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%
127.651127659112762211275941128747112640711276060.08
227.661133735113330011335180.03
单位质量响应值RSD%判断
40781.4140980.400.35数据可信
供试品溶液-2024022221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%
5min1119753-1197534.8326.2920.934.836.2920.94
2171096-1710966.9046.90
3201205-2012058.1198.12
4120900-1209004.8784.88
5176010-1760107.1027.10
6146023-1460235.8925.89
10min1486403-48640319.62622.467.2519.6422.487.26
2562017-56201722.67722.69
3591266-59126623.85723.88
4548755-54875522.14222.15
5600029-60002924.21124.23
6551933-55193322.27022.28
15min1811690-81169032.75135.174.1532.8135.244.15
2893570-89357036.05536.12
3905352-90535236.53036.60
4851901-85190134.37434.43
5901354-90135436.36936.44
6866017-86601734.94335.01
20min11067764-106776443.08444.702.5343.2144.842.54
21135043-113504345.79845.94
31136012-113601245.83845.99
41084007-108400743.73943.88
51121342-112134245.24645.40
61102285-110228544.47744.62
30min11295062-129506252.25552.501.2452.4852.741.25
21311512-131151252.91953.17
31326236-132623653.51353.77
41286934-128693451.92752.16
51303312-130331252.58852.84
61283713-128371351.79752.04
45min11297042-129704252.33552.541.2252.6752.901.23
21316053-131605353.10253.47
31323126-132312653.38753.76
41289393-128939352.02652.38
51305700-130570052.68453.05
61281748-128174851.71852.07
60min11294930-129493052.25052.461.2252.7152.941.23
21312623-131262352.96453.45
31322895-132289553.37853.87
41286575-128657551.91352.38
51302634-130263452.56153.05
61281378-128137851.70352.17
极限11295104-129510452.25752.341.2352.8352.931.24
21309589-130958952.84153.44
31318923-131892353.21853.83
41284122-128412251.81452.39
51299492-129949252.43453.04
61276047-127604751.48852.07
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0.5142
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
127.651944519194547819465331944625194371519449740.06
227.661959278195843119588540.04
单位质量响应值RSD%判断
70342.6470819.020.48数据可信
供试品溶液-2024022221批-缬沙坦-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%
5min1191889-1918894.7476.3723.284.756.3723.26
2286625-2866257.0907.09
3339256-3392568.3928.39
4192386-1923864.7594.76
5296772-2967727.3417.34
6238599-2385995.9025.90
10min1829448-82944820.51823.597.3920.5323.617.39
2963350-96335023.83023.85
31012226-101222625.04025.06
4940579-94057923.26723.28
51028572-102857225.44425.46
6947797-94779723.44623.46
15min11392264-139226434.44137.054.1834.5037.124.19
21533732-153373237.94038.01
31554406-155440638.45138.53
41465693-146569336.25736.32
51551308-155130838.37538.45
61490017-149001736.85936.92
20min11833633-183363345.35947.122.5645.4947.262.58
21950774-195077448.25648.41
31954831-195483148.35748.52
41865084-186508446.13746.28
51928060-192806047.69547.85
61895704-189570446.89447.04
30min12226757-222675755.08455.351.2155.3255.601.21
22255522-225552255.79556.06
32278213-227821356.35656.62
42214882-221488254.79055.04
52243071-224307155.48755.75
62206329-220632954.57854.83
45min12235732-223573255.30655.501.2055.6655.881.21
22264771-226477156.02456.41
32279745-227974556.39456.79
42219484-221948454.90455.27
52251213-225121355.68856.08
62209927-220992754.66755.04
60min12226434-222643455.07655.351.1755.5555.851.18
22257761-225776155.85056.36
32275359-227535956.28656.80
42215823-221582354.81355.30
52242942-224294255.48456.00
62206829-220682954.59155.08
极限12230330-223033055.17255.271.2555.7755.891.26
22253135-225313555.73656.37
32273280-227328056.23456.88
42211592-221159254.70855.32
52241070-224107055.43856.07
62196473-219647354.33454.95
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%
127.651128432112917511277071127002112698211278600.09
227.661135912113830911371100.15
单位质量响应值RSD%判断
40790.6041110.270.56数据可信
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%
5min1216940-2169408.7398.488.408.748.498.40
2235493-2354939.4869.49
3215365-2153658.6758.68
4203024-2030248.1788.18
5181900-1819007.3277.33
6211076-2110768.5028.50
10min1582394-58239423.46022.005.8523.4822.025.85
2591082-59108223.81023.83
3528952-52895221.30721.33
4528326-52832621.28221.30
5516797-51679720.81720.83
6529145-52914521.31521.33
15min1846581-84658134.10132.584.4934.1732.644.50
2862569-86256934.74534.82
3783192-78319231.54831.61
4795629-79562932.04932.11
5777780-77778031.33031.39
6786873-78687331.69631.76
20min11040481-104048141.91240.823.3942.0640.963.39
21070557-107055743.12343.27
3986339-98633939.73139.87
4999078-99907840.24440.38
5989470-98947039.85739.99
6994086-99408640.04340.18
30min11258582-125858250.69750.842.4350.9451.072.42
21311466-131146652.82853.07
31251487-125148750.41250.64
41216675-121667549.00949.24
51265174-126517450.96351.18
61268794-126879451.10951.33
45min11260299-126029950.76751.832.9151.1252.172.89
21323089-132308953.29653.66
31296796-129679652.23752.57
41227442-122744249.44349.78
51323225-132322553.30153.64
61289300-128930051.93552.27
60min11256525-125652550.61551.692.9551.0852.152.94
21320920-132092053.20853.69
31295698-129569852.19252.65
41222779-122277949.25549.70
51318099-131809953.09553.55
61285863-128586351.79652.25
极限11257094-125709450.63751.582.9151.2252.162.90
21316185-131618553.01853.62
31290934-129093452.00152.57
41219413-121941349.12049.67
51315509-131550952.99053.56
61284211-128421151.73052.30
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0.5142
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
127.651943639194659119456141945333194361319449580.07
227.661962770196486819638190.08
单位质量响应值RSD%判断
70342.0670998.520.66数据可信
供试品溶液-TYN28批-缬沙坦-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%
5min1366095-3660959.0458.729.289.048.729.27
2398791-3987919.8539.85
3360924-3609248.9178.92
4338497-3384978.3638.36
5299934-2999347.4107.41
6354523-3545238.7598.76
10min1994779-99477924.57723.055.9124.6023.075.92
21012218-101221825.00825.03
3901802-90180222.28022.30
4901951-90195122.28422.30
5885852-88585221.88621.90
6902279-90227922.29222.31
15min11453226-145322635.90334.284.4935.9834.354.49
21479185-147918536.54536.62
31343459-134345933.19233.26
41365620-136562033.73933.81
51337518-133751833.04533.11
61346076-134607633.25633.33
20min11787750-178775044.16842.973.4544.3243.113.46
21838371-183837145.41945.58
31694207-169420741.85742.00
41714358-171435842.35542.50
51693987-169398741.85241.99
61705970-170597042.14842.29
30min12163776-216377653.45853.602.4053.7153.842.40
22256951-225695155.76056.02
32152721-215272153.18553.42
42095438-209543851.77052.01
52170755-217075553.63153.86
62176380-217638053.77054.01
45min12170389-217038953.62254.692.9553.9955.052.93
22278694-227869456.29756.68
32233544-223354455.18255.54
42108168-210816852.08452.44
52273413-227341356.16756.52
62217210-221721054.77855.13
60min12163764-216376453.45854.562.9953.9555.052.97
22272700-227270056.14956.66
32231870-223187055.14155.62
42102342-210234251.94152.41
52269623-226962356.07356.55
62210936-221093654.62355.10
极限12160172-216017253.36954.442.9553.9855.042.93
22266499-226649955.99656.63
32222721-222272154.91555.51
42097933-209793351.83252.42
52264335-226433555.94356.54
62208500-220850054.56355.16
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%
127.651130446113033111302021131712112965611304690.07
227.661138958113866711388120.02
单位质量响应值RSD%判断
40884.9541171.800.50数据可信
供试品溶液-2024022221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%
5min1278913-27891311.21413.0012.7111.2112.9912.72
2299483-29948312.04112.04
3315716-31571612.69312.69
4396944-39694415.95915.96
5309787-30978712.45512.45
6338456-33845613.60813.61
10min1735454-73545429.56930.542.2629.5930.572.27
2756830-75683030.42830.45
3754690-75469030.34230.37
4762323-76232330.64930.68
5760133-76013330.56130.59
6788653-78865331.70831.74
15min11073653-107365343.16643.681.1943.2643.771.19
21087956-108795643.74143.84
31075666-107566643.24743.34
41084441-108444143.60043.70
51086633-108663343.68843.78
61109616-110961644.61244.71
20min11256732-125673250.52750.770.4250.7150.960.42
21260270-126027050.66950.86
31257675-125767550.56450.76
41266758-126675850.93051.13
51268758-126875851.01051.20
61266708-126670850.92851.13
30min11277685-127768551.36951.770.8451.6752.070.84
21297215-129721552.15452.46
31301752-130175252.33752.64
41284920-128492051.66051.97
51289756-128975651.85452.16
61274231-127423151.23051.54
45min11276075-127607551.30451.720.9051.7252.140.89
21296448-129644852.12352.54
31303143-130314352.39252.81
41282975-128297551.58252.01
51285799-128579951.69552.12
61273498-127349851.20151.63
60min11273468-127346851.19951.570.8351.7352.100.82
21291915-129191551.94152.48
31297787-129778752.17752.71
41280253-128025351.47252.02
51281528-128152851.52352.06
61270481-127048151.07951.62
极限11269969-126996951.05951.470.8151.7052.120.81
21287936-128793651.78152.43
31294740-129474052.05552.71
41278111-127811151.38652.04
51282059-128205951.54552.20
61267834-126783450.97351.63
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0.5142
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
127.651948051194786119486761950904194796419486910.07
227.661963418196569219645550.09
单位质量响应值RSD%判断
70477.0771025.130.55数据可信
供试品溶液-2024022221批-缬沙坦-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%
5min1476480-47648011.75813.5911.4211.7613.5911.41
2512496-51249612.64712.65
3541688-54168813.36813.37
4657441-65744116.22416.22
5533422-53342213.16413.16
6582559-58255914.37614.38
10min11262875-126287531.16532.222.3131.1932.252.32
21301931-130193132.12932.16
31297603-129760332.02232.05
41311233-131123332.35832.39
51303931-130393132.17832.21
61356417-135641733.47333.51
15min11846407-184640745.56546.101.2245.6646.201.22
21864998-186499846.02446.12
31852368-185236845.71245.81
41863127-186312745.97846.09
51871198-187119846.17746.28
61910552-191055247.14847.25
20min12165481-216548153.43953.610.4053.6453.810.40
22168762-216876253.52053.72
32160874-216087453.32553.53
42176555-217655553.71253.92
52181215-218121553.82754.03
62180878-218087853.81954.03
30min12201000-220100054.31654.690.8254.6355.010.82
22235655-223565555.17155.49
32239194-223919455.25855.58
42209121-220912154.51654.85
52217021-221702154.71155.03
62194769-219476954.16254.49
45min12196303-219630354.20054.630.8154.6455.070.81
22229955-222995555.03055.47
32238422-223842255.23955.68
42210422-221042254.54855.00
52213771-221377154.63155.08
62193233-219323354.12454.57
60min12192986-219298654.11854.520.8254.6755.090.81
22223641-222364154.87455.44
32235617-223561755.17055.74
42204862-220486254.41154.98
52210765-221076554.55655.12
62188699-218869954.01254.58
极限12187432-218743253.98154.380.8454.6655.060.83
22218901-221890154.75755.44
32228450-222845054.99355.68
42201008-220100854.31655.01
52205450-220545054.42555.11
62179533-217953353.78654.48
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%
127.651138899113929011380421138702113726811384400.07
227.661151768115217811519730.03
单位质量响应值RSD%判断
41173.2441647.610.82数据可信
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%
5min1312448-31244812.44611.417.5312.4511.417.52
2313385-31338512.48412.48
3261285-26128510.40810.41
4278492-27849211.09411.09
5272763-27276310.86510.87
6280494-28049411.17311.17
10min1723290-72329028.81227.094.4528.8427.114.46
2709444-70944428.26028.29
3644020-64402025.65425.68
4667600-66760026.59426.62
5661184-66118426.33826.36
6674176-67417626.85626.88
15min11024628-102462840.81638.793.5740.9138.883.57
21005115-100511540.03840.13
3936159-93615937.29237.37
4969420-96942038.61638.70
5943461-94346137.58237.67
6964104-96410438.40538.49
20min11196772-119677247.67346.472.4147.8646.642.42
21193584-119358447.54647.73
31134647-113464745.19845.36
41174111-117411146.77046.94
51131760-113176045.08345.25
61168642-116864246.55246.72
30min11235186-123518649.20350.882.6149.4951.152.59
21276211-127621150.83751.12
31281138-128113851.03451.30
41336533-133653353.24053.51
51271577-127157750.65350.92
61262396-126239650.28750.56
45min11233170-123317049.12350.832.6149.5251.222.59
21274152-127415250.75551.15
31279389-127938950.96451.34
41334984-133498453.17953.57
51271597-127159750.65451.03
61262935-126293550.30950.69
60min11229214-122921448.96550.732.6149.4751.242.59
21271370-127137050.64551.16
31278474-127847450.92851.42
41331347-133134753.03453.54
51270774-127077450.62151.11
61260519-126051950.21250.71
极限11229603-122960348.98150.612.5549.6051.222.52
21268060-126806050.51351.14
31275297-127529750.80151.40
41327905-132790552.89753.52
51265831-126583150.42451.03
61256237-125623750.04250.65
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0.5142
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
127.651964996196547919628341962779196169419635560.09
227.661974617197587619752460.05
单位质量响应值RSD%判断
71014.6871411.640.40数据可信
供试品溶液-TYN28批-缬沙坦-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%
5min1533031-53303113.06911.977.7013.0711.977.69
2535212-53521213.12213.12
3443224-44322410.86710.87
4474144-47414411.62511.62
5465414-46541411.41111.41
6478419-47841911.73011.73
10min11242601-124260130.46528.584.6330.4928.604.63
21218463-121846329.87329.90
31101746-110174627.01227.04
41142798-114279828.01828.04
51132033-113203327.75427.78
61156225-115622528.34828.37
15min11756100-175610043.05540.983.5943.1541.073.59
21727656-172765642.35842.45
31605230-160523039.35639.44
41665045-166504540.82340.91
51616756-161675639.63939.73
61657362-165736240.63440.72
20min12057279-205727950.43949.172.4050.6349.362.40
22051595-205159550.30050.49
31946646-194664647.72747.90
42016148-201614849.43149.61
51949852-194985247.80547.98
62012380-201238049.33849.52
30min12126498-212649852.13653.852.5152.4454.142.49
22193164-219316453.77154.07
32204766-220476654.05554.33
42294298-229429856.25056.54
52188027-218802753.64553.93
62172807-217280753.27153.56
45min12122323-212232352.03453.812.5752.4554.222.54
22190279-219027953.70054.12
32201600-220160053.97754.38
42294694-229469456.26056.67
52186952-218695253.61854.02
62173581-217358153.29053.70
60min12117815-211781551.92353.752.6152.4654.282.58
22190531-219053153.70654.25
32198384-219838453.89954.42
42292444-229244456.20556.74
52186582-218658253.60954.13
62167259-216725953.13553.66
极限12116102-211610251.88153.592.5552.5354.242.53
22185789-218578953.59054.25
32191214-219121453.72354.36
42285221-228522156.02856.69
52176278-217627853.35754.00
62160675-216067552.97453.62
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%
127.651146980114685911445171144948114380111454210.13
227.661151670115196611518180.02
单位质量响应值RSD%判断
41425.7141642.010.37数据可信
供试品溶液批-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%
5min1394330-39433015.66117.2014.2615.6617.2014.25
2479782-47978219.05519.05
3433539-43353917.21817.22
4489020-48902019.42219.42
5329555-32955513.08813.09
6471948-47194818.74418.74
10min1862095-86209534.23836.145.8034.2736.185.81
2960980-96098038.16638.21
3904240-90424035.91235.95
4962850-96285038.24038.28
5835483-83548333.18133.21
6934860-93486037.12837.17
15min11181634-118163446.92947.803.0647.0447.923.08
21245105-124510549.45049.58
31191652-119165247.32747.44
41245961-124596149.48449.61
51152262-115226245.76245.87
61205120-120512047.86247.99
20min11297243-129724351.52052.221.2851.7452.451.28
21340483-134048353.23853.47
31311904-131190452.10352.33
41328729-132872952.77153.01
51310616-131061652.05152.26
61300178-130017851.63751.87
30min11289600-128960051.21752.251.4251.5552.591.42
21340114-134011453.22353.58
31311902-131190252.10252.44
41328673-132867352.76953.12
51322650-132265052.52952.85
61300562-130056251.65252.00
45min11288666-128866651.18052.231.7051.6252.681.71
21351047-135104753.65754.13
31309104-130910451.99152.45
41325354-132535452.63753.11
51319586-131958652.40852.84
61296557-129655751.49351.95
60min11286624-128662451.09952.051.4051.6652.621.40
21335517-133551753.04053.63
31306511-130651151.88852.46
41322390-132239052.51953.11
51318207-131820752.35352.91
61294418-129441851.40851.98
极限11285465-128546551.05251.991.4451.7252.681.44
21335835-133583553.05353.76
31304293-130429351.80052.49
41320910-132091052.46053.17
51315143-131514352.23152.90
61292187-129218751.31952.01
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0.5142
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
127.651967921196783119642791964961196295819655900.12
227.661976689197628419764860.02
单位质量响应值RSD%判断
71088.2571456.470.37数据可信
供试品溶液批-缬沙坦-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%
5min1677735-67773516.60218.2314.3716.6018.2314.37
2825175-82517520.21420.21
3744539-74453918.23918.24
4840793-84079320.59720.60
5564476-56447613.82813.83
6811705-81170519.88419.88
10min11474009-147400936.10938.135.8336.1538.185.84
21644255-164425540.27940.32
31545043-154504337.84937.89
41647577-164757740.36140.41
51428786-142878635.00135.03
61600394-160039439.20539.25
15min12022714-202271449.55050.463.0649.6750.593.07
22132021-213202152.22852.36
32038101-203810149.92750.05
42130546-213054652.19252.33
51972201-197220148.31348.42
62064267-206426750.56850.70
20min12217067-221706754.31155.101.2854.5455.341.28
22293063-229306356.17356.42
32243948-224394854.97055.21
42272618-227261855.67255.92
52242295-224229554.92955.15
62226504-222650454.54354.79
30min12205899-220589954.03855.131.4454.3955.491.44
22291539-229153956.13656.51
32245277-224527755.00255.36
42274568-227456855.72056.10
52262980-226298055.43655.77
62222727-222272754.45054.81
45min12204752-220475254.01055.131.7354.4855.621.73
22313355-231335556.67057.17
32240066-224006654.87555.35
42268092-226809255.56156.06
52258250-225825055.32055.78
62219113-221911354.36254.85
60min12201867-220186753.93954.941.3954.5355.551.39
22285235-228523555.98156.61
32235957-223595754.77455.38
42262168-226216855.41656.04
52256234-225623455.27155.85
62215466-221546654.27254.88
极限12199667-219966753.88554.871.4354.5955.601.43
22284991-228499155.97556.73
32232297-223229754.68555.41
42260428-226042855.37456.12
52250726-225072655.13655.84
62211428-221142854.17354.90
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)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%
127.651147409114741711472071147244114685211472260.02
227.661157182115651011568460.05
单位质量响应值RSD%判断
41490.9941823.790.57数据可信
供试品溶液批-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%
5min1410642-41064216.26115.844.8916.2615.844.87
2410432-41043216.25216.25
3379448-37944815.02515.03
4405108-40510816.04116.04
5372427-37242714.74714.75
6421833-42183316.70416.70
10min1822117-82211732.55432.182.2232.5932.212.22
2818091-81809132.39532.43
3800132-80013231.68331.72
4794920-79492031.47731.51
5798731-79873131.62831.66
6841514-84151433.32233.36
15min11107527-110752743.85643.402.2043.9643.502.20
21096133-109613343.40443.51
31094166-109416643.32743.43
41054992-105499241.77541.88
51094017-109401743.32143.42
61128785-112878544.69744.81
20min11278466-127846650.62450.322.1550.8350.532.14
21256215-125621549.74349.95
31280777-128077750.71650.92
41224773-122477348.49848.70
51280553-128055350.70750.91
61304439-130443951.65351.86
30min11323739-132373952.41752.102.7352.7452.422.72
21281860-128186050.75951.07
31341884-134188453.13653.45
41262197-126219749.98050.29
51332568-133256852.76753.08
61352599-135259953.56053.89
45min11323021-132302152.38952.132.7752.8252.562.75
21281866-128186650.75951.19
31343307-134330753.19253.62
41262530-126253049.99350.41
51334306-133430652.83653.26
61354110-135411053.62054.06
60min11322869-132286952.38352.032.7352.9352.572.72
21279529-127952950.66751.21
31340585-134058553.08453.63
41260227-126022749.90250.43
51329693-132969352.65353.20
61350251-135025153.46754.03
极限11316636-131663652.13651.882.7352.8052.542.72
21276231-127623150.53651.19
31338140-133814052.98753.65
41256958-125695849.77350.41
51326952-132695252.54453.21
61346083-134608353.30253.98
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0.5142
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
127.651966106196696319664441966819196708719666840.03
227.661984498198414519843220.02
单位质量响应值RSD%判断
71127.8171739.770.61数据可信
供试品溶液批-缬沙坦-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%
5min1702418-70241817.16816.714.9117.1716.724.91
2701882-70188217.15517.16
3648513-64851315.85115.85
4692352-69235216.92216.92
5636413-63641315.55515.56
6721120-72112017.62617.63
10min11404243-140424334.32233.932.2134.3633.972.21
21397682-139768234.16234.20
31368119-136811933.43933.47
41358323-135832333.20033.24
51364193-136419333.34333.38
61437809-143780935.14335.18
15min11889841-188984146.19145.752.1246.3145.862.11
21872474-187247445.76745.88
31868998-186899845.68245.79
41805247-180524744.12444.24
51867854-186785445.65445.76
61926883-192688347.09747.21
20min12183409-218340953.36753.072.1353.5853.282.13
22146899-214689952.47452.69
32187943-218794353.47753.69
42093171-209317151.16151.37
52188215-218821553.48453.69
62228154-222815454.46054.68
30min12262622-226262255.30354.982.7355.6455.322.73
22191852-219185253.57353.91
32294890-229489056.09156.42
42157280-215728052.72853.05
52278118-227811855.68256.01
62312556-231255656.52356.87
45min12262490-226249055.30055.022.7855.7655.472.77
22191400-219140053.56254.01
32297309-229730956.15156.61
42158430-215843052.75653.20
52280008-228000855.72856.18
62316128-231612856.61157.08
60min12262325-226232555.29654.932.7355.8855.512.72
22189373-218937353.51254.08
32292863-229286356.04256.62
42155265-215526552.67953.24
52274649-227464955.59756.17
62309616-230961656.45157.05
极限12252056-225205655.04554.772.7355.7555.472.72
22182700-218270053.34954.04
32288048-228804855.92456.63
42150043-215004352.55153.23
52269215-226921555.46456.16
62302668-230266856.28257.00
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