沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
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0.4858
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.015660765681935670735660185657595666240.18
228.025719985706695713340.17
单位质量响应值RSD%判断
20229.3520390.220.57数据可信
影响因素30天-包装高温-供试品溶液-TAWW4批-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%
5min166024-660245.3626.2216.415.366.2216.41
282305-823056.6856.68
368519-685195.5655.57
499609-996098.0908.09
571811-718115.8325.83
671340-713405.7945.79
10min1180001-18000114.61915.866.3914.6315.876.39
2210388-21038817.08717.10
3193265-19326515.69715.71
4195464-19546415.87515.89
5208661-20866116.94716.96
6183795-18379514.92814.94
15min1288905-28890523.46523.694.3823.5123.744.38
2302231-30223124.54724.60
3291076-29107623.64123.69
4283948-28394823.06223.12
5309672-30967225.15125.20
6274023-27402322.25622.30
20min1384881-38488131.26030.243.9931.3630.343.98
2367728-36772829.86629.97
3366348-36634829.75429.85
4354860-35486028.82128.93
5395329-39532932.10832.21
6364964-36496429.64229.74
30min1460277-46027737.38336.664.5037.5536.824.49
2433533-43353335.21135.38
3446996-44699636.30536.47
4428875-42887534.83335.00
5485027-48502739.39339.57
6453294-45329436.81636.98
45min1501024-50102440.69340.594.6040.9440.844.58
2478142-47814238.83439.09
3492852-49285240.02940.28
4481276-48127639.08939.33
5541720-54172043.99844.26
6503247-50324740.87341.12
60min1523039-52303942.48142.664.6942.8243.004.67
2503585-50358540.90141.24
3516121-51612141.91942.25
4508440-50844041.29541.63
5571845-57184546.44546.81
6528756-52875642.94543.28
极限1584220-58422047.45047.672.1347.8848.112.13
2572250-57225046.47846.91
3581283-58128347.21147.64
4583042-58304247.35447.78
5608763-60876349.44349.91
6592316-59231648.10748.54
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
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0.4858
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.015755715746135759395763975760075757050.12
228.025865385865075865220.01
单位质量响应值RSD%判断
20553.5520932.261.30数据可信
影响因素30天-包装高温-供试品溶液-TAWW4批-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%
5min190473-904737.1957.2513.287.207.2513.27
267481-674815.3675.37
394526-945267.5187.52
499652-996527.9257.93
595179-951797.5697.57
699615-996157.9227.92
10min1215992-21599217.17817.569.9717.1917.589.98
2181022-18102214.39614.41
3225640-22564017.94517.96
4232386-23238618.48118.50
5223336-22333617.76217.78
6246301-24630119.58819.61
15min1354179-35417928.16727.359.0328.2227.419.04
2282839-28283922.49422.54
3345029-34502927.44027.50
4363497-36349728.90828.97
5350721-35072127.89227.95
6367499-36749929.22729.29
20min1441979-44197935.15033.954.5035.2734.074.51
2402707-40270732.02732.12
3414947-41494733.00033.12
4455776-45577636.24736.37
5419859-41985933.39133.51
6426009-42600933.88034.01
30min1495879-49587939.43639.824.2439.6340.014.20
2527261-52726141.93242.10
3481323-48132338.27938.47
4527117-52711741.92142.12
5483187-48318738.42738.62
6489084-48908438.89639.10
45min1529341-52934142.09842.893.4942.3843.173.46
2566387-56638745.04445.30
3527142-52714241.92342.20
4559803-55980344.52044.82
5522212-52221241.53141.81
6531018-53101842.23142.52
60min1555303-55530344.16244.743.1344.5445.113.10
2588762-58876246.82347.18
3551346-55134643.84844.22
4580015-58001546.12846.52
5544445-54444543.29943.67
6555420-55542044.17244.55
极限1585315-58531546.54947.512.0347.0247.982.01
2615222-61522248.92849.39
3601558-60155847.84148.31
4605964-60596448.19148.69
5586989-58698946.68247.15
6588992-58899246.84247.32
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
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0.4858
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.015757335765195765505760265756805761020.08
228.025863805857605860700.08
单位质量响应值RSD%判断
20567.7320916.131.19数据可信
影响因素30天-包装高湿-供试品溶液-TAWW4批-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%
5min173456-734565.8427.0918.225.847.0918.23
285440-854406.7956.80
370314-703145.5925.59
4108237-1082378.6088.61
5107513-1075138.5518.55
689756-897567.1387.14
10min1219526-21952617.45916.8515.1217.4716.8715.12
2183791-18379114.61714.63
3170091-17009113.52813.54
4235488-23548818.72918.75
5256059-25605920.36520.38
6206453-20645316.41916.44
15min1314107-31410724.98125.422.7525.0325.472.78
2311645-31164524.78624.83
3310432-31043224.68924.73
4322199-32219925.62525.69
5331164-33116426.33826.40
6327840-32784026.07426.13
20min1416486-41648633.12432.334.2033.2332.444.19
2391958-39195831.17331.28
3392771-39277131.23831.33
4402194-40219431.98732.10
5399234-39923431.75231.87
6436235-43623534.69434.80
30min1525664-52566441.80739.725.4141.9939.905.36
2481465-48146538.29138.46
3534222-53422242.48742.65
4482071-48207138.34038.53
5466774-46677437.12337.32
6506415-50641540.27640.46
45min1569091-56909145.26043.404.4245.5343.674.38
2528071-52807141.99842.26
3579536-57953646.09146.35
4533608-53360842.43842.71
5518357-51835741.22641.50
6545714-54571443.40143.68
60min1598802-59880247.62345.654.2248.0046.024.19
2559135-55913544.46944.82
3607019-60701948.27748.64
4558694-55869444.43444.80
5546395-54639543.45543.82
6574254-57425445.67146.04
极限1618130-61813049.16147.933.2649.6448.403.24
2591684-59168447.05747.51
3635528-63552850.54451.02
4592873-59287347.15247.62
5586496-58649646.64547.11
6591236-59123647.02247.50
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
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0.4858
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.015815335814195810325808565803075810290.09
228.025887595896865892220.12
单位质量响应值RSD%判断
20743.6321028.620.97数据可信
影响因素30天-包装高湿-供试品溶液-TAWW4批-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%
5min171061-710615.6126.5213.005.616.5212.99
297283-972837.6837.68
383048-830486.5596.56
491169-911697.2017.20
570277-702775.5505.55
682199-821996.4926.49
10min1184554-18455414.57615.073.8514.5915.083.86
2197930-19793015.63315.65
3185319-18531914.63714.65
4194895-19489515.39315.41
5182760-18276014.43414.45
6199051-19905115.72115.74
15min1283022-28302222.35324.045.3822.4024.085.38
2312644-31264424.69324.74
3300939-30093923.76823.82
4309603-30960324.45324.50
5290939-29093922.97823.02
6328766-32876625.96626.02
20min1360104-36010428.44130.497.1828.5430.597.18
2390062-39006230.80730.91
3388284-38828430.66730.77
4381662-38166230.14430.25
5360309-36030928.45728.55
6435664-43566434.40934.52
30min1447546-44754635.34736.955.2735.5137.125.27
2480372-48037237.94038.12
3469052-46905237.04637.21
4458205-45820536.18936.36
5442423-44242334.94335.10
6509303-50930340.22540.41
45min1503429-50342939.76140.993.7840.0041.243.78
2530777-53077741.92142.18
3523805-52380541.37041.62
4508538-50853840.16440.42
5497615-49761539.30239.54
6549722-54972243.41743.69
60min1538464-53846442.52843.323.4242.8543.663.43
2558453-55845344.10744.46
3552216-55221643.61443.96
4535514-53551442.29542.64
5527425-52742541.65641.98
6578928-57892845.72446.09
极限1598771-59877147.29146.731.1147.7147.171.11
2596232-59623247.09147.54
3593543-59354346.87847.32
4581004-58100445.88846.32
5586995-58699546.36146.78
6593691-59369146.89047.36
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
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0.4858
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.015932515932055933555923545910985926530.17
228.026042936038906040920.05
单位质量响应值RSD%判断
21158.6221559.311.33数据可信
影响因素30天-包装光照-供试品溶液-TAWW4批-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%
5min196285-962857.4378.0316.447.448.0316.41
296237-962377.4337.43
3120213-1202139.2859.28
4119907-1199079.2619.26
577114-771145.9565.96
6114110-1141108.8138.81
10min1230299-23029917.78718.3519.2017.8018.3619.20
2192367-19236714.85714.87
3293165-29316522.64322.66
4287561-28756122.21022.23
5185536-18553614.33014.34
6236423-23642318.26018.28
15min1320748-32074824.77325.5812.2324.8325.6412.25
2281289-28128921.72521.77
3378458-37845829.23029.30
4372134-37213428.74228.81
5291785-29178522.53622.58
6343027-34302726.49426.55
20min1387307-38730729.91431.5612.3830.0231.6812.39
2346130-34613026.73326.83
3445519-44551934.41034.55
4463234-46323435.77835.91
5359930-35993027.79927.89
6449949-44994934.75234.87
30min1459904-45990435.52136.889.0135.7037.079.03
2423033-42303332.67332.83
3501129-50112938.70538.92
4522345-52234540.34340.56
5438192-43819233.84434.00
6520513-52051340.20240.40
45min1498002-49800238.46339.996.9038.7240.266.94
2475034-47503436.68936.92
3538069-53806941.55841.86
4554623-55462342.83643.14
5486071-48607137.54237.77
6555019-55501942.86743.15
60min1522273-52227340.33841.796.3440.6842.146.37
2499975-49997538.61638.93
3561109-56110943.33743.73
4576158-57615844.50044.90
5510359-51035939.41839.73
6576467-57646744.52344.90
极限1573848-57384844.32145.742.7144.7546.192.76
2570868-57086844.09144.49
3607922-60792246.95347.44
4604555-60455546.69347.19
5594710-59471045.93246.34
6601258-60125846.43846.92
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
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0.4858
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.015997955996395992595992065988945993590.07
228.026118396122176120280.05
单位质量响应值RSD%判断
21398.0421842.541.46数据可信
影响因素30天-包装光照-供试品溶液-TAWW4批-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%
5min191416-914166.9756.8116.626.986.8216.63
287139-871396.6496.65
372487-724875.5315.53
4116638-1166388.9008.90
586002-860026.5626.56
682143-821436.2686.27
10min1200591-20059115.30618.2214.6415.3218.2314.63
2236208-23620818.02318.04
3201858-20185815.40215.41
4286030-28603021.82521.84
5270954-27095420.67520.69
6236759-23675918.06518.08
15min1309867-30986723.64426.6410.3023.6926.7010.30
2378084-37808428.84928.90
3299145-29914522.82622.87
4374478-37447828.57428.64
5354140-35414027.02227.08
6379292-37929228.94129.00
20min1406656-40665631.02932.968.3831.1333.078.38
2473283-47328336.11336.23
3377527-37752728.80628.90
4459520-45952035.06335.19
5422951-42295132.27232.39
6451558-45155834.45534.57
30min1497937-49793737.99438.615.1538.1638.795.17
2527071-52707140.21740.42
3461001-46100135.17635.34
4528183-52818340.30240.51
5498167-49816738.01238.20
6523385-52338539.93640.13
45min1541603-54160341.32641.743.8541.5842.013.87
2569828-56982843.47943.77
3510872-51087238.98139.22
4559187-55918742.66842.97
5540628-54062841.25141.53
6559746-55974642.71042.99
60min1560778-56077842.78943.443.9743.1443.813.99
2596279-59627945.49845.88
3532437-53243740.62640.95
4581021-58102144.33444.73
5562272-56227242.90343.27
6583318-58331844.50944.89
极限1590953-59095345.09146.321.8845.5346.781.91
2611939-61193946.69347.18
3594631-59463145.37245.79
4614919-61491946.92047.41
5618223-61822347.17247.64
6611655-61165546.67147.15
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