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125
标示量(mg)50供试品稀释倍数1系数0.5142
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.565826855825685822715823455821525824040.04
228.565823135826865825000.05
单位质量响应值RSD%判断
20392.3020395.660.02数据可信
影响因素30天-供试品溶液-2024032421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%
5min116098-160985.51313.6167.435.5113.6167.45
232512-3251211.13411.13
34009-40091.3731.37
461961-6196121.21821.22
572515-7251524.83224.83
651358-5135817.58717.59
10min1167028-16702857.19863.2220.1357.2163.2420.14
2213745-21374573.19673.21
3118296-11829640.51040.51
4193139-19313966.13966.17
5217781-21778174.57874.62
6197644-19764467.68267.71
15min1283845-28384597.201104.6412.2697.31104.7712.27
2323186-323186110.673110.81
3252086-25208686.32586.39
4307886-307886105.433105.58
5363493-363493124.476124.64
6302933-302933103.737103.88
20min1344995-344995118.141127.898.42118.41128.198.44
2372963-372963127.719128.04
3342846-342846117.405117.62
4378772-378772129.708130.03
5429645-429645147.129147.50
6371499-371499127.217127.53
30min1408330-408330139.830156.237.05140.29156.757.05
2464531-464531159.076159.61
3447251-447251153.158153.57
4437792-437792149.919150.46
5481649-481649164.937165.56
6497833-497833170.480171.01
45min1446562-446562152.922173.197.44153.62173.977.43
2519567-519567177.922178.73
3512079-512079175.358176.02
4478776-478776163.954164.74
5524030-524030179.451180.34
6553479-553479189.535190.35
60min1470882-470882161.250185.216.90162.20186.276.89
2547238-547238187.398188.50
3538280-538280184.330185.29
4561127-561127192.154193.21
5547350-547350187.436188.63
6580200-580200198.686199.81
极限1584666-584666200.215203.541.96201.44204.911.96
2602502-602502206.323207.73
3596391-596391204.230205.49
4580824-580824198.899200.28
5590005-590005202.043203.55
6611863-611863209.528210.99
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125
标示量(mg)50供试品稀释倍数1系数0.4858
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.561007135100696710065691006623100651910067630.03
228.561005987100641710062020.04
单位质量响应值RSD%判断
35250.8135231.160.04数据可信
影响因素30天-供试品溶液-2024032421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%
5min118306-183063.4279.1571.923.439.1571.91
238339-383397.1787.18
32567-25670.4810.48
478540-7854014.70514.70
592577-9257717.33317.33
662868-6286811.77111.77
10min1212778-21277839.83844.7120.9339.8444.7220.95
2275965-27596551.66851.68
3150994-15099428.27028.27
4251997-25199747.18147.21
5286826-28682653.70253.73
6254116-25411647.57747.60
15min1371017-37101769.46476.2713.5069.5476.3713.52
2431781-43178180.84180.94
3332542-33254262.26162.31
4411128-41112876.97477.08
5494387-49438792.56292.68
6403505-40350575.54775.65
20min1462902-46290286.66895.289.8886.8695.509.90
2503521-50352194.27394.51
3464260-46426086.92287.07
4516885-51688596.77597.01
5600685-600685112.464112.74
6505221-50522194.59194.82
30min1567237-567237106.202120.667.83106.53121.037.84
2652866-652866122.234122.62
3627387-627387117.464117.76
4621907-621907116.438116.83
5696313-696313130.368130.83
6700912-700912131.230131.61
45min1644367-644367120.643139.678.36121.15140.258.35
2765392-765392143.302143.90
3754788-754788141.317141.81
4706554-706554132.286132.87
5784008-784008146.787147.46
6820997-820997153.713154.31
60min1699403-699403130.947153.927.87131.66154.737.86
2835044-835044156.343157.18
3820241-820241153.571154.30
4842039-842039157.652158.46
5844695-844695158.150159.07
6891151-891151166.847167.70
极限1920164-920164172.279177.562.49173.21178.632.50
2963195-963195180.336181.43
3953541-953541178.528179.51
4924828-924828173.153174.22
5945921-945921177.102178.29
6982625-982625183.974185.11
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125
标示量(mg)50供试品稀释倍数1系数0.5142
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.565826665824405824505825425813015822800.10
228.565845505845685845590.01
单位质量响应值RSD%判断
20387.9620467.750.28数据可信
影响因素30天-供试品溶液-2024032421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%
5min187978-8797830.07813.0479.4130.0813.0479.41
245274-4527415.47815.48
35052-50521.7271.73
47997-79972.7342.73
537405-3740512.78812.79
645182-4518215.44715.45
10min1225466-22546677.08255.2430.3577.1355.2630.35
296303-9630332.92432.95
3112373-11237338.41838.42
4194768-19476866.58766.59
5171337-17133758.57658.60
6169220-16922057.85257.88
15min1316311-316311108.13992.609.84108.3292.729.86
2268521-26852191.80191.88
3233856-23385679.95080.02
4273138-27313893.38093.50
5272437-27243793.14093.26
6260952-26095289.21389.34
20min1382113-382113130.636117.337.76130.99117.607.77
2363773-363773124.366124.60
3323085-323085110.455110.66
4327343-327343111.911112.18
5349709-349709119.557119.83
6313118-313118107.048107.32
30min1447476-447476152.982146.049.41153.56146.509.40
2441187-441187150.832151.27
3413834-413834141.480141.86
4407665-407665139.371139.83
5485195-485195165.877166.35
6367707-367707125.710126.16
45min1506696-506696173.228163.339.40174.06164.049.40
2494833-494833169.172169.86
3450819-450819154.125154.74
4463270-463270158.381159.07
5538706-538706184.171184.92
6412152-412152140.905141.56
60min1535248-535248182.989172.499.36184.11173.479.35
2517469-517469176.911177.88
3495657-495657169.454170.33
4490254-490254167.606168.56
5563409-563409192.616193.67
6425247-425247145.382146.28
极限1592680-592680202.623201.292.24204.05202.562.26
2585291-585291200.097201.37
3591150-591150202.100203.26
4576473-576473197.083198.32
5611342-611342209.004210.38
6575704-575704196.820197.96
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125
标示量(mg)50供试品稀释倍数1系数0.4858
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.561007302100700310072811007243100527010068200.09
228.561011093101101810110560.01
单位质量响应值RSD%判断
35252.8035401.120.30数据可信
影响因素30天-供试品溶液-2024032421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%
5min1112822-11282221.0728.5586.9221.078.5586.93
251366-513669.5949.59
33500-35000.6540.65
47062-70621.3191.32
543956-439568.2108.21
656055-5605510.47010.47
10min1295850-29585055.25637.7431.9855.2937.7631.99
2116046-11604621.67421.69
3141310-14131026.39326.39
4225583-22558342.13342.13
5215590-21559040.26640.28
6218140-21814040.74240.76
15min1425291-42529179.43267.2610.8479.5667.3410.86
2356213-35621366.53166.58
3305775-30577557.11057.16
4372174-37217469.51269.58
5356635-35663566.60966.69
6344611-34461164.36464.45
20min1524519-52451997.96587.188.3598.2387.378.36
2497606-49760692.93993.10
3431869-43186980.66180.80
4453621-45362184.72484.91
5469841-46984187.75387.94
6423264-42326479.05479.25
30min1635034-635034118.607112.749.84119.03113.089.83
2628053-628053117.303117.62
3580026-580026108.333108.61
4581465-581465108.601108.93
5685047-685047127.948128.29
6512205-51220595.66695.99
45min1750733-750733140.216130.4510.62140.84130.9710.61
2714223-714223133.397133.91
3653046-653046121.971122.43
4684637-684637127.871128.38
5799348-799348149.296149.85
6588550-588550109.925110.41
60min1813373-813373151.915142.3510.62152.77143.0910.61
2784995-784995146.615147.35
3743731-743731138.908139.57
4743275-743275138.823139.55
5862570-862570161.104161.90
6625000-625000116.732117.40
极限1949834-949834177.402175.242.73178.51176.212.76
2937415-937415175.083176.06
3934794-934794174.593175.48
4916906-916906171.252172.21
5981083-981083183.239184.31
6909413-909413169.853170.71
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125
标示量(mg)50供试品稀释倍数1系数0.5142
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.565836945836255837145834715832755835560.04
228.565815555817705816620.03
单位质量响应值RSD%判断
20432.6320366.320.23数据可信
影响因素30天-供试品溶液-2024032421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%
5min118435-184356.31111.14116.306.3111.14116.31
27690-76902.6332.63
311204-112043.8363.84
433043-3304311.31211.31
517176-171765.8805.88
6107744-10774436.88636.89
10min1161403-16140355.25759.0031.6155.2759.0231.63
2115685-11568539.60539.61
3123376-12337642.23842.24
4176722-17672260.50160.52
5191041-19104165.40365.41
6265799-26579990.99791.06
15min1286943-28694398.235103.7916.4798.34103.9116.50
2234472-23447280.27280.34
3275840-27584094.43494.51
4310579-310579106.327106.45
5331397-331397113.454113.57
6379801-379801130.026130.24
20min1368253-368253126.072132.8311.37126.34133.1211.40
2329078-329078112.660112.86
3356038-356038121.890122.12
4402517-402517137.802138.10
5432742-432742148.150148.46
6439309-439309150.398150.83
30min1441607-441607151.185159.666.80151.66160.186.83
2428762-428762146.787147.18
3444822-444822152.286152.72
4499846-499846171.123171.65
5499842-499842171.122171.68
6483366-483366165.481166.16
45min1485243-485243166.124174.525.02166.85175.305.05
2485988-485988166.379167.02
3491612-491612168.304169.00
4536633-536633183.717184.53
5541144-541144185.262186.10
6518048-518048177.355178.31
60min1528001-528001180.762184.863.88181.77185.933.91
2516435-516435176.803177.72
3522008-522008178.710179.68
4556825-556825190.630191.75
5568663-568663194.683195.83
6547922-547922187.582188.83
极限1603627-603627206.653206.141.68207.96207.511.73
2584939-584939200.255201.46
3596547-596547204.229205.50
4604893-604893207.086208.52
5610417-610417208.977210.45
6612295-612295209.620211.18
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125
标示量(mg)50供试品稀释倍数1系数0.4858
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.561008214100823110081391008270100772610081160.03
228.561005360100533210053460.01
单位质量响应值RSD%判断
35298.1835201.190.20数据可信
影响因素30天-供试品溶液-2024032421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%
5min127477-274775.1438.68108.425.148.68108.39
211410-114102.1362.14
320500-205003.8373.84
447314-473148.8568.86
525417-254174.7584.76
6146111-14611127.34927.35
10min1213337-21333739.93342.7732.9039.9442.7932.93
2150859-15085928.23828.24
3163173-16317330.54330.55
4232670-23267043.55143.57
5251465-25146547.06947.08
6359612-35961267.31367.36
15min1386175-38617572.28577.2418.0372.3677.3218.06
2312929-31292958.57458.62
3370949-37094969.43569.49
4423869-42386979.34079.43
5453054-45305484.80384.89
6528887-52888798.99899.16
20min1507390-50739094.974101.0712.8995.17101.2812.92
2449161-44916184.07484.22
3489812-48981291.68391.86
4559560-559560104.739104.96
5607803-607803113.769114.00
6625912-625912117.159117.48
30min1630606-630606118.037126.108.18118.39126.488.21
2608303-608303113.863114.15
3633895-633895118.653118.98
4722992-722992135.330135.72
5731752-731752136.970137.39
6714403-714403133.723134.24
45min1718354-718354134.462143.056.30135.01143.646.33
2717860-717860134.370134.85
3728967-728967136.449136.97
4810333-810333151.679152.30
5822770-822770154.007154.65
6787127-787127147.335148.08
60min1798891-798891149.537155.555.22150.31156.385.25
2785286-785286146.991147.69
3795694-795694148.939149.69
4864093-864093161.742162.61
5889967-889967166.585167.49
6852212-852212159.518160.50
极限1966675-966675180.943180.872.67181.97181.962.71
2922651-922651172.703173.65
3951758-951758178.151179.15
4978564-978564183.169184.31
5991585-991585185.606186.79
6986353-986353184.626185.88
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125
标示量(mg)50供试品稀释倍数1系数0.5142
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.565824855824795822145824435822895823820.03
228.565839325840865840090.02
单位质量响应值RSD%判断
20391.5320448.490.20数据可信
影响因素30天-供试品溶液-2024032421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%
5min190763-9076331.04212.9080.7131.0412.9080.72
211199-111993.8303.83
326177-261778.9538.95
49161-91613.1333.13
538364-3836413.12113.12
650662-5066217.32717.33
10min1241164-24116482.48055.8835.9482.5355.9035.95
2153167-15316752.38452.39
3197288-19728867.47467.49
482129-8212928.08928.09
5192878-19287865.96665.99
6113771-11377138.91138.94
15min1341451-341451116.779101.5815.11116.97101.7015.13
2294713-294713100.794100.89
3320626-320626109.656109.78
4219139-21913974.94775.00
5329399-329399112.657112.79
6276800-27680094.66894.76
20min1401586-401586137.345130.139.77137.73130.429.80
2404242-404242138.254138.52
3403974-403974138.162138.47
4317524-317524108.596108.77
5403964-403964138.159138.48
6351673-351673120.275120.53
30min1463802-463802158.624157.458.22159.24157.958.23
2520837-520837178.130178.62
3470165-470165160.800161.34
4414054-414054141.610141.97
5467526-467526159.897160.45
6425766-425766145.615146.07
45min1491032-491032167.937171.686.67168.81172.446.66
2564053-564053192.910193.70
3507906-507906173.708174.52
4471027-471027161.095161.69
5500877-500877171.304172.12
6476973-476973163.128163.82
60min1525388-525388179.687182.015.42180.84183.065.42
2585026-585026200.083201.19
3529176-529176180.982182.08
4518979-518979177.495178.36
5535873-535873183.273184.37
6498691-498691170.556171.52
极限1593338-593338202.926205.772.04204.38207.122.06
2620949-620949212.369213.81
3606088-606088207.287208.69
4586530-586530200.598201.76
5606928-606928207.574208.98
6596024-596024203.845205.10
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125
标示量(mg)50供试品稀释倍数1系数0.4858
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.561006949100689710068171007134100683710069270.02
228.561009350100973810095440.03
单位质量响应值RSD%判断
35256.5535348.180.19数据可信
影响因素30天-供试品溶液-2024032421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%
5min1118302-11830222.1119.6873.8922.119.6873.87
216840-168403.1473.15
338903-389037.2717.27
415726-157262.9392.94
555055-5505510.29010.29
666051-6605112.34512.35
10min1321474-32147460.08440.6237.4460.1240.6337.44
2202929-20292937.92837.93
3267553-26755350.00650.02
4106536-10653619.91219.92
5261064-26106448.79348.81
6144326-14432626.97527.00
15min1467275-46727587.33475.7316.2887.4775.8216.30
2401263-40126374.99775.07
3443795-44379582.94683.04
4293409-29340954.83954.88
5456123-45612385.25085.35
6369236-36923669.01169.08
20min1564426-564426105.49299.4411.17105.7799.6511.19
2566593-566593105.897106.09
3572184-572184106.942107.18
4433933-43393381.10381.23
5572951-572951107.085107.33
6482232-48223290.13090.31
30min1674298-674298126.027124.619.34126.49124.999.35
2756686-756686141.426141.80
3689387-689387128.848129.26
4587961-587961109.891110.16
5688742-688742128.727129.15
6603224-603224112.744113.07
45min1740568-740568138.413141.398.00139.08141.987.99
2862022-862022161.113161.72
3773525-773525144.573145.20
4696776-696776130.229130.68
5764125-764125142.816143.45
6702009-702009131.207131.73
60min1810903-810903151.559153.457.05152.46154.277.06
2919098-919098171.781172.66
3826756-826756154.522155.39
4786905-786905147.074147.74
5836187-836187156.285157.16
6746200-746200139.466140.20
极限1956896-956896178.845181.663.06180.00182.733.08
21018884-1018884190.431191.59
3981913-981913183.521184.65
4937614-937614175.242176.15
5986404-986404184.360185.49
6949917-949917177.541178.51
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125
标示量(mg)50供试品稀释倍数1系数0.5142
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.565827335828625829835828065827005828170.02
228.565844505840395842440.05
单位质量响应值RSD%判断
20406.7620456.720.18数据可信
影响因素30天-供试品溶液-2024032421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%
5min144755-4475515.29817.0155.8515.3017.0155.86
260654-6065420.73220.73
326284-262848.9848.98
415922-159225.4425.44
594171-9417132.18932.19
656794-5679419.41319.41
10min1192379-19237965.75765.9224.1165.7865.9524.11
2219200-21920074.92574.96
3203508-20350869.56169.58
4101277-10127734.61834.63
5227196-22719677.65877.71
6213570-21357073.00173.03
15min1326106-326106111.467106.579.25111.60106.719.27
2318796-318796108.968109.13
3324205-324205110.817110.95
4253371-25337186.60586.67
5320224-320224109.456109.64
6327987-327987112.110112.26
20min1438244-438244149.797137.727.40150.12138.047.41
2393560-393560134.523134.86
3411398-411398140.620140.94
4349990-349990119.630119.84
5417379-417379142.665143.03
6406964-406964139.105139.45
30min1493664-493664168.740164.124.82169.31164.674.82
2447453-447453152.944153.51
3466222-466222159.360159.91
4473051-473051161.694162.10
5486679-486679166.352166.96
6513900-513900175.657176.23
45min1530277-530277181.254177.974.31182.11178.794.30
2487636-487636166.679167.50
3504368-504368172.398173.21
4524839-524839179.396180.08
5523953-523953179.093179.97
6552881-552881188.981189.85
60min1558368-558368190.856187.363.64192.01188.473.63
2525438-525438179.600180.70
3528999-528999180.818181.92
4550926-550926188.312189.29
5545535-545535186.470187.65
6579505-579505198.081199.26
极限1604896-604896206.760205.830.97208.23207.260.99
2598837-598837204.689206.09
3597534-597534204.244205.65
4597041-597041204.075205.37
5602520-602520205.948207.44
6612293-612293209.288210.80
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125
标示量(mg)50供试品稀释倍数1系数0.4858
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.561007334100738210073141006901100704610071950.03
228.561009462100892910091960.04
单位质量响应值RSD%判断
35265.9335335.990.15数据可信
影响因素30天-供试品溶液-2024032421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%
5min164194-6419411.99812.6654.9612.0012.6654.98
280562-8056215.05815.06
336394-363946.8026.80
421517-215174.0224.02
5127365-12736523.80623.81
676266-7626614.25514.25
10min1253049-25304947.29747.6425.4947.3247.6625.50
2292770-29277054.72154.75
3267826-26782650.05950.07
4127527-12752723.83623.84
5304122-30412256.84356.88
6284096-28409653.10053.12
15min1440564-44056482.34578.8610.0082.4478.9610.02
2434659-43465981.24281.36
3439272-43927282.10482.20
4336124-33612462.82562.87
5436612-43661281.60781.74
6444171-44417183.01983.13
20min1609261-609261113.876104.597.94114.11104.827.96
2549322-549322102.673102.92
3573460-573460107.185107.42
4478465-47846589.42989.58
5581697-581697108.724108.99
6565345-565345105.668105.92
30min1718317-718317134.260129.655.11134.69130.065.10
2644982-644982120.553120.98
3675293-675293126.218126.63
4673731-673731125.926126.23
5707430-707430132.225132.68
6742253-742253138.734139.16
45min1805408-805408150.538146.514.82151.19147.144.81
2727973-727973136.065136.69
3758961-758961141.857142.48
4781013-781013145.978146.49
5792864-792864148.193148.87
6837045-837045156.451157.11
60min1872668-872668163.109158.624.35164.01159.494.35
2799828-799828149.495150.35
3818931-818931153.065153.92
4846883-846883158.290159.04
5850753-850753159.013159.93
6902989-902989168.777169.70
极限1984194-984194183.955181.911.59185.13183.041.61
2956085-956085178.701179.80
3963241-963241180.038181.15
4964884-964884180.345181.36
5973245-973245181.908183.09
6997904-997904186.517187.72
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125
标示量(mg)50供试品稀释倍数1系数0.5142
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.565837855841475837045835135834225837140.05
228.565854225854445854330.01
单位质量响应值RSD%判断
20438.1720498.350.21数据可信
影响因素30天-供试品溶液-2024032421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%
5min110092-100923.44310.8563.973.4410.8563.99
255566-5556618.95918.96
328393-283939.6889.69
48894-88943.0353.03
554018-5401818.43118.43
633911-3391111.57011.57
10min1153258-15325852.29254.0816.9452.3054.1016.94
2192122-19212265.55265.58
3192131-19213165.55565.57
4138491-13849147.25347.26
5141419-14141948.25248.28
6133593-13359345.58245.60
15min1268649-26864991.66396.1710.4591.7696.2810.46
2308836-308836105.375105.52
3328781-328781112.180112.31
4262465-26246589.55389.64
5262073-26207389.42089.53
6260293-26029388.81288.91
20min1343204-343204117.102124.597.19117.35124.867.20
2397319-397319135.566135.88
3400250-400250136.566136.88
4349955-349955119.405119.64
5352365-352365120.227120.49
6347822-347822118.677118.92
30min1414460-414460141.414152.474.70141.86152.954.70
2471514-471514160.881161.42
3461764-461764157.554158.09
4440282-440282150.225150.66
5434871-434871148.379148.84
6458347-458347156.389156.83
45min1468200-468200159.750169.333.93160.43170.063.93
2513273-513273175.129175.94
3500202-500202170.670171.47
4492183-492183167.933168.62
5482864-482864164.754165.46
6520869-520869177.721178.42
60min1512584-512584174.894179.752.49175.84180.762.49
2536987-536987183.221184.32
3527588-527588180.014181.10
4526704-526704179.712180.67
5512023-512023174.703175.69
6545063-545063185.976186.97
极限1586908-586908200.254202.211.09201.49203.531.10
2593869-593869202.629204.04
3601742-601742205.315206.70
4586720-586720200.190201.45
5588251-588251200.712201.99
6598421-598421204.182205.49
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125
标示量(mg)50供试品稀释倍数1系数0.4858
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.561008925100898610085251008175100798110085180.05
228.561012031101166210118460.03
单位质量响应值RSD%判断
35312.2535428.780.24数据可信
影响因素30天-供试品溶液-2024032421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%
5min113682-136822.5527.9463.162.557.9463.19
275041-7504113.99814.00
338079-380797.1037.10
413209-132092.4642.46
571521-7152113.34213.34
643796-437968.1708.17
10min1203260-20326037.91638.7717.7237.9238.7817.72
2252725-25272547.14447.17
3254312-25431247.44047.45
4182179-18217933.98433.99
5182562-18256234.05534.08
6172023-17202332.08932.10
15min1363358-36335867.78170.7611.4667.8570.8411.46
2415757-41575777.55677.66
3450340-45034084.00784.10
4352681-35268165.79065.85
5348892-34889265.08365.16
6345089-34508964.37364.44
20min1474508-47450888.51593.968.1888.7094.168.19
2549329-549329102.473102.70
3563231-563231105.066105.30
4480586-48058689.64989.82
5482571-48257190.02090.21
6471932-47193288.03588.21
30min1594957-594957110.984119.615.17111.31119.965.18
2681874-681874127.198127.60
3674561-674561125.834126.24
4628342-628342117.212117.53
5621427-621427115.922116.26
6645913-645913120.490120.81
45min1698049-698049130.215138.014.18130.73138.564.19
2772011-772011144.012144.63
3756637-756637141.144141.76
4733828-733828136.889137.40
5710298-710298132.500133.03
6768253-768253143.311143.83
60min1784510-784510146.344150.703.05147.07151.483.06
2832650-832650155.324156.18
3820697-820697153.094153.95
4807366-807366150.607151.35
5772667-772667144.135144.89
6829267-829267154.693155.45
极限1943681-943681176.036177.551.35177.01178.581.37
2957328-957328178.582179.69
3970952-970952181.123182.23
4941342-941342175.599176.59
5938089-938089174.993175.98
6959370-959370178.962179.98
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