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%
1 27.675753465748395755615754085751855752680.05
2 27.675774385779685777030.07
单位质量响应值RSD%判断
20790.3120878.320.30数据可信
供试品溶液-2024032421批-缬沙坦-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min130219-302192.3490.46203.882.350.46204.25
2-0.0000.00
3-0.0000.00
42963-29630.2300.23
52113-21130.1640.16
6-0.0000.00
10min1-0.0000.62160.480.000.62160.13
232827-328272.5522.55
38710-87100.6770.68
46122-61220.4760.48
5-0.0000.00
6-0.0000.00
15min13221-32210.2501.76130.270.251.76130.18
251964-519644.0404.04
368158-681585.2985.30
47839-78390.6090.61
52018-20180.1570.16
62694-26940.2090.21
20min12612-26120.2033.17103.830.213.18103.85
276909-769095.9795.99
389188-891886.9336.94
471389-713895.5505.55
52625-26250.2040.20
62235-22350.1740.17
30min14337-43370.3375.08106.540.345.08106.56
2157974-15797412.28112.30
3105620-1056208.2118.23
4116629-1166299.0669.08
53643-36430.2830.28
63493-34930.2720.27
45min1122700-1227009.53810.5446.639.5410.5646.69
2180408-18040814.02414.07
3163467-16346712.70812.74
4197847-19784715.38015.41
5128269-1282699.9719.97
621076-210761.6381.64
60min1137029-13702910.65213.0439.9110.6713.0839.96
2190221-19022114.78714.85
3227017-22701717.64817.70
4214155-21415516.64816.70
5191672-19167214.90014.92
646430-464303.6093.61
90min1149757-14975711.64214.3038.3111.6814.3538.36
2202501-20250115.74215.83
3250140-25014019.44519.53
4229757-22975717.86117.94
5213585-21358516.60416.65
657681-576814.4844.49
120min1159732-15973212.41715.1337.0812.4815.2237.10
2211062-21106216.40716.52
3262939-26293920.44020.56
4242248-24224818.83218.94
5226229-22622917.58617.66
665715-657155.1095.13
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1252471-25247119.62620.668.8019.7120.778.97
2262614-26261420.41520.56
3297234-29723423.10623.26
4285697-28569722.20922.35
5265151-26515120.61220.71
6231694-23169418.01118.04
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%
1 27.679808399799739797209813989803039804470.07
2 27.679834339835439834880.01
单位质量响应值RSD%判断
35433.5735543.480.22数据可信
供试品溶液-2024032421批-沙库巴曲-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min146387-463872.0000.36224.482.000.36223.89
2-0.0000.00
3-0.0000.00
43602-36020.1550.16
5-0.0000.00
6-0.0000.00
10min1-0.0000.64164.210.000.64164.35
262976-629762.7152.72
315795-157950.6810.68
410660-106600.4600.46
5-0.0000.00
6-0.0000.00
15min1-0.0001.79142.040.001.79142.02
299397-993974.2864.29
3133182-1331825.7425.74
413945-139450.6010.60
52992-29920.1290.13
6-0.0000.00
20min14367-43670.1883.35104.740.193.36104.81
2146159-1461596.3026.31
3170494-1704947.3517.36
4137933-1379335.9475.95
54049-40490.1750.17
63754-37540.1620.16
30min17087-70870.3065.31107.770.315.32107.72
2299961-29996112.93312.96
3199809-1998098.6158.64
4221210-2212109.5389.55
55345-53450.2300.23
65252-52520.2260.23
45min1236759-23675910.20811.0846.0910.2111.1046.14
2336656-33665614.51614.56
3309836-30983613.35913.40
4372249-37224916.05016.08
5247205-24720510.65910.66
639607-396071.7081.71
60min1260704-26070411.24113.5739.4611.2613.6139.50
2350350-35035015.10615.17
3423946-42394618.27918.34
4398342-39834217.17517.23
5367024-36702415.82515.84
688273-882733.8063.81
90min1279702-27970212.06014.6538.2712.1014.7138.30
2369361-36936115.92616.02
3459969-45996919.83319.92
4422424-42242418.21418.30
5402074-40207417.33617.38
6105441-1054414.5464.56
120min1292669-29266912.61915.3337.4812.6815.4137.50
2381481-38148116.44816.57
3479415-47941520.67120.79
4440972-44097219.01319.13
5421614-42161418.17918.25
6116609-1166095.0285.05
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1452643-45264319.51720.498.5819.6020.608.75
2466523-46652320.11520.26
3529838-52983822.84523.00
4508620-50862021.93022.08
5478392-47839220.62720.73
6415131-41513117.89917.93
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%
1 27.675781165770765766595754915747135764110.24
2 27.675782845781475782160.02
单位质量响应值RSD%判断
20831.6220896.860.23数据可信
供试品溶液-2024032421批-缬沙坦-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min14148-41480.3220.12116.590.320.12116.91
22862-28620.2220.22
32247-22470.1740.17
4-0.0000.00
5-0.0000.00
6-0.0000.00
10min1-0.0000.26129.820.000.26130.15
211810-118100.9170.92
33241-32410.2520.25
42158-21580.1680.17
5-0.0000.00
62990-29900.2320.23
15min12778-27780.2161.27193.910.221.27193.68
281047-810476.2916.29
34152-41520.3220.32
43182-31820.2470.25
52986-29860.2320.23
63938-39380.3060.31
20min12207-22070.1711.55201.980.171.55202.05
2101995-1019957.9177.93
35351-53510.4150.42
42454-24540.1900.19
52479-24790.1920.19
65050-50500.3920.39
30min1101516-1015167.8804.04100.527.884.05100.53
2109929-1099298.5338.56
386564-865646.7206.72
43662-36620.2840.29
53631-36310.2820.28
67104-71040.5510.55
45min1127542-1275429.9019.984.649.919.994.71
2132417-13241710.27910.32
3131882-13188210.23710.25
4127615-1276159.9069.91
5134316-13431610.42610.43
6117770-1177709.1429.14
60min1139650-13965010.84011.9516.1810.8711.9816.13
2140517-14051710.90810.96
3200337-20033715.55115.58
4145308-14530811.28011.30
5163781-16378112.71412.73
6134092-13409210.40910.43
90min1151197-15119711.73712.8217.0011.7912.8716.97
2150050-15005011.64811.72
3220809-22080917.14017.20
4165849-16584912.87412.91
5155876-15587612.10012.14
6146960-14696011.40811.44
120min1161034-16103412.50013.9616.6712.5714.0416.59
2157304-15730412.21112.31
3234826-23482618.22918.31
4180974-18097414.04814.11
5188439-18843914.62814.69
6156808-15680812.17212.23
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1273310-27331021.21620.794.3621.3120.894.37
2269685-26968520.93521.05
3273877-27387721.26021.37
4245018-24501819.02019.10
5277300-27730021.52621.61
6268050-26805020.80820.88
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%
1 27.679850069841309838119811529801739828540.22
2 27.679847479846849847160.01
单位质量响应值RSD%判断
35520.5635587.860.14数据可信
供试品溶液-2024032421批-沙库巴曲-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min16706-67060.2890.10119.090.290.10118.61
24713-47130.2030.20
33146-31460.1350.14
4-0.0000.00
5-0.0000.00
6-0.0000.00
10min1-0.0000.23157.300.000.23156.62
221702-217020.9340.93
35262-52620.2260.23
4-0.0000.00
5-0.0000.00
65101-51010.2200.22
15min1-0.0001.21221.340.001.21221.45
2155390-1553906.6886.69
36996-69960.3010.30
4-0.0000.00
5-0.0000.00
66789-67890.2920.29
20min13825-38250.1651.61206.790.171.61206.75
2195005-1950058.3938.41
38785-87850.3780.38
43997-39970.1720.17
53963-39630.1710.17
68602-86020.3700.37
30min1192998-1929988.3064.23102.098.314.24102.11
2207707-2077078.9398.97
3166865-1668657.1817.18
45589-55890.2410.24
55470-54700.2350.24
611440-114400.4920.49
45min1241194-24119410.38010.484.6510.3910.504.66
2246679-24667910.61610.66
3250682-25068210.78910.80
4243245-24324510.46910.47
5256550-25655011.04111.04
6223421-2234219.6159.62
60min1261939-26193911.27312.4216.6911.3112.4516.64
2258483-25848311.12411.18
3378460-37846016.28816.32
4273641-27364111.77711.79
5307277-30727713.22413.24
6252078-25207810.84910.87
90min1279887-27988712.04613.1517.5412.1013.2017.49
2272638-27263811.73411.81
3411568-41156817.71317.77
4308298-30829813.26813.31
5288854-28885412.43212.47
6272477-27247711.72711.76
120min1294883-29488312.69114.1717.4012.7614.2417.34
2282393-28239312.15312.25
3434356-43435618.69418.78
4330200-33020014.21114.27
5345871-34587114.88514.95
6287932-28793212.39212.45
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1488670-48867021.03120.604.5821.1220.694.59
2481611-48161120.72720.85
3491876-49187621.16921.29
4435596-43559618.74718.83
5494777-49477721.29421.38
6478796-47879620.60620.68
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%
1 27.675759265761495757775762415760855760360.04
2 27.675746755743935745340.04
单位质量响应值RSD%判断
20818.0720763.790.19数据可信
供试品溶液-2024032621批-缬沙坦-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min16899-68990.5370.48105.580.540.48105.70
22636-26360.2050.21
319065-190651.4851.49
43112-31120.2420.24
53364-33640.2620.26
62070-20700.1610.16
10min18785-87850.6840.4382.340.690.4483.03
22483-24830.1930.19
313513-135131.0531.06
42563-25630.2000.20
53384-33840.2640.26
62684-26840.2090.21
15min118261-182611.4231.00140.511.421.00140.61
22928-29280.2280.23
347607-476073.7093.71
42055-20550.1600.16
54010-40100.3120.31
62451-24510.1910.19
20min143620-436203.3981.95146.643.401.96146.62
23625-36250.2820.28
392613-926137.2157.22
42629-26290.2050.21
54875-48750.3800.38
63094-30940.2410.24
30min160016-600164.6754.7755.774.694.7855.79
260835-608354.7394.74
3104633-1046338.1518.17
486856-868566.7666.77
550101-501013.9033.90
64985-49850.3880.39
45min174057-740575.7696.6843.175.796.7043.17
280299-802996.2556.26
3114381-1143818.9108.95
4141539-14153911.02611.04
568137-681375.3085.32
636291-362912.8272.83
60min181572-815726.3547.2941.576.387.3241.58
290394-903947.0427.06
3121568-1215689.4709.52
4154331-15433112.02212.05
568188-681885.3125.33
645630-456303.5553.56
90min191580-915807.1348.2240.007.178.2540.01
2100810-1008107.8537.88
3129500-12950010.08810.15
4175806-17580613.69513.75
579477-794776.1916.22
655666-556664.3364.35
120min198979-989797.71010.5323.517.7610.5823.47
2110745-1107458.6278.67
3136727-13672710.65110.73
4190388-19038814.83114.90
5143413-14341311.17211.21
6130775-13077510.18710.21
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1248415-24841519.35119.345.1719.4119.415.23
2247508-24750819.28119.34
3239800-23980018.68018.78
4271022-27102221.11221.21
5249724-24972419.45319.51
6233066-23306618.15618.19
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%
1 27.679821719824019811869816799820509818970.05
2 27.679801279788259794760.10
单位质量响应值RSD%判断
35485.9835398.480.18数据可信
供试品溶液-2024032621批-沙库巴曲-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min111815-118150.5100.3194.740.510.3194.69
24287-42870.1850.19
318872-188720.8150.81
4-0.0000.00
55882-58820.2540.25
62870-28700.1240.12
10min115330-153300.6620.38120.170.660.38120.22
24273-42730.1840.18
327070-270701.1691.17
4-0.0000.00
56139-61390.2650.27
6-0.0000.00
15min134125-341251.4731.06146.681.481.06147.01
25112-51120.2210.22
394180-941804.0664.07
43342-33420.1440.14
57245-72450.3130.31
63557-35570.1540.15
20min183511-835113.6052.08150.353.612.08150.42
26255-62550.2700.27
3181313-1813137.8287.84
44326-43260.1870.19
58604-86040.3710.37
64485-44850.1940.19
30min1114025-1140254.9235.1056.684.935.1156.75
2118225-1182255.1045.11
3201140-2011408.6848.71
4171101-1711017.3877.39
597429-974294.2064.21
67246-72460.3130.31
45min1138242-1382425.9687.0244.515.997.0444.49
2154811-1548116.6846.69
3215283-2152839.2959.33
4273270-27327011.79811.81
5128389-1283895.5435.55
665912-659122.8462.85
60min1149854-1498546.4707.5742.666.507.6042.65
2171998-1719987.4267.45
3225578-2255789.7399.79
4293427-29342712.66812.70
5128431-1284315.5455.56
682489-824893.5613.57
90min1164177-1641777.0888.3341.627.138.3841.62
2187600-1876008.0998.13
3236870-23687010.22710.30
4327364-32736414.13314.19
5144660-1446606.2456.27
697610-976104.2144.23
120min1174173-1741737.52010.6824.417.5710.7324.37
2202267-2022678.7338.78
3247302-24730210.67710.76
4348968-34896815.06615.14
5269204-26920411.62211.66
6241827-24182710.44110.46
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1443031-44303119.12719.285.3719.1919.355.42
2446185-44618519.26319.32
3426636-42663618.41918.52
4488137-48813721.07521.18
5454494-45449419.62219.68
6420679-42067918.16218.20
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%
1 27.675762565753475757595756945761915758490.07
2 27.675787745782115784920.07
单位质量响应值RSD%判断
20811.3120906.830.33数据可信
供试品溶液-2024032621批-缬沙坦-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min12283-22830.1770.2317.130.180.2316.95
23243-32430.2520.25
32358-23580.1830.18
43192-31920.2480.25
53508-35080.2720.27
63079-30790.2390.24
10min13160-31600.2450.60113.620.250.60113.15
22910-29100.2260.23
32577-25770.2000.20
48328-83280.6470.65
54232-42320.3290.33
625078-250781.9471.95
15min14948-49480.3841.28159.580.381.28159.59
22180-21800.1690.17
33355-33550.2600.26
413643-136431.0591.06
55234-52340.4060.41
669485-694855.3955.40
20min16194-61940.4811.59160.330.481.60160.14
22776-27760.2160.22
34048-40480.3140.32
412431-124310.9650.97
510435-104350.8100.81
687274-872746.7766.79
30min18236-82360.6394.9395.840.644.9495.81
2102308-1023087.9447.95
363598-635984.9384.94
415594-155941.2111.22
526332-263322.0452.05
6164859-16485912.80112.82
45min155383-553834.3007.9855.154.307.9955.24
2119211-1192119.2569.27
393178-931787.2357.24
4129144-12914410.02710.03
530195-301952.3442.35
6189225-18922514.69214.74
60min176855-768555.96710.3543.115.9810.3843.16
2191636-19163614.88014.91
3104038-1040388.0788.10
4153720-15372011.93611.96
571070-710705.5185.53
6202331-20233115.71015.78
90min189756-897566.96911.8041.126.9911.8541.18
2216691-21669116.82516.88
3117817-1178179.1489.18
4172272-17227213.37613.42
587655-876556.8066.83
6227822-22782217.68917.79
120min199538-995387.72912.6939.277.7612.7539.34
2228163-22816317.71617.80
3127126-1271269.8719.92
4184945-18494514.36014.43
598060-980607.6147.64
6242471-24247118.82718.95
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1245664-24566419.07520.247.2919.1220.327.47
2271320-27132021.06721.18
3253070-25307019.65019.72
4266215-26621520.67020.76
5237714-23771418.45718.50
6289771-28977122.49922.66
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%
1 27.679826599818709818429815929818089819540.05
2 27.679859019845209852100.10
单位质量响应值RSD%判断
35488.0435605.710.24数据可信
供试品溶液-2024032621批-沙库巴曲-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min14104-41040.1770.10112.420.180.10112.22
2-0.0000.00
34033-40330.1740.17
45666-56660.2440.24
5-0.0000.00
6-0.0000.00
10min15419-54190.2330.58133.280.230.58133.60
2-0.0000.00
34277-42770.1840.18
415183-151830.6540.65
57368-73680.3170.32
648824-488242.1022.10
15min18273-82730.3561.33165.060.361.33164.86
23772-37720.1620.16
35531-55310.2380.24
424954-249541.0741.08
59065-90650.3900.39
6133942-1339425.7665.77
20min110363-103630.4461.64166.120.451.64166.07
24687-46870.2020.20
36906-69060.2970.30
422397-223970.9640.97
517732-177320.7630.76
6166693-1666937.1767.19
30min113748-137480.5925.1996.830.595.2096.86
2198222-1982228.5338.53
3123009-1230095.2955.30
427404-274041.1801.18
548620-486202.0932.10
6312587-31258713.45613.48
45min1103875-1038754.4718.3555.134.478.3655.18
2228034-2280349.8169.83
3177605-1776057.6457.66
4244868-24486810.54110.55
555065-550652.3702.38
6354398-35439815.25615.30
60min1142102-1421026.11710.7543.326.1310.7843.38
2364386-36438615.68615.72
3196960-1969608.4788.50
4286703-28670312.34212.37
5132373-1323735.6985.71
6375511-37551116.16416.24
90min1162275-1622756.98512.0441.947.0112.0942.00
2404641-40464117.41817.48
3218209-2182099.3939.43
4316062-31606213.60513.65
5158074-1580746.8056.82
6419404-41940418.05418.15
120min1176745-1767457.60812.7940.577.6412.8540.63
2422379-42237918.18218.27
3231360-2313609.95910.01
4335072-33507214.42414.49
5173564-1735647.4717.50
6443356-44335619.08519.21
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1435679-43567918.75419.937.5618.8020.027.75
2485549-48554920.90121.02
3451304-45130419.42719.50
4472895-47289520.35620.45
5418632-41863218.02118.06
6514547-51454722.14922.31
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