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125
标示量(mg)200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%
128.011131334113250011320801133261113219611322740.07
228.021151828115153611516820.02
单位质量响应值RSD%判断
40423.9241102.141.18数据可信
影响因素30天-包装高温-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%
5min1206120-2061208.82912.3230.618.8312.3230.60
2370145-37014515.85515.85
3268455-26845511.49911.50
4420039-42003917.99217.99
5251464-25146410.77110.77
6209671-2096718.9818.98
10min1568967-56896724.37128.5718.5024.3928.5918.50
2637358-63735827.30127.33
3666602-66660228.55428.57
4906542-90654238.83138.86
5642517-64251727.52227.54
6579869-57986924.83824.85
15min1868384-86838437.19740.9214.7837.2540.9914.79
2854232-85423236.59136.66
3994192-99419242.58642.65
41218768-121876852.20552.30
5945742-94574240.51040.57
6851107-85110736.45736.51
20min11102767-110276747.23748.699.8847.3548.839.89
2986457-98645742.25442.39
31207233-120723351.71151.85
41297948-129794855.59755.78
51172545-117254550.22550.36
61053078-105307845.10845.23
30min11287016-128701655.12954.075.2955.3254.295.29
21129144-112914448.36648.57
31286668-128666855.11455.34
41297917-129791755.59655.87
51307566-130756656.00956.22
61265734-126573454.21754.41
45min11292680-129268055.37155.022.5855.6655.322.58
21218690-121869052.20252.49
31286409-128640955.10355.42
41296443-129644355.53355.90
51307909-130790956.02456.33
61304115-130411555.86156.14
60min11293682-129368255.41455.031.7755.7955.431.78
21241085-124108553.16153.53
31283414-128341454.97455.38
41293418-129341855.40355.86
51306263-130626355.95356.35
61290576-129057655.28155.66
极限11296539-129653955.53755.460.6256.0155.960.60
21301666-130166655.75656.22
31282899-128289954.95255.45
41291519-129151955.32255.87
51304822-130482255.89156.39
61291487-129148755.32055.79
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DSMF-4022-230920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125
标示量(mg)200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%
128.011958873196069119597341961115196060219602030.05
228.021992230199262719924280.02
单位质量响应值RSD%判断
69982.2671107.351.13数据可信
影响因素30天-包装高温-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%
5min1346615-3466158.10511.5031.488.1111.5031.47
2637747-63774714.91314.91
3456862-45686210.68310.68
4723900-72390016.92816.93
5430673-43067310.07110.07
6355442-3554428.3128.31
10min1977312-97731222.85326.8718.7322.8726.8918.73
21097643-109764325.66725.70
31147629-114762926.83626.86
41566694-156669436.63636.67
51107066-110706625.88825.91
6997243-99724323.32023.34
15min11497004-149700435.00638.5514.9635.0738.6314.96
21470653-147065334.39034.48
31716049-171604940.12840.21
42108063-210806349.29549.41
51631823-163182338.15938.24
61466733-146673334.29834.37
20min11903502-190350244.51145.889.9944.6646.0610.01
21698748-169874839.72439.89
32085927-208592748.77748.95
42242264-224226452.43352.66
52026750-202675047.39447.56
61816113-181611342.46842.61
30min12220775-222077551.93150.965.4252.1851.245.42
21944015-194401545.45945.71
32223170-222317051.98752.27
42242298-224229852.43452.78
52259922-225992252.84653.12
62186350-218635051.12651.37
45min12231255-223125552.17651.872.7352.5452.252.74
22097676-209767649.05249.41
32224486-222448652.01752.41
42241071-224107152.40552.87
52262651-226265152.91053.30
62250971-225097152.63752.99
60min12234113-223411352.24251.901.9452.7252.401.96
22136420-213642049.95850.42
32219452-221945251.90052.41
42235632-223563252.27852.86
52260953-226095352.87053.38
62230335-223033552.15452.63
极限12242782-224278252.44552.380.6253.0453.000.59
22252055-225205552.66253.24
32219861-221986151.90952.54
42234041-223404152.24152.94
52257690-225769052.79453.42
62234751-223475152.25752.84
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125
标示量(mg)200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%
128.011137034113842111382671137246113681511375570.07
228.021161162116046911608160.05
单位质量响应值RSD%判断
40612.5341428.121.41数据可信
影响因素30天-包装高温-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%
5min1352849-35284915.02012.5724.5115.0212.5724.51
2267851-26785111.40211.40
3319619-31961913.60513.61
4378267-37826716.10216.10
5175707-1757077.4797.48
6277075-27707511.79411.79
10min1702932-70293229.92231.1414.7529.9531.1614.75
2781359-78135933.26033.28
3770560-77056032.80132.82
4844529-84452935.94935.98
5531729-53172922.63422.65
6757575-75757532.24832.27
15min1893170-89317038.02043.0313.5338.0943.1013.54
21110644-111064447.27747.35
31098724-109872446.77046.85
41174639-117463950.00150.09
5831467-83146735.39335.44
6956363-95636340.71040.78
20min11058480-105848045.05649.8810.4645.1950.0210.47
21280590-128059054.51154.66
31267918-126791853.97254.13
41301090-130109055.38455.55
51054903-105490344.90445.01
61067880-106788045.45745.60
30min11145209-114520948.74852.886.0048.9653.116.01
21303167-130316755.47255.72
31299935-129993555.33555.58
41299344-129934455.30955.57
51253335-125333553.35153.53
61153182-115318249.08849.30
45min11196331-119633150.92453.924.1951.2254.244.20
21305610-130561055.57655.91
31298536-129853655.27555.61
41298929-129892955.29255.65
51300953-130095355.37855.65
61200468-120046851.10051.40
60min11241940-124194052.86654.462.3053.2554.862.31
21303458-130345855.48455.91
31297082-129708255.21355.64
41296864-129686455.20455.65
51295493-129549355.14555.51
61241380-124138052.84253.23
极限11318673-131867356.13255.430.7356.6055.920.69
21301049-130104955.38255.90
31294017-129401755.08355.60
41292977-129297755.03855.58
51299771-129977155.32855.78
61306420-130642055.61156.08
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DSMF-4022-230920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125
标示量(mg)200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%
128.011970036197115319699971968564196872719696950.06
228.021996870199763819972540.03
单位质量响应值RSD%判断
70321.1471279.590.96数据可信
影响因素30天-包装高温-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%
5min1608063-60806314.16711.7925.2314.1711.7925.23
2457246-45724610.65310.65
3549283-54928312.79812.80
4651315-65131515.17515.18
5294719-2947196.8676.87
6474709-47470911.06011.06
10min11212189-121218928.24329.3814.9028.2729.4014.91
21347849-134784931.40431.43
31331125-133112531.01431.04
41456053-145605333.92533.96
5912431-91243121.25921.27
61306182-130618230.43330.46
15min11540645-154064535.89640.6513.6435.9940.7413.64
21917471-191747144.67544.77
31898495-189849544.23344.33
42028995-202899547.27447.38
51431352-143135233.34933.41
61650082-165008238.44638.54
20min11826505-182650542.55647.1510.5542.7347.3310.56
22212781-221278151.55651.75
32191818-219181851.06851.26
42248191-224819152.38152.60
51819321-181932142.38942.53
61842598-184259842.93143.11
30min11973680-197368045.98549.976.1546.2550.266.16
22252116-225211652.47252.78
32246581-224658152.34352.65
42247250-224725052.35952.69
52163293-216329350.40350.63
61986641-198664146.28746.56
45min12059524-205952447.98550.964.3948.3651.364.39
22258177-225817752.61453.04
32246462-224646252.34152.77
42247136-224713652.35652.80
52244982-224498252.30652.65
62068229-206822948.18848.56
60min12140678-214067849.87651.482.4650.3552.002.49
22254112-225411252.51953.06
32244317-224431752.29152.83
42243579-224357952.27452.84
52236077-223607752.09952.56
62139429-213942949.84750.33
极限12280191-228019153.12752.480.7153.7153.110.64
22250215-225021552.42853.09
32238778-223877852.16252.82
42237480-223748052.13152.81
52248868-224886852.39752.97
62259716-225971652.65053.24
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125
标示量(mg)200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%
128.011145480114610511459731145579114218011450630.15
228.021143922114350711437140.03
单位质量响应值RSD%判断
40880.5140817.770.11数据可信
影响因素30天-包装高温-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%
5min1198339-1983398.47710.8218.408.4810.8218.39
2324805-32480513.88313.88
3212770-2127709.0949.09
4243005-24300510.38610.39
5256359-25635910.95710.96
6284248-28424812.14912.15
10min1519041-51904122.18426.6314.0622.2026.6414.06
2772505-77250533.01833.04
3572757-57275724.48024.50
4630281-63028126.93926.96
5585613-58561325.03025.05
6657543-65754328.10428.12
15min1804297-80429734.37737.8812.9234.4337.9412.93
21112216-111221647.53847.62
3813924-81392434.78834.84
4883350-88335037.75637.82
5843206-84320636.04036.10
6860776-86077636.79136.86
20min11043974-104397444.62145.2612.0944.7345.3912.09
21314430-131443056.18056.34
3975364-97536441.68841.80
41004567-100456742.93743.06
51032593-103259344.13444.25
6982983-98298342.01442.14
30min11258792-125879253.80251.006.9953.9951.206.99
21318940-131894056.37356.62
31134452-113445248.48848.67
41122347-112234747.97148.17
51208796-120879651.66651.86
61116451-111645147.71947.92
45min11294387-129438755.32453.613.9255.6053.893.92
21316023-131602356.24956.59
31255590-125559053.66653.93
41182199-118219950.52950.81
51259888-125988853.84954.13
61217206-121720652.02552.30
60min11294279-129427955.31954.083.0155.6854.463.03
21312674-131267456.10556.54
31268841-126884154.23254.59
41207359-120735951.60451.96
51270906-127090654.32054.69
61237699-123769952.90153.27
极限11295649-129564955.37855.281.4055.8355.751.42
21309827-130982755.98456.52
31310259-131025956.00256.45
41261271-126127153.90854.36
51295634-129563455.37755.84
61287415-128741555.02655.48
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DSMF-4022-230920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125
标示量(mg)200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%
128.011985467198584419863141985426198050019847100.12
228.021970879197069519707870.01
单位质量响应值RSD%判断
70857.1970335.010.53数据可信
影响因素30天-包装高温-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%
5min1332465-3324657.76810.0619.297.7710.0619.28
2557701-55770113.03113.03
3357790-3577908.3608.36
4413850-4138509.6709.67
5436154-43615410.19110.19
6486371-48637111.36411.36
10min1891138-89113820.82225.0414.2420.8425.0714.25
21331918-133191831.12131.15
3983403-98340322.97823.00
41086287-108628725.38225.40
51005309-100530923.49023.51
61132951-113295126.47226.50
15min11386905-138690532.40635.7113.0332.4735.7813.03
21920847-192084744.88244.98
31400414-140041432.72232.79
41524579-152457935.62335.70
51453624-145362433.96534.04
61482751-148275134.64634.73
20min11802819-180281942.12442.6812.2642.2642.8412.26
22272488-227248853.09953.30
31677223-167722339.19039.33
41733238-173323840.49940.66
51781285-178128541.62141.77
61692360-169236039.54339.70
30min12173540-217354050.78748.087.2151.0248.337.22
22281782-228178253.31653.63
31950028-195002845.56445.79
41932320-193232045.15045.40
52085776-208577648.73648.98
61922690-192269044.92545.17
45min12233967-223396752.19850.544.0952.5450.904.10
22277131-227713153.20753.64
32161577-216157750.50750.84
42034866-203486647.54647.89
52173245-217324550.78051.13
62096856-209685648.99549.34
60min12233214-223321452.18150.983.1952.6451.453.21
22271700-227170053.08053.63
32185715-218571551.07151.51
42077243-207724348.53748.99
52190802-219080251.19051.65
62132525-213252549.82850.29
极限12240387-224038752.34952.281.4452.9252.861.46
22267154-226715452.97453.64
32267650-226765052.98653.54
42180490-218049050.94951.51
52241218-224121852.36852.95
62227703-222770352.05252.62
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)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125
标示量(mg)200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%
128.011162781116355511618111160800116010611618110.13
228.021151738115167511517060.01
单位质量响应值RSD%判断
41478.4441103.000.65数据可信
影响因素30天-包装高温-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%
5min1276760-27676011.70312.1023.6211.7012.1023.61
2186826-1868267.9007.90
3249993-24999310.57110.57
4389066-38906616.45216.45
5300190-30019012.69412.69
6313860-31386013.27213.27
10min1705072-70507229.81428.9314.6829.8328.9514.68
2540107-54010722.83822.85
3644210-64421027.24027.26
4845354-84535435.74635.77
5656409-65640927.75627.78
6713423-71342330.16730.19
15min11041084-104108444.02240.9615.0544.0941.0315.05
2829281-82928135.06635.12
3848585-84858535.88235.95
41191121-119112150.36750.45
5858822-85882236.31536.38
61043680-104368044.13244.20
20min11258473-125847353.21548.1613.5553.3648.3013.55
21030263-103026343.56543.67
3992567-99256741.97142.09
41316304-131630455.66055.83
5978272-97827241.36641.49
61257928-125792853.19253.34
30min11323907-132390755.98251.369.0456.2151.589.05
21181843-118184349.97450.16
31108058-110805846.85447.05
41316049-131604955.64955.91
51071631-107163145.31445.51
61286533-128653354.40154.64
45min11318215-131821555.74152.486.0956.0752.786.12
21216397-121639751.43551.70
31163977-116397749.21949.49
41313134-131313455.52655.88
51147715-114771548.53148.80
61286497-128649754.40054.72
60min11319153-131915355.78053.144.2756.2053.544.31
21234602-123460252.20552.56
31200974-120097450.78351.14
41310994-131099455.43555.88
51197778-119777850.64851.00
61277284-127728454.01054.43
极限11312312-131231255.49154.721.1256.0055.201.16
21275771-127577153.94654.38
31297902-129790254.88255.32
41306641-130664155.25155.79
51292212-129221254.64155.08
61279797-127979754.11654.62
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DSMF-4022-230920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125
标示量(mg)200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%
128.011997237199833619970321995967199562019968380.06
228.021985042198448219847620.02
单位质量响应值RSD%判断
71290.1870833.760.46数据可信
影响因素30天-包装高温-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%
5min1471884-47188410.95411.3424.5410.9511.3424.55
2310771-3107717.2147.21
3426270-4262709.8959.89
4670079-67007915.55415.55
5514160-51416011.93511.93
6538027-53802712.48912.49
10min11213903-121390328.17827.3514.8928.2027.3714.89
2925374-92537421.48021.50
31109380-110938025.75225.77
41458483-145848333.85533.89
51129495-112949526.21826.25
61231641-123164128.59028.62
15min11796387-179638741.69938.7915.2141.7938.8815.21
21428066-142806633.14933.21
31460896-146089633.91133.99
42057839-205783947.76847.88
51479596-147959634.34534.43
61803922-180392241.87441.96
20min12174267-217426750.47045.6313.7450.6545.8013.74
21775421-177542141.21241.35
31710286-171028639.70039.85
42276897-227689752.85353.07
51684037-168403739.09139.25
62173764-217376450.45950.64
30min12289194-228919453.13848.689.2653.4348.969.28
22037505-203750547.29647.52
31909880-190988044.33344.58
42277814-227781452.87453.21
51844255-184425542.81043.06
62224738-222473851.64251.94
45min12280459-228045952.93549.756.2953.3550.146.33
22096820-209682048.67349.01
32005499-200549946.55346.89
42273034-227303452.76353.21
51978800-197880045.93346.28
62225999-222599951.67152.08
60min12282441-228244152.98150.394.4753.5150.884.53
22128806-212880649.41549.86
32070154-207015448.05448.50
42269473-226947352.68053.25
52063840-206384047.90748.35
62209622-220962251.29151.82
极限12270455-227045552.70351.981.1253.3552.581.17
22208830-220883051.27351.82
32246297-224629752.14252.69
42261764-226176452.50153.19
52233698-223369851.85052.40
62214361-221436151.40152.04
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125
标示量(mg)200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%
128.011164542116480911644251164716116507111647130.03
228.021182690118126411819770.09
单位质量响应值RSD%判断
41582.0442183.331.02数据可信
影响因素30天-包装光照-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%
5min1248835-24883510.37411.4332.9610.3711.4332.96
2248316-24831610.35210.35
3171001-1710017.1297.13
4442375-44237518.44218.44
5251505-25150510.48510.48
6283652-28365211.82511.83
10min1546899-54689922.80027.6320.0022.8227.6520.00
2619213-61921325.81425.83
3581494-58149424.24224.25
4905132-90513237.73437.76
5722102-72210230.10330.12
6602458-60245825.11625.14
15min1785877-78587732.76239.3517.3932.8239.4117.39
2901021-90102137.56237.62
3821847-82184734.26234.31
41219249-121924950.82950.92
51056739-105673944.05444.12
6878357-87835736.61836.68
20min1935210-93521038.98845.9212.6139.1046.0512.63
21088436-108843645.37545.50
31034310-103431043.11943.23
41300253-130025354.20654.38
51233890-123389051.43951.58
61017252-101725242.40842.53
30min11076506-107650644.87849.906.9645.0550.106.99
21214797-121479750.64350.84
31196057-119605749.86250.04
41297954-129795454.11054.38
51267340-126734052.83453.06
61128537-112853747.04747.24
45min11143405-114340547.66751.344.8947.9251.634.92
21265296-126529652.74953.03
31243449-124344951.83852.10
41296134-129613454.03454.39
51268589-126858952.88653.20
61172303-117230348.87249.14
60min11176381-117638149.04251.943.5649.3752.323.61
21279462-127946253.33953.71
31249933-124993352.10852.46
41292391-129239153.87854.33
51266907-126690752.81653.22
61210481-121048150.46350.82
极限11314767-131476754.81154.201.6955.2254.661.64
21320672-132067255.05755.52
31316962-131696254.90255.34
41292066-129206653.86554.40
51263212-126321252.66253.15
61292614-129261453.88754.32
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DSMF-4022-230920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125
标示量(mg)200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%
128.012000297200205820015532001897200257320016760.05
228.022019263201864520189540.03
单位质量响应值RSD%判断
71462.9172054.030.59数据可信
影响因素30天-包装光照-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%
5min1424206-4242069.75110.7734.059.7510.7734.07
2424077-4240779.7489.75
3284086-2840866.5306.53
4764149-76414917.56617.57
5429020-4290209.8629.86
6485100-48510011.15111.15
10min1939939-93993921.60726.2120.2921.6326.2420.30
21066884-106688424.52524.55
3992046-99204622.80522.82
41562121-156212135.90935.95
51245110-124511028.62228.64
61034942-103494223.79123.82
15min11353245-135324531.10837.4217.5831.1837.5017.59
21555504-155550435.75735.83
31412032-141203232.45932.52
42107897-210789748.45548.57
51823993-182399341.92942.01
61513429-151342934.79034.87
20min11610608-161060837.02443.6812.8037.1643.8512.83
21878099-187809943.17343.33
31778813-177881340.89041.03
42248580-224858051.68951.92
52131603-213160349.00049.18
61753487-175348740.30840.46
30min11851018-185101842.55047.437.1642.7747.707.21
22094095-209409548.13848.39
32058027-205802747.30947.54
42243726-224372651.57751.92
52190299-219029950.34950.64
61943336-194333644.67244.92
45min11964907-196490745.16848.815.1145.4849.185.16
22181344-218134450.14350.50
32140804-214080449.21249.54
42241761-224176151.53251.99
52193707-219370750.42850.83
62018542-201854246.40146.74
60min12024294-202429446.53349.383.6946.9549.863.75
22203098-220309850.64451.11
32150304-215030449.43049.87
42234742-223474251.37151.94
52190613-219061350.35750.87
62087028-208702847.97548.42
极限12273362-227336252.25951.681.7152.7852.261.63
22284781-228478152.52153.10
32277201-227720152.34752.90
42233330-223333051.33852.02
52183943-218394350.20350.83
62235542-223554251.38951.94
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125
标示量(mg)200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%
128.011163809116384711633451161089115815611620490.22
228.021186728118539311860600.08
单位质量响应值RSD%判断
41486.9342329.051.43数据可信
影响因素30天-包装光照-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%
5min1291172-29117212.13210.7917.0512.1310.7917.07
2263720-26372010.98810.99
3274567-27456711.44011.44
4197872-1978728.2448.24
5311753-31175312.98912.99
6215119-2151198.9638.96
10min1634302-63430226.42924.9011.2726.4524.9211.27
2570122-57012223.75423.77
3713513-71351329.72929.75
4533657-53365722.23522.25
5591080-59108024.62824.65
6543020-54302022.62522.64
15min1825203-82520334.38335.929.6134.4535.989.60
2829130-82913034.54634.60
3960062-96006240.00240.07
4769585-76958532.06532.12
5970247-97024740.42640.49
6818002-81800234.08334.14
20min1946216-94621639.42542.269.9939.5542.399.97
21002040-100204041.75141.87
31049703-104970343.73643.87
4927649-92764938.65138.76
51200754-120075450.03050.16
6959960-95996039.99740.11
30min11066745-106674544.44747.877.3944.6348.057.39
21200974-120097450.03950.22
31123391-112339146.80747.01
41089297-108929745.38645.55
51295099-129509953.96154.17
61117672-111767246.56846.74
45min11145554-114555447.73050.744.9647.9951.014.95
21278167-127816753.25653.52
31166748-116674848.61348.90
41218644-121864450.77651.02
51297887-129788754.07754.38
61199864-119986449.99350.25
60min11213728-121372850.57151.833.1850.9152.193.18
21285748-128574853.57153.93
31203215-120321550.13350.50
41249077-124907752.04452.37
51295982-129598253.99854.39
61216500-121650050.68651.02
极限11272908-127290853.03653.531.3753.4653.971.38
21293588-129358853.89854.34
31290327-129032753.76254.21
41301604-130160454.23254.65
51295209-129520953.96654.45
61254697-125469752.27852.70
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DSMF-4022-230920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125
标示量(mg)200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%
128.012008817200888220086022004323200055520062360.19
228.022037146203536720362560.07
单位质量响应值RSD%判断
71625.7172671.521.03数据可信
影响因素30天-包装光照-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%
5min1498060-49806011.38810.0717.7611.3910.0717.76
2447346-44734610.22810.23
3467697-46769710.69310.69
4332028-3320287.5917.59
5534619-53461912.22312.22
6363783-3637838.3188.32
10min11093068-109306824.99223.4811.4725.0223.5011.47
2978001-97800122.36122.38
31228642-122864228.09228.12
4913634-91363420.88920.91
51015374-101537423.21523.24
6933005-93300521.33221.35
15min11422620-142262032.52733.969.7432.6134.049.74
21428082-142808232.65232.72
31655779-165577937.85837.94
41321422-132142230.21330.28
51674737-167473738.29138.37
61410273-141027332.24432.31
20min11630793-163079337.28639.9710.1137.4440.1210.11
21726677-172667739.47939.62
31809302-180930241.36841.54
41594754-159475436.46236.59
52073642-207364247.41247.58
61654650-165465037.83237.97
30min11838589-183858942.03745.297.5442.2745.537.54
22072480-207248047.38547.62
31936539-193653944.27744.54
41873574-187357442.83743.05
52238410-223841051.17951.45
61925380-192538044.02244.24
45min11973251-197325145.11648.025.0945.4548.365.08
22206701-220670150.45450.79
32011241-201124145.98546.35
42097895-209789547.96648.27
52243979-224397951.30651.69
62068203-206820347.28747.61
60min12088906-208890647.76149.053.3248.1949.493.32
22219862-221986250.75551.20
32074998-207499847.44347.91
42149873-214987349.15549.57
52241008-224100851.23851.74
62095909-209590947.92148.35
极限12201425-220142550.33350.821.3950.8751.371.40
22238095-223809551.17251.73
32232246-223224651.03851.61
42251674-225167451.48252.00
52241373-224137351.24751.86
62170387-217038749.62450.15
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