缬沙坦氨氯地平片项目信息
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100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.332510592508742514802506032507432509520.14
214.372495602491472493540.12
单位质量响应值RSD%判断
17512.3517352.400.65数据可信
长期24月-供试品溶液-BDJL7批-氨氯地平-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min168385-6838525.43125.365.2725.4325.365.28
261645-6164522.92422.92
368183-6818325.35525.36
469717-6971725.92625.93
572548-7254826.97926.98
668744-6874425.56425.56
10min1117344-11734443.63745.564.8343.6845.604.82
2133185-13318549.52849.57
3120489-12048944.80744.85
4124710-12471046.37646.42
5121837-12183745.30845.35
6117549-11754943.71343.76
15min1134756-13475650.11251.233.9250.2351.353.91
2147047-14704754.68354.80
3134565-13456550.04150.16
4139835-13983552.00152.12
5138563-13856351.52851.65
6131818-13181849.02049.14
20min1144867-14486753.87254.924.2354.0755.124.23
2158806-15880659.05659.27
3143470-14347053.35353.55
4149070-14907055.43555.64
5148686-14868655.29255.50
6141156-14115652.49252.69
30min1157694-15769458.64259.684.0858.9359.974.07
2170576-17057663.43363.74
3155916-15591657.98158.27
4165476-16547661.53661.84
5160365-16036559.63659.93
6152866-15286656.84757.13
45min1169801-16980163.14564.073.5963.5364.473.59
2182618-18261867.91168.33
3168496-16849662.65963.05
4176607-17660765.67666.08
5170362-17036263.35363.75
6165889-16588961.69062.07
60min1179706-17970666.82867.172.9467.3267.672.94
2189940-18994070.63471.16
3177876-17787666.14766.64
4180780-18078067.22767.74
5181450-18145067.47767.98
6173954-17395464.68965.17
极限1191471-19147171.20371.723.3671.8172.333.36
2202442-20244275.28375.93
3184964-18496468.78369.38
4197227-19722773.34473.97
5193929-19392972.11772.73
6187131-18713169.58970.18
缬沙坦氨氯地平片项目信息
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100651-202307对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.1对照品水分(%)0对照品稀释倍数200
标示量(mg)80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%
116.304647654465117846592764649414464548646506020.12
216.084652306465125246517790.02
单位质量响应值RSD%判断
285313.01289289.740.98数据可信
长期24月-供试品溶液-BDJL7批-缬沙坦-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1111789-1117892.1692.124.482.172.134.36
2113792-1137922.2082.21
3114634-1146342.2242.22
4102874-1028741.9962.00
5109583-1095832.1262.13
6104376-1043762.0252.03
10min1255284-2552844.9534.984.324.964.994.34
2273854-2738545.3145.32
3258600-2586005.0185.02
4257219-2572194.9914.99
5257505-2575054.9965.00
6239031-2390314.6384.64
15min1387941-3879417.5277.594.827.547.604.81
2415594-4155948.0648.08
3389167-3891677.5517.56
4398424-3984247.7317.74
5397373-3973737.7107.72
6358438-3584386.9556.97
20min1501683-5016839.7349.865.389.769.885.37
2551798-55179810.70710.73
3505409-5054099.8079.83
4511843-5118439.9329.96
5510532-5105329.9069.93
6466334-4663349.0489.07
30min1688820-68882013.36513.435.4413.4113.485.43
2745335-74533514.46214.51
3684624-68462413.28413.33
4715698-71569813.88713.93
5686350-68635013.31813.36
6632288-63228812.26912.31
45min1910758-91075817.67217.874.6117.7317.934.62
2990128-99012819.21219.28
3914105-91410517.73717.80
4942827-94282718.29418.36
5905387-90538717.56817.63
6863044-86304416.74616.80
60min11111470-111147021.56621.763.9721.6621.863.98
21193728-119372823.16223.26
31127152-112715221.87121.96
41128410-112841021.89521.99
51113932-111393221.61421.71
61054700-105470020.46520.55
极限11544129-154412929.96130.203.0830.0930.333.09
21641377-164137731.84831.99
31545580-154558029.99030.12
41561985-156198530.30830.44
51550553-155055330.08630.21
61493801-149380128.98529.11
缬沙坦氨氯地平片项目信息
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100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.332481852492022502092504312491072494270.37
214.372487692493642490660.17
单位质量响应值RSD%判断
17405.9317332.360.30数据可信
长期24月-供试品溶液-BDJL7批-氨氯地平-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min171116-7111626.54224.3621.2826.5424.3621.28
279006-7900629.48729.49
369230-6923025.83825.84
438588-3858814.40214.40
568924-6892425.72425.72
664799-6479924.18424.18
10min1117555-11755543.87444.109.2443.9244.149.25
2126761-12676147.31047.36
3117767-11776743.95344.00
497905-9790536.54036.56
5120638-12063845.02545.07
6128354-12835447.90447.94
15min1134904-13490450.34950.136.5950.4750.246.60
2140620-14062052.48252.61
3133364-13336449.77449.89
4117609-11760943.89443.98
5137124-13712451.17851.30
6142256-14225653.09353.21
20min1143475-14347553.54853.657.0953.7553.857.10
2151054-15105456.37756.59
3142375-14237553.13753.34
4124705-12470546.54346.70
5148184-14818455.30555.51
6152751-15275157.01057.22
30min1157168-15716858.65859.355.1058.9559.645.12
2164702-16470261.47061.78
3155810-15581058.15258.44
4145187-14518754.18754.42
5164444-16444461.37461.67
6166885-16688562.28562.59
45min1168808-16880863.00363.743.9363.3964.123.96
2176259-17625965.78466.20
3167108-16710862.36862.75
4159952-15995259.69860.02
5176801-17680165.98666.38
6175700-17570065.57565.98
60min1177769-17776966.34767.173.7866.8467.663.80
2182907-18290768.26568.79
3176842-17684266.00166.49
4169112-16911263.11663.54
5185475-18547569.22369.73
6187687-18768770.04970.57
极限1190209-19020970.99071.823.0771.5972.433.09
2195611-19561173.00673.64
3188943-18894370.51871.12
4183501-18350168.48769.02
5198383-19838374.04174.66
6198003-19800373.89974.53
缬沙坦氨氯地平片项目信息
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100651-202307对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.1对照品水分(%)0对照品稀释倍数200
标示量(mg)80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%
116.304636365464892746555764661351465096446506370.20
216.084654935466694346609390.19
单位质量响应值RSD%判断
285315.15289859.391.12数据可信
长期24月-供试品溶液-BDJL7批-缬沙坦-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1116661-1166612.2612.1420.602.262.1420.61
2120776-1207762.3412.34
3131311-1313112.5452.55
467062-670621.3001.30
5106564-1065642.0662.07
6121389-1213892.3532.35
10min1258393-2583935.0095.1113.295.015.1213.26
2277974-2779745.3885.39
3297625-2976255.7695.77
4200944-2009443.8953.90
5256064-2560644.9644.97
6291274-2912745.6465.65
15min1392434-3924347.6077.7110.397.627.7210.42
2410259-4102597.9537.97
3433694-4336948.4078.42
4322209-3222096.2466.25
5394236-3942367.6427.65
6434311-4343118.4198.43
20min1503179-5031799.75410.059.199.7810.089.21
2532086-53208610.31410.34
3552340-55234010.70710.73
4435148-4351488.4358.45
5517072-51707210.02310.05
6571712-57171211.08211.11
30min1698450-69845013.53914.077.3213.5814.117.33
2733904-73390414.22614.27
3749740-74974014.53314.58
4632839-63283912.26712.30
5758100-75810014.69514.74
6780761-78076115.13515.18
45min1920414-92041417.84218.615.5917.9118.685.59
2956746-95674618.54618.61
3968594-96859418.77618.85
4881054-88105417.07917.13
51020836-102083619.78819.85
61012672-101267219.63019.70
60min11116064-111606421.63422.565.2021.7322.665.19
21140098-114009822.10022.20
31170829-117082922.69622.80
41089829-108982921.12621.21
51241463-124146324.06524.16
61225962-122596223.76523.87
极限11546677-154667729.98131.043.5130.1131.173.53
21575958-157595830.54930.68
31603230-160323031.07831.22
41546470-154647029.97730.09
51682647-168264732.61732.76
61651243-165124332.00832.15
缬沙坦氨氯地平片项目信息
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100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.332486322486352485252487822486712486490.04
214.372516172509742512960.19
单位质量响应值RSD%判断
17351.6417487.540.56数据可信
长期24月-供试品溶液-BDJL7批-氨氯地平-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%
5min111276-112764.1964.8913.584.204.8913.56
213500-135005.0245.02
312138-121384.5174.52
416255-162556.0496.05
513616-136165.0675.07
611981-119814.4594.46
10min138147-3814714.19614.565.8214.2014.575.83
239848-3984814.82914.84
338082-3808214.17214.18
442695-4269515.88915.90
539954-3995414.86914.88
635978-3597813.38913.40
15min154841-5484120.40920.476.2220.4420.506.22
254220-5422020.17820.21
354355-5435520.22820.26
460173-6017322.39322.43
556730-5673021.11221.14
649741-4974118.51118.54
20min171487-7148726.60426.323.6926.6726.383.69
271106-7110626.46226.53
369107-6910725.71825.78
474377-7437727.67927.75
571592-7159226.64326.71
666659-6665924.80724.87
30min197789-9778936.39235.624.4236.5035.734.42
298083-9808336.50136.61
393551-9355134.81534.92
498663-9866336.71736.84
598175-9817536.53536.65
687977-8797732.74032.84
45min1130373-13037348.51847.274.0948.6947.444.10
2129160-12916048.06648.24
3123886-12388646.10446.27
4130770-13077048.66548.85
5130171-13017148.44248.62
6117794-11779443.83643.99
60min1155856-15585658.00156.723.4158.2556.973.41
2156563-15656358.26458.52
3147064-14706454.72954.97
4155489-15548957.86458.13
5154895-15489557.64357.90
6144596-14459653.81154.04
极限1199061-19906174.08073.631.8374.4373.981.84
2200309-20030974.54474.89
3196843-19684373.25473.59
4201626-20162675.03475.39
5197966-19796673.67274.02
6191363-19136371.21571.53
缬沙坦氨氯地平片项目信息
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100651-202307对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.1对照品水分(%)0对照品稀释倍数200
标示量(mg)80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%
116.304662458465768746515844651749465062846548210.11
216.084705283469271446989980.19
单位质量响应值RSD%判断
285571.84292226.241.63数据可信
长期24月-供试品溶液-BDJL7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%
5min1770860-77086014.87615.885.3114.8815.885.29
2848917-84891716.38216.38
3793637-79363715.31515.32
4894526-89452617.26217.26
5816070-81607015.74815.75
6813129-81312915.69215.69
10min11457692-145769228.13028.782.7128.1628.812.71
21503974-150397429.02329.05
31449247-144924727.96727.99
41560338-156033830.11130.14
51500298-150029828.95228.98
61476714-147671428.49728.52
15min11891728-189172836.50636.612.2836.5836.682.28
21887460-188746036.42436.50
31849949-184994935.70035.77
41972855-197285538.07238.15
51914007-191400736.93637.01
61866935-186693536.02836.10
20min12212800-221280042.70242.821.7142.8342.951.71
22221881-222188142.87743.01
32162338-216233841.72841.86
42277274-227727443.94644.09
52234847-223484743.12843.26
62203415-220341542.52142.65
30min12729240-272924052.66852.261.5052.8752.461.50
22723368-272336852.55552.76
32649722-264972251.13451.33
42753577-275357753.13853.35
52725919-272591952.60452.81
62666731-266673151.46251.67
45min13282595-328259563.34763.091.1963.6463.381.19
23300164-330016463.68663.98
33210145-321014561.94962.24
43297539-329753963.63563.94
53294102-329410263.56963.86
63230733-323073362.34662.64
60min13692409-369240971.25571.071.0371.6571.471.03
23718156-371815671.75272.15
33618153-361815369.82270.21
43711266-371126671.61972.03
53697896-369789671.36171.76
63659228-365922870.61571.01
极限14297317-429731782.92983.300.5683.4483.820.56
24332474-433247483.60784.13
34304326-430432683.06483.57
44357165-435716584.08484.61
54313123-431312383.23483.75
64296139-429613982.90683.42
缬沙坦氨氯地平片项目信息
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100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.332509542512162515162512072509212511630.10
214.372478952480322479640.04
单位质量响应值RSD%判断
17527.0817255.671.11数据可信
长期24月-供试品溶液-BDJL7批-氨氯地平-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%
5min114091-140915.2535.4317.815.255.4317.81
211720-117204.3694.37
313840-138405.1595.16
412859-128594.7934.79
515797-157975.8895.89
619077-190777.1117.11
10min142903-4290315.99317.987.4116.0017.987.41
252240-5224019.47319.48
347475-4747517.69717.71
446440-4644017.31117.32
548102-4810217.93117.94
652179-5217919.45119.46
15min174181-7418127.65228.144.4627.6928.184.46
279396-7939629.59629.64
374176-7417627.65027.69
472469-7246927.01427.05
572723-7272327.10927.15
680075-8007529.84929.89
20min196588-9658836.00536.333.4436.0936.423.45
2102530-10253038.22038.31
396555-9655535.99236.08
494607-9460735.26635.35
594025-9402535.04935.13
6100448-10044837.44437.54
30min1127667-12766747.59049.072.4447.7349.222.45
2136538-13653850.89751.05
3130241-13024148.54948.69
4131030-13103048.84348.98
5130078-13007848.48948.63
6134283-13428350.05650.21
45min1162371-16237160.52662.261.9260.7562.491.92
2171275-17127563.84564.08
3165945-16594561.85962.08
4167905-16790562.58962.81
5165176-16517661.57261.80
6169472-16947263.17363.41
60min1189185-18918570.52271.411.6870.8471.741.68
2195861-19586173.01073.35
3188447-18844770.24770.57
4189510-18951070.64370.97
5191204-19120471.27471.60
6195174-19517472.75473.10
极限1216194-21619480.59081.883.4481.0382.333.44
2226577-22657784.46084.93
3208331-20833177.65978.10
4219784-21978481.92882.37
5217691-21769181.14881.59
6229322-22932285.48385.95
缬沙坦氨氯地平片项目信息
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100651-202307对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.1对照品水分(%)0对照品稀释倍数200
标示量(mg)80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%
116.304700931470374647049384704995470397347037170.04
216.084656067465467546553710.03
单位质量响应值RSD%判断
288571.60289513.120.24数据可信
长期24月-供试品溶液-BDJL7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%
5min1840368-84036816.20716.498.4116.2116.488.40
2837253-83725316.14716.15
3847302-84730216.34116.34
4762394-76239414.70314.70
5857816-85781616.54416.54
6983871-98387118.97518.97
10min11644565-164456531.71732.714.0231.7432.744.02
21771913-177191334.17334.20
31660796-166079632.03032.06
41642235-164223531.67231.70
51663642-166364232.08532.11
61794143-179414334.60134.63
15min12232533-223253343.05644.073.1443.1444.163.14
22374714-237471445.79845.88
32243555-224355543.26943.35
42248886-224888643.37143.45
52231425-223142543.03543.12
62380009-238000945.90045.99
20min12652252-265225251.15152.312.7351.3052.472.73
22806963-280696354.13454.29
32678483-267848351.65651.81
42679611-267961151.67851.83
52651580-265158051.13851.29
62806040-280604054.11654.28
30min13247652-324765262.63363.912.1562.8764.152.15
23402509-340250965.62065.87
33269855-326985563.06263.30
43292944-329294463.50763.74
53265467-326546762.97763.21
63404506-340450665.65865.91
45min13794620-379462073.18274.821.8473.5275.171.85
23968656-396865676.53876.90
33854135-385413574.33074.67
43866432-386643274.56774.91
53830270-383027073.87074.21
63963716-396371676.44376.81
60min14162915-416291580.28581.911.9280.7582.391.92
24345582-434558283.80884.30
34203419-420341981.06681.53
44227442-422744281.52982.00
54193345-419334580.87281.34
64351843-435184383.92884.42
极限14527882-452788287.32389.652.0987.9290.262.09
24750819-475081991.62392.25
34613746-461374688.97989.58
44628371-462837189.26189.86
54592062-459206288.56189.16
64779198-477919892.17092.80
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