培哚普利吲达帕胺片项目信息
介质体积(ml)1000取样体积(ml)2补液体积(ml)2
对照品批号x1252对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数1000
标示量(mg)10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%
110.333105353110983114773108543117773111480.16
210.223122643106303114470.38
单位质量响应值RSD%判断
30120.8130474.270.83数据可信
稳定性考察-长期36月-供试品溶液-1批-成分1-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min182311-8231127.16840.3037.7527.1740.3037.75
2162509-16250953.64053.64
3195840-19584064.64164.64
4101820-10182033.60833.61
5101841-10184133.61533.61
688279-8827929.13829.14
10min1215139-21513971.01183.9010.8071.0783.9810.81
2276005-27600591.10191.21
3277073-27707391.45491.58
4279526-27952692.26392.33
5246427-24642781.33881.41
6231002-23100276.24776.31
15min1276689-27668991.32794.782.3291.5295.032.34
2286687-28668794.62794.92
3288863-28886395.34595.66
4297094-29709498.06298.31
5289019-28901995.39795.63
6284554-28455493.92394.13
20min1288123-28812395.10197.321.9595.4897.761.94
2288683-28868395.28695.76
3293127-29312796.75397.26
4301053-30105399.36999.82
5300445-30044599.16899.59
6297651-29765198.24698.64
30min1296155-29615597.75298.762.1698.3299.402.13
2289705-28970595.62396.29
3295359-29535997.48998.19
4303752-303752100.260100.91
5304268-304268100.430101.05
6306069-306069101.025101.62
45min1300856-30085699.30499.492.28100.07100.322.24
2290214-29021495.79196.65
3297015-29701598.03698.93
4305306-305306100.773101.62
5307963-307963101.650102.47
6307081-307081101.359102.16
60min1300223-30022399.09599.312.68100.06100.342.63
2287461-28746194.88395.93
3296466-29646697.85598.94
4304656-304656100.558101.61
5307880-307880101.622102.65
6308594-308594101.858102.86
90min1303047-303047100.02799.902.57101.19101.122.53
2289992-28999295.71896.96
3297211-29721198.10199.38
4306327-306327101.110102.36
5309473-309473102.148103.37
6309861-309861102.276103.48
120min1302241-30224199.76199.194.00101.12100.623.93
2277856-27785691.71293.15
3297428-29742898.17299.65
4307416-307416101.469102.92
5309074-309074102.016103.45
6309028-309028102.001103.41
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1300996-30099699.35099.342.65100.91100.962.61
2287811-28781194.99896.61
3295750-29575097.61999.29
4305134-305134100.716102.37
5307693-307693101.561103.20
6308335-308335101.772103.38
培哚普利吲达帕胺片项目信息
介质体积(ml)1000取样体积(ml)2补液体积(ml)2
对照品批号S2561对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数1000
标示量(mg)25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%
125.225548555585615572295581165571025571730.26
225.335567835559025563420.12
单位质量响应值RSD%判断
22092.5121963.760.42数据可信
稳定性考察-长期36月-供试品溶液-1批-成分2-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min127421-274214.9798.2646.664.988.2646.66
260766-6076611.03411.03
381403-8140314.78214.78
435526-355266.4516.45
538394-383946.9726.97
629537-295375.3645.36
10min1123220-12322022.37529.5525.3722.3929.5725.37
2177109-17710932.16132.18
3224305-22430540.73140.76
4190582-19058234.60734.62
5138264-13826425.10725.12
6122899-12289922.31722.33
15min1227009-22700941.22246.3114.5041.2846.3914.52
2268749-26874948.80148.89
3299797-29979754.43954.55
4293427-29342753.28353.36
5223609-22360940.60540.67
6217665-21766539.52539.58
20min1284624-28462451.68456.669.6051.8256.839.63
2322410-32241058.54658.73
3347903-34790363.17563.39
4343630-34363062.39962.59
5280922-28092251.01251.16
6292743-29274353.15853.29
30min1370376-37037667.25666.517.8067.5066.797.80
2374842-37484268.06768.37
3376358-37635868.34268.69
4395552-39555271.82772.14
5311316-31131656.53156.78
6369111-36911167.02667.27
45min1430927-43092778.25176.174.9678.6376.584.96
2417211-41721175.76076.20
3434240-43424078.85379.34
4428063-42806377.73178.19
5378691-37869168.76669.13
6427615-42761577.65078.02
60min1472075-47207585.72380.935.5986.2581.505.56
2424059-42405977.00477.59
3453965-45396582.43483.08
4452072-45207282.09182.70
5407399-40739973.97974.48
6464573-46457384.36184.89
90min1514798-51479893.48186.696.0494.1887.426.00
2461599-46159983.82184.56
3477834-47783486.76987.57
4474598-47459886.18186.96
5433786-43378678.77079.42
6501713-50171391.10591.80
120min1543212-54321298.64186.5411.6299.5387.4411.51
2394938-39493871.71672.63
3489335-48933588.85789.84
4482984-48298487.70488.65
5429768-42976878.04178.84
6519169-51916994.27595.16
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1576504-576504104.68697.685.65105.7798.765.60
2496931-49693190.23691.29
3529297-52929796.11497.27
4531207-53120796.46197.59
5522710-52271094.91895.88
6570858-570858103.661104.73
培哚普利吲达帕胺片项目信息
介质体积(ml)1000取样体积(ml)2补液体积(ml)2
对照品批号x1252对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数1000
标示量(mg)10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%
110.333223213227683230573229093232113228530.11
210.223251253248353249800.07
单位质量响应值RSD%判断
31253.9231798.431.23数据可信
稳定性考察-长期36月-供试品溶液-1批-成分1-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1183653-18365358.25854.8130.8658.2654.8230.86
2115118-11511836.51836.52
3231028-23102873.28773.29
4123410-12341039.14839.15
5237709-23770975.40675.41
6145821-14582146.25746.26
10min1292635-29263592.83094.953.6492.9595.063.65
2311928-31192898.95099.02
3306384-30638497.19197.34
4285515-28551590.57190.65
5308346-30834697.81497.96
6291156-29115692.36192.45
15min1300677-30067795.38197.841.9895.6898.141.99
2313560-31356099.46899.74
3310962-31096298.64398.98
4310028-31002898.34798.61
5314362-31436299.722100.07
6301007-30100795.48695.76
20min1301609-30160995.67798.291.8296.1798.781.82
2313422-31342299.42499.89
3311774-31177498.90199.44
4314416-31441699.739100.20
5313990-31399099.604100.15
6303877-30387796.39696.86
30min1304555-30455596.61198.671.5797.3099.371.57
2312744-31274499.20999.88
3310038-31003898.35099.09
4316623-316623100.439101.09
5315748-315748100.162100.91
6306622-30662297.26797.93
45min1304973-30497396.74499.041.5997.6299.931.59
2314173-31417399.662100.53
3311543-31154398.82899.76
4317905-317905100.846101.70
5316484-316484100.395101.34
6308250-30825097.78398.64
60min1304191-30419196.49698.921.6197.57100.011.60
2313470-31347099.439100.51
3311905-31190598.943100.07
4318207-318207100.942102.00
5315004-31500499.926101.07
6308245-30824597.78298.83
90min1305570-30557096.93399.271.4598.20100.561.44
2314275-31427599.694100.96
3311922-31192298.948100.28
4318817-318817101.135102.40
5315803-315803100.179101.53
6311294-31129498.749100.00
120min1302793-30279396.05298.861.6397.51100.351.62
2312428-31242899.109100.57
3310887-31088798.620100.15
4316775-316775100.487101.95
5316258-316258100.323101.87
6310818-31081898.598100.04
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1302716-30271696.02898.561.5397.68100.241.52
2312570-31257099.154100.82
3309473-30947398.17199.89
4316047-316047100.257101.92
5314290-31429099.699101.45
6309124-30912498.06099.70
培哚普利吲达帕胺片项目信息
介质体积(ml)1000取样体积(ml)2补液体积(ml)2
对照品批号S2561对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数1000
标示量(mg)25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%
125.225936265931655930915934295929355932490.05
225.335929035940405934720.14
单位质量响应值RSD%判断
23522.9623429.610.29数据可信
稳定性考察-长期36月-供试品溶液-1批-成分2-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min176479-7647913.03110.7431.0313.0310.7331.03
237490-374906.3886.39
379672-7967213.57513.57
448666-486668.2928.29
584411-8441114.38214.38
651309-513098.7428.74
10min1221430-22143037.72835.4916.3637.7535.5116.35
2260386-26038644.36644.38
3203267-20326734.63434.66
4174656-17465629.75929.78
5221528-22152837.74537.77
6168484-16848428.70728.72
15min1310429-31042952.89350.1112.3252.9950.2012.32
2339376-33937657.82557.93
3295622-29562250.37050.47
4283933-28393348.37848.45
5304565-30456551.89352.00
6230647-23064739.29939.37
20min1365612-36561262.29559.6511.7262.5059.8411.72
2394656-39465667.24467.46
3352686-35268660.09360.29
4339880-33988057.91158.08
5372220-37222063.42163.63
6275357-27535746.91747.07
30min1422494-42249471.98767.949.5472.3268.269.54
2412051-41205170.20770.56
3382399-38239965.15565.47
4417398-41739871.11971.41
5429642-42964273.20573.54
6328646-32864655.99656.24
45min1461165-46116578.57677.2510.0079.0577.6910.00
2483004-48300482.29782.79
3456359-45635977.75778.20
4476647-47664781.21481.64
5479549-47954981.70882.19
6363428-36342861.92362.28
60min1479528-47952881.70580.789.6482.3481.389.64
2485885-48588582.78883.44
3471731-47173180.37680.98
4513394-51339487.47588.07
5507319-50731986.44087.08
6386828-38682865.91066.39
90min1516560-51656088.01486.299.6188.8187.059.61
2527000-52700089.79390.62
3502465-50246585.61386.38
4545949-54594993.02293.79
5534697-53469791.10591.92
6411920-41192070.18570.80
120min1509027-50902786.73188.0410.2587.7088.9810.24
2545895-54589593.01394.01
3512159-51215987.26488.20
4568006-56800696.78097.73
5546331-54633193.08794.09
6418848-41884871.36672.12
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1584347-58434799.56498.474.78100.7199.584.81
2574617-57461797.90699.09
3554988-55498894.56295.67
4606355-606355103.314104.46
5608044-608044103.602104.79
6539059-53905991.84892.75
培哚普利吲达帕胺片项目信息
介质体积(ml)1000取样体积(ml)2补液体积(ml)2
对照品批号x1252对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数1000
标示量(mg)10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%
110.333223163226633227183231553216643225030.18
210.223214443221513217980.16
单位质量响应值RSD%判断
31220.0431487.080.61数据可信
稳定性考察-长期36月-供试品溶液-2批-成分1-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%
5min1210648-21064867.18628.5366.4567.1928.5366.46
262905-6290520.06320.06
363654-6365420.30220.30
467665-6766521.58221.58
568992-6899222.00522.00
662830-6283020.04020.04
10min1295938-29593894.38972.1816.2994.5272.2416.33
2224806-22480671.70271.74
3188369-18836960.08060.12
4226643-22664372.28872.33
5215443-21544368.71568.76
6206709-20670965.93065.97
15min1304113-30411396.99692.502.8297.3292.702.87
2289645-28964592.38292.57
3286238-28623891.29591.46
4280476-28047689.45789.65
5293582-29358293.63893.82
6285944-28594491.20291.37
20min1304484-30448497.11596.760.7797.6397.150.78
2305057-30505797.29897.67
3304428-30442897.09797.44
4299064-29906495.38695.75
5304816-30481697.22197.59
6302374-30237496.44296.80
30min1305300-30530097.37598.300.7898.0998.880.74
2309328-30932898.66099.22
3308040-30804098.24998.79
4305931-30593197.57698.13
5308593-30859398.42598.99
6311921-31192199.487100.03
45min1305568-30556897.46199.251.1998.37100.021.14
2310973-31097399.18499.94
3310848-31084899.14599.88
4309341-30934198.66499.42
5314152-314152100.198100.96
6316114-316114100.824101.57
60min1305091-30509197.30899.201.4798.41100.181.42
2311023-31102399.200100.16
3310913-31091399.165100.10
4306887-30688797.88198.83
5316132-316132100.830101.79
6316076-316076100.812101.76
90min1304307-30430797.05899.011.5798.35100.181.52
2309379-30937998.67699.83
3309514-30951498.71999.85
4307022-30702297.92499.07
5315533-315533100.639101.80
6316847-316847101.058102.21
120min1302725-30272596.55498.571.5398.0499.941.48
2308923-30892398.53199.88
3308502-30850298.39699.72
4305336-30533697.38798.73
5314654-314654100.359101.72
6314082-314082100.176101.53
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1302825-30282596.58698.291.5698.2799.861.52
2308423-30842398.37199.92
3307280-30728098.00799.53
4303167-30316796.69598.23
5313345-31334599.941101.51
6314018-314018100.156101.71
培哚普利吲达帕胺片项目信息
介质体积(ml)1000取样体积(ml)2补液体积(ml)2
对照品批号S2561对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数1000
标示量(mg)25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%
125.226019816020536028066010486017336019240.11
225.336015676003936009800.14
单位质量响应值RSD%判断
23866.9323726.020.42数据可信
稳定性考察-长期36月-供试品溶液-2批-成分2-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%
5min177347-7734713.0025.4368.6313.005.4368.59
222893-228933.8483.85
320787-207873.4943.49
425973-259734.3664.37
524245-242454.0754.08
622425-224253.7693.77
10min1213203-21320335.83820.3339.1235.8620.3439.13
2118818-11881819.97319.98
381897-8189713.76613.77
4117532-11753219.75619.77
598061-9806116.48316.49
696168-9616816.16516.17
15min1296767-29676749.88537.5217.2849.9837.5817.31
2230043-23004338.66938.72
3193423-19342332.51332.55
4217074-21707436.48936.54
5195349-19534932.83732.88
6206662-20666234.73934.78
20min1355651-35565159.78350.1110.5459.9850.2310.59
2307008-30700851.60651.73
3280818-28081847.20447.30
4293548-29354849.34449.46
5265175-26517544.57444.68
6286312-28631248.12748.24
30min1413501-41350169.50765.413.2469.8265.633.30
2390569-39056965.65265.88
3378356-37835663.59963.79
4383202-38320264.41464.63
5383321-38332164.43464.63
6385747-38574764.84265.05
45min1456647-45664776.75975.623.2977.2275.983.29
2454302-45430276.36576.72
3452255-45225576.02176.34
4451297-45129775.86076.21
5421111-42111170.78671.11
6463657-46365777.93878.27
60min1479921-47992180.67281.893.5781.2882.403.54
2493056-49305682.88083.39
3487822-48782282.00082.47
4495450-49545083.28283.78
5457734-45773476.94277.41
6509117-50911785.57986.07
90min1498141-49814183.73487.273.9684.5187.943.92
2519946-51994687.40088.08
3522920-52292087.90088.54
4533454-53345489.67090.34
5493325-49332582.92583.55
6547152-54715291.97392.64
120min1510914-51091485.88191.174.8886.8292.024.82
2541409-54140991.00791.86
3550640-55064092.55993.37
4559018-55901893.96794.81
5513570-51357086.32887.11
6578820-57882097.29698.14
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1562347-56234794.52798.293.6395.6499.323.57
2561151-56115194.32695.36
3607905-607905102.185103.18
4583848-58384898.14199.18
5582933-58293397.98798.95
6610074-610074102.550103.59
培哚普利吲达帕胺片项目信息
介质体积(ml)1000取样体积(ml)2补液体积(ml)2
对照品批号x1252对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数1000
标示量(mg)10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%
110.333213843230973229483225933230353226110.23
210.223219193217073218130.05
单位质量响应值RSD%判断
31230.4931488.550.59数据可信
稳定性考察-长期36月-供试品溶液-2批-成分1-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%
5min154893-5489317.50530.2441.4617.5030.2441.46
2132366-13236642.21042.21
369125-6912522.04322.04
4150937-15093748.13248.13
596980-9698030.92630.93
664680-6468020.62620.63
10min1179216-17921657.15075.5415.2657.1875.6015.28
2256604-25660481.82881.91
3209268-20926866.73366.78
4272905-27290587.02687.12
5264313-26431384.28684.35
6239061-23906176.23476.27
15min1255744-25574481.55488.666.2381.7088.876.27
2285239-28523990.95991.21
3260264-26026482.99583.17
4295154-29515494.12194.39
5296309-29630994.48994.72
6275473-27547387.84588.04
20min1285286-28528690.97494.332.4991.2994.722.53
2297747-29774794.94895.38
3292700-29270093.33893.68
4303119-30311996.66197.12
5304437-30443797.08197.50
6291506-29150692.95893.33
30min1303867-30386796.89997.890.8397.3998.460.83
2306527-30652797.74898.37
3311247-31124799.25399.78
4307711-30771198.12598.78
5307189-30718997.95998.57
6305239-30523997.33797.89
45min1309404-30940498.66598.801.1299.3599.581.08
2308326-30832698.32199.14
3316399-316399100.896101.62
4309031-30903198.54699.39
5306211-30621197.64798.46
6309638-30963898.74099.49
60min1309708-30970898.76298.981.3299.6599.961.28
2308996-30899698.53599.55
3317906-317906101.376102.31
4309388-30938898.66099.71
5305591-30559197.44998.45
6310842-31084299.124100.07
90min1309654-30965498.74598.771.2499.8399.941.20
2309077-30907798.56199.77
3316701-316701100.992102.13
4308581-30858198.40399.65
5305010-30501097.26498.46
6309311-30931198.63699.78
120min1311106-31110699.20898.721.18100.49100.091.13
2307738-30773898.13499.54
3315529-315529100.618101.95
4309466-30946698.685100.12
5304621-30462197.14098.53
6309066-30906698.55799.90
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1309832-30983298.80298.321.28100.2899.881.23
2305310-30531097.36098.96
3314414-314414100.263101.80
4308839-30883998.485100.12
5303032-30303296.63398.22
6308533-30853398.38799.93
培哚普利吲达帕胺片项目信息
介质体积(ml)1000取样体积(ml)2补液体积(ml)2
对照品批号S2561对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数1000
标示量(mg)25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%
125.226038436012706012966041466047036030520.28
225.336023936001086012500.27
单位质量响应值RSD%判断
23911.6623736.680.52数据可信
稳定性考察-长期36月-供试品溶液-2批-成分2-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%
5min118240-182403.0625.8337.173.065.8337.16
244606-446067.4897.49
330953-309535.1975.20
453248-532488.9408.94
536598-365986.1456.14
624631-246314.1364.14
10min193613-9361315.71823.6021.2415.7223.6121.26
2161567-16156727.12727.14
3125452-12545221.06321.07
4173416-17341629.11629.13
5160055-16005526.87326.89
6129403-12940321.72721.73
15min1190521-19052131.98838.7711.9432.0338.8311.95
2249331-24933141.86241.93
3210178-21017835.28935.34
4259190-25919043.51843.59
5253813-25381342.61542.68
6222434-22243437.34637.40
20min1269435-26943545.23849.597.5645.3449.727.58
2306355-30635551.43751.59
3274877-27487746.15246.27
4314086-31408652.73552.90
5323506-32350654.31654.47
6283845-28384547.65747.78
30min1361231-36123160.65062.115.4160.8462.355.42
2372700-37270062.57662.83
3346674-34667458.20658.42
4376584-37658463.22863.50
5404388-40438867.89668.16
6358048-35804860.11660.34
45min1430809-43080972.33271.574.6972.6571.934.69
2422914-42291471.00771.39
3400294-40029467.20967.54
4422140-42214070.87771.27
5461346-46134677.46077.86
6420040-42004070.52470.87
60min1474745-47474579.70977.004.7880.1777.514.77
2448084-44808475.23375.76
3432332-43233272.58873.05
4444171-44417174.57675.11
5492226-49222682.64483.19
6460274-46027477.28077.76
90min1531599-53159989.25582.445.8389.8783.105.79
2473240-47324079.45780.13
3460766-46076677.36277.97
4473353-47335379.47580.16
5520659-52065987.41888.13
6486605-48660581.70082.34
120min1567464-56746495.27786.106.4496.0786.926.39
2489531-48953182.19283.02
3480275-48027580.63881.40
4495808-49580883.24684.09
5536130-53613090.01690.91
6507485-50748585.20686.01
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1597844-597844100.37794.863.41101.3695.853.36
2550627-55062792.45093.45
3573913-57391396.35997.29
4543642-54364291.27792.29
5563753-56375394.65495.72
6560050-56005094.03295.00
培哚普利吲达帕胺片项目信息
介质体积(ml)1000取样体积(ml)2补液体积(ml)2
对照品批号x1252对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数1000
标示量(mg)10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%
110.333058653060743060123061213059023059950.04
210.223064763065783065270.03
单位质量响应值RSD%判断
29621.9729992.860.88数据可信
稳定性考察-长期36月-供试品溶液-3批-成分1-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%
5min168220-6822022.88840.7846.2822.8940.7846.27
2176083-17608359.07659.08
386901-8690129.15529.16
4180455-18045560.54360.54
5158882-15888253.30553.30
658804-5880419.72919.73
10min1235917-23591779.15085.5916.5079.2085.6816.52
2286734-28673496.19996.32
3277295-27729593.03293.09
4283684-28368495.17695.30
5269320-26932090.35790.46
6177780-17778059.64559.68
15min1281870-28187094.56797.143.0294.7797.393.06
2298159-298159100.032100.34
3295322-29532299.08199.32
4297337-29733799.757100.07
5287160-28716096.34296.63
6277412-27741293.07293.23
20min1293581-29358198.49699.571.6598.89100.011.69
2302731-302731101.566102.08
3297321-29732199.751100.19
4302306-302306101.424101.93
5290992-29099297.62898.11
6293683-29368398.53198.88
30min1296801-29680199.577100.201.28100.17100.851.28
2303525-303525101.833102.55
3297637-29763799.857100.50
4300982-300982100.979101.69
5292671-29267198.19198.87
6300353-300353100.768101.31
45min1298433-298433100.124100.561.05100.91101.411.05
2303558-303558101.844102.76
3298404-298404100.115100.96
4301122-301122101.026101.94
5294860-29486098.92699.80
6302085-302085101.350102.09
60min1298703-298703100.215100.441.23101.20101.491.21
2302398-302398101.455102.58
3298407-298407100.116101.16
4301216-301216101.058102.18
5292875-29287598.26099.33
6302643-302643101.537102.48
90min1296908-29690899.613100.041.27100.80101.291.24
2301368-301368101.109102.43
3296900-29690099.610100.85
4299028-299028100.324101.64
5292169-29216998.02399.29
6302712-302712101.560102.71
120min1295977-29597799.30099.871.15100.69101.311.14
2301123-301123101.027102.55
3296641-29664199.523100.96
4299085-299085100.343101.86
5292209-29220998.03699.50
6300933-300933100.963102.32
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1294729-29472998.88299.561.31100.47101.211.30
2300499-300499100.817102.55
3295653-29565399.192100.83
4297647-29764799.861101.58
5290806-29080697.56599.22
6301202-301202101.053102.61
培哚普利吲达帕胺片项目信息
介质体积(ml)1000取样体积(ml)2补液体积(ml)2
对照品批号S2561对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数1000
标示量(mg)25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%
125.225580185582005593655579185576785582360.12
225.335585345583495584420.03
单位质量响应值RSD%判断
22134.6622046.660.29数据可信
稳定性考察-长期36月-供试品溶液-3批-成分2-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%
5min127518-275184.9837.9441.744.987.9441.73
253441-534419.6779.68
338998-389987.0617.06
462422-6242211.30311.30
561810-6181011.19211.19
618871-188713.4173.42
10min1131447-13144723.80127.7025.4823.8127.7225.49
2179055-17905532.42232.44
3150808-15080827.30727.32
4192101-19210134.78434.81
5177349-17734932.11332.14
687235-8723515.79615.80
15min1234548-23454842.47044.4611.7942.5344.5311.81
2262328-26232847.50047.58
3248082-24808244.92144.99
4277222-27722250.19750.29
5256873-25687346.51346.60
6194125-19412535.15135.19
20min1303577-30357754.97055.706.8255.1155.866.85
2317707-31770757.52857.71
3308713-30871355.90056.06
4336048-33604860.84961.04
5307682-30768255.71355.89
6272024-27202449.25649.36
30min1382141-38214169.19567.983.7669.4568.253.78
2375988-37598868.08168.38
3369432-36943266.89467.16
4399446-39944672.32972.64
5365610-36561066.20266.49
6360041-36004165.19465.40
45min1449628-44962881.41577.783.8681.8178.193.84
2419472-41947275.95576.39
3421734-42173476.36576.77
4448147-44814781.14781.61
5408152-40815273.90574.33
6430265-43026577.90978.25
60min1494950-49495089.62283.525.0590.1884.085.01
2442910-44291080.19980.78
3448986-44898681.29981.86
4475431-47543186.08886.71
5433416-43341678.48079.05
6471826-47182685.43585.93
90min1534780-53478096.83489.055.9497.5789.785.89
2464409-46440984.09284.83
3473605-47360585.75786.48
4499734-49973490.48891.28
5464037-46403784.02484.75
6514183-51418393.10593.77
120min1557724-557724100.98992.426.20101.9293.336.14
2481080-48108087.11088.02
3491083-49108388.92289.81
4515018-51501893.25694.23
5481463-48146387.18088.08
6536203-53620397.09297.94
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1568585-568585102.95598.273.40104.0899.373.37
2528303-52830395.66196.75
3528369-52836995.67396.74
4539509-53950997.69098.85
5528736-52873695.74096.81
6562875-562875101.921102.97
培哚普利吲达帕胺片项目信息
介质体积(ml)1000取样体积(ml)2补液体积(ml)2
对照品批号x1252对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数1000
标示量(mg)10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%
110.333176043176343187383194403192933185420.28
210.223173793173433173610.01
单位质量响应值RSD%判断
30836.5931052.940.50数据可信
稳定性考察-长期36月-供试品溶液-3批-成分1-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%
5min158287-5828718.83633.6548.6218.8433.6548.62
2144964-14496446.84746.85
3160050-16005051.72251.72
454842-5484217.72317.72
561549-6154919.89019.89
6145066-14506646.88046.88
10min1193224-19322462.44275.5719.0862.4875.6419.11
2282130-28213091.17391.27
3279226-27922690.23590.34
4189923-18992361.37661.41
5198137-19813764.03064.07
6260400-26040084.15184.24
15min1280910-28091090.77992.534.4090.9492.744.45
2302712-30271297.82598.10
3298470-29847096.45496.74
4268126-26812686.64886.81
5282491-28249191.29091.46
6285188-28518892.16192.42
20min1306018-30601898.89397.681.6899.2498.081.69
2307678-30767899.42999.90
3303132-30313297.96098.44
4296104-29610495.68996.02
5304745-30474598.48298.83
6295914-29591495.62896.07
30min1313042-313042101.16399.621.52101.70100.221.46
2309413-30941399.990100.66
3302945-30294597.90098.57
4311695-311695100.727101.25
5310608-310608100.376100.92
6301945-30194597.57798.21
45min1315384-315384101.920100.391.45102.66101.181.38
2309332-30933299.964100.83
3304218-30421898.31199.18
4315708-315708102.024102.75
5311606-311606100.699101.45
6307600-30760099.404100.24
60min1315250-315250101.876100.541.15102.82101.531.09
2310877-310877100.463101.53
3305420-30542098.70099.76
4314037-314037101.484102.41
5312118-312118100.864101.81
6308946-30894699.839100.87
90min1315729-315729102.031100.721.10103.18101.921.03
2310486-310486100.337101.61
3306121-30612198.926100.19
4314649-314649101.682102.81
5311824-311824100.769101.92
6311200-311200100.568101.80
120min1315541-315541101.97099.991.63103.33101.391.56
2303588-30358898.10899.58
3303547-30354798.09499.55
4313937-313937101.452102.79
5310036-310036100.191101.54
6309797-309797100.114101.55
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1312945-312945101.131100.171.25102.69101.771.20
2308978-30897899.849101.52
3303386-30338698.04299.70
4313414-313414101.283102.82
5308425-30842599.671101.22
6312622-312622101.027102.66
培哚普利吲达帕胺片项目信息
介质体积(ml)1000取样体积(ml)2补液体积(ml)2
对照品批号S2561对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数1000
标示量(mg)25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%
125.225967335973505967465959125971665967810.10
225.335951385935345943360.20
单位质量响应值RSD%判断
23663.0123463.720.60数据可信
稳定性考察-长期36月-供试品溶液-3批-成分2-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%
5min119827-198273.3666.9357.833.376.9357.83
256610-566109.6109.61
360049-6004910.19410.19
417987-179873.0533.05
521088-210883.5803.58
669387-6938711.77911.78
10min193916-9391615.94323.4336.1515.9523.4436.16
2189310-18931032.13732.16
3194657-19465733.04533.06
492807-9280715.75515.76
593748-9374815.91415.92
6163549-16354927.76427.79
15min1205055-20505534.81039.7115.9134.8539.7715.94
2284111-28411148.23048.31
3277114-27711447.04247.13
4205845-20584534.94434.98
5204457-20445734.70834.75
6226873-22687338.51438.59
20min1288050-28805048.89951.2610.7349.0151.4010.75
2347580-34758059.00559.18
3334962-33496256.86357.04
4287046-28704648.72848.84
5291451-29145149.47649.58
6262583-26258344.57644.73
30min1380371-38037164.57163.9710.7264.7864.2210.70
2420615-42061571.40371.70
3400176-40017667.93368.23
4372911-37291163.30563.51
5384919-38491965.34365.55
6302044-30204451.27451.52
45min1452381-45238176.79573.8211.8477.1374.1911.81
2473191-47319180.32880.77
3449370-44937076.28476.71
4443743-44374375.32975.66
5458542-45854277.84178.18
6331785-33178556.32356.67
60min1499732-49973284.83479.6812.7285.3280.2012.67
2506335-50633585.95486.56
3476630-47663080.91281.49
4481951-48195181.81582.30
5501633-50163385.15685.65
6349881-34988159.39559.86
90min1546616-54661692.79285.6513.1193.4586.3313.06
2537331-53733191.21691.99
3502601-50260185.32186.07
4518465-51846588.01488.66
5547852-54785293.00293.67
6374380-37438063.55464.13
120min1571986-57198697.09988.2013.1297.9489.0513.05
2515761-51576187.55588.51
3518189-51818987.96788.88
4544355-54435592.40993.23
5576478-57647897.86298.71
6390734-39073466.33067.04
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1602008-602008102.19698.354.58103.2399.374.55
2573233-57323397.31198.44
3546913-54691392.84393.93
4603047-603047102.372103.38
5601064-601064102.035103.08
6549828-54982893.33894.18
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