沙库巴曲缬沙坦钠片项目信息
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DSMF-4022-230920对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.85对照品水分(%)5.54对照品稀释倍数500
标示量(mg)50供试品稀释倍数1系数0.47699
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
127.342767982766522767542766832767952767360.03
227.252770592768592769590.06
单位质量响应值RSD%判断
10122.0210163.630.30数据可信
加速6月-供试品溶液-2024032721批-缬沙坦钠-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%
5min12226-22260.3551.52147.950.361.52147.92
22012-20120.3210.32
337574-375746.0006.00
49942-99421.5881.59
53191-31910.5100.51
62154-21540.3440.34
10min131422-314225.0178.8068.795.028.8068.81
256067-560678.9538.95
3118154-11815418.86718.88
473028-7302811.66111.66
543844-438447.0017.00
68191-81911.3081.31
15min1132021-13202121.08121.9118.6221.0921.9218.67
2144238-14423823.03223.05
3173820-17382027.75627.80
4148365-14836523.69123.71
5127843-12784320.41420.43
696808-9680815.45815.46
20min1187280-18728029.90530.747.6529.9530.797.69
2190002-19000230.34030.39
3210920-21092033.68033.77
4206086-20608632.90832.97
5191008-19100830.50030.55
6169639-16963927.08827.12
30min1243785-24378538.92837.445.1439.0237.545.16
2226535-22653536.17336.28
3235229-23522937.56137.71
4253070-25307040.41040.53
5226231-22623136.12536.22
6221786-22178635.41535.49
45min1267660-26766042.74041.234.6942.9041.404.71
2248466-24846639.67539.84
3258778-25877841.32241.53
4276661-27666144.17744.36
5253093-25309340.41440.57
6244747-24474739.08139.21
60min1281438-28143844.94043.494.3645.1743.734.37
2261266-26126641.71941.95
3273308-27330843.64243.92
4290361-29036146.36546.62
5268042-26804242.80143.03
6259887-25988741.49941.70
极限1295795-29579547.23347.172.0047.5447.472.01
2299751-29975147.86448.16
3291020-29102046.47046.82
4304731-30473148.65948.99
5289811-28981146.27746.57
6291186-29118646.49746.76
沙库巴曲缬沙坦钠片项目信息
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DSMF-4022-230920对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.85对照品水分(%)5.54对照品稀释倍数500
标示量(mg)50供试品稀释倍数1系数0.45065
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
127.344774274781064781954772694787124779420.13
227.254777134782574779850.09
单位质量响应值RSD%判断
17481.4217540.730.24数据可信
加速6月-供试品溶液-2024032721批-沙库巴曲-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%
5min1-0.0000.83186.340.000.83186.28
2-0.0000.00
344562-445623.8943.89
410200-102000.8910.89
52043-20430.1790.18
6-0.0000.00
10min136106-361063.1555.9573.193.165.9573.22
270477-704776.1586.16
3151442-15144213.23313.24
491037-910377.9557.96
551965-519654.5414.54
67599-75990.6640.66
15min1173135-17313515.12915.7119.6615.1315.7219.70
2191267-19126716.71316.72
3229263-22926320.03420.06
4196494-19649417.17017.18
5164836-16483614.40414.41
6123930-12393010.82910.83
20min1254793-25479322.26522.988.4522.3023.028.49
2263524-26352423.02723.07
3289940-28994025.33625.40
4283343-28334324.75924.80
5258448-25844822.58422.62
6227815-22781519.90719.93
30min1348630-34863030.46429.465.9230.5329.535.94
2328971-32897128.74628.82
3340460-34046029.75029.85
4368551-36855132.20532.29
5323565-32356528.27428.34
6312491-31249127.30627.36
45min1404867-40486735.37834.075.8235.5034.205.84
2377396-37739632.97833.10
3391329-39132934.19534.35
4425457-42545737.17837.32
5378849-37884933.10533.22
6361560-36156031.59431.69
60min1440158-44015838.46237.175.4738.6437.355.49
2410685-41068535.88736.07
3428328-42832837.42937.64
4461769-46176940.35140.55
5414874-41487436.25336.42
6396576-39657634.65434.80
极限1476957-47695741.67841.393.0541.9241.633.06
2483542-48354242.25342.49
3462844-46284440.44540.72
4495980-49598043.34043.61
5460188-46018840.21340.44
6462169-46216940.38640.59
沙库巴曲缬沙坦钠片项目信息
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DSMF-4022-230920对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.85对照品水分(%)5.54对照品稀释倍数500
标示量(mg)50供试品稀释倍数1系数0.47699
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
127.342768782769762768952770602772632770140.06
227.252771942768342770140.10
单位质量响应值RSD%判断
10132.1910165.650.24数据可信
加速6月-供试品溶液-2024032821批-缬沙坦钠-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%
5min1-0.0001.8684.890.001.8685.01
213263-132632.1172.12
310055-100551.6051.60
426738-267384.2674.27
517670-176702.8202.82
62346-23460.3740.37
10min13732-37320.5969.2280.530.609.2280.50
293919-9391914.98814.99
3103390-10339016.49916.50
4101778-10177816.24216.25
524663-246633.9363.94
619234-192343.0693.07
15min185714-8571413.67921.2733.6513.6821.2933.69
2174511-17451127.84927.88
3180409-18040928.79028.82
4160186-16018625.56325.60
5120335-12033519.20419.21
678663-7866312.55312.56
20min1147308-14730823.50830.1015.9523.5330.1616.00
2218695-21869534.90034.98
3219928-21992835.09735.18
4195119-19511931.13831.21
5191741-19174130.59930.64
6158977-15897725.37025.40
30min1205291-20529132.76137.336.6732.8237.436.73
2245563-24556339.18839.32
3249079-24907939.74939.89
4235676-23567637.61037.74
5237581-23758137.91438.01
6230234-23023436.74236.81
45min1242667-24266738.72642.254.5838.8442.424.64
2272326-27232643.45943.66
3273589-27358943.66043.86
4274447-27444743.79743.99
5260665-26066541.59841.76
6264774-26477442.25442.38
60min1261079-26107941.66444.824.0141.8545.064.06
2290763-29076346.40146.67
3287274-28727445.84446.12
4288732-28873246.07746.34
5274769-27476943.84944.08
6282428-28242845.07145.27
极限1291614-29161446.53747.742.3946.7948.062.44
2299791-29979147.84248.19
3304089-30408948.52848.88
4310412-31041249.53749.88
5293120-29312046.77747.08
6296079-29607947.24947.53
沙库巴曲缬沙坦钠片项目信息
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DSMF-4022-230920对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.85对照品水分(%)5.54对照品稀释倍数500
标示量(mg)50供试品稀释倍数1系数0.45065
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
127.344781044781944782704777934777054780130.06
227.254787314783014785160.07
单位质量响应值RSD%判断
17484.0217560.220.31数据可信
加速6月-供试品溶液-2024032821批-沙库巴曲-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%
5min1-0.0000.98103.470.000.98103.54
214286-142861.2481.25
39776-97760.8540.85
431597-315972.7592.76
511913-119131.0401.04
6-0.0000.00
10min12459-24590.2156.3384.040.216.3384.07
2120130-12013010.49110.49
3132840-13284011.60111.60
4129254-12925411.28711.29
529055-290552.5372.54
621208-212081.8521.85
15min1111755-1117559.75915.4135.489.7615.4235.51
2234402-23440220.47020.49
3243451-24345121.26021.28
4212582-21258218.56418.59
5156598-15659813.67513.68
699898-998988.7248.73
20min1198393-19839317.32522.7517.7217.3422.7917.78
2307248-30724826.83126.89
3309633-30963327.04027.10
4272105-27210523.76223.82
5260799-26079922.77522.80
6215094-21509418.78418.80
30min1292495-29249525.54329.878.1125.5929.948.16
2365479-36547931.91732.01
3368782-36878232.20532.31
4349696-34969630.53830.63
5341846-34184629.85329.92
6333976-33397629.16529.21
45min1365440-36544031.91335.515.6932.0035.645.75
2421945-42194536.84837.00
3422733-42273336.91637.07
4426241-42624137.22337.37
5396578-39657834.63234.75
6407150-40715035.55635.65
60min1407224-40722435.56238.864.9435.7039.044.99
2462923-46292340.42640.64
3457668-45766839.96740.18
4463033-46303340.43640.64
5431780-43178037.70637.88
6447202-44720239.05339.21
极限1467768-46776840.84942.293.1841.0542.543.23
2485958-48595842.43842.72
3495247-49524743.24943.53
4508185-50818544.37944.65
5471837-47183741.20541.44
6476606-47660641.62141.84
沙库巴曲缬沙坦钠片项目信息
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DSMF-4022-230920对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.85对照品水分(%)5.54对照品稀释倍数500
标示量(mg)50供试品稀释倍数1系数0.47699
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
127.342773582774312771012771822771652772470.06
227.252771002771142771070.01
单位质量响应值RSD%判断
10140.7110169.060.20数据可信
加速6月-供试品溶液-2024032921批-缬沙坦钠-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%
5min119020-190203.0342.8374.363.032.8474.39
234769-347695.5455.55
33755-37550.5990.60
416253-162532.5922.59
52629-26290.4190.42
630209-302094.8184.82
10min194920-9492015.13910.1976.3715.1410.1976.37
298686-9868615.73915.75
35281-52810.8420.84
464136-6413610.22910.23
54183-41830.6670.67
6116088-11608818.51518.52
15min1170257-17025727.15423.3620.5727.1823.3820.61
2142248-14224822.68722.72
3125156-12515619.96119.96
4152003-15200324.24324.26
5102995-10299516.42716.43
6186222-18622229.70129.74
20min1213755-21375534.09231.4813.1334.1731.5413.15
2166462-16646226.54926.62
3188416-18841630.05030.09
4211734-21173433.76933.83
5171946-17194627.42427.45
6231999-23199937.00237.09
30min1237612-23761237.89737.817.7338.0337.927.74
2209927-20992733.48133.60
3226299-22629936.09236.18
4244653-24465339.02039.14
5239111-23911138.13638.21
6264661-26466142.21142.36
45min1257360-25736041.04641.905.1541.2442.085.16
2251319-25131940.08340.26
3247495-24749539.47339.62
4264824-26482442.23742.42
5271690-27169043.33243.47
6283630-28363045.23645.46
60min1271415-27141543.28844.304.5443.5544.544.55
2270434-27043443.13243.37
3262877-26287741.92642.14
4276544-27654444.10644.36
5288533-28853346.01846.23
6296719-29671947.32447.62
极限1298807-29880747.65747.821.7747.9948.141.78
2296689-29668947.31947.63
3294175-29417546.91847.20
4296635-29663547.31047.64
5306914-30691448.95049.24
6305835-30583548.77849.15
沙库巴曲缬沙坦钠片项目信息
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DSMF-4022-230920对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.85对照品水分(%)5.54对照品稀释倍数500
标示量(mg)50供试品稀释倍数1系数0.45065
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
127.344787094782264789434785694785824786060.06
227.254782114779644780880.04
单位质量响应值RSD%判断
17505.7117544.510.16数据可信
加速6月-供试品溶液-2024032921批-沙库巴曲-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%
5min123262-232622.0311.9074.512.031.9074.47
241899-418993.6583.66
34248-42480.3710.37
420474-204741.7881.79
53041-30410.2660.27
637299-372993.2573.26
10min1122118-12211810.6627.0778.0410.677.0878.02
2123110-12311010.74910.76
35060-50600.4420.44
481111-811117.0827.09
54087-40870.3570.36
6150484-15048413.13913.14
15min1229128-22912820.00617.0321.2920.0317.0421.33
2184204-18420416.08316.11
3169289-16928914.78114.78
4201787-20178717.61917.63
5135340-13534011.81711.82
6250370-25037021.86021.89
20min1298289-29828926.04423.7714.6026.1023.8114.62
2221306-22130619.32319.37
3264168-26416823.06523.09
4293411-29341125.61925.66
5233063-23306320.34920.37
6322931-32293128.19628.26
30min1348003-34800330.38529.999.2930.4830.079.30
2290929-29092925.40225.48
3333358-33335829.10629.17
4360807-36080731.50331.59
5340852-34085229.76129.82
6387044-38704433.79433.90
45min1395313-39531334.51634.885.7834.6635.015.79
2367791-36779132.11332.24
3381766-38176633.33333.45
4408824-40882435.69635.83
5410069-41006935.80435.91
6433029-43302937.80937.98
60min1426169-42616937.21037.995.0337.4238.185.04
2411776-41177635.95336.13
3414467-41446736.18836.36
4438919-43891938.32338.52
5451699-45169939.43939.60
6467532-46753240.82241.05
极限1480410-48041041.94642.172.1242.2142.422.13
2468883-46888340.93941.18
3477123-47712341.65941.89
4481680-48168042.05742.32
5496050-49605043.31143.54
6493484-49348443.08743.39
沙库巴曲缬沙坦钠片项目信息
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DSMF-4022-230920对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.85对照品水分(%)5.54对照品稀释倍数500
标示量(mg)50供试品稀释倍数1系数0.47699
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
127.342773222772822771712769342770632771540.06
227.252767562771332769440.10
单位质量响应值RSD%判断
10137.3110163.080.18数据可信
长期6月-供试品溶液-2024032721批-缬沙坦钠-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%
5min117512-175122.7943.8066.212.793.8066.23
241150-411506.5666.57
328505-285054.5484.55
441595-415956.6376.64
59437-94371.5061.51
64834-48340.7710.77
10min123207-232073.7038.7086.893.718.7086.88
2111783-11178317.83717.85
338133-381336.0856.09
4116148-11614818.53318.54
532318-323185.1575.16
65521-55210.8810.88
15min1136343-13634321.75522.5123.8321.7722.5323.87
2166894-16689426.63026.67
3127445-12744520.33620.35
4184951-18495129.51129.55
5143075-14307522.83022.84
687742-8774214.00014.00
20min1196734-19673431.39231.0414.8531.4431.1014.89
2202684-20268432.34132.43
3182272-18227229.08429.14
4232001-23200137.01937.11
5207815-20781533.16033.21
6145834-14583423.27023.30
30min1246862-24686239.39038.218.3939.4938.328.44
2232177-23217737.04737.19
3236699-23669937.76937.87
4266935-26693542.59342.75
5247534-24753439.49739.60
6206556-20655632.95933.02
45min1269405-26940542.98742.376.1143.1542.546.15
2252773-25277340.33340.53
3264404-26440442.18942.35
4292200-29220046.62546.85
5269084-26908442.93643.11
6245249-24524939.13339.25
60min1281657-28165744.94244.835.6045.1845.085.63
2265364-26536442.34242.61
3281001-28100144.83845.07
4308375-30837549.20549.51
5283683-28368345.26645.51
6265679-26567942.39342.58
极限1299320-29932047.76150.4010.0348.0750.729.98
2299080-29908047.72248.06
3378496-37849660.39460.70
4318280-31828050.78651.17
5303992-30399248.50648.82
6296083-29608347.24447.50
沙库巴曲缬沙坦钠片项目信息
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DSMF-4022-230920对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.85对照品水分(%)5.54对照品稀释倍数500
标示量(mg)50供试品稀释倍数1系数0.45065
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
127.344790154784374785714784204785674786020.06
227.254779574781914780740.04
单位质量响应值RSD%判断
17505.5617544.000.16数据可信
长期6月-供试品溶液-2024032721批-沙库巴曲-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%
5min123803-238032.0782.6762.962.082.6762.97
251867-518674.5294.53
337151-371513.2443.24
451174-511744.4684.47
510906-109060.9520.95
68335-83350.7280.73
10min129343-293432.5626.0387.482.576.0387.47
2141885-14188512.38912.40
348056-480564.1964.20
4148013-14801312.92412.93
539738-397383.4703.47
67241-72410.6320.63
15min1184217-18421716.08516.4124.0816.0916.4224.13
2219437-21943719.16019.19
3169277-16927714.78014.79
4246788-24678821.54821.58
5193106-19310616.86116.87
6114513-1145139.99910.00
20min1275198-27519824.02923.3115.3924.0623.3615.42
2276555-27655524.14724.21
3248162-24816221.66821.71
4318778-31877827.83427.90
5286244-28624424.99325.03
6197195-19719517.21817.24
30min1365308-36530831.89730.308.8931.9730.388.91
2334169-33416929.17829.28
3340249-34024929.70929.78
4386734-38673433.76733.88
5358477-35847731.30031.38
6297059-29705925.93825.99
45min1418796-41879636.56735.396.6636.6935.526.69
2382980-38298033.44033.59
3398949-39894934.83434.96
4449773-44977339.27239.44
5406907-40690735.52935.66
6374622-37462232.71032.80
60min1450306-45030639.31838.756.5739.5138.946.60
2417055-41705536.41536.62
3435931-43593138.06338.24
4496207-49620743.32643.56
5445843-44584338.92939.12
6417701-41770136.47136.62
极限1493888-49388843.12444.026.1543.3844.286.14
2480782-48078241.97942.24
3557883-55788348.71148.96
4524470-52447045.79446.10
5488546-48854642.65742.91
6479478-47947841.86542.07
沙库巴曲缬沙坦钠片项目信息
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DSMF-4022-230920对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.85对照品水分(%)5.54对照品稀释倍数500
标示量(mg)50供试品稀释倍数1系数0.47699
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
127.342774082776242775982771712772192774040.08
227.252775662776442776050.02
单位质量响应值RSD%判断
10146.4510187.340.29数据可信
长期6月-供试品溶液-2024032821批-缬沙坦钠-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%
5min112589-125892.0054.0159.302.014.0259.26
234884-348845.5575.56
320982-209823.3423.34
447673-476737.5947.59
528108-281084.4784.48
66977-69771.1111.11
10min149653-496537.91012.1057.557.9112.1057.55
2100204-10020415.96315.97
3109726-10972617.48017.49
4132521-13252121.11121.12
535890-358905.7175.72
627730-277304.4174.42
15min1142862-14286222.75825.0719.8422.7725.1019.87
2154074-15407424.54424.58
3185853-18585329.60729.64
4204107-20410732.51532.56
5125927-12592720.06020.08
6131531-13153120.95320.96
20min1204015-20401532.50033.229.5132.5533.299.55
2196829-19682931.35531.43
3220854-22085435.18235.27
4240653-24065338.33638.44
5183821-18382129.28329.33
6205114-20511432.67532.72
30min1230280-23028036.68439.035.3336.7939.155.35
2237563-23756337.84437.97
3244370-24437038.92939.07
4263743-26374342.01542.18
5236465-23646537.66937.77
6257467-25746741.01541.11
45min1252765-25276540.26642.854.1140.4443.044.11
2267814-26781442.66342.86
3263359-26335941.95442.16
4281278-28127844.80845.04
5266996-26699642.53342.70
6281560-28156044.85345.02
60min1267012-26701242.53645.113.6742.7745.383.67
2287633-28763345.82146.08
3274830-27483043.78144.06
4290463-29046346.27146.58
5284571-28457145.33345.57
6294696-29469646.94647.19
极限1295951-29595147.14648.471.7947.4548.801.82
2302405-30240548.17448.51
3304493-30449348.50648.86
4310193-31019349.41449.80
5302162-30216248.13548.44
6310261-31026149.42549.75
沙库巴曲缬沙坦钠片项目信息
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DSMF-4022-230920对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.85对照品水分(%)5.54对照品稀释倍数500
标示量(mg)50供试品稀释倍数1系数0.45065
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
127.344783614787674788464780994784634785070.07
227.254794114796584795340.04
单位质量响应值RSD%判断
17502.0817597.580.39数据可信
长期6月-供试品溶液-2024032821批-沙库巴曲-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%
5min120263-202631.7672.8957.051.772.9056.97
249382-493824.3064.31
326486-264862.3092.31
459430-594305.1825.18
535343-353433.0823.08
68203-82030.7150.72
10min163438-634385.5318.5259.685.538.5259.68
2129654-12965411.30511.31
3141110-14111012.30312.31
4174616-17461615.22515.23
544926-449263.9173.92
632667-326672.8482.85
15min1193487-19348716.87018.5521.4416.8818.5721.46
2204027-20402717.78917.82
3252242-25224221.99322.02
4283378-28337824.70824.74
5167956-16795614.64414.66
6175443-17544315.29715.30
20min1287857-28785725.09825.5011.8925.1425.5511.92
2267748-26774823.34523.40
3309809-30980927.01227.07
4351200-35120030.62130.70
5252248-25224821.99422.03
6285964-28596424.93324.96
30min1338093-33809329.47831.387.0729.5631.477.10
2339570-33957029.60729.70
3360242-36024231.41031.52
4403034-40303435.14135.27
5343535-34353529.95330.03
6374663-37466332.66732.74
45min1383940-38394033.47635.995.5033.6136.145.51
2400313-40031334.90335.05
3406559-40655935.44835.61
4447782-44778239.04239.23
5408304-40830435.60035.72
6430073-43007337.49837.63
60min1414871-41487136.17338.974.6436.3639.184.65
2445492-44549238.84339.04
3435915-43591538.00838.23
4472604-47260441.20641.46
5447821-44782139.04639.23
6465308-46530840.57040.76
极限1475886-47588641.49343.082.7941.7443.352.82
2485240-48524042.30842.58
3495280-49528043.18443.46
4512198-51219844.65944.98
5488298-48829842.57542.82
6507392-50739244.24044.50
沙库巴曲缬沙坦钠片项目信息
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DSMF-4022-230920对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.85对照品水分(%)5.54对照品稀释倍数500
标示量(mg)50供试品稀释倍数1系数0.47699
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
127.342773452775572775182773532773172774180.04
227.252789412792132790770.07
单位质量响应值RSD%判断
10146.9610241.360.66数据可信
长期6月-供试品溶液-2024032921批-缬沙坦钠-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%
5min114140-141402.2473.6485.932.253.6485.97
253790-537908.5468.55
34525-45250.7190.72
421804-218043.4643.46
538567-385676.1276.13
64811-48110.7640.76
10min120582-205823.2709.5475.053.279.5475.07
298378-9837815.63015.64
342734-427346.7906.79
471706-7170611.39311.40
5121095-12109519.23919.25
65662-56620.9000.90
15min1144718-14471822.99323.4919.2323.0023.5119.28
2167233-16723326.57026.61
3120565-12056519.15519.17
4159004-15900425.26225.29
5185031-18503129.39729.44
6110402-11040217.54117.54
20min1204594-20459432.50632.1010.0132.5532.1610.06
2215556-21555634.24734.33
3185880-18588029.53229.58
4216339-21633934.37234.44
5220440-22044035.02335.11
6169624-16962426.95026.98
30min1234221-23422137.21339.594.2637.3139.704.29
2259868-25986841.28741.43
3242017-24201738.45138.55
4262288-26228841.67241.80
5248744-24874439.52039.67
6247836-24783639.37639.45
45min1251582-25158239.97143.474.8840.1343.654.89
2284680-28468045.23045.44
3266763-26676342.38342.54
4285574-28557445.37245.57
5270373-27037342.95743.17
6282662-28266244.90945.05
60min1271382-27138243.11746.014.2443.3546.264.23
2299022-29902247.50847.79
3282766-28276644.92545.15
4299080-29908047.51747.79
5283288-28328845.00845.30
6301985-30198547.97948.20
极限1297178-29717847.21548.452.4147.5248.782.40
2307558-30755848.86449.23
3299914-29991447.65047.95
4314908-31490850.03250.38
5298868-29886847.48447.85
6311239-31123949.44949.75
沙库巴曲缬沙坦钠片项目信息
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DSMF-4022-230920对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.85对照品水分(%)5.54对照品稀释倍数500
标示量(mg)50供试品稀释倍数1系数0.45065
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
127.344786444789174784734784364787954786530.05
227.254811934809284810600.04
单位质量响应值RSD%判断
17507.4317653.580.59数据可信
长期6月-供试品溶液-2024032921批-沙库巴曲-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%
5min118203-182031.5842.6788.221.582.6688.22
275727-757276.5916.59
35376-53760.4680.47
427545-275452.3972.40
548508-485084.2224.22
68395-83950.7310.73
10min124042-240422.0936.6877.232.106.6877.23
2128976-12897611.22611.24
352991-529914.6124.61
489981-899817.8327.84
5157061-15706113.67013.68
67122-71220.6200.62
15min1195339-19533917.00217.2519.6417.0117.2619.69
2225606-22560619.63719.67
3160093-16009313.93413.94
4212387-21238718.48618.50
5248618-24861821.63921.67
6147065-14706512.80012.80
20min1289328-28932825.18324.4310.7125.2224.4810.76
2299290-29929026.05026.11
3255593-25559322.24722.28
4300937-30093726.19326.24
5306982-30698226.71926.79
6232036-23203620.19620.22
30min1347862-34786230.27831.734.4030.3531.824.42
2379781-37978133.05633.16
3351918-35191830.63130.70
4388255-38825533.79333.88
5361401-36140131.45631.57
6358134-35813431.17231.23
45min1386094-38609433.60536.545.4633.7336.685.45
2435262-43526237.88538.05
3407366-40736635.45735.58
4444913-44491338.72538.87
5407580-40758035.47535.64
6437418-43741838.07238.18
60min1424480-42448036.94639.845.4437.1340.045.42
2473492-47349241.21241.44
3442408-44240838.50738.69
4481042-48104241.86942.08
5441022-44102238.38638.61
6483905-48390542.11942.29
极限1478873-47887341.68143.133.7441.9343.393.72
2500486-50048643.56243.85
3486457-48645742.34142.58
4519267-51926745.19745.48
5474444-47444441.29541.58
6513344-51334444.68144.92
点击查看处理图标(人工保存)
 
原始图谱下载图谱(谢鑫慧 于 2024-10-17 14:51:40 完成)
生成报告数据部分下载报告(谢鑫慧 于 2024-10-17 14:52:18 完成)
Current page cost:79 ms