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对照品来源自制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)200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%
128.002751902750472751712750322747642750410.07
228.072768532768002768260.02
单位质量响应值RSD%判断
9822.899861.990.29数据可信
供试品溶液-24111401批-缬沙坦钠-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1144451-14445123.77020.2612.0423.7720.2612.04
2106967-10696717.60217.60
3116550-11655019.17919.18
4130719-13071921.51021.51
5108529-10852917.85917.86
6131330-13133021.61121.61
10min1242000-24200039.82234.6011.8439.8634.6311.84
2176787-17678729.09129.12
3224677-22467736.97137.00
4212971-21297135.04535.08
5184717-18471730.39630.43
6220420-22042036.27136.31
15min1305447-30544750.26244.4411.9850.3744.5411.98
2225176-22517637.05337.13
3302720-30272049.81449.91
4264007-26400743.44343.54
5242637-24263739.92740.01
6280547-28054746.16546.26
20min1321413-32141352.89049.449.4153.0849.619.42
2259542-25954242.70942.85
3331706-33170654.58354.76
4293167-29316748.24248.41
5277922-27792245.73345.88
6319058-31905852.50252.68
30min1317043-31704352.17052.225.0552.4552.475.06
2288632-28863247.49547.71
3334829-33482955.09755.36
4315654-31565451.94252.19
5318452-31845252.40252.63
6329581-32958154.23454.49
45min1316609-31660952.09953.484.0252.4653.824.02
2305771-30577150.31650.61
3341822-34182256.24856.61
4320959-32095952.81553.15
5332809-33280954.76555.08
6332182-33218254.66255.01
60min1316447-31644752.07253.803.2352.5254.223.21
2315540-31554051.92352.30
3333753-33375354.92055.37
4322153-32215353.01153.43
5341781-34178156.24156.64
6332099-33209954.64855.09
极限1316169-31616952.02753.923.2852.5754.443.25
2320274-32027452.70253.16
3329627-32962754.24154.79
4322423-32242353.05653.57
5346261-34626156.97857.47
6331276-33127654.51355.05
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对照品来源自制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)200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%
128.004785764781734782454781574778594782020.06
228.074814674810694812680.06
单位质量响应值RSD%判断
17078.6417145.280.28数据可信
供试品溶液-24111401批-沙库巴曲-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1250305-25030522.38318.8113.2322.3818.8113.23
2183071-18307116.37016.37
3200236-20023617.90517.91
4225034-22503420.12320.12
5178618-17861815.97215.97
6224633-22463320.08720.09
10min1418454-41845437.41932.4112.1637.4632.4412.16
2302761-30276127.07327.10
3387770-38777034.67534.70
4367051-36705132.82232.86
5317740-31774028.41328.44
6380815-38081534.05334.09
15min1531557-53155747.53241.7912.2747.6341.8812.27
2387688-38768834.66734.74
3523435-52343546.80646.89
4458164-45816440.97041.06
5418255-41825537.40137.47
6485202-48520243.38743.48
20min1560103-56010350.08546.499.6950.2646.649.70
2447547-44754740.02040.15
3574827-57482751.40251.57
4506063-50606345.25345.41
5479423-47942342.87143.01
6551333-55133349.30149.46
30min1549446-54944649.13249.105.2149.3949.335.22
2497819-49781944.51544.71
3580931-58093151.94752.20
4545892-54589248.81449.05
5550774-55077449.25149.46
6569743-56974350.94751.19
45min1549389-54938949.12750.594.7349.4750.904.73
2530002-53000247.39347.66
3607305-60730554.30654.64
4555881-55588149.70750.02
5576495-57649551.55151.84
6575260-57526051.44051.77
60min1548692-54869249.06550.653.2649.4951.043.25
2545422-54542248.77249.12
3579343-57934351.80552.23
4557795-55779549.87950.27
5591074-59107452.85453.23
6576047-57604751.51151.93
极限1548358-54835849.03550.903.3649.5451.383.33
2555327-55532749.65850.09
3576745-57674551.57352.09
4559128-55912849.99850.48
5600895-60089553.73354.20
6574754-57475451.39551.90
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对照品来源自制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)200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%
128.002755652753852756122755552749382754110.11
228.072752572755992754280.09
单位质量响应值RSD%判断
9836.119812.180.18数据可信
供试品溶液-24111401批-缬沙坦钠-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1104516-10451617.23013.5025.8417.2313.5025.85
272181-7218111.90011.90
346403-464037.6507.65
490094-9009414.85314.85
579028-7902813.02913.03
699165-9916516.34816.35
10min1223613-22361336.86532.7612.1836.8932.7912.19
2183155-18315530.19530.21
3161016-16101626.54526.56
4204148-20414833.65633.68
5197079-19707932.49032.51
6223459-22345936.83936.87
15min1286854-28685447.29144.746.5647.3844.826.57
2265620-26562043.79043.86
3238120-23812039.25639.31
4278008-27800845.83245.91
5277456-27745645.74145.82
6282359-28235946.55046.64
20min1302773-30277349.91550.355.2650.0850.505.27
2311779-31177951.40051.54
3279031-27903146.00146.12
4317154-31715452.28652.44
5324137-32413753.43753.59
6297759-29775949.08849.25
30min1306549-30654950.53752.045.4650.7952.285.45
2328653-32865354.18254.41
3293136-29313648.32648.53
4333232-33323254.93655.18
5330595-33059554.50254.74
6301772-30177249.75050.00
45min1307286-30728650.65952.195.4851.0052.525.47
2328947-32894754.23054.55
3294091-29409148.48448.76
4334274-33427455.10855.44
5332409-33240954.80155.13
6302588-30258849.88450.22
60min1307235-30723550.65152.185.4351.0752.595.41
2329575-32957554.33454.74
3294369-29436948.52948.89
4334559-33455955.15555.58
5330845-33084554.54354.97
6302577-30257749.88350.30
极限1313209-31320951.63552.984.2352.1453.484.24
2330168-33016854.43154.93
3302392-30239249.85250.29
4337424-33742455.62856.15
5331394-33139454.63355.15
6313665-31366551.71152.21
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对照品来源自制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)200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%
128.004789054790044788654787104781864787340.07
228.074781894783364782620.03
单位质量响应值RSD%判断
17097.6417038.190.25数据可信
供试品溶液-24111401批-沙库巴曲-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1180623-18062316.19312.6526.1416.1912.6526.14
2122974-12297411.02511.02
379430-794307.1217.12
4154900-15490013.88713.89
5137513-13751312.32812.33
6171068-17106815.33715.34
10min1389626-38962634.93130.9812.3634.9631.0012.38
2317449-31744928.46028.48
3279211-27921125.03225.04
4354506-35450631.78231.81
5343502-34350230.79630.82
6389177-38917734.89034.92
15min1499030-49903044.73942.266.6344.8242.336.64
2460893-46089341.32041.39
3413062-41306237.03237.09
4482047-48204743.21643.29
5482540-48254043.26143.33
6490386-49038643.96444.05
20min1525308-52530847.09547.485.3447.2547.635.35
2540596-54059648.46548.60
3483411-48341143.33943.45
4548310-54831049.15749.31
5564185-56418550.58050.72
6516136-51613646.27246.43
30min1531659-53165947.66449.085.5747.9049.305.56
2569982-56998251.10051.32
3507575-50757545.50545.69
4578651-57865151.87752.11
5574063-57406351.46651.69
6522712-52271246.86247.10
45min1532601-53260147.74949.255.7048.0749.555.69
2571369-57136951.22451.52
3508912-50891245.62545.89
4579938-57993851.99252.31
5579300-57930051.93552.25
6523663-52366346.94747.26
60min1531869-53186947.68349.155.5748.0849.535.56
2571312-57131251.21951.61
3509133-50913345.64545.98
4579732-57973251.97452.38
5574334-57433451.49051.89
6522844-52284446.87447.26
极限1541888-54188848.58150.014.3549.0650.484.34
2575318-57531851.57852.05
3526164-52616447.17247.59
4585590-58559052.49952.99
5576310-57631051.66752.15
6541784-54178448.57249.04
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对照品来源自制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)200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%
128.002759592759662759562759122760142759610.02
228.072773412775432774420.06
单位质量响应值RSD%判断
9855.759883.930.21数据可信
供试品溶液-24111401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%
5min17918-79181.2999.0953.011.309.0953.01
275999-7599912.47112.47
329800-298004.8904.89
477555-7755512.72612.73
566813-6681310.96410.96
674135-7413512.16512.17
10min178407-7840712.86620.4824.4112.8720.4924.44
2153062-15306225.11725.14
396374-9637415.81515.82
4139488-13948822.88922.91
5131737-13173721.61821.64
6149603-14960324.54924.57
15min1144786-14478623.75930.2013.0323.7830.2513.06
2201571-20157133.07733.14
3175765-17576528.84228.88
4204576-20457633.57033.63
5173099-17309928.40528.46
6204445-20444533.54933.61
20min1192693-19269331.62035.9911.0731.6836.0911.08
2218482-21848235.85235.97
3221705-22170536.38136.46
4239762-23976239.34439.46
5191646-19164631.44831.55
6251618-25161841.29041.41
30min1251590-25159041.28540.739.7341.4040.899.71
2235434-23543438.63438.81
3248958-24895840.85341.00
4258634-25863442.44142.62
5211042-21104234.63134.79
6283548-28354846.52946.72
45min1279731-27973145.90343.849.4646.0944.089.44
2252162-25216241.37941.62
3267184-26718443.84444.06
4274253-27425345.00445.26
5227821-22782137.38537.60
6301983-30198349.55449.82
60min1294495-29449548.32645.918.9148.5946.218.89
2270791-27079144.43644.75
3277707-27770745.57145.86
4284336-28433646.65846.99
5238582-23858239.15039.42
6312680-31268051.31051.66
极限1311313-31131351.08550.065.0751.4350.445.07
2301845-30184549.53249.92
3312815-31281551.33251.69
4293897-29389748.22748.63
5283334-28333446.49446.83
6327103-32710353.67654.11
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对照品来源自制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)200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%
128.004799444796354797394796724797664797510.03
228.074819604824924822260.08
单位质量响应值RSD%判断
17133.9617179.410.19数据可信
供试品溶液-24111401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%
5min19122-91220.8146.2054.460.816.2054.48
296318-963188.5908.59
334954-349543.1173.12
494406-944068.4208.42
586276-862767.6957.69
696165-961658.5778.58
10min1103864-1038649.26314.6924.319.2614.7024.34
2201282-20128217.95217.97
3127826-12782611.40111.41
4181904-18190416.22416.24
5173263-17326315.45315.47
6199999-19999917.83717.85
15min1196834-19683417.55522.4813.3817.5722.5213.41
2276852-27685224.69224.74
3241807-24180721.56621.59
4280359-28035925.00525.05
5235492-23549221.00321.04
6280922-28092225.05525.10
20min1268042-26804223.90627.6111.8023.9527.6811.80
2308798-30879827.54127.63
3314277-31427728.03028.09
4340952-34095230.40930.49
5268458-26845823.94324.02
6356902-35690231.83131.92
30min1364088-36408832.47232.4810.5732.5632.6010.56
2344901-34490130.76130.89
3369185-36918532.92733.03
4382869-38286934.14734.28
5304410-30441027.15027.26
6419743-41974337.43637.57
45min1425503-42550337.95036.5210.4138.0936.6910.38
2384288-38428834.27434.46
3414716-41471636.98837.15
4425127-42512737.91638.11
5340936-34093630.40730.57
6466181-46618141.57841.78
60min1465388-46538841.50739.399.7941.7139.629.77
2425913-42591337.98638.23
3441642-44164239.38939.61
4453807-45380740.47440.73
5367573-36757332.78332.99
6495381-49538144.18244.45
极限1506978-50697845.21644.216.1945.4944.506.19
2489059-48905943.61843.92
3511217-51121745.59445.88
4482628-48262843.04543.37
5446761-44676139.84640.11
6537227-53722747.91448.26
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对照品来源自制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)200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%
128.002764652765162763592763612766282764660.05
228.072782982780682781830.06
单位质量响应值RSD%判断
9873.799910.330.27数据可信
供试品溶液-24111401批-缬沙坦钠-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%
5min1107265-10726517.56218.0216.1017.5618.0216.09
289947-8994714.72714.73
393095-9309515.24215.24
4125416-12541620.53420.53
5109308-10930817.89717.90
6135177-13517722.13222.13
10min1230050-23005037.66633.2712.0537.6933.3012.05
2201936-20193633.06333.09
3183434-18343430.03330.06
4221962-22196236.34136.38
5166143-16614327.20227.23
6215778-21577835.32935.37
15min1290166-29016647.50843.8910.5947.6043.9810.58
2286647-28664746.93247.01
3244662-24466240.05840.13
4293816-29381648.10648.20
5223612-22361236.61236.69
6269593-26959344.14044.24
20min1317867-31786752.04449.299.3152.2149.449.31
2323094-32309452.89953.06
3281250-28125046.04846.19
4326797-32679753.50653.68
5255261-25526141.79341.93
6301933-30193349.43549.60
30min1321240-32124052.59651.344.2452.8551.584.25
2326913-32691353.52553.77
3308965-30896550.58650.81
4325444-32544453.28453.55
5293120-29312047.99248.20
6305610-30561050.03750.29
45min1321423-32142352.62652.012.5552.9752.332.56
2326746-32674653.49753.83
3313940-31394051.40151.70
4324755-32475553.17153.52
5313639-31363951.35151.64
6305431-30543150.00850.34
60min1320816-32081652.52752.142.6252.9652.562.60
2325779-32577953.33953.76
3314061-31406151.42151.81
4323927-32392753.03653.48
5322717-32271752.83853.21
6303599-30359949.70850.13
极限1320762-32076252.51852.441.9853.0452.941.97
2324906-32490653.19653.71
3313318-31331851.29951.77
4323026-32302652.88853.42
5327746-32774653.66154.12
6312051-31205151.09151.59
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对照品来源自制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)200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%
128.004796064795074795414790944794124794320.05
228.074819784817294818540.04
单位质量响应值RSD%判断
17122.5717166.160.18数据可信
供试品溶液-24111401批-沙库巴曲-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%
5min1182866-18286616.32116.7416.6916.3216.7416.68
2152234-15223413.58713.59
3157470-15747014.05414.05
4215282-21528219.21419.21
5186013-18601316.60216.60
6231729-23172920.68220.68
10min1396421-39642135.38131.1712.5035.4131.2012.49
2347562-34756231.02131.04
3314814-31481428.09828.12
4382914-38291434.17634.21
5282326-28232625.19825.23
6371463-37146333.15433.19
15min1501717-50171744.77941.2810.8944.8741.3610.89
2495692-49569244.24144.32
3421016-42101637.57637.65
4507899-50789945.33145.42
5383458-38345834.22434.29
6465298-46529841.52941.62
20min1550528-55052849.13646.449.6249.3046.599.62
2559709-55970949.95550.10
3484603-48460343.25243.38
4566807-56680750.58950.75
5439026-43902639.18439.31
6521227-52122746.52046.68
30min1555624-55562449.59048.384.4749.8348.604.49
2566572-56657250.56850.80
3532819-53281947.55547.76
4563845-56384550.32450.57
5504434-50443445.02245.21
6529005-52900547.21547.45
45min1556374-55637449.65749.082.6049.9849.392.61
2566089-56608950.52450.84
3542438-54243848.41448.70
4563148-56314850.26250.59
5542169-54216948.39048.66
6529243-52924347.23647.55
60min1555178-55517849.55149.212.6049.9649.602.59
2564507-56450750.38350.78
3543604-54360448.51848.88
4561191-56119150.08750.50
5557905-55790549.79450.14
6526088-52608846.95447.35
极限1555719-55571949.59949.611.8350.0950.081.81
2563362-56336250.28150.76
3543108-54310848.47348.92
4559812-55981249.96450.46
5568315-56831550.72351.15
6544677-54467748.61349.09
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