培哚普利叔丁胺片项目信息
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1000
标示量(mg)8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%
110.524478364479824476904479174478214478490.03
210.384466154461444463800.08
单位质量响应值RSD%判断
42571.2043003.850.72数据可信
供试品溶液-2025072412批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1126585-12658533.21761.8135.5233.2261.8135.52
2294441-29444177.26477.26
3270992-27099271.11071.11
4155104-15510440.70140.70
5343957-34395790.25790.26
6222275-22227558.32758.33
10min1349756-34975691.77992.174.2791.8392.274.29
2355068-35506893.17393.30
3351947-35194792.35492.47
4323210-32321084.81384.88
5365357-36535795.87396.02
6362075-36207595.01195.11
15min1371189-37118997.40396.131.5597.6196.381.55
2363888-36388895.48795.77
3363348-36334895.34595.62
4358030-35803093.95094.16
5368119-36811996.59796.91
6373366-37336697.97498.23
20min1374748-37474898.33797.390.8598.7197.810.83
2372294-37229497.69398.14
3370660-37066097.26497.70
4367610-36761096.46496.83
5367525-36752596.44196.91
6374061-37406198.15798.58
30min1379423-37942399.56498.131.18100.1098.711.14
2372323-37232397.70198.31
3372811-37281197.82998.42
4377342-37734299.01899.54
5366883-36688396.27396.90
6375063-37506398.42099.00
极限1378829-37882999.40898.791.25100.1199.541.21
2377418-37741899.03799.81
3378347-37834799.281100.04
4379733-37973399.645100.34
5367099-36709996.33097.12
6377500-37750099.05999.81
培哚普利叔丁胺片项目信息
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1000
标示量(mg)8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%
110.524470834456794461644459324456034460920.14
210.384437534431054434290.11
单位质量响应值RSD%判断
42404.1842719.560.53数据可信
供试品溶液-2025072412批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1105548-10554827.84367.6632.8127.8467.6632.81
2290579-29057976.65476.65
3211885-21188555.89455.89
4306050-30605080.73580.73
5331715-33171587.50587.51
6293151-29315177.33277.33
10min1319411-31941184.25992.875.2484.3192.985.27
2354747-35474793.58193.71
3342276-34227690.29190.38
4364588-36458896.17796.31
5364457-36445796.14296.29
6366778-36677896.75596.88
15min1349908-34990892.30496.452.1792.4996.722.21
2369191-36919197.39197.67
3366697-36669796.73396.98
4369808-36980897.55497.85
5366671-36667196.72697.03
6371428-37142897.98198.27
20min1362699-36269995.67997.361.5096.0297.781.52
2372812-37281298.34698.79
3367633-36763396.98097.39
4376247-37624799.25299.71
5363039-36303995.76896.24
6371905-37190598.10798.56
30min1367747-36774797.01097.361.1097.5197.951.10
2374336-37433698.74899.36
3369716-36971697.53098.10
4372497-37249798.26398.89
5363066-36306695.77596.40
6367027-36702796.82097.44
极限1372487-37248798.26197.971.0398.9298.721.02
2375398-37539899.02999.80
3368779-36877997.28298.01
4374627-37462798.82599.61
5365262-36526296.35597.14
6371675-37167598.04698.82
培哚普利叔丁胺片项目信息
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1000
标示量(mg)8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%
110.524465524460284461194456444466094461900.09
210.384447014437014442010.16
单位质量响应值RSD%判断
42413.5042793.930.64数据可信
供试品溶液-2025072512批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1252819-25281966.62851.8037.9766.6351.8037.97
2119045-11904531.37331.37
3299168-29916878.84278.84
4106849-10684928.15928.16
5195381-19538151.49051.49
6206059-20605954.30554.30
10min1345788-34578891.12892.235.0791.2492.325.07
2325347-32534785.74185.79
3363245-36324595.72995.86
4366987-36698796.71596.76
5333796-33379687.96888.05
6364726-36472696.11996.21
15min1356939-35693994.06796.102.8794.3396.342.87
2353446-35344693.14793.34
3373106-37310698.32898.62
4376236-37623699.15399.36
5355346-35534693.64793.88
6372933-37293398.28298.53
20min1365291-36529196.26897.441.8896.6997.841.88
2364332-36433296.01696.37
3370515-37051597.64598.10
4380558-380558100.292100.67
5362838-36283895.62296.01
6374929-37492998.80899.22
30min1368837-36883797.20398.371.0797.7898.941.06
2374657-37465798.73799.25
3373587-37358798.45599.07
4379893-379893100.116100.66
5369517-36951797.38297.93
6373159-37315998.34298.92
极限1371949-37194998.02398.630.8298.7799.360.78
2378122-37812299.650100.32
3373104-37310498.32799.11
4378147-37814799.656100.36
5372676-37267698.21598.92
6371593-37159397.92998.67
培哚普利叔丁胺片项目信息
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1000
标示量(mg)8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%
110.524451254456344450964455264456784454120.07
210.384442624444114443360.03
单位质量响应值RSD%判断
42339.5442806.940.78数据可信
供试品溶液-2025072512批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1206572-20657254.47956.4519.3354.4856.4519.33
2280871-28087174.07474.07
3209723-20972355.31055.31
4163566-16356643.13743.14
5238777-23877762.97362.97
6184775-18477548.73148.73
10min1344599-34459990.88191.492.5890.9791.582.60
2360746-36074695.14095.26
3345163-34516391.03091.12
4334594-33459488.24288.31
5352891-35289193.06893.17
6343478-34347890.58590.67
15min1370065-37006597.59797.181.1797.8497.431.19
2373485-37348598.49998.78
3371197-37119797.89698.14
4361544-36154495.35095.57
5369166-36916697.36097.62
6365528-36552896.40196.63
20min1378839-37883999.91198.660.82100.3299.070.82
2371536-37153697.98598.43
3376877-37687799.39499.80
4371359-37135997.93898.32
5373209-37320998.42698.85
6372692-37269298.29098.68
30min1379397-379397100.05898.790.71100.6399.360.70
2373101-37310198.39899.01
3375370-37537098.99699.57
4372143-37214398.14598.69
5372996-37299698.37098.96
6374526-37452698.77499.33
极限1379678-379678100.13298.890.80100.8799.630.78
2370986-37098697.84098.61
3375673-37567399.07699.81
4375733-37573399.09299.80
5372662-37266298.28299.03
6375125-37512598.93299.65
培哚普利叔丁胺片项目信息
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1000
标示量(mg)8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%
110.524441754434964435844424904437044434900.14
210.384439044436024437530.05
单位质量响应值RSD%判断
42156.8442750.770.99数据可信
供试品溶液-2025072612批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1200230-20023052.95651.3724.5952.9651.3824.59
2135655-13565535.87835.88
3206113-20611354.51254.51
4219671-21967158.09858.10
5142620-14262037.72037.72
6261205-26120569.08369.08
10min1315263-31526383.38085.7810.7883.4785.8610.80
2284200-28420075.16475.22
3318790-31879084.31384.40
4364892-36489296.50596.60
5295099-29509978.04778.11
6367783-36778397.27097.39
15min1339509-33950989.79291.766.4490.0291.986.46
2315299-31529983.38983.57
3348376-34837692.13792.37
4371651-37165198.29398.55
5334169-33416988.38088.57
6372647-37264798.55798.83
20min1352531-35253193.23694.364.3093.6194.744.33
2333407-33340788.17888.50
3358158-35815894.72595.11
4373308-37330898.73199.15
5349576-34957692.45592.80
6373610-37361098.81199.25
30min1361526-36152695.61597.202.1796.1597.742.20
2356246-35624694.21994.69
3373507-37350798.78499.33
4375657-37565799.35399.94
5364291-36429196.34796.84
6373871-37387198.88099.49
极限1370270-37027097.928100.371.5698.62101.061.52
2385088-385088101.847102.47
3382363-382363101.126101.83
4377696-37769699.892100.64
5385430-385430101.937102.59
6376093-37609399.468100.24
培哚普利叔丁胺片项目信息
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1000
标示量(mg)8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%
110.524445744449824460784445274446164449550.15
210.384415944422994419460.12
单位质量响应值RSD%判断
42296.1042576.690.47数据可信
供试品溶液-2025072612批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1202558-20255853.59243.3222.8853.5943.3222.88
2212870-21287056.32056.32
3134896-13489635.69035.69
4118343-11834331.31131.31
5149599-14959939.58039.58
6164212-16421243.44643.45
10min1333626-33362688.26985.576.6288.3685.646.61
2308472-30847281.61481.71
3347203-34720391.86191.92
4301157-30115779.67979.73
5303940-30394080.41580.48
6346182-34618291.59191.66
15min1355047-35504793.93793.104.1094.1793.314.09
2333218-33321888.16188.39
3368285-36828597.43997.65
4345051-34505191.29291.48
5341712-34171290.40990.61
6367960-36796097.35397.58
20min1363622-36362296.20595.722.7896.6096.082.77
2346651-34665191.71592.09
3372109-37210998.45198.83
4359618-35961895.14695.48
5355787-35578794.13294.48
6372851-37285198.64799.03
30min1371411-37141198.26698.131.0498.8298.661.05
2365265-36526596.64097.17
3375033-37503399.22499.76
4371334-37133498.24698.74
5367629-36762997.26697.77
6374650-37465099.12399.67
极限1381468-381468100.927100.100.56101.64100.790.56
2376013-37601399.484100.17
3376765-37676599.683100.39
4379292-379292100.351101.01
5379586-379586100.429101.10
6376869-37686999.710100.43
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