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%
128.275762055758655755715748905751775755420.10
228.325760505759105759800.02
单位质量响应值RSD%判断
20358.7520338.280.08数据可信
加速3月-供试品溶液-TAWW4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%
5min1185196-18519614.74014.8513.9114.7414.8613.90
2151734-15173412.07712.08
3210795-21079516.77816.78
4222141-22214117.68117.68
5171225-17122513.62813.63
6178612-17861214.21614.22
10min1379196-37919630.18131.577.4730.2131.607.48
2361880-36188028.80328.82
3412204-41220432.80932.84
4442241-44224135.19935.23
5376291-37629129.95029.97
6408275-40827532.49632.52
15min1551640-55164043.90743.263.3743.9843.343.37
2509601-50960140.56140.63
3552360-55236043.96444.05
4551389-55138943.88743.97
5536512-53651242.70342.78
6559921-55992144.56644.64
20min1636243-63624350.64149.042.9350.7949.192.92
2610818-61081848.61748.75
3614727-61472748.92849.08
4587250-58725046.74146.90
5613236-61323648.80948.95
6634645-63464550.51350.67
30min1643602-64360251.22649.801.8351.4650.031.82
2625017-62501749.74749.96
3615734-61573449.00849.25
4616214-61621449.04649.29
5618369-61836949.21849.44
6635070-63507050.54750.78
45min1642683-64268351.15349.761.7851.4750.071.77
2625235-62523549.76450.06
3615065-61506548.95549.27
4617719-61771949.16649.49
5616526-61652649.07149.38
6633800-63380050.44650.77
60min1640084-64008450.94649.631.7851.3550.021.77
2623978-62397849.66450.05
3612100-61210048.71949.12
4616421-61642149.06349.47
5615363-61536348.97949.37
6633048-63304850.38650.79
极限1639672-63967250.91349.531.8551.4050.011.84
2623557-62355749.63150.10
3611275-61127548.65349.14
4615007-61500748.95049.43
5612594-61259448.75849.23
6631466-63146650.26050.75
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%
128.2710011401000820100012499877399949110000700.10
228.321001841100170710017740.01
单位质量响应值RSD%判断
35375.6635373.380.01数据可信
加速3月-供试品溶液-TAWW4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%
5min1316179-31617913.67713.7914.3113.6813.7914.34
2258084-25808411.16411.16
3362168-36216815.66615.67
4381149-38114916.48716.49
5292086-29208612.63512.63
6303650-30365013.13513.13
10min1653141-65314128.25229.577.5428.2829.607.53
2622058-62205826.90826.93
3711549-71154930.77930.80
4762524-76252432.98433.01
5649637-64963728.10128.12
6703024-70302430.41030.43
15min1954167-95416741.27440.663.4441.3440.733.45
2879383-87938338.03938.10
3956565-95656541.37741.45
4953210-95321041.23241.31
5929033-92903340.18640.25
6967989-96798941.87141.94
20min11102084-110208447.67246.162.9647.8146.302.95
21056296-105629645.69145.82
31065494-106549446.08946.24
41016344-101634443.96344.11
51063072-106307245.98446.12
61099385-109938547.55547.70
30min11115244-111524448.24146.891.8148.4647.111.80
21081721-108172146.79146.99
31067925-106792546.19446.42
41067492-106749246.17646.40
51072130-107213046.37646.59
61099937-109993747.57947.80
45min11113923-111392348.18446.861.7848.4847.151.77
21081953-108195346.80147.08
31066216-106621646.12046.42
41069514-106951446.26346.56
51069203-106920346.25046.54
61098405-109840547.51347.81
60min11108882-110888247.96646.731.7748.3447.101.75
21080208-108020846.72647.08
31060625-106062545.87846.26
41067853-106785346.19146.57
51066949-106694946.15246.52
61097022-109702247.45347.83
极限11108872-110887247.96546.651.8648.4247.101.85
21080166-108016646.72447.16
31058735-105873545.79746.25
41066305-106630546.12446.58
51061810-106181045.93046.37
61094688-109468847.35247.81
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%
128.271148538114963011481401148972114888411488330.05
228.321149687114890611492960.05
单位质量响应值RSD%判断
40637.8840582.490.10数据可信
加速3月-供试品溶液-TYN28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%
5min1313182-31318212.49012.4527.4712.4912.4527.48
2393791-39379115.70515.71
3208674-2086748.3228.32
4424833-42483316.94316.94
5302016-30201612.04512.04
6230992-2309929.2129.21
10min1678809-67880927.07227.298.8527.0927.318.87
2741492-74149229.57229.60
3635311-63531125.33725.35
4765095-76509530.51330.54
5678650-67865027.06627.09
6606515-60651524.18924.20
15min1981650-98165039.15037.873.5539.2237.943.57
2953534-95353438.02938.10
3934470-93447037.26837.32
4995871-99587139.71739.80
5918949-91894936.64936.71
6913428-91342836.42936.48
20min11085103-108510343.27644.951.9843.4145.081.98
21137589-113758945.36945.51
31130862-113086245.10145.22
41149090-114909045.82845.97
51136961-113696145.34445.47
61123147-112314744.79344.91
30min11187669-118766947.36649.192.4147.5749.392.42
21261675-126167550.31850.53
31208290-120829048.18948.38
41255928-125592850.08850.31
51252986-125298649.97150.17
61233307-123330749.18649.38
45min11274879-127487950.84450.714.0351.1351.004.04
21315416-131541652.46152.76
31207422-120742248.15448.43
41344369-134436953.61653.92
51253428-125342849.98950.27
61233537-123353749.19549.47
60min11312509-131250952.34550.944.5052.7151.314.49
21317049-131704952.52652.91
31204217-120421748.02648.38
41349986-134998653.84054.23
51250246-125024649.86250.23
61229259-122925949.02549.38
极限11319030-131903052.60550.924.6753.0651.374.66
21315736-131573652.47452.95
31201776-120177647.92948.36
41350115-135011553.84554.33
51247088-124708849.73650.19
61226410-122641048.91149.35
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%
128.271994020199557819938221994996199508519947000.04
228.321996596199568119961380.04
单位质量响应值RSD%判断
70558.9070485.100.08数据可信
加速3月-供试品溶液-TYN28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%
5min1537232-53723211.65711.6228.1811.6611.6228.17
2679421-67942114.74214.74
3353914-3539147.6797.68
4733220-73322015.90915.91
5519072-51907211.26311.26
6391105-3911058.4868.49
10min11169862-116986225.38325.638.8925.4025.658.91
21280152-128015227.77627.80
31097266-109726623.80823.82
41320947-132094728.66128.69
51173780-117378025.46825.49
61044953-104495322.67322.69
15min11695945-169594536.79835.633.5136.8635.693.52
21646597-164659735.72735.80
31618589-161858935.12035.17
41722241-172224137.36937.44
51590667-159066734.51434.58
61578606-157860634.25234.30
20min11877331-187733140.73442.352.0240.8642.472.02
21968406-196840642.71042.84
31959833-195983342.52442.63
41989643-198964343.17143.31
51970142-197014242.74842.87
61944915-194491542.20042.31
30min12051238-205123844.50746.342.4744.7046.532.47
22184822-218482247.40647.61
32095367-209536745.46545.65
42172219-217221947.13247.34
52172548-217254847.13947.33
62137242-213724246.37346.55
45min12204202-220420247.82647.793.9448.0948.063.94
22277976-227797649.42749.71
32094154-209415445.43845.70
42325532-232553250.45950.75
52173641-217364147.16347.43
62138445-213844546.39946.66
60min12271503-227150349.28648.024.4449.6348.364.44
22280874-228087449.49049.85
32087382-208738245.29145.62
42338302-233830250.73651.11
52168265-216826547.04647.39
62131870-213187046.25746.59
极限12286146-228614649.60448.024.6850.0348.454.67
22281300-228130049.49949.94
32082811-208281145.19245.60
42341422-234142250.80351.26
52161087-216108746.89147.32
62127189-212718946.15546.57
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%
128.272943002950932930622914122925432932820.50
228.322918462920432919440.05
单位质量响应值RSD%判断
10374.3210308.760.45数据可信
加速3月-供试品溶液-SDR926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%
5min191601-9160114.34615.846.8414.3515.846.83
2104564-10456416.37616.38
395853-9585315.01215.01
4107249-10724916.79716.80
5109140-10914017.09317.09
698518-9851815.42915.43
10min1191265-19126529.95532.445.9829.9832.465.97
2219558-21955834.38634.41
3208467-20846732.64932.67
4211159-21115933.07033.10
5193078-19307830.23830.27
6219161-21916134.32334.35
15min1223524-22352435.00741.438.7635.0841.518.75
2257119-25711940.26840.35
3286530-28653044.87444.95
4261654-26165440.97841.06
5275764-27576443.18843.27
6282558-28255844.25244.34
20min1256808-25680840.21946.297.4640.3546.447.45
2297794-29779446.63846.79
3307297-30729748.12748.28
4284945-28494544.62644.78
5308647-30864748.33848.49
6317824-31782449.77549.93
30min1305211-30521147.80049.522.9248.0049.742.93
2317820-31782049.77550.00
3314564-31456449.26549.50
4306829-30682948.05348.28
5324779-32477950.86551.10
6327873-32787351.34951.59
45min1317563-31756349.73450.672.4250.0150.982.42
2327354-32735451.26851.58
3317653-31765349.74850.07
4314915-31491549.32049.63
5333991-33399152.30752.62
6329563-32956351.61451.94
60min1319592-31959250.05250.842.3050.4151.242.30
2329096-32909651.54151.94
3319313-31931350.00850.41
4315746-31574649.45049.84
5334827-33482752.43852.84
6329285-32928551.57051.98
极限1321847-32184750.40550.942.1350.8551.422.13
2329810-32981051.65252.14
3321561-32156150.36150.84
4315568-31556849.42249.89
5334717-33471752.42152.91
6328248-32824851.40851.90
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%
128.275082605091295075185061815065585075290.24
228.325062045065395063720.05
单位质量响应值RSD%判断
17952.9217880.370.29数据可信
加速3月-供试品溶液-SDR926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%
5min1154178-15417813.16814.637.2413.1714.637.24
2177418-17741815.15215.15
3161256-16125613.77213.77
4182894-18289415.62015.62
5184909-18490915.79215.79
6167049-16704914.26714.27
10min1324353-32435327.70130.126.3227.7230.156.32
2375868-37586832.10132.13
3354978-35497830.31730.34
4359903-35990330.73730.76
5327438-32743827.96527.99
6373769-37376931.92231.95
15min1378716-37871632.34438.719.2632.4138.789.25
2439958-43995837.57537.65
3493268-49326842.12842.20
4448699-44869938.32138.40
5473161-47316140.41040.48
6485527-48552741.46641.54
20min1435639-43563937.20643.378.0237.3343.518.01
2512691-51269143.78643.93
3530008-53000845.26545.41
4488828-48882841.74841.89
5530896-53089645.34145.48
6548617-54861746.85547.00
30min1526528-52652844.96846.572.9545.1546.782.96
2547397-54739746.75046.96
3542238-54223846.31046.53
4528996-52899645.17945.39
5560038-56003847.83048.05
6566350-56635048.36948.59
45min1548056-54805646.80747.702.4547.0747.992.45
2564361-56436148.19948.49
3546718-54671846.69246.99
4545132-54513246.55746.84
5576868-57686849.26749.56
6570157-57015748.69449.00
60min1551601-55160147.10947.912.4247.4548.282.42
2568971-56897148.59348.97
3549902-54990246.96447.34
4546146-54614646.64447.01
5579471-57947149.49049.87
6570085-57008548.68849.07
极限1556882-55688247.56048.122.0947.9848.572.10
2571657-57165748.82249.28
3556367-55636747.51647.97
4547650-54765046.77247.21
5579440-57944049.48749.95
6568665-56866548.56749.03
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