.04
2160485-160485100.462102.21
3155000-15500097.02898.95
4157833-15783398.801100.58
5157930-15793098.862100.61
6157628-15762898.673100.39
60min1158202-15820299.03299.111.50101.15101.281.43
2162309-162309101.603103.76
3154947-15494796.99599.30
4158014-15801498.915101.09
5158806-15880699.410101.56
6157689-15768998.711100.83
极限1157659-15765998.69298.721.36101.20101.291.30
2161507-161507101.101103.66
3154908-15490896.97099.67
4157388-15738898.523101.09
5157817-15781798.791101.34
6156944-15694498.245100.76
培哚普利吲达帕胺片项目信息
介质体积(ml)500取样体积(ml)2补液体积(ml)2
对照品批号100275-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.2对照品水分(%)0对照品稀释倍数10000
标示量(mg)0.625供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.303002643000782998723003833002213001640.07
212.353011053010083010560.03
单位质量响应值RSD%判断
24403.5824377.000.08数据可信
加速6月-供试品溶液-2023110821批-吲达帕胺-pH4.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min139138-3913812.60616.1525.8412.6116.1525.84
240171-4017112.93912.94
373569-7356923.69623.70
455503-5550317.87717.88
548427-4842715.59815.60
644007-4400714.17414.17
10min1135690-13569043.70547.347.6143.7647.417.62
2131587-13158742.38442.44
3158189-15818950.95251.05
4157551-15755150.74650.82
5151699-15169948.86248.92
6147146-14714647.39547.45
15min1186990-18699060.22962.743.3860.4563.003.40
2187325-18732560.33760.56
3196555-19655563.30963.61
4203679-20367965.60465.88
5198927-19892764.07364.33
6195313-19531362.90963.16
20min1215329-21532969.35671.412.5569.8271.912.56
2216708-21670869.80170.26
3219281-21928170.62971.18
4230141-23014174.12774.66
5225412-22541272.60473.12
6223311-22331171.92772.43
30min1248498-24849880.04081.682.2380.7882.472.23
2250119-25011980.56281.30
3248029-24802979.88980.72
4262123-26212384.42985.26
5257242-25724282.85683.66
6255529-25552982.30583.09
45min1271046-27104687.30388.712.1188.3789.832.11
2273247-27324788.01289.08
3267701-26770186.22587.38
4283526-28352691.32292.49
5278946-27894689.84790.98
6278116-27811689.58090.69
60min1284136-28413691.51992.391.9692.9393.861.93
2287304-28730492.53993.96
3276867-27686789.17890.68
4290953-29095393.71595.25
5291159-29115993.78195.28
6290596-29059693.60095.07
极限1291262-29126293.81494.932.1795.5996.772.15
2293580-29358094.56196.35
3284129-28412991.51793.37
4300254-30025496.71098.62
5299034-29903496.31798.19
6300073-30007396.65298.50
培哚普利吲达帕胺片项目信息
介质体积(ml)500取样体积(ml)2补液体积(ml)2
对照品批号101072-202303对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数4000
标示量(mg)2供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.411637241638261640461635641641171638550.14
216.471638381639301638840.04
单位质量响应值RSD%判断
9985.079950.460.25数据可信
长期6月-供试品溶液-2023110821批-培哚普利-pH4.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min157885-5788536.22332.099.5536.2232.099.55
255459-5545934.70534.70
351123-5112331.99131.99
450693-5069331.72231.72
548241-4824130.18830.19
644272-4427227.70427.70
10min1152214-15221495.25197.123.2895.4097.253.27
2161810-161810101.256101.39
3156922-15692298.19798.32
4154684-15468496.79696.92
5158352-15835299.09299.21
6147253-14725392.14692.26
15min1159287-15928799.677100.352.09100.20100.872.09
2162496-162496101.685102.23
3163235-163235102.147102.67
4154731-15473196.82697.34
5163306-163306102.192102.71
6159110-15911099.566100.05
20min1157918-15791898.82099.942.0799.74100.862.06
2161998-161998101.373102.32
3162958-162958101.974102.90
4154650-15465096.77597.68
5162455-162455101.659102.59
6158263-15826399.03699.91
30min1157324-15732498.44999.641.9999.77100.951.99
2160945-160945100.714102.07
3162110-162110101.443102.78
4154310-15431096.56297.85
5162402-162402101.626102.96
6158232-15823299.017100.29
45min1157313-15731398.44299.372.11100.16101.082.10
2160606-160606100.502102.26
3161825-161825101.265103.01
4153301-15330195.93197.61
5161920-161920101.325103.06
6157777-15777798.732100.40
60min1155947-15594797.587100.141.3199.69102.261.28
2159665-15966599.913102.07
3161211-161211100.881103.03
4161307-161307100.941103.00
5161099-161099100.811102.96
6160952-160952100.719102.78
极限1155956-15595697.59299.911.27100.09102.431.24
2158989-15898999.490102.05
3161281-161281100.925103.48
4161407-161407101.004103.47
5160103-160103100.188102.74
6160237-160237100.271102.74
培哚普利吲达帕胺片项目信息
介质体积(ml)500取样体积(ml)2补液体积(ml)2
对照品批号100275-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.2对照品水分(%)0对照品稀释倍数10000
标示量(mg)0.625供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.303003902998033006363000083004153002500.12
212.352998472998612998540.01
单位质量响应值RSD%判断
24410.5724279.680.39数据可信
长期6月-供试品溶液-2023110821批-吲达帕胺-pH4.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min139803-3980312.84411.2012.2012.8411.2012.21
237529-3752912.11012.11
331575-3157510.18910.19
437228-3722812.01312.01
533570-3357010.83310.83
628523-285239.2049.20
10min1132791-13279142.85140.259.9942.9040.3010.00
2133943-13394343.22343.27
3116001-11600137.43337.47
4134966-13496643.55343.60
5126977-12697740.97541.02
6103745-10374533.47833.51
15min1189047-18904761.00559.223.5761.2359.433.60
2189942-18994261.29361.51
3177878-17787857.40057.59
4185496-18549659.85960.08
5185415-18541559.83360.04
6173360-17336055.94256.11
20min1219359-21935970.78669.342.2771.2569.782.29
2221213-22121371.38471.85
3210948-21094868.07268.49
4213323-21332368.83869.30
5215748-21574869.62170.07
6208584-20858467.30967.70
30min1252347-25234781.43180.512.0282.1881.232.03
2254445-25444582.10882.86
3244282-24428278.82979.52
4244541-24454178.91279.65
5255112-25511282.32383.05
6246241-24624179.46180.12
45min1276445-27644589.20887.711.8590.2888.761.84
2277243-27724389.46590.55
3267172-26717286.21587.22
4264685-26468585.41386.47
5271901-27190187.74188.80
6273398-27339888.22489.21
60min1288197-28819793.00091.871.5994.4393.261.60
2291152-29115293.95395.39
3285510-28551092.13393.49
4281449-28144990.82292.22
5282927-28292791.29992.70
6278910-27891090.00391.34
极限1297799-29779996.09894.751.7397.9096.511.74
2300862-30086297.08798.90
3294798-29479895.13096.85
4289963-28996393.57095.33
5290556-29055693.76195.53
6287756-28775692.85894.55
培哚普利吲达帕胺片项目信息
介质体积(ml)500取样体积(ml)2补液体积(ml)2
对照品批号101072-202303对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数4000
标示量(mg)2供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.411639561647191644581638571644061642790.23
216.471640861640981640920.01
单位质量响应值RSD%判断
10010.919963.080.34数据可信
长期6月-供试品溶液-2023110822批-培哚普利-pH4.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min153131-5313133.18443.4824.8233.1843.4824.82
260603-6060337.85137.85
353889-5388933.65733.66
470687-7068744.14944.15
583201-8320151.96451.96
696186-9618660.07460.07
10min1157824-15782498.57198.270.7698.7098.440.74
2157504-15750498.37298.52
3158704-15870499.12199.26
4156961-15696198.03298.21
5155209-15520996.93897.15
6157820-15782098.56998.81
15min1167856-167856104.837100.002.52105.36100.572.48
2157849-15784998.58799.13
3160755-160755100.402100.93
4156748-15674897.89998.47
5158404-15840498.93499.53
6159060-15906099.34399.98
20min1168138-168138105.013100.182.45105.96101.152.41
2158296-15829698.86699.81
3160788-160788100.423101.36
4158087-15808798.73699.70
5158913-15891399.252100.24
6158208-15820898.81199.84
30min1171142-171142106.889100.303.35108.26101.673.31
2158449-15844998.962100.30
3160998-160998100.554101.89
4156380-15638097.67099.02
5158536-15853699.016100.40
6158073-15807398.727100.15
45min1167965-167965104.90599.982.59106.70101.752.55
2158525-15852599.009100.74
3161097-161097100.616102.35
4156694-15669497.86699.61
5157622-15762298.445100.23
6158559-15855999.031100.85
60min1168127-168127105.00699.542.90107.22101.712.85
2158341-15834198.894101.02
3160353-160353100.151102.29
4156093-15609397.49099.63
5155661-15566197.22199.40
6157666-15766698.473100.69
极限1168140-168140105.01499.922.59107.65102.492.56
2158294-15829498.865101.39
3160328-160328100.135102.68
4157064-15706498.097100.62
5157776-15777698.541101.11
6158304-15830498.871101.48
培哚普利吲达帕胺片项目信息
介质体积(ml)500取样体积(ml)2补液体积(ml)2
对照品批号100275-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.2对照品水分(%)0对照品稀释倍数10000
标示量(mg)0.625供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.303004643009293003123002203005983005050.10
212.353003293007813005550.11
单位质量响应值RSD%判断
24431.3024336.440.28数据可信
长期6月-供试品溶液-2023110822批-吲达帕胺-pH4.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min134355-3435511.06914.6521.0011.0714.6520.98
244194-4419414.23814.24
334876-3487611.23611.24
448490-4849015.62315.62
553149-5314917.12417.12
657713-5771318.59418.59
10min1121050-12105039.00045.2710.0439.0445.3310.05
2145011-14501146.72046.78
3124286-12428640.04340.09
4150492-15049248.48648.55
5149168-14916848.05948.13
6153047-15304749.30949.38
15min1181794-18179458.57161.653.4258.7761.893.46
2194994-19499462.82363.07
3184174-18417459.33759.54
4195667-19566763.04063.30
5195371-19537162.94563.21
6196152-19615263.19763.47
20min1215754-21575469.51271.351.8169.9571.841.84
2225024-22502472.49972.99
3217234-21723469.98970.43
4224955-22495572.47672.98
5223393-22339371.97372.49
6222417-22241771.65972.18
30min1251565-25156581.05081.620.9281.7682.390.93
2257493-25749382.95983.74
3252439-25243981.33182.05
4253487-25348781.66982.47
5254032-25403281.84482.64
6251006-25100680.86981.68
45min1279210-27921089.95689.700.9690.9990.800.93
2282495-28249591.01592.13
3279523-27952390.05791.10
4277975-27797589.55890.68
5276598-27659889.11590.24
6274742-27474288.51789.65
60min1294077-29407794.74693.831.2396.1495.291.19
2294810-29481094.98296.46
3293669-29366994.61596.02
4290481-29048193.58895.07
5288657-28865793.00094.48
6285750-28575092.06393.55
极限1305585-30558598.45497.031.17100.2398.861.12
2302614-30261497.49799.36
3304169-30416997.99899.78
4299754-29975496.57598.43
5297929-29792995.98797.84
6296872-29687295.64797.50
培哚普利吲达帕胺片项目信息
介质体积(ml)500取样体积(ml)2补液体积(ml)2
对照品批号101072-202303对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数4000
标示量(mg)2供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.411628111630841629431627291627641628660.09
216.471635211637041636120.08
单位质量响应值RSD%判断
9924.809933.940.07数据可信
长期6月-供试品溶液-2023110821批-培哚普利-pH2.0(内含0.19%EDTA)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min163977-6397740.19052.4349.0940.1952.4349.09
2116876-11687673.42073.42
350233-5023331.55631.56
472941-7294145.82145.82
5149538-14953893.93893.94
647218-4721829.66229.66
10min1153344-15334496.32996.162.6896.4996.372.77
2153439-15343996.38896.68
3150970-15097094.83794.96
4153430-15343096.38396.57
5159913-159913100.455100.83
6147364-14736492.57292.69
15min1151804-15180495.36197.942.3495.9198.542.33
2153217-15321796.24996.93
3160013-160013100.518101.02
4152931-15293196.06996.64
5159116-15911699.955100.73
6158384-15838499.49599.98
20min1153512-15351296.43497.882.0497.3698.862.03
2153481-15348196.41597.48
3159340-159340100.095101.00
4152003-15200395.48696.44
5158632-15863299.651100.83
6157910-15791099.197100.08
30min1153135-15313596.19797.951.9997.5199.331.97
2152963-15296396.08997.54
3159352-159352100.103101.41
4153251-15325196.27097.61
5158272-15827299.424101.00
6158557-15855799.603100.89
45min1152579-15257995.84897.582.0797.5599.352.08
2152672-15267295.90797.74
3157964-15796499.231100.94
4152370-15237095.71797.44
5159712-159712100.329102.30
6156682-15668298.426100.11
60min1152883-15288396.03997.141.8398.1299.301.83
2151835-15183595.38197.60
3157558-15755898.976101.08
4151636-15163695.25697.36
5157579-15757998.989101.36
6156315-15631598.195100.27
极限1150561-15056194.58096.992.4197.0599.542.40
2151049-15104994.88797.49
3157392-15739298.872101.37
4151459-15145995.14597.63
5158209-15820999.385102.16
6157728-15772899.083101.55
培哚普利吲达帕胺片项目信息
介质体积(ml)500取样体积(ml)2补液体积(ml)2
对照品批号100275-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.2对照品水分(%)0对照品稀释倍数10000
标示量(mg)0.625供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.302965202967782972112965022967012967420.10
212.352969272968732969000.02
单位质量响应值RSD%判断
24125.3724040.490.25数据可信
长期6月-供试品溶液-2023110821批-吲达帕胺-pH2.0(内含0.19%EDTA)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min146385-4638515.13116.3946.3015.1316.4046.31
261313-6131320.00120.00
328659-286599.3499.35
446060-4606015.02515.03
590489-9048929.51829.52
628646-286469.3459.34
10min1140456-14045645.81844.7017.5245.8844.7617.56
2151913-15191349.55549.64
3107081-10708134.93134.97
4142450-14245046.46846.53
5169292-16929255.22455.34
6110960-11096036.19636.23
15min1176047-17604757.42860.336.4657.6760.586.53
2190089-19008962.00862.29
3174796-17479657.02057.20
4185596-18559660.54360.79
5205997-20599767.19867.54
6177142-17714257.78557.97
20min1208312-20831267.95369.733.9868.4370.224.05
2216676-21667670.68171.21
3207375-20737567.64768.05
4212005-21200569.15869.65
5229638-22963874.91075.52
6208640-20864068.06068.47
30min1239542-23954278.14079.502.3778.8980.262.43
2241818-24181878.88379.69
3241487-24148778.77579.45
4241060-24106078.63679.40
5255239-25523983.26184.17
6243112-24311279.30579.99
45min1260606-26060685.01286.432.3586.0787.522.39
2260364-26036484.93386.06
3265500-26550086.60887.60
4261385-26138585.26686.34
5276780-27678090.28891.53
6265120-26512086.48487.49
60min1269653-26965387.96389.821.8389.3691.251.86
2272535-27253588.90390.37
3274885-27488589.66991.01
4272981-27298189.04890.47
5283824-28382492.58594.19
6278138-27813890.73192.08
极限1276391-27639190.16192.812.0991.9194.602.08
2281132-28113291.70793.53
3287615-28761593.82295.52
4280808-28080891.60293.38
5291546-29154695.10497.08
6289555-28955594.45596.17
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原始图谱下载图谱(谢鑫慧 于 2024-05-22 17:18:27 完成)
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