沙库巴曲缬沙坦钠片项目信息
介质体积(ml)1000取样体积(ml)2补液体积(ml)2
对照品批号DSMF-4022-230920对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.06 5526045522575521995522455516885521990.06
228.015544545546245545390.03
单位质量响应值RSD%判断
19679.2219797.890.43数据可信
加速6月-供试品溶液-23090601批-缬沙坦钠-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%
5min15402-54022.7371.4078.852.741.4079.05
25151-51512.6102.61
3819-8190.4150.41
43345-33451.6951.69
51128-11280.5710.57
6712-7120.3610.36
10min113341-133416.75915.0146.456.7615.0246.46
247582-4758224.10624.11
332449-3244916.44016.44
443226-4322621.89921.90
519173-191739.7149.71
622048-2204811.17011.17
15min177693-7769339.36131.5825.3439.3831.6125.33
286522-8652243.83443.89
353397-5339727.05227.09
451687-5168726.18626.23
556391-5639128.56928.59
648284-4828424.46224.49
20min197080-9708049.18343.9119.8349.2844.0119.78
297492-9749249.39249.53
382287-8228741.68941.78
454707-5470727.71627.82
587345-8734544.25144.33
6101136-10113651.23851.31
30min1157527-15752779.80762.8619.6380.0063.0419.56
2106022-10602253.71453.95
3101139-10113951.24051.41
4141790-14179071.83571.99
5101289-10128951.31651.48
6136703-13670369.25769.43
45min1183974-18397493.20685.6118.3593.5685.9218.31
2184014-18401493.22693.57
3167282-16728284.75085.02
4168316-16831685.27385.57
5110631-11063156.04956.32
6199712-199712101.180101.49
60min1197521-197521100.07099.246.89100.6199.726.89
2207210-207210104.978105.51
3187341-18734194.91295.36
4179430-17943090.90491.37
5188477-18847795.48895.87
6215360-215360109.107109.62
极限1263463-263463133.478133.972.18134.22134.652.20
2266753-266753135.144135.89
3265653-265653134.587135.22
4260382-260382131.917132.57
5256825-256825130.115130.69
6273538-273538138.582139.32
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)1000取样体积(ml)2补液体积(ml)2
对照品批号DSMF-4022-230920对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.06 9571599564259567109558039561819564560.06
228.019611729616599614160.04
单位质量响应值RSD%判断
34086.1034324.030.50数据可信
加速6月-供试品溶液-23090601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%
5min19429-94292.7571.3979.482.761.3979.44
28734-87342.5532.55
31394-13940.4080.41
45843-58431.7081.71
51944-19440.5680.57
61135-11350.3320.33
10min123228-232286.79116.2648.946.8016.2748.92
291457-9145726.73826.74
361274-6127417.91417.91
482043-8204323.98623.99
535304-3530410.32110.32
640485-4048511.83611.84
15min1151287-15128744.23034.8126.5444.2534.8426.53
2166209-16620948.59348.65
3100027-10002729.24429.28
496492-9649228.21028.26
5108671-10867131.77131.79
691702-9170226.81026.83
20min1186588-18658854.55048.5220.9354.6648.6320.89
2185364-18536454.19354.35
3157191-15719145.95646.05
4101481-10148129.66929.78
5167701-16770149.02949.11
6197480-19748057.73557.81
30min1303922-30392288.85469.1920.8989.0769.3920.82
2198148-19814857.93058.19
3191614-19161456.02056.21
4272259-27225979.59779.76
5190067-19006755.56855.75
6263893-26389377.15177.34
45min1352294-352294102.99694.0519.41103.3994.3919.37
2350224-350224102.391102.77
3320328-32032893.65093.95
4320023-32002393.56193.89
5203765-20376559.57259.87
6383489-383489112.116112.46
60min1374325-374325109.437108.277.12110.04108.807.13
2391937-391937114.586115.17
3356018-356018104.085104.57
4338131-33813198.85599.37
5353135-353135103.242103.66
6408427-408427119.407119.98
极限1482555-482555141.079142.352.13141.90143.102.16
2491521-491521143.700144.51
3489363-489363143.069143.76
4479105-479105140.070140.78
5475053-475053138.886139.51
6503872-503872147.311148.12
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)1000取样体积(ml)2补液体积(ml)2
对照品批号DSMF-4022-230920对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.06 5538555531285530355533595534545533660.06
228.015574515576825575660.03
单位质量响应值RSD%判断
19720.8119905.960.67数据可信
加速6月-供试品溶液-23090601批-缬沙坦钠-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%
5min110708-107085.4052.5673.515.402.5673.49
28854-88544.4694.47
33521-35211.7771.78
42241-22411.1311.13
52875-28751.4511.45
62224-22241.1221.12
10min131991-3199116.14711.4765.2216.1611.4865.20
229967-2996715.12515.13
35279-52792.6642.67
43240-32401.6351.64
538743-3874319.55419.56
627139-2713913.69813.70
15min135226-3522617.77918.8576.8717.8218.8876.83
235127-3512717.72917.77
318827-188279.5029.51
44567-45672.3052.31
589093-8909344.96745.01
641215-4121520.80220.83
20min138991-3899119.68038.3935.0219.7638.4634.95
291764-9176446.31546.39
394852-9485247.87447.90
489176-8917645.00945.02
596723-9672348.81848.95
644850-4485022.63722.71
30min1156854-15685479.16768.7014.7379.2968.8414.64
2125169-12516963.17563.34
3152804-15280477.12377.25
4149308-14930875.35975.46
5105837-10583753.41853.65
6126671-12667163.93364.05
45min1180868-18086891.28878.4714.9291.5678.7514.84
2154075-15407577.76578.06
3172302-17230286.96487.24
4165349-16534983.45583.71
5116454-11645458.77759.11
6143773-14377372.56572.81
60min1190282-19028296.03983.7815.7396.5084.2215.65
2162294-16229481.91382.36
3181892-18189291.80592.26
4186991-18699194.37894.80
5122134-12213461.64462.10
6152359-15235976.89977.29
极限1254776-254776128.591123.533.04129.24124.143.05
2238205-238205120.227120.84
3251679-251679127.027127.66
4246930-246930124.631125.24
5237935-237935120.091120.67
6238968-238968120.612121.16
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)1000取样体积(ml)2补液体积(ml)2
对照品批号DSMF-4022-230920对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.06 9592779583109579279588819585079585800.06
228.019670179672869671520.02
单位质量响应值RSD%判断
34161.8034528.810.76数据可信
加速6月-供试品溶液-23090601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%
5min121298-212986.2012.8576.756.202.8476.71
217189-171895.0055.00
36574-65741.9141.91
44195-41951.2211.22
55210-52101.5171.52
64175-41751.2161.22
10min162295-6229518.13813.1066.7018.1513.1066.68
258277-5827716.96816.98
39739-97392.8362.84
45999-59991.7471.75
579266-7926623.08023.08
654369-5436915.83115.83
15min167337-6733719.60621.3479.4019.6621.3779.35
266577-6657719.38519.43
337537-3753710.93010.94
48267-82672.4072.41
5179547-17954752.27952.33
680476-8047623.43223.47
20min173328-7332821.35143.5636.4821.4443.6436.40
2178038-17803851.83951.92
3188101-18810154.76954.80
4179284-17928452.20252.21
5192810-19281056.14056.29
686088-8608825.06625.15
30min1303761-30376188.44676.4114.1688.5876.5714.07
2238995-23899569.58869.77
3279821-27982181.47581.62
4296066-29606686.20586.32
5207636-20763660.45760.72
6248218-24821872.27372.40
45min1344358-344358100.26687.0715.06100.5787.3914.97
2292230-29223085.08885.41
3333862-33386297.21097.51
4324201-32420194.39794.68
5223884-22388465.18865.58
6275771-27577180.29680.57
60min1359245-359245104.60192.0916.20105.1192.5816.11
2305319-30531988.89989.40
3349534-349534101.773102.27
4362991-362991105.692106.17
5232088-23208867.57768.09
6288459-28845983.99084.43
极限1470521-470521137.001132.353.22137.72133.033.23
2438841-438841127.777128.45
3469395-469395136.673137.38
4462920-462920134.788135.48
5443160-443160129.034129.69
6442496-442496128.841129.45
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)1000取样体积(ml)2补液体积(ml)2
对照品批号DSMF-4022-230920对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.06 5550255556015551525552245542165550440.10
228.015641905642915642400.02
单位质量响应值RSD%判断
19780.6120144.231.29数据可信
-供试品溶液-01批-缬沙坦钠-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%
5min11294-12940.6481.2644.780.651.2644.76
23986-39861.9972.00
31750-17500.8770.88
43532-35321.7691.77
52995-29951.5001.50
61578-15780.7910.79
10min11917-19170.96010.9766.620.9610.9766.61
226870-2687013.46113.47
339482-3948219.78019.78
412952-129526.4896.49
514342-143427.1857.19
635806-3580617.93817.94
15min163467-6346731.79631.3026.8031.8031.3226.79
234084-3408417.07517.11
367651-6765133.89233.93
470788-7078835.46435.48
555233-5523327.67127.69
683591-8359141.87841.92
20min184855-8485542.51142.7324.1942.5842.8224.18
246397-4639723.24423.31
3101818-10181851.00951.12
488968-8896844.57144.66
586390-8639043.28043.35
6103364-10336451.78451.90
30min1130879-13087965.56861.0431.5865.7261.2131.52
253057-5305726.58126.69
3128095-12809564.17364.38
4167761-16776184.04584.22
5139964-13996470.12070.28
6111291-11129155.75555.98
45min1166892-16689283.61077.1123.7783.8977.4023.75
284844-8484442.50542.67
3144051-14405172.16772.51
4183378-18337891.86992.21
5179838-17983890.09690.40
6164448-16444882.38682.72
60min1179968-17996890.16185.2222.1390.6185.6722.12
293888-9388847.03647.29
3185603-18560392.98493.47
4190923-19092395.64996.18
5190065-19006595.21995.70
6180221-18022190.28890.79
极限1248439-248439124.464119.226.55125.09119.846.63
2207552-207552103.980104.32
3241487-241487120.981121.65
4249818-249818125.155125.87
5237390-237390118.928119.60
6243121-243121121.799122.48
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)1000取样体积(ml)2补液体积(ml)2
对照品批号DSMF-4022-230920对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.06 9633029645259636869634509617999633520.11
228.019740709737369739030.03
单位质量响应值RSD%判断
34331.8634769.830.90数据可信
-供试品溶液-01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%
5min12155-21550.6241.2944.770.621.2944.97
27174-71742.0762.08
33035-30350.8780.88
46223-62231.8011.80
55041-50411.4591.46
63125-31250.9050.90
10min13367-33670.97512.3967.830.9812.4067.80
251964-5196415.04015.04
376563-7656322.16022.16
424538-245387.1027.11
527946-279468.0898.09
672540-7254020.99621.00
15min1126830-12683036.71035.8127.7536.7135.8427.74
265830-6583019.05419.09
3133027-13302738.50338.55
4139901-13990140.49340.51
5108744-10874431.47531.49
6167985-16798548.62248.67
20min1167490-16749048.47848.7224.5748.5548.8224.56
290264-9026426.12626.20
3201300-20130058.26458.39
4175542-17554250.80950.91
5170917-17091749.47049.55
6204491-20449159.18859.33
30min1257434-25743474.51269.2232.0174.6969.4231.96
2101881-10188129.48829.61
3252327-25232773.03473.27
4328861-32886195.18695.39
5277014-27701480.17980.36
6217453-21745362.94063.20
45min1325693-32569394.26986.6224.0094.5986.9623.98
2163291-16329147.26347.45
3280300-28030081.13081.52
4354771-354771102.685103.08
5351487-351487101.734102.08
6320000-32000092.62193.01
60min1346855-346855100.39494.7622.57100.9095.2722.57
2177805-17780551.46451.74
3359958-359958104.186104.73
4366018-366018105.940106.54
5367807-367807106.458107.00
6345971-345971100.138100.71
极限1466499-466499135.024128.966.94135.74129.667.02
2384557-384557111.306111.69
3455086-455086131.720132.48
4466621-466621135.059135.87
5445784-445784129.028129.79
6454832-454832131.647132.42
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)1000取样体积(ml)2补液体积(ml)2
对照品批号DSMF-4022-230920对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.06 2755222756902755212748062751962753470.13
228.012754082757002755540.08
单位质量响应值RSD%判断
9812.799837.700.18数据可信
-供试品溶液-02批-缬沙坦钠-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%
5min14123-41234.1962.8335.794.202.8235.82
22011-20112.0472.05
31544-15441.5711.57
43194-31943.2513.25
52254-22542.2942.29
63531-35313.5943.59
10min18949-89499.1084.6251.599.124.6351.61
22904-29042.9562.96
32291-22912.3322.33
44162-41624.2364.24
54717-47174.8014.81
64225-42254.3004.31
15min132949-3294933.53517.6166.6333.5617.6266.59
23309-33093.3683.38
324478-2447824.91324.92
44694-46944.7774.79
517446-1744617.75617.77
620932-2093221.30421.32
20min139361-3936140.06135.9551.6640.1536.0051.62
26999-69997.1237.14
358604-5860459.64659.70
443115-4311543.88243.91
521442-2144221.82321.87
642400-4240043.15443.21
30min142504-4250443.26042.5547.3243.4342.6747.28
212877-1287713.10613.14
365041-6504166.19866.37
458002-5800259.03459.15
524939-2493925.38325.48
647446-4744648.29048.43
45min146233-4623347.05551.3250.0147.3251.5349.94
220406-2040620.76920.83
368872-6887270.09770.41
487855-8785589.41889.65
527678-2767828.17028.31
651513-5151352.42952.67
60min149151-4915150.02555.5147.5550.3855.8247.50
224516-2451624.95225.05
372113-7211373.39673.85
494389-9438996.06896.48
531436-3143631.99532.20
655618-5561856.60756.95
极限1116475-116475118.547121.8910.62119.00122.3110.72
2104030-104030105.880106.03
3131601-131601133.942134.54
4136439-136439138.866139.47
5108471-108471110.400110.66
6121551-121551123.713124.17
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)1000取样体积(ml)2补液体积(ml)2
对照品批号DSMF-4022-230920对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.06 4778554774914774104768074772834773690.08
228.014780794786554783670.09
单位质量响应值RSD%判断
17012.4417078.440.28数据可信
-供试品溶液-02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%
5min17593-75934.4552.7639.704.452.7539.69
23433-34332.0142.01
32576-25761.5111.51
45134-51343.0123.01
53563-35632.0902.09
65886-58863.4533.45
10min116926-169269.9304.8055.819.944.8155.79
25143-51433.0173.02
34028-40282.3632.37
47310-73104.2894.29
58324-83244.8834.89
67392-73924.3374.34
15min164948-6494838.10319.7468.6438.1319.7668.61
25829-58293.4203.43
348171-4817128.26028.27
48179-81794.7984.81
533794-3379419.82619.84
640984-4098424.04424.06
20min177262-7726245.32740.7052.0345.4340.7652.00
213508-135087.9257.94
3115335-11533567.66467.73
484994-8499449.86349.89
541586-4158624.39724.45
683566-8356649.02649.09
30min182576-8257648.44547.8347.3448.6447.9747.31
225510-2551014.96615.00
3127122-12712274.57974.78
4113127-11312766.36866.49
548251-4825128.30728.41
692601-9260154.32654.49
45min188412-8841251.86957.0750.3752.1657.3050.30
239469-3946923.15523.22
3133452-13345278.29278.64
4169977-16997799.72099.98
552731-5273130.93631.09
699668-9966858.47258.74
60min193026-9302654.57660.9648.4854.9761.3048.42
245926-4592626.94327.05
3138409-13840981.20081.71
4180915-180915106.137106.59
558326-5832634.21834.44
6106845-10684562.68363.07
极限1215112-215112126.200129.4411.06126.71129.9111.17
2191212-191212112.178112.34
3243712-243712142.978143.65
4252609-252609148.198148.87
5197918-197918116.112116.40
6223296-223296131.001131.51
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)1000取样体积(ml)2补液体积(ml)2
对照品批号DSMF-4022-230920对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.06 2780632781222781262778062776492779530.08
228.012833732834562834140.03
单位质量响应值RSD%判断
9905.6710118.311.51数据可信
-供试品溶液-01批-缬沙坦钠-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%
5min1-0.0001.8795.330.001.8795.27
24397-43974.3924.39
31118-11181.1171.12
42981-29812.9782.98
52741-27412.7382.74
6-0.0000.00
10min12740-27402.73710.3477.252.7410.3477.23
26219-62196.2126.22
312282-1228212.26912.27
419383-1938319.36219.37
519646-1964619.62519.63
61820-18201.8181.82
15min132382-3238232.34726.8956.7232.3526.9256.72
231697-3169731.66331.68
314904-1490414.88814.91
447855-4785547.80347.85
530515-3051530.48230.53
64175-41754.1704.17
20min152127-5212752.07048.6027.8852.1448.6827.90
237826-3782637.78537.87
353941-5394153.88253.94
469334-6933469.25969.40
548301-4830148.24948.35
630371-3037130.33830.35
30min165781-6578165.71070.0915.6865.8870.2615.72
265259-6525965.18865.35
380887-8088780.79980.96
485775-8577585.68285.96
567032-6703266.95967.16
656258-5625856.19756.27
45min195089-9508994.98682.7013.8795.2983.0213.88
278581-7858178.49678.79
390396-9039690.29890.62
492212-9221292.11292.56
573978-7397873.89874.23
666498-6649866.42666.61
60min1100953-100953100.84392.319.11101.3492.799.10
284249-8424984.15884.61
398106-9810698.00098.51
498299-9829998.19298.83
580280-8028080.19380.68
692549-9254992.44992.77
极限1127866-127866127.727124.443.60128.42125.103.58
2121145-121145121.014121.63
3129321-129321129.181129.88
4123165-123165123.031123.86
5118057-118057117.929118.57
6127887-127887127.748128.25
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)1000取样体积(ml)2补液体积(ml)2
对照品批号DSMF-4022-230920对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.06 4815744817184818614815804824874818440.08
228.014883394883774883580.01
单位质量响应值RSD%判断
17171.9217435.131.08数据可信
-供试品溶液-01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%
5min1-0.0002.0597.860.002.0597.94
28559-85594.9474.95
31858-18581.0741.07
45423-54233.1343.13
55447-54473.1483.15
6-0.0000.00
10min15344-53443.08911.9977.723.0912.0077.70
212255-122557.0837.09
324663-2466314.25414.26
438107-3810722.02422.03
540372-4037223.33323.34
63752-37522.1682.17
15min164351-6435137.19230.9456.3237.2030.9756.31
263117-6311736.47836.50
329370-2937016.97417.01
494190-9419054.43754.49
561747-6174735.68735.74
68457-84574.8884.89
20min1103222-10322259.65755.7826.9459.7455.8726.96
274918-7491843.29943.40
3106851-10685161.75561.82
4135570-13557078.35378.51
597140-9714056.14256.27
661387-6138735.47935.49
30min1129549-12954974.87380.0114.8775.0780.2114.90
2128915-12891574.50674.69
3158961-15896191.87292.06
4166980-16698096.50696.82
5134094-13409477.50077.74
6112129-11212964.80564.89
45min1185158-185158107.01293.3113.25107.3693.6813.26
2154032-15403289.02389.36
3175414-175414101.381101.75
4178050-178050102.904103.41
5145168-14516883.90084.29
6130912-13091275.66175.88
60min1195015-195015112.709103.178.89113.27103.728.87
2163657-16365794.58695.10
3189191-189191109.343109.92
4187912-187912108.604109.32
5154865-15486589.50490.06
6180431-180431104.280104.65
极限1235830-235830136.298132.993.76137.09133.743.72
2224865-224865129.961130.66
3239572-239572138.461139.25
4226499-226499130.905131.84
5217184-217184125.522126.26
6236652-236652136.773137.35
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