缬沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
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2000
标示量(mg)5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.112512832517822515132518332513932515610.10
214.042540422546182543300.17
单位质量响应值RSD%判断
17828.5618114.671.13数据可信
供试品溶液-1批-氨氯地平-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%
5min118155-181556.5497.136.546.557.136.54
220194-201947.2857.28
321100-211007.6117.61
418157-181576.5506.55
520753-207537.4867.49
620231-202317.2987.30
10min151797-5179718.68519.492.5318.7019.502.52
255559-5555920.04220.05
354461-5446119.64619.66
453022-5302219.12719.14
554774-5477419.75919.77
654497-5449719.65919.67
15min174914-7491427.02427.192.2027.0727.242.21
275049-7504927.07327.12
377620-7762028.00028.05
472626-7262626.19826.24
576044-7604427.43127.48
675974-7597427.40627.45
20min196755-9675534.90334.671.5334.9934.761.52
294760-9476034.18334.27
398521-9852135.54035.63
495445-9544534.43034.52
594670-9467034.15034.24
696445-9644534.79134.88
30min1129827-12982746.83347.341.0546.9847.491.05
2130846-13084647.20047.35
3133322-13332248.09348.24
4132025-13202547.62647.77
5129771-12977146.81246.96
6131615-13161547.47847.63
45min1174615-17461562.98961.801.7563.2162.021.74
2170946-17094661.66661.89
3172243-17224362.13362.36
4174327-17432762.88563.11
5167669-16766960.48360.71
6168077-16807760.63160.86
60min1208077-20807775.06072.372.5975.3972.702.58
2201809-20180972.79973.13
3199528-19952871.97672.31
4204316-20431673.70374.03
5194877-19487770.29870.63
6195136-19513670.39270.72
90min1242153-24215387.35285.042.1587.8185.492.15
2238689-23868986.10386.55
3233243-23324384.13884.59
4239574-23957486.42286.87
5230718-23071883.22783.67
6230071-23007182.99483.44
120min1261681-26168194.39692.091.5795.0092.691.57
2257353-25735392.83593.43
3251943-25194390.88491.48
4256644-25664492.57993.17
5252891-25289191.22691.81
6251289-25128990.64891.23
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1258756-25875693.34194.570.8394.1095.320.82
2265238-26523895.68096.43
3261989-26198994.50895.25
4263511-26351195.05795.81
5261774-26177494.43095.16
6261780-26178094.43295.17
缬沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100651-202307对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.1对照品水分(%)0对照品稀释倍数100
标示量(mg)160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%
115.504613029461269746128114617187461269246136830.05
215.614669504467681246731580.12
单位质量响应值RSD%判断
297656.97299369.510.41数据可信
供试品溶液-1批-缬沙坦-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%
5min11293381-129338124.15324.652.1924.1524.652.20
21354274-135427425.29025.29
31344509-134450925.10725.11
41281145-128114523.92423.92
51314460-131446024.54624.55
61331626-133162624.86724.87
10min12000979-200097937.36638.051.4837.4138.091.47
22055042-205504238.37638.42
32060730-206073038.48238.52
41999956-199995637.34737.39
52041769-204176938.12838.17
62067452-206745238.60738.65
15min12545759-254575947.53947.571.1947.6447.671.19
22555522-255552247.72247.83
32572399-257239948.03748.14
42496599-249659946.62146.72
52533718-253371847.31547.42
62580329-258032948.18548.29
20min12951958-295195855.12555.200.8755.3155.380.87
22962594-296259455.32355.51
32985349-298534955.74855.93
42925569-292556954.63254.81
52928614-292861454.68954.87
62982160-298216055.68955.87
30min13534861-353486166.01066.010.6966.2866.290.69
23551945-355194566.32966.61
33556908-355690866.42266.70
43529144-352914465.90366.17
53490290-349029065.17765.45
63546782-354678266.23266.51
45min14257133-425713379.49777.131.5979.8877.521.58
24124932-412493277.02977.42
34112627-411262776.79977.19
44125760-412576077.04477.42
54070251-407025176.00876.39
64092260-409226076.41976.81
60min14552083-455208385.00583.641.1185.5284.151.10
24507772-450777284.17884.69
34470968-447096883.49184.01
44488662-448866283.82184.33
54411106-441110682.37382.88
64443347-444334782.97583.49
90min14958246-495824692.59091.171.1693.2591.831.15
24938841-493884192.22892.88
34862261-486226190.79891.45
44881168-488116891.15191.80
54813728-481372889.89190.54
64840438-484043890.39091.05
120min15149712-514971296.16595.221.2996.9896.031.28
25206882-520688297.23398.04
35068304-506830494.64595.45
45063595-506359594.55795.36
55032854-503285493.98394.78
65073614-507361494.74495.55
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限15206823-520682397.23296.690.6898.2097.660.68
25207349-520734997.24298.21
35190598-519059896.92997.89
45132569-513256995.84596.80
55135341-513534195.89796.85
65195364-519536497.01897.98
缬沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
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2000
标示量(mg)5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.112521072522772523942519982520622521680.07
214.042505972509822507900.11
单位质量响应值RSD%判断
17871.5817862.540.04数据可信
供试品溶液-3批-氨氯地平-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%
5min124522-245228.8977.789.008.907.789.01
221769-217697.8987.90
318521-185216.7206.72
420858-208587.5687.57
521233-212337.7047.70
621775-217757.9007.90
10min169423-6942325.18823.733.6825.2023.743.68
266921-6692124.28024.29
363509-6350923.04223.05
464708-6470823.47723.49
562919-6291922.82822.84
664953-6495323.56623.58
15min190127-9012732.70031.712.9632.7631.762.95
288423-8842332.08232.14
383474-8347430.28630.34
489914-8991432.62332.67
586003-8600331.20431.25
686371-8637131.33731.39
20min1110556-11055640.11239.464.1440.2239.574.13
2110378-11037840.04740.15
399998-9999836.28136.38
4111487-11148740.45040.56
5108162-10816239.24339.35
6112012-11201240.64040.74
30min1142039-14203951.53451.735.6251.7151.905.61
2147678-14767853.58053.75
3126896-12689646.04046.20
4145536-14553652.80352.98
5144757-14475752.52152.69
6148498-14849853.87854.05
45min1180454-18045465.47265.395.0165.7465.655.01
2185940-18594067.46367.73
3162787-16278759.06259.30
4182347-18234766.15966.42
5181713-18171365.92966.18
6188196-18819668.28168.54
60min1204526-20452674.20674.624.7774.5874.984.76
2214896-21489677.96878.34
3190482-19048269.11169.45
4198440-19844071.99872.37
5210797-21079776.48176.85
6214842-21484277.94978.32
90min1237072-23707286.01485.633.6286.5186.133.62
2241957-24195787.78788.29
3220288-22028879.92580.38
4234785-23478585.18585.68
5237288-23728886.09386.59
6244757-24475788.80389.31
120min1251938-25193891.40890.184.9592.0590.814.94
2257915-25791593.57794.23
3224627-22462781.49982.08
4247830-24783089.91790.55
5252088-25208891.46292.10
6256899-25689993.20893.86
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1258371-25837193.74292.343.1994.5393.123.20
2262927-26292795.39596.20
3240127-24012787.12387.84
4251564-25156491.27292.06
5254305-25430592.26793.06
6259734-25973494.23695.05
缬沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100651-202307对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.1对照品水分(%)0对照品稀释倍数100
标示量(mg)160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%
115.504628139462947946351544633584462965146312010.07
215.614608363461520946117860.11
单位质量响应值RSD%判断
298787.16295437.920.80数据可信
供试品溶液-3批-缬沙坦-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%
5min11451218-145121827.22826.392.7727.2326.392.77
21386848-138684826.02126.02
31436761-143676126.95726.96
41434237-143423726.91026.91
51363380-136338025.58025.58
61366219-136621925.63425.63
10min12211091-221109141.48541.241.6741.5341.281.67
22172252-217225240.75740.80
32256520-225652042.33842.38
42214710-221471041.55341.60
52156923-215692340.46940.51
62176932-217693240.84540.89
15min12677050-267705050.22850.671.4550.3450.781.46
22674551-267455150.18150.29
32761661-276166151.81551.93
42733713-273371351.29151.41
52661276-266127649.93250.04
62694261-269426150.55150.66
20min13049779-304977957.22158.261.4157.4258.461.41
23084663-308466357.87658.07
33171361-317136159.50259.70
43129563-312956358.71858.92
53076294-307629457.71957.91
63120692-312069258.55258.75
30min13591399-359139967.38369.011.5267.6869.301.51
23675596-367559668.96369.25
33755487-375548770.46270.76
43694223-369422369.31369.61
53646974-364697468.42668.72
63704618-370461869.50869.80
45min14146799-414679977.80479.311.2978.2179.721.29
24239129-423912979.53679.94
34307002-430700280.81081.23
44216739-421673979.11679.53
54197210-419721078.75079.15
64256386-425638679.86080.27
60min14486249-448624984.17385.501.2084.7186.041.20
24578462-457846285.90386.44
34635308-463530886.97087.52
44520003-452000384.80685.35
54530646-453064685.00685.54
64591996-459199686.15786.70
90min14842277-484227790.85391.791.0491.5392.471.03
24939988-493998892.68693.37
34956793-495679393.00193.70
44851726-485172691.03091.72
54850192-485019291.00191.68
64911693-491169392.15592.84
120min15026523-502652394.31094.691.0995.1495.521.09
25109938-510993895.87596.71
35109905-510990595.87496.73
44998935-499893593.79294.63
54981588-498158893.46794.29
65053104-505310494.80895.65
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限15083016-508301695.37095.681.2696.3596.671.26
25175053-517505397.09798.09
35181174-518117497.21198.22
45057795-505779594.89795.89
55024061-502406194.26495.25
65076538-507653895.24896.24
缬沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
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2000
标示量(mg)5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.112523012531492525742524672528362526650.14
214.042539872541382540620.05
单位质量响应值RSD%判断
17906.8018095.580.75数据可信
供试品溶液-1批-氨氯地平-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%
5min126247-262479.45210.968.999.4510.968.99
234684-3468412.49112.49
331253-3125311.25511.26
429394-2939410.58610.59
530510-3051010.98710.99
630489-3048910.98010.98
10min161742-6174222.23523.096.1122.2523.116.11
270469-7046925.37825.40
367338-6733824.25024.27
460876-6087621.92321.94
561160-6116022.02522.04
663155-6315522.74422.76
15min189057-8905732.07232.455.5832.1232.505.59
295418-9541834.36234.43
396473-9647334.74234.80
484813-8481330.54330.60
584767-8476730.52730.58
690104-9010432.44932.50
20min1109761-10976139.52839.715.0039.6339.825.00
2117404-11740442.28042.40
3115888-11588841.73441.85
4104527-10452737.64337.75
5104319-10431937.56837.67
6109642-10964239.48539.60
30min1143369-14336951.63151.384.2551.8051.564.26
2150544-15054454.21554.41
3147999-14799953.29853.48
4136610-13661049.19749.36
5135193-13519348.68648.85
6142346-14234651.26251.44
45min1181620-18162065.40664.514.2865.6664.774.28
2190558-19055868.62568.91
3183095-18309565.93766.21
4174187-17418762.72962.98
5168633-16863360.72960.98
6176695-17669563.63263.89
60min1204256-20425673.55873.383.7573.9373.763.76
2215762-21576277.70178.10
3207207-20720774.62175.01
4200160-20016072.08372.44
5192783-19278369.42669.78
6202438-20243872.90373.27
90min1240277-24027786.53084.922.5087.0285.422.50
2243915-24391587.84088.37
3236463-23646385.15685.67
4232986-23298683.90484.38
5227126-22712681.79482.26
6234078-23407884.29784.79
120min1259871-25987193.58691.362.4394.2291.992.44
2258141-25814192.96393.63
3257043-25704392.56893.22
4252494-25249490.93091.54
5242997-24299787.50988.11
6251573-25157390.59891.23
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1262569-26256994.55893.402.3895.3594.182.39
2266633-26663396.02196.85
3260500-26050093.81394.62
4259007-25900793.27594.04
5248155-24815589.36790.12
6259202-25920293.34594.13
缬沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100651-202307对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.1对照品水分(%)0对照品稀释倍数100
标示量(mg)160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%
115.504651422465711946608004665145466907346607120.15
215.614683132468769646854140.07
单位质量响应值RSD%判断
300691.10300154.640.13数据可信
供试品溶液-1批-缬沙坦-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%
5min11399317-139931725.96427.524.2425.9627.524.24
21571606-157160629.16129.16
31537580-153758028.53028.53
41441386-144138626.74526.75
51469695-146969527.27027.27
61479217-147921727.44727.45
10min12273810-227381042.19142.673.2342.2342.713.23
22410434-241043444.72644.77
32371964-237196444.01244.06
42230011-223001141.37841.42
52237459-223745941.51641.56
62273854-227385442.19242.24
15min12790012-279001251.76951.863.4551.8851.983.46
22916040-291604054.10754.23
32901332-290133253.83553.96
42701607-270160750.12950.24
52688691-268869149.88950.00
62773361-277336151.46051.58
20min13159262-315926258.62058.433.0758.8258.633.07
23277356-327735660.81261.03
33239396-323939660.10760.32
43068659-306865956.93957.14
53029268-302926856.20856.41
63118786-311878657.86958.07
30min13679769-367976968.27967.692.9268.5868.002.92
23791972-379197270.36070.68
33734079-373407969.28669.60
43567492-356749266.19566.49
53509791-350979165.12565.42
63606133-360613366.91267.21
45min14199664-419966477.92577.062.8478.3477.482.84
24309452-430945279.96280.39
34233587-423358778.55578.98
44096150-409615076.00576.41
53979128-397912873.83374.23
64101280-410128076.10076.51
60min14529824-452982484.05182.952.6584.5983.492.65
24625818-462581885.83386.40
34532260-453226084.09784.65
44433060-443306082.25682.78
54285761-428576179.52380.05
64415208-441520881.92582.46
90min14903451-490345190.98489.692.2991.6790.372.29
24965963-496596392.14492.85
34880654-488065490.56191.26
44814386-481438689.33190.00
54649069-464906986.26486.92
64787700-478770088.83689.51
120min15096642-509664294.56993.032.2195.4093.862.21
25119461-511946194.99295.85
35076294-507629494.19195.04
45009562-500956292.95393.77
54826017-482601789.54790.35
64952926-495292691.90292.72
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限15153607-515360795.62695.022.7396.6296.012.72
25332882-533288298.95299.97
35129884-512988495.18696.19
45091073-509107394.46595.44
54897060-489706090.86591.81
65121618-512161895.03296.01
缬沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
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2000
标示量(mg)5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.112510412522162519672520142517542517980.19
214.042497472494682496080.08
单位质量响应值RSD%判断
17845.3617778.350.27数据可信
供试品溶液-3批-氨氯地平-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%
5min128008-2800810.1939.886.8610.199.886.89
227501-2750110.00910.01
323942-239428.7148.71
429041-2904110.56910.57
528347-2834710.31710.32
626060-260609.4849.48
10min165544-6554423.85422.754.5223.8722.774.51
262955-6295522.91222.93
357295-5729520.85220.87
464295-6429523.40023.42
562628-6262822.79322.81
662386-6238622.70522.72
15min191629-9162933.34832.454.1733.4032.504.17
291469-9146933.29033.34
383297-8329730.31630.36
492134-9213433.53233.59
590709-9070933.01333.07
685709-8570931.19331.25
20min1111944-11194440.74140.003.6840.8540.113.69
2112046-11204640.77940.89
3102521-10252137.31237.41
4113871-11387141.44341.56
5110666-11066640.27640.39
6108451-10845139.47039.58
30min1146261-14626153.23152.404.5453.4152.584.54
2147699-14769953.75453.93
3131284-13128447.78047.94
4149429-14942954.38454.57
5145726-14572653.03653.21
6143537-14353752.24052.41
45min1182894-18289466.56365.943.4666.8366.203.46
2184824-18482467.26667.53
3168886-16888661.46561.71
4186289-18628967.79968.07
5182882-18288266.55966.82
6181267-18126765.97166.23
60min1209286-20928676.16976.293.3276.5576.663.33
2214747-21474778.15678.54
3196397-19639771.47871.82
4215613-21561378.47178.86
5211846-21184677.10077.48
6209800-20980076.35676.72
90min1242182-24218288.14187.372.6388.6587.872.64
2247568-24756890.10190.61
3228591-22859183.19583.66
4239213-23921387.06087.58
5242455-24245588.24088.75
6240387-24038787.48887.98
120min1253923-25392392.41492.352.9693.0793.002.96
2259559-25955994.46595.13
3239358-23935887.11387.71
4259450-25945094.42695.09
5253839-25383992.38393.04
6256426-25642693.32593.97
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1257445-25744593.69694.802.3194.5095.602.32
2268148-26814897.59198.41
3250665-25066591.22891.98
4263743-26374395.98896.81
5262758-26275895.62996.44
6260147-26014794.67995.48
缬沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100651-202307对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.1对照品水分(%)0对照品稀释倍数100
标示量(mg)160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%
115.504618460463932546380664645307464742846377170.25
215.614634444461892346266840.24
单位质量响应值RSD%判断
299207.55296392.310.67数据可信
供试品溶液-3批-缬沙坦-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%
5min11371644-137164425.67625.423.7625.6825.423.77
21349997-134999725.27125.27
31307162-130716224.46924.47
41372258-137225825.68725.69
51442695-144269527.00627.01
61305350-130535024.43524.43
10min12271396-227139642.51842.352.6042.5642.402.59
22362956-236295644.23244.27
32230292-223029241.74941.79
42279796-227979642.67542.72
52241723-224172341.96342.01
62189505-218950540.98541.03
15min12796126-279612652.34152.141.3652.4552.261.36
22803437-280343752.47752.59
32783196-278319652.09852.21
42827585-282758552.92953.04
52788134-278813452.19152.31
62715233-271523350.82650.94
20min13134187-313418758.66959.031.4158.8759.241.41
23172918-317291859.39459.60
33170612-317061259.35159.55
43209415-320941560.07760.28
53156931-315693159.09459.30
63078383-307838357.62457.82
30min13740282-374028270.01469.381.2970.3169.681.29
23725771-372577169.74270.04
33705390-370539069.36169.66
43753607-375360770.26470.57
53692749-369274969.12469.42
63620339-362033967.76968.06
45min14203367-420336778.68379.151.0779.1079.561.08
24264495-426449579.82780.25
34242183-424218379.40979.82
44276696-427669680.05580.47
54230840-423084079.19779.61
64152517-415251777.73178.13
60min14517949-451794984.57185.401.0985.1285.951.09
24602531-460253186.15586.71
34583790-458379085.80486.35
44618602-461860286.45587.01
54560615-456061585.37085.92
64491214-449121484.07184.60
90min14889200-488920091.52192.231.0392.2192.921.03
24974605-497460593.11993.81
34980104-498010493.22293.91
44956006-495600692.77193.47
54908624-490862491.88492.57
64855606-485560690.89291.56
120min15034517-503451794.24194.840.8095.0895.680.80
25110897-511089795.67196.52
35065795-506579594.82695.67
45118743-511874395.81796.67
55047955-504795594.49295.34
65021784-502178494.00294.83
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限15121507-512150795.86996.070.9996.8797.080.99
25202073-520207397.37798.39
35138806-513880696.19397.19
45163429-516342996.65497.67
55117015-511701595.78596.79
65051759-505175994.56495.54
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