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%
128.012915272907252906282894972900292904810.27
228.022884552884602884580.01
单位质量响应值RSD%判断
10370.6210294.720.52数据可信
影响因素30天-包装高温-供试品溶液-SDR926批-缬沙坦-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%
5min152910-5291051.20755.7014.0751.2155.7014.07
243286-4328641.89341.89
364984-6498462.89362.89
461405-6140559.42959.43
560072-6007258.13958.14
662674-6267460.65760.66
10min1131742-131742127.502137.1512.19127.60137.2612.19
2114479-114479110.795110.88
3162321-162321157.097157.22
4142226-142226137.649137.77
5142807-142807138.211138.33
6156668-156668151.626151.75
15min1197289-197289190.940207.8611.87191.30208.2511.87
2177199-177199171.496171.80
3244303-244303236.441236.88
4210206-210206203.441203.84
5220168-220168213.082213.48
6239458-239458231.752232.18
20min1280616-280616271.585256.967.31272.32257.777.30
2234949-234949227.388228.04
3274673-274673265.833266.75
4249102-249102241.085241.89
5284124-284124274.980275.80
6269587-269587260.911261.80
30min1303350-303350293.587277.794.09294.87279.104.08
2277766-277766268.827269.93
3285911-285911276.710278.15
4274621-274621265.783267.07
5299193-299193289.564290.93
6281321-281321272.267273.68
45min1308585-308585298.654282.993.90300.52284.863.89
2283523-283523274.398276.04
3290418-290418281.072283.07
4280758-280758271.722273.54
5304131-304131294.343296.29
6287000-287000277.764279.72
60min1309362-309362299.406284.623.60301.87287.063.60
2285819-285819276.621278.81
3293025-293025283.595286.15
4282997-282997273.889276.25
5304434-304434294.636297.17
6288862-288862279.566282.08
极限1324381-324381313.942306.971.62317.01309.981.61
2318037-318037307.802310.54
3317264-317264307.054310.18
4315792-315792305.629308.53
5319000-319000308.734311.86
6308596-308596298.665301.73
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%
128.015011005002174996564987964998104999160.17
228.024968514966874967690.03
单位质量响应值RSD%判断
17847.7717729.090.48数据可信
影响因素30天-包装高温-供试品溶液-SDR926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%
5min169075-6907538.83242.0314.5138.8342.0314.50
255513-5551331.20831.21
384660-8466047.59347.59
478944-7894444.38044.38
577909-7790943.79843.80
682468-8246846.36146.36
10min1189281-189281106.408114.5412.75106.49114.6212.75
2162129-16212991.14491.21
3234128-234128131.620131.71
4204654-204654115.050115.14
5206122-206122115.876115.96
6226163-226163127.142127.23
15min1299577-299577168.413183.4212.47168.70183.7312.47
2267128-267128150.171150.42
3374062-374062210.286210.64
4317609-317609178.550178.87
5332219-332219186.763187.08
6367021-367021206.328206.68
20min1442937-442937249.006236.567.91249.63237.247.91
2366230-366230205.883206.43
3438701-438701246.624247.40
4393870-393870221.422222.10
5450462-450462253.236253.93
6432562-432562243.173243.93
30min1503465-503465283.033266.934.43284.16268.084.42
2457565-457565257.229258.19
3472917-472917265.860267.13
4450906-450906253.486254.60
5496245-496245278.974280.17
6467788-467788262.976264.22
45min1522652-522652293.819277.084.30295.51278.774.29
2478235-478235268.849270.32
3488421-488421274.575276.38
4469118-469118263.724265.35
5514776-514776289.391291.15
6484094-484094272.143273.91
60min1525203-525203295.253279.464.07297.53281.704.07
2482913-482913271.479273.49
3493632-493632277.505279.86
4474075-474075266.511268.66
5518097-518097291.258293.59
6488699-488699274.732277.05
极限1557237-557237313.262304.631.90316.13307.431.89
2543613-543613305.603308.15
3540955-540955304.108307.02
4534127-534127300.270302.96
5547423-547423307.745310.66
6527940-527940296.792299.66
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%
128.012898282899412897172897352896712897780.04
228.022943242942412942820.02
单位质量响应值RSD%判断
10345.5210502.571.07数据可信
影响因素30天-包装高温-供试品溶液-SDR926批-缬沙坦-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%
5min161897-6189759.38257.656.0059.3857.656.00
261607-6160759.10459.10
364071-6407161.46861.47
461013-6101358.53458.53
558075-5807555.71655.72
653881-5388151.69251.69
10min1138042-138042132.434138.963.03132.55139.073.03
2149106-149106143.049143.17
3145745-145745139.824139.95
4141972-141972136.204136.32
5149563-149563143.487143.60
6144626-144626138.751138.85
15min1231490-231490222.086217.224.96222.47217.614.95
2228644-228644219.355219.76
3205367-205367197.024197.43
4223937-223937214.840215.23
5237548-237548227.898228.30
6231504-231504222.099222.48
20min1291124-291124279.297273.612.29280.12274.442.28
2284840-284840273.268274.11
3291355-291355279.519280.32
4284549-284549272.989273.81
5285901-285901274.286275.14
6273429-273429262.321263.15
30min1304850-304850292.465289.042.24293.85290.422.23
2299533-299533287.364288.75
3311333-311333298.685300.04
4299756-299756287.578288.94
5301312-301312289.071290.47
6290924-290924279.105280.45
45min1308718-308718296.176293.452.11298.15295.402.10
2302346-302346290.063292.03
3316498-316498303.640305.59
4302898-302898290.593292.53
5306968-306968294.497296.48
6297833-297833285.734287.64
60min1309305-309305296.739294.351.94299.30296.891.93
2302471-302471290.183292.73
3316453-316453303.597306.16
4303638-303638291.303293.82
5308813-308813296.267298.84
6300194-300194287.999290.48
极限1314495-314495301.719307.862.49304.88310.992.47
2314262-314262301.495304.62
3334564-334564320.972324.14
4315773-315773302.945306.05
5325322-325322312.106315.27
6320989-320989307.949311.00
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%
128.015010485016465013785015535014385014130.05
228.025071575071055071310.01
单位质量响应值RSD%判断
17901.2118098.890.78数据可信
影响因素30天-包装高温-供试品溶液-SDR926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%
5min181388-8138845.21743.926.5145.2243.926.50
281438-8143845.24545.24
385016-8501647.23247.23
479794-7979444.33144.33
576402-7640242.44742.45
670234-7023439.02039.02
10min1200801-200801111.559116.612.94111.65116.702.93
2217394-217394120.778120.87
3211910-211910117.731117.83
4206325-206325114.628114.72
5215224-215224119.572119.66
6207665-207665115.373115.45
15min1354964-354964197.208192.244.78197.52192.564.76
2349712-349712194.290194.62
3315155-315155175.091175.42
4342103-342103190.062190.38
5362330-362330201.300201.62
6351897-351897195.504195.81
20min1465894-465894258.837252.712.24259.54253.412.23
2456439-456439253.584254.30
3460183-460183255.664256.34
4454711-454711252.624253.32
5456122-456122253.408254.13
6435830-435830242.134242.83
30min1508762-508762282.653278.832.30283.88280.042.29
2501500-501500278.619279.85
3516974-516974287.216288.41
4501812-501812278.792280.00
5499896-499896277.728278.96
6482300-482300267.952269.14
45min1524147-524147291.201287.442.13292.99289.212.13
2514380-514380285.774287.56
3534100-534100296.730298.50
4513418-513418285.240287.00
5516850-516850287.147288.94
6501385-501385278.555280.27
60min1529076-529076293.939290.131.98296.31292.471.97
2516226-516226286.800289.16
3538318-538318299.074301.43
4517068-517068287.268289.60
5523056-523056290.595292.96
6509570-509570283.102285.38
极限1541140-541140300.642305.672.24303.60308.592.23
2540414-540414300.238303.17
3572263-572263317.933320.89
4542760-542760301.542304.45
5556163-556163308.988311.93
6548398-548398304.674307.52
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%
128.012906672906222903072891722880192897570.40
228.022925062922312923680.07
单位质量响应值RSD%判断
10344.7710434.260.61数据可信
影响因素30天-包装高湿-供试品溶液-SDR926批-缬沙坦-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%
5min158939-5893956.73051.598.5156.7351.608.51
252544-5254450.57550.58
349843-4984347.97547.98
457663-5766355.50255.50
555385-5538553.31053.31
647244-4724445.47445.47
10min1143594-143594138.213139.886.39138.33139.986.38
2153117-153117147.379147.48
3130426-130426125.539125.63
4139822-139822134.582134.69
5150146-150146144.520144.63
6154863-154863149.060149.15
15min1223988-223988215.594222.575.61215.98222.955.60
2238677-238677229.733230.13
3208283-208283200.478200.82
4243398-243398234.277234.66
5236564-236564227.699228.09
6236481-236481227.619228.01
20min1258471-258471248.785266.657.68249.61267.487.67
2297674-297674286.519287.37
3247924-247924238.633239.38
4295192-295192284.130284.98
5293193-293193282.206283.06
6269747-269747259.639260.48
30min1273113-273113262.879283.236.22264.20284.596.22
2314153-314153302.381303.81
3278508-278508268.071269.30
4309644-309644298.041299.46
5308204-308204296.655298.07
6281909-281909271.345272.71
45min1277336-277336266.943287.516.07268.79289.446.06
2319218-319218307.256309.29
3284250-284250273.598275.36
4313140-313140301.406303.42
5312247-312247300.546302.55
6286020-286020275.302277.21
60min1296227-296227285.126292.975.41287.50295.475.41
2320515-320515308.504311.15
3285679-285679274.974277.28
4321879-321879309.817312.43
5314122-314122302.351304.96
6287831-287831277.045279.50
极限1318828-318828306.880309.061.29309.83312.151.30
2322785-322785310.689313.95
3323273-323273311.159314.02
4323986-323986311.845315.08
5324018-324018311.876315.09
6313651-313651301.897304.91
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%
128.015012065011175010414995044979775001690.29
228.025009845010725010280.02
单位质量响应值RSD%判断
17856.8017881.080.10数据可信
影响因素30天-包装高湿-供试品溶液-SDR926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%
5min176477-7647742.79938.688.6642.8038.688.66
267978-6797838.04338.04
364131-6413135.89035.89
475100-7510042.02842.03
569787-6978739.05539.05
661211-6121134.25634.26
10min1206217-206217115.405116.266.57115.49116.346.57
2217460-217460121.697121.77
3184632-184632103.326103.40
4201748-201748112.904112.99
5213480-213480119.470119.55
6222938-222938124.763124.83
15min1342527-342527191.689196.425.63192.00196.735.63
2354956-354956198.644198.96
3315370-315370176.491176.77
4370453-370453207.317207.63
5360028-360028201.483201.80
6362531-362531202.883203.20
20min1412038-412038230.589246.357.61231.29247.067.60
2469702-469702262.860263.58
3391605-391605219.154219.79
4470236-470236263.158263.88
5465041-465041260.251260.97
6432630-432630242.113242.84
30min1451396-451396252.615272.886.22253.78274.086.21
2518788-518788290.330291.57
3459875-459875257.360258.43
4514752-514752288.071289.32
5510214-510214285.531286.77
6470640-470640263.384264.59
45min1465428-465428260.468282.186.43262.13283.926.42
2540498-540498302.479304.30
3475633-475633266.179267.76
4531406-531406297.391299.22
5526979-526979294.913296.73
6485360-485360271.622273.36
60min1495322-495322277.197288.786.00279.38291.086.00
2547555-547555306.428308.86
3481519-481519269.473271.59
4548484-548484306.948309.37
5534907-534907299.350301.75
6488334-488334273.287275.56
极限1538594-538594301.414307.121.80304.16310.011.82
2554631-554631310.388313.43
3547972-547972306.662309.32
4559979-559979313.381316.42
5555926-555926311.113314.11
6535692-535692299.790302.61
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%
128.012865242869232868982867832867642867780.06
228.022928952922682925820.16
单位质量响应值RSD%判断
10238.4110441.901.40数据可信
影响因素30天-包装高湿-供试品溶液-SDR926批-缬沙坦-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%
5min155134-5513453.32555.155.7153.3355.155.71
259956-5995657.98957.99
358267-5826756.35656.36
452155-5215550.44450.44
560784-6078458.79058.79
655840-5584054.00854.01
10min1144499-144499139.759149.265.33139.87149.375.33
2157156-157156152.001152.12
3156545-156545151.410151.52
4145585-145585140.809140.91
5155521-155521150.419150.54
6166609-166609161.144161.25
15min1205333-205333198.597223.656.24198.98224.066.24
2248412-248412240.263240.68
3229118-229118221.602222.02
4235210-235210227.494227.88
5238561-238561230.735231.15
6230763-230763223.193223.62
20min1259297-259297250.791272.556.86251.57273.406.84
2284051-284051274.733275.63
3276789-276789267.709268.57
4305586-305586295.562296.40
5302049-302049292.141293.02
6262993-262993254.366255.24
30min1283339-283339274.045289.675.75275.33291.075.74
2295123-295123285.442286.89
3301159-301159291.280292.67
4321577-321577311.028312.46
5316639-316639306.252307.72
6279107-279107269.951271.34
45min1287432-287432278.003293.625.45279.84295.605.44
2298686-298686288.888290.91
3306322-306322296.274298.25
4324326-324326313.687315.74
5320253-320253309.748311.82
6284467-284467275.136277.06
60min1288463-288463279.001296.015.27281.39298.585.26
2299111-299111289.299291.90
3314443-314443304.128306.70
4324453-324453313.810316.49
5321179-321179310.643313.34
6288671-288671279.202281.68
极限1326595-326595315.882315.931.52318.83319.091.51
2317893-317893307.465310.64
3330589-330589319.745322.92
4331997-331997321.106324.41
5327010-327010316.283319.60
6325776-325776315.090318.12
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%
128.014955674957434960074962714957944958760.06
228.024998945000364999650.03
单位质量响应值RSD%判断
17703.5317843.150.56数据可信
影响因素30天-包装高湿-供试品溶液-SDR926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%
5min171712-7171240.34941.686.5640.3541.686.57
278434-7843444.13144.13
375573-7557342.52142.52
466689-6668937.52337.52
579848-7984844.92644.93
672243-7224340.64740.65
10min1209984-209984118.147125.304.94118.23125.384.94
2227202-227202127.835127.92
3224997-224997126.594126.68
4211164-211164118.811118.89
5223295-223295125.637125.73
6239525-239525134.769134.85
15min1316075-316075177.839200.136.35178.16200.476.35
2384450-384450216.310216.65
3351965-351965198.033198.37
4360840-360840203.026203.34
5366274-366274206.084206.42
6354585-354585199.507199.86
20min1414682-414682233.320253.876.95233.99254.616.93
2459311-459311258.431259.21
3439545-439545247.310248.04
4490690-490690276.086276.81
5481614-481614270.980271.73
6421409-421409237.105237.86
30min1472767-472767266.002280.966.11267.14282.206.10
2493180-493180277.487278.78
3500555-500555281.637282.87
4541148-541148304.476305.75
5526644-526644296.316297.61
6461793-461793259.827261.05
45min1485822-485822273.347288.825.94275.02290.625.93
2505578-505578284.463286.31
3516669-516669290.703292.50
4552335-552335310.771312.65
5543422-543422305.756307.64
6476066-476066267.858269.60
60min1486666-486666273.822292.125.91276.04294.505.90
2509213-509213286.508288.93
3531131-531131298.840301.21
4555853-555853312.750315.25
5548088-548088308.381310.88
6484177-484177272.422274.70
极限1557185-557185313.500314.661.71316.27317.621.72
2544918-544918306.598309.59
3565913-565913318.410321.38
4571428-571428321.513324.64
5562917-562917316.725319.84
6553086-553086311.193314.02
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%
128.012964442965852963592962842960042963350.08
228.022936072936892936480.02
单位质量响应值RSD%判断
10579.6110479.940.67数据可信
影响因素30天-包装光照-供试品溶液-SDR926批-缬沙坦-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%
5min172317-7231768.68050.8718.8468.6850.8718.83
247536-4753645.14545.15
353429-5342950.74250.74
456084-5608453.26353.26
545821-4582143.51743.52
646192-4619243.86943.87
10min1165616-165616157.287132.599.84157.42132.699.84
2135300-135300128.496128.59
3140449-140449133.386133.49
4127160-127160120.765120.87
5139058-139058132.065132.15
6130055-130055123.514123.60
15min1224025-224025212.759206.796.04213.21207.166.03
2216229-216229205.355205.70
3208252-208252197.779198.15
4197363-197363187.437187.79
5229063-229063217.543217.89
6231495-231495219.853220.19
20min1254637-254637241.831259.267.14242.71260.047.12
2277488-277488263.533264.29
3273909-273909260.134260.90
4246155-246155233.776234.50
5289209-289209274.664275.45
6296548-296548281.634282.41
30min1266176-266176252.790276.596.77254.15277.896.75
2301178-301178286.031287.32
3291779-291779277.105278.39
4268751-268751255.235256.43
5306292-306292290.888292.22
6313228-313228297.475298.81
45min1270811-270811257.192280.576.47259.06282.436.45
2305663-305663290.291292.15
3296585-296585281.669283.51
4273591-273591259.832261.53
5309852-309852294.269296.19
6316092-316092300.195302.13
60min1271829-271829258.158281.666.35260.54284.086.33
2306607-306607291.187293.63
3297400-297400282.443284.85
4275807-275807261.936264.16
5310470-310470294.856297.36
6317362-317362301.402303.93
极限1307405-307405291.945302.762.30294.84305.742.31
2323254-323254306.997310.02
3327975-327975311.481314.45
4314040-314040298.247300.99
5317911-317911301.923305.02
6322168-322168305.966309.10
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%
128.015097285101225105165106035104395102820.08
228.025019505022285020890.04
单位质量响应值RSD%判断
18217.8517918.951.17数据可信
影响因素30天-包装光照-供试品溶液-SDR926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%
5min195534-9553452.87738.4719.8552.8838.4719.85
261636-6163634.11534.11
369407-6940738.41638.42
471745-7174539.71039.71
559072-5907232.69632.70
659631-5963133.00533.01
10min1238785-238785132.165110.6910.11132.27110.7710.12
2195333-195333108.115108.18
3200324-200324110.877110.95
4182347-182347100.927101.01
5197204-197204109.150109.22
6185940-185940102.916102.98
15min1342569-342569189.609183.096.08189.98183.386.08
2328424-328424181.779182.06
3316210-316210175.019175.32
4299523-299523165.783166.06
5345504-345504191.233191.52
6352478-352478195.093195.36
20min1407198-407198225.380239.887.23226.13240.557.21
2438784-438784242.863243.51
3433317-433317239.837240.49
4389168-389168215.401216.01
5458468-458468253.758254.42
6473484-473484262.069262.73
30min1440832-440832243.996268.387.15245.20269.527.13
2502652-502652278.213279.35
3485026-485026268.457269.59
4446094-446094246.909247.95
5509204-509204281.839283.01
6525500-525500290.859292.05
45min1455662-455662252.204276.926.97253.89278.606.95
2518202-518202286.820288.51
3502105-502105277.910279.58
4460662-460662254.972256.51
5525743-525743290.994292.73
6539494-539494298.605300.37
60min1458997-458997254.050278.886.93256.24281.116.91
2521348-521348288.561290.82
3504190-504190279.064281.29
4465006-465006257.376259.42
5529900-529900293.294295.61
6543663-543663300.912303.28
极限1523618-523618289.817301.952.68292.52304.742.69
2555147-555147307.268310.11
3559864-559864309.879312.66
4531821-531821294.358296.92
5547311-547311302.931305.84
6555417-555417307.418310.38
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%
128.012937972934272936582935252926562934130.16
228.022955342953582954460.05
单位质量响应值RSD%判断
10475.2910544.110.47数据可信
影响因素30天-包装光照-供试品溶液-SDR926批-缬沙坦-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%
5min159041-5904156.17853.598.1756.1853.588.17
260255-6025557.33357.33
358039-5803955.22555.22
459652-5965256.76056.76
550369-5036947.92747.93
650542-5054248.09148.09
10min1144175-144175137.184139.693.95137.30139.793.95
2146135-146135139.049139.16
3146787-146787139.670139.78
4157852-157852150.198150.31
5144972-144972137.943138.04
6140900-140900134.068134.16
15min1213858-213858203.488209.177.10203.88209.567.10
2214250-214250203.861204.25
3209761-209761199.590199.98
4246770-246770234.805235.22
5229618-229618218.484218.86
6204740-204740194.813195.18
20min1269873-269873256.787256.377.48257.58257.187.47
2262335-262335249.615250.42
3250237-250237238.103238.89
4301278-301278286.670287.55
5283416-283416269.674270.48
6249473-249473237.377238.13
30min1288677-288677274.680276.196.49275.99277.516.49
2282943-282943269.224270.52
3269576-269576256.505257.77
4314141-314141298.909300.37
5311874-311874296.752298.10
6274400-274400261.095262.32
45min1291695-291695277.551281.007.04279.41282.877.03
2286707-286707272.805274.64
3273216-273216259.968261.75
4316883-316883301.518303.57
5324450-324450308.718310.66
6278981-278981265.454267.20
60min1292067-292067277.905280.916.20280.32283.346.20
2287766-287766273.813276.20
3274476-274476261.167263.47
4317777-317777302.369305.03
5317390-317390302.000304.56
6281857-281857268.190270.47
极限1315446-315446300.151305.762.69303.12308.752.71
2319972-319972304.457307.39
3310713-310713295.647298.47
4330016-330016314.014317.28
5333158-333158317.004320.17
6318717-318717303.263306.08
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%
128.015067145069105077205078345068415072040.11
228.025066305067205066750.02
单位质量响应值RSD%判断
18107.9618082.620.10数据可信
影响因素30天-包装光照-供试品溶液-SDR926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%
5min178603-7860343.43840.368.5843.4440.368.58
278128-7812843.17643.18
374790-7479041.33141.33
476339-7633942.18742.19
564546-6454635.67035.67
665754-6575436.33836.34
10min1211368-211368116.808117.513.92116.90117.603.92
2213218-213218117.831117.92
3210692-210692116.435116.52
4228520-228520126.287126.37
5206803-206803114.286114.36
6205248-205248113.426113.50
15min1332665-332665183.841186.696.80184.16187.006.79
2330528-330528182.660182.98
3321912-321912177.898178.21
4377001-377001208.342208.68
5351204-351204194.086194.39
6313586-313586173.297173.60
20min1433264-433264239.435238.167.50240.12238.857.49
2420569-420569232.419233.11
3400047-400047221.078221.75
4483478-483478267.185267.94
5449686-449686248.510249.20
6398712-398712220.340220.99
30min1484505-484505267.752267.866.50268.92269.036.49
2472591-472591261.168262.32
3449142-449142248.209249.32
4526812-526812291.132292.42
5517149-517149285.792286.98
6458009-458009253.110254.20
45min1495092-495092273.603276.097.10275.31277.797.09
2486050-486050268.606270.28
3460150-460150254.293255.90
4538007-538007297.319299.19
5546926-546926302.248304.00
6471320-471320260.466262.06
60min1496532-496532274.399276.896.71276.65279.156.70
2488078-488078269.727271.94
3463246-463246256.004258.12
4542754-542754299.942302.41
5540966-540966298.954301.32
6474717-474717262.343264.46
极限1540284-540284298.577303.783.10301.38306.583.12
2547350-547350302.482305.23
3527084-527084291.283293.91
4568292-568292314.055317.12
5571234-571234315.681318.64
6543931-543931300.593303.23
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