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对照品来源中检院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%
128.011133754113671311341591132514113176211337800.17
228.021154038115482711544320.05
单位质量响应值RSD%判断
40477.6941200.291.26数据可信
影响因素30天-裸片高温-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%
5min1311820-31182013.33210.6135.9813.3310.6135.98
2171043-1710437.3137.31
3212717-2127179.0959.09
4134004-1340045.7295.73
5363332-36333215.53415.53
6296389-29638912.67212.67
10min1641746-64174627.43826.4221.4927.4626.4421.50
2479691-47969120.50920.52
3571504-57150424.43524.45
4475660-47566020.33720.35
5767045-76704532.79532.82
6772460-77246033.02733.05
15min1838635-83863535.85638.4717.2535.9238.5317.26
2747309-74730931.95132.00
3840622-84062235.94136.00
4782569-78256933.45933.50
51092311-109231146.70246.78
61097539-109753946.92647.00
20min1957222-95722240.92645.7914.0441.0545.9114.05
2941243-94124340.24340.34
31004135-100413542.93243.05
4997858-99785842.66442.76
51263563-126356354.02454.18
61261235-126123553.92454.08
30min11070069-107006945.75150.977.3545.9551.187.37
21140487-114048748.76248.93
31160360-116036049.61249.80
41199949-119994951.30451.47
51294404-129440455.34355.59
61288089-128808955.07355.32
45min11139734-113973448.73052.944.6149.0053.224.64
21216104-121610451.99552.24
31230286-123028652.60152.87
41262811-126281153.99254.25
51294372-129437255.34155.68
61285825-128582554.97655.31
60min11188437-118843750.81253.643.0351.1754.023.06
21242027-124202753.10353.44
31248368-124836853.37453.73
41272197-127219754.39354.74
51293213-129321355.29255.72
61283672-128367254.88455.31
极限11303081-130308155.71455.460.8256.1555.920.75
21313188-131318856.14656.57
31295107-129510755.37355.82
41297881-129788155.49155.93
51290806-129080655.18955.71
61282119-128211954.81755.34
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对照品来源中检院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%
128.011955353195459519539521951498195179119534380.09
228.021974970197658419757770.06
单位质量响应值RSD%判断
69740.7470513.100.78数据可信
影响因素30天-裸片高温-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%
5min1532828-53282812.5339.8937.6612.539.8937.65
2282765-2827656.6516.65
3354310-3543108.3348.33
4219364-2193645.1605.16
5622122-62212214.63414.63
6510870-51087012.01712.02
10min11098222-109822225.83324.8721.9225.8524.8921.92
2816029-81602919.19519.21
3977015-97701522.98223.00
4808910-80891019.02819.04
51316539-131653930.96830.99
61328151-132815131.24231.26
15min11438721-143872133.84236.3117.4633.9136.3717.47
21280499-128049930.12130.16
31438853-143885333.84533.90
41338791-133879131.49231.53
51878052-187805244.17744.25
61886895-188689544.38544.46
20min11641032-164103238.60143.2314.2338.7243.3414.24
21613259-161325937.94838.04
31721336-172133640.49040.60
41708461-170846140.18740.28
52174887-217488751.15951.31
62167112-216711250.97651.12
30min11834967-183496743.16348.107.5043.3548.297.53
21951974-195197445.91546.07
31986464-198646446.72746.90
42056882-205688248.38348.54
52225347-222534752.34652.58
62214235-221423552.08452.32
45min11951787-195178745.91149.994.7846.1750.264.81
22087274-208727449.09849.33
32107394-210739449.57149.83
42165630-216563050.94151.18
52229128-222912852.43552.76
62210822-221082252.00452.32
60min12037926-203792647.93750.703.2148.2751.053.24
22130211-213021150.10850.42
32140593-214059350.35250.69
42184690-218469051.38951.71
52228574-222857452.42252.83
62209972-220997251.98452.39
极限12240868-224086852.71152.490.7853.1252.920.70
22256887-225688753.08853.49
32228094-222809452.41052.83
42233156-223315652.53052.94
52223085-222308552.29352.79
62205754-220575451.88552.38
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对照品来源中检院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%
128.011138424113638211354391136166113495311362730.12
228.021161149116024111606950.06
单位质量响应值RSD%判断
40566.6941423.801.48数据可信
影响因素30天-裸片高温-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%
5min1234528-2345289.98910.0542.169.9910.0542.13
2307405-30740513.09313.09
3129728-1297285.5265.53
4189849-1898498.0868.09
5394239-39423916.79216.79
6159388-1593886.7896.79
10min1627068-62706826.70926.3421.8626.7326.3621.88
2688043-68804329.30629.33
3512721-51272121.83921.85
4536472-53647222.85022.86
5850116-85011636.21036.24
6496563-49656321.15021.16
15min1840916-84091635.81838.0315.2135.8838.0915.22
2935412-93541239.84339.91
3839078-83907835.73935.78
4805284-80528434.30034.35
51149510-114951048.96249.05
6787201-78720133.53033.58
20min11024837-102483743.65246.1510.3343.7746.2710.35
21110817-111081747.31447.45
31087346-108734646.31446.42
4993862-99386242.33242.44
51289350-128935054.91855.09
6994474-99447442.35842.46
30min11176079-117607950.09352.065.7750.2952.265.78
21217125-121712551.84252.06
31309650-130965055.78355.97
41132974-113297448.25748.44
51302092-130209255.46155.72
61195407-119540750.91751.09
45min11287697-128769754.84853.764.1255.1254.054.13
21255447-125544753.47453.78
31309971-130997155.79656.07
41170157-117015749.84150.10
51304130-130413055.54855.90
61245699-124569953.05953.32
60min11297437-129743755.26354.193.4155.6354.573.43
21276232-127623254.35954.75
31307609-130760955.69656.06
41191144-119114450.73551.08
51300397-130039755.38955.84
61261343-126134353.72554.07
极限11299595-129959555.35455.310.7055.8255.780.73
21312051-131205155.88556.37
31304616-130461655.56856.03
41292379-129237955.04755.47
51296544-129654455.22555.76
61286484-128648454.79655.23
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对照品来源中检院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%
128.011959000195846919568571957544195451519572770.09
228.021984819198429019845540.02
单位质量响应值RSD%判断
69877.7970826.340.96数据可信
影响因素30天-裸片高温-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%
5min1393882-3938829.2369.3443.919.249.3443.92
2524693-52469312.30312.30
3212397-2123974.9804.98
4319213-3192137.4857.48
5676824-67682415.87015.87
6262467-2624676.1546.15
10min11043526-104352624.46824.6822.3724.4824.7022.38
21179204-117920427.65027.67
3874211-87421120.49820.51
4915632-91563221.46921.48
51460728-146072834.25134.28
6842972-84297219.76619.78
15min11443667-144366733.85135.9215.4133.9135.9815.42
21607334-160733437.68837.75
31436371-143637133.67933.72
41378063-137806332.31232.36
51977603-197760346.37046.45
61348973-134897331.63031.67
20min11747098-174709840.96543.5810.4841.0843.6910.51
21908569-190856944.75144.88
31869392-186939243.83343.93
41702733-170273339.92540.03
52215538-221553851.94952.11
61707596-170759640.03940.13
30min12016127-201612747.27349.175.9447.4549.365.96
22090600-209060049.02049.22
32248017-224801752.71152.88
41936389-193638945.40445.57
52239260-223926052.50552.75
62051227-205122748.09648.26
45min12209894-220989451.81750.814.3152.0851.084.32
22155350-215535050.53850.82
32254903-225490352.87253.13
42000908-200090846.91747.16
52240981-224098152.54652.88
62140821-214082150.19750.44
60min12230103-223010352.29151.213.6652.6451.563.68
22188750-218875051.32151.69
32250511-225051152.76953.12
42036389-203638947.74848.07
52237796-223779652.47152.89
62159995-215999550.64750.97
极限12232821-223282152.35452.390.7252.7952.830.74
22257532-225753252.93453.39
32245492-224549252.65153.09
42225461-222546152.18252.58
52232240-223224052.34152.85
62211557-221155751.85652.27
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对照品来源中检院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%
128.011153979115366211537671153523115074511531350.12
228.021158467115894411587060.03
单位质量响应值RSD%判断
41168.6941352.820.32数据可信
影响因素30天-裸片高湿-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%
5min1417169-41716917.65314.9423.3617.6514.9423.34
2466612-46661219.74519.74
3379929-37992916.07716.08
4254404-25440410.76510.77
5278090-27809011.76711.77
6322597-32259713.65113.65
10min1851907-85190736.04931.7715.7336.0831.8015.74
2892039-89203937.74737.78
3780615-78061533.03233.06
4598587-59858725.32925.35
5626369-62636926.50526.52
6755524-75552431.97031.99
15min11154325-115432548.84544.4112.2248.9344.4912.23
21172478-117247849.61449.71
31103888-110388846.71146.79
4878866-87886637.18937.25
5899304-89930438.05438.12
61088020-108802046.04046.12
20min11302980-130298055.13651.568.5955.3151.718.61
21300621-130062155.03655.21
31260200-126020053.32653.49
41076668-107666845.55945.68
51093457-109345746.27046.40
61276557-127655754.01854.17
30min11319305-131930555.82753.615.1656.0953.855.18
21310082-131008255.43655.71
31289327-128932754.55854.81
41170965-117096549.55049.75
51197765-119776550.68450.89
61313731-131373155.59155.83
45min11320712-132071255.88653.984.0856.2454.314.11
21309350-130935055.40555.77
31288276-128827654.51454.85
41203787-120378750.93851.22
51217152-121715251.50451.79
61315396-131539655.66156.00
60min11314932-131493255.64254.173.2256.0954.583.26
21308481-130848155.36955.82
31286455-128645554.43654.87
41223666-122366651.78052.15
51234026-123402652.21852.59
61313156-131315655.56655.99
极限11315277-131527755.65654.961.0256.2055.461.06
21305310-130531055.23455.78
31283403-128340354.30754.83
41284013-128401354.33354.79
51295831-129583154.83355.29
61308486-130848655.36955.89
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对照品来源中检院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%
128.011984265198344919823261979890197763119815120.14
228.021984314198611819852160.07
单位质量响应值RSD%判断
70743.0270849.960.11数据可信
影响因素30天-裸片高湿-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%
5min1703042-70304216.38013.7225.0216.3813.7225.01
2791125-79112518.43318.43
3636095-63609514.82114.82
4411424-4114249.5869.59
5454951-45495110.60010.60
6535663-53566312.48112.48
10min11462393-146239334.07329.8916.3034.1029.9216.31
21531518-153151835.68335.71
31335809-133580931.12431.15
41012123-101212323.58223.60
51062893-106289324.76524.78
61293669-129366930.14230.16
15min11985919-198591946.27141.9812.5546.3542.0612.55
22016749-201674946.98947.08
31898884-189888444.24344.32
41502196-150219635.00035.06
51535103-153510335.76735.83
61872885-187288543.63743.71
20min12239704-223970452.18448.708.9252.3448.848.94
22236621-223662152.11252.28
32167551-216755150.50350.65
41840685-184068542.88743.00
51864131-186413143.43343.55
62193635-219363551.11051.25
30min12268235-226823552.84850.685.4153.1050.915.44
22254258-225425852.52352.78
32217623-221762351.66951.90
42003892-200389246.68946.87
52048999-204899947.74047.93
62259311-225931152.64152.87
45min12268538-226853852.85651.004.3253.1951.304.36
22251180-225118052.45152.79
32217548-221754851.66851.99
42058114-205811447.95348.22
52079999-207999948.46348.73
62256906-225690652.58552.90
60min12262438-226243852.71351.193.4653.1451.583.51
22248678-224867852.39352.82
32211877-221187751.53551.94
42091086-209108648.72149.06
52112943-211294349.23049.58
62255501-225550152.55252.96
极限12260882-226088252.67752.031.0153.1952.521.06
22245134-224513452.31052.83
32208003-220800351.44551.94
42206459-220645951.40951.83
52229802-222980251.95352.39
62249550-224955052.41352.91
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对照品来源中检院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%
128.011170016117059611688641169036116866711694360.08
228.021180329118010911802190.02
单位质量响应值RSD%判断
41750.6642120.590.63数据可信
影响因素30天-裸片高湿-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%
5min1469182-46918219.53417.1216.2819.5317.1216.28
2434263-43426318.08018.08
3304561-30456112.68012.68
4458014-45801419.06919.07
5351815-35181514.64814.65
6448658-44865818.68018.68
10min1894809-89480937.25534.889.5737.2934.919.57
2869916-86991636.21936.25
3690038-69003828.73028.75
4874933-87493336.42836.46
5801652-80165233.37733.40
6895046-89504637.26537.30
15min11188146-118814649.46847.394.7149.5647.474.72
21138246-113824647.39147.48
31042967-104296743.42443.49
41172464-117246448.81548.91
51116009-111600946.46546.54
61171191-117119148.76248.86
20min11319882-131988254.95353.222.1855.1353.392.19
21262898-126289852.58052.75
31236195-123619551.46951.61
41279534-127953453.27353.45
51284121-128412153.46453.62
61287146-128714653.59053.76
30min11320345-132034554.97253.811.6855.2454.061.68
21266834-126683452.74453.00
31278599-127859953.23453.46
41281709-128170953.36453.63
51316969-131696954.83255.08
61289815-128981553.70153.96
45min11319748-131974854.94753.721.7055.3154.061.70
21263362-126336252.60052.94
31277890-127789053.20553.52
41279565-127956553.27453.63
51313177-131317754.67455.01
61287961-128796153.62453.98
60min11314313-131431354.72153.631.7355.1754.061.72
21262417-126241752.56052.99
31275055-127505553.08753.49
41273735-127373553.03253.47
51315143-131514354.75655.18
61287715-128771553.61454.06
极限11313650-131365054.69353.501.6855.2454.021.68
21259554-125955452.44152.96
31273338-127333853.01553.51
41270975-127097552.91753.45
51307830-130783054.45154.97
61284097-128409753.46354.00
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对照品来源中检院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%
128.011999096199899719993041999568199781919989570.04
228.022010996201087320109340.01
单位质量响应值RSD%判断
71365.8371767.810.40数据可信
影响因素30天-裸片高湿-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%
5min1794568-79456818.31415.9717.0518.3115.9717.05
2734041-73404116.91916.92
3503756-50375611.61111.61
4773104-77310417.81917.82
5589723-58972313.59213.59
6762811-76281117.58217.58
10min11537703-153770335.44233.149.5935.4733.169.59
21493354-149335434.42034.45
31184770-118477027.30727.33
41497025-149702534.50534.53
51374476-137447631.68031.70
61539194-153919435.47735.51
15min12041456-204145647.05345.134.5547.1445.214.55
21957869-195786945.12645.21
31798806-179880641.46041.53
42015152-201515246.44746.53
51923760-192376044.34044.42
62010566-201056646.34146.43
20min12266703-226670352.24550.642.1352.4150.802.15
22173034-217303450.08650.25
32125050-212505048.98049.11
42200001-220000150.70750.87
52204738-220473850.81650.97
62212351-221235150.99251.16
30min12268299-226829952.28151.231.6552.5451.481.65
22179384-217938450.23250.48
32199569-219956950.69750.91
42201249-220124950.73650.99
52264605-226460552.19652.43
62223393-222339351.24651.50
45min12270601-227060152.33551.171.7052.6851.501.70
22174886-217488650.12850.46
32198062-219806250.66350.96
42199938-219993850.70651.04
52260064-226006452.09252.41
62216516-221651651.08851.42
60min12262846-226284652.15651.041.7852.5951.451.78
22170949-217094950.03850.45
32190133-219013350.48050.86
42186622-218662250.39950.82
52260288-226028852.09752.50
62214918-221491851.05151.47
极限12260207-226020752.09550.961.6952.6151.461.69
22168168-216816849.97450.47
32188557-218855750.44450.91
42186728-218672850.40150.90
52250850-225085051.87952.37
62211643-221164350.97651.48
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
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(%)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%
128.011148190114768211468061146822114808011475160.06
228.021169910116717111685400.17
单位质量响应值RSD%判断
40968.0841703.781.26数据可信
影响因素30天-裸片光照-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%
5min1440590-44059018.61113.5724.1918.6113.5724.18
2241909-24190910.21910.22
3321699-32169913.58913.59
4275826-27582611.65111.65
5261987-26198711.06711.07
6384932-38493216.26016.26
10min1890079-89007937.59828.8317.9937.6328.8518.00
2578821-57882124.45024.47
3690053-69005329.14929.17
4577355-57735524.38824.41
5607102-60710225.64525.66
6751080-75108031.72731.75
15min11061164-106116444.82539.8811.6444.9239.9611.66
2842486-84248635.58835.65
3981728-98172841.46941.54
4831474-83147435.12335.18
5873104-87310436.88136.94
61075320-107532045.42345.50
20min11116035-111603547.14346.728.0747.3146.868.08
21017098-101709842.96443.08
31186110-118611050.10350.24
41014516-101451642.85442.97
51070964-107096445.23945.36
61231583-123158352.02452.18
30min11154647-115464748.77450.385.6049.0250.605.61
21142814-114281448.27448.46
31293195-129319554.62654.85
41121858-112185847.38947.58
51194027-119402750.43750.64
61249611-124961152.78553.03
45min11217891-121789151.44551.683.6251.7751.983.64
21180128-118012849.85050.12
31294896-129489654.69855.01
41178820-117882049.79550.06
51218495-121849551.47151.75
61250768-125076852.83453.16
60min11252620-125262052.91252.572.2053.3352.962.22
21210628-121062851.13851.49
31291530-129153054.55654.96
41235959-123595952.20952.56
51229423-122942351.93252.30
61246973-124697352.67453.09
极限11294267-129426754.67254.061.6555.1754.541.61
21299690-129969054.90155.34
31289759-128975954.48154.98
41287360-128736054.38054.82
51261433-126143353.28553.74
61246390-124639052.64953.16
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
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(%)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%
128.011976006197369519749951974922197322719745690.06
228.021994379199210319932410.09
单位质量响应值RSD%判断
70495.1471136.370.65数据可信
影响因素30天-裸片光照-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%
5min1756601-75660117.62412.7524.9117.6212.7524.90
2406814-4068149.4769.48
3546382-54638212.72712.73
4470246-47024610.95410.95
5444004-44400410.34210.34
6660100-66010015.37615.38
10min11529871-152987135.63627.2118.3635.6727.2318.37
2983502-98350222.90922.93
31181541-118154127.52227.54
4986723-98672322.98423.00
51037133-103713324.15824.18
61289294-128929430.03230.06
15min11818776-181877642.36637.7011.7442.4537.7711.75
21442634-144263433.60433.66
31685467-168546739.26039.33
41422306-142230633.13133.19
51497087-149708734.87234.93
61845784-184578442.99543.07
20min11913948-191394844.58344.228.1744.7444.358.17
21745203-174520340.65240.76
32039194-203919447.50047.63
41740482-174048240.54240.65
51834903-183490342.74142.86
62116290-211629049.29649.44
30min11976473-197647346.03947.685.7946.2747.885.79
21959358-195935845.64045.82
32223118-222311851.78452.00
41921319-192131944.75444.93
52050539-205053947.76447.95
62149548-214954850.07150.30
45min12088858-208885848.65748.893.7548.9749.173.78
22021194-202119447.08147.33
32225188-222518851.83252.13
42020163-202016347.05747.31
52087993-208799348.63748.90
62149665-214966550.07350.39
60min12148971-214897150.05749.732.3150.4550.102.34
22074165-207416548.31548.65
32219664-221966451.70452.09
42117229-211722949.31849.65
52108127-210812749.10649.45
62141815-214181549.89050.29
极限12226677-222667751.86751.291.6652.3451.741.62
22237020-223702052.10852.52
32217355-221735551.65052.12
42215283-221528351.60252.02
52170510-217051050.55950.99
62143968-214396849.94150.42
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对照品来源中检院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%
128.011183134118195611813291180398117815011809930.16
228.021191044119045911907520.04
单位质量响应值RSD%判断
42163.2642496.500.56数据可信
影响因素30天-裸片光照-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%
5min1373237-37323715.39512.2028.1615.3912.2028.15
2409993-40999316.91116.91
3258177-25817710.64910.65
4268329-26832911.06811.07
5180149-1801497.4317.43
6285170-28517011.76211.76
10min1775502-77550231.98727.8416.4232.0127.8616.42
2818773-81877333.77233.80
3619782-61978225.56425.58
4638333-63833326.32926.35
5513339-51333921.17421.19
6683794-68379428.20428.22
15min11084995-108499544.75339.1010.8644.8339.1610.87
21069427-106942744.11044.19
3912851-91285137.65237.71
4892749-89274936.82336.89
5842632-84263234.75634.80
6884541-88454136.48436.55
20min11270912-127091252.42145.9310.3852.5746.0610.39
21248720-124872051.50651.66
31057108-105710843.60243.73
41069607-106960744.11844.24
51013381-101338141.79941.90
61020906-102090642.10942.24
30min11291416-129141653.26749.625.5453.5149.825.56
21279397-127939752.77153.01
31151392-115139247.49147.69
41158420-115842047.78147.98
51195696-119569649.31949.49
61141259-114125947.07347.27
45min11287651-128765153.11151.283.3453.4451.573.36
21279867-127986752.79053.12
31204027-120402749.66249.94
41207774-120777449.81750.09
51275507-127550752.61152.87
61204926-120492649.69949.98
60min11286702-128670253.07252.271.4453.4952.651.47
21277765-127776552.70453.12
31242565-124256551.25251.61
41253436-125343651.70052.06
51284575-128457552.98553.33
61258781-125878151.92152.28
极限11281629-128162952.86353.160.6853.3753.630.62
21276257-127625752.64253.15
31288407-128840753.14353.59
41298134-129813453.54453.99
51291077-129107753.25353.69
61297661-129766153.52453.97
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对照品来源中检院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%
128.012021205202267820221362020639201890520211130.08
228.022016490201582120161560.03
单位质量响应值RSD%判断
72156.8471954.180.20数据可信
影响因素30天-裸片光照-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%
5min1637667-63766714.59811.5228.9314.6011.5228.94
2704581-70458116.12916.13
3434487-4344879.9469.95
4455676-45567610.43110.43
5303159-3031596.9406.94
6484181-48418111.08411.08
10min11329872-132987230.44426.4616.6030.4726.4816.61
21404033-140403332.14232.17
31057650-105765024.21224.23
41094599-109459925.05825.08
5875803-87580320.04920.06
61173972-117397226.87526.89
15min11865227-186522742.69937.2011.0142.7737.2711.02
21834469-183446941.99542.08
31565251-156525135.83235.89
41528240-152824034.98535.04
51442148-144214833.01433.06
61515794-151579434.70034.76
20min12182523-218252349.96343.7610.4950.1143.8810.51
22147678-214767849.16549.32
31813114-181311441.50641.62
41839792-183979242.11742.23
51736045-173604539.74239.84
61749789-174978940.05740.18
30min12218177-221817750.77947.235.6151.0147.425.64
22194017-219401750.22650.46
31972591-197259145.15745.34
41985649-198564945.45645.64
52050770-205077046.94747.11
61956399-195639944.78744.97
45min12211820-221182050.63448.843.4250.9549.123.44
22200293-220029350.37050.69
32062502-206250247.21547.48
42072320-207232047.44047.70
52186218-218621850.04850.29
62067565-206756547.33147.59
60min12211815-221181550.63449.801.5251.0350.161.55
22198810-219881050.33650.74
32131674-213167448.79949.14
42149968-214996849.21849.56
52202122-220212250.41250.74
62157662-215766249.39449.74
极限12204636-220463650.46950.750.6650.9551.190.60
22195740-219574050.26650.75
32217356-221735650.76051.18
42232822-223282251.11451.54
52219803-221980350.81651.23
62230585-223058551.06351.49
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