替米沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100629-202204对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数2500
标示量(mg)40供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.113832823836623833183830393833863833370.06
211.033830213829283829740.02
单位质量响应值RSD%判断
34503.7834721.120.45数据可信
供试品溶液-24041801批-pH1.0盐酸溶液
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min153208-5320813.83514.087.3313.8414.087.32
259135-5913515.37715.38
353168-5316813.82513.82
449323-4932312.82512.83
551393-5139313.36313.36
658740-5874015.27415.27
10min1108434-10843428.19627.653.7628.2727.723.76
2102290-10229026.59826.68
3105789-10578927.50827.58
4101384-10138426.36226.43
5108127-10812728.11628.19
6111896-11189629.09629.18
15min1164165-16416542.68742.173.9242.9242.403.91
2164760-16476042.84243.07
3165414-16541443.01243.24
4149956-14995638.99239.21
5161126-16112641.89742.13
6167617-16761743.58543.83
20min1204276-20427653.11752.263.2553.5952.723.22
2203194-20319452.83553.31
3187716-18771648.81149.28
4203330-20333052.87153.31
5202764-20276452.72453.19
6204513-20451353.17853.67
30min1217626-21762656.58861.925.0257.3562.684.97
2241455-24145562.78463.55
3241588-24158862.81963.56
4231021-23102160.07160.80
5248015-24801564.49065.25
6249139-24913964.78265.57
45min1300584-30058478.15977.092.4479.2478.192.42
2300638-30063878.17379.29
3300523-30052378.14379.23
4282158-28215873.36874.43
5298515-29851577.62178.74
6296374-29637477.06578.21
60min1344348-34434889.53987.933.8391.0589.463.79
2348932-34893290.73192.28
3340609-34060988.56790.09
4315015-31501581.91283.38
5331913-33191386.30687.85
6348186-34818690.53792.11
90min1344731-34473189.63990.172.9391.6592.192.87
2359403-35940393.45495.51
3332284-33228486.40288.42
4348579-34857990.63992.56
5356049-35604992.58194.61
6339648-33964888.31790.39
120min1361905-36190594.10492.051.5196.6194.561.48
2357037-35703792.83895.41
3354824-35482492.26394.76
4348773-34877390.69093.12
5353916-35391692.02794.57
6347463-34746390.34992.91
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1353285-35328591.86390.592.3094.9093.622.17
2339798-33979888.35691.44
3355863-35586392.53395.54
4357050-35705092.84295.77
5344672-34467289.62392.67
6339674-33967488.32491.39
替米沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100629-202204对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数2500
标示量(mg)40供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.113835563848283846983849773847003845520.15
211.033860913863653862280.06
单位质量响应值RSD%判断
34613.1435016.140.82数据可信
供试品溶液-24041801批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min148541-4854112.54914.1110.3112.5514.1110.31
251911-5191113.42013.42
349564-4956412.81312.81
455402-5540214.32314.32
559544-5954415.39315.39
662584-6258416.17916.18
10min195566-9556624.70628.278.8924.7828.358.88
2121263-12126331.34931.42
3100150-10015025.89125.96
4112816-11281629.16529.24
5110524-11052428.57328.66
6115875-11587529.95630.05
15min1160372-16037241.45944.123.7241.6744.363.74
2179176-17917646.32146.57
3168515-16851543.56543.78
4169093-16909343.71443.96
5173725-17372544.91145.16
6173186-17318644.77245.03
20min1209703-20970354.21355.531.6554.6556.011.64
2216343-21634355.92956.44
3218750-21875056.55157.01
4217905-21790556.33356.82
5214157-21415755.36455.86
6211948-21194854.79355.30
30min1247642-24764264.02164.041.2064.7664.831.21
2250076-25007664.65065.47
3242054-24205462.57663.35
4247711-24771164.03864.84
5249142-24914264.40865.21
6249717-24971764.55765.37
45min1301052-30105277.82878.682.0878.9279.832.07
2311573-31157380.54881.72
3299517-29951777.43178.55
4310806-31080680.35081.50
5296319-29631976.60577.76
6306897-30689779.33980.51
60min1339449-33944987.75589.090.9289.2890.680.94
2344859-34485989.15390.78
3343009-34300988.67590.22
4346096-34609689.47391.07
5345642-34564289.35690.94
6348743-34874390.15791.77
90min1359920-35992093.04792.911.4795.0694.991.44
2352459-35245991.11893.24
3354031-35403191.52493.57
4360318-36031893.15095.25
5363546-36354693.98496.07
6366006-36600694.62096.73
120min1363560-36356093.98893.381.4296.5295.981.39
2355864-35586491.99894.62
3353573-35357391.40693.96
4364778-36477894.30396.92
5365111-36511194.38996.99
6364402-36440294.20596.84
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1350775-35077590.68390.911.4793.7494.021.43
2342824-34282488.62791.76
3351251-35125190.80693.86
4358428-35842892.66195.80
5354537-35453791.65594.78
6352165-35216591.04294.20
替米沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100629-202204对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数2500
标示量(mg)40供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.113838053835723832983835413831203834670.07
211.033813503812223812860.03
单位质量响应值RSD%判断
34515.4834568.090.11数据可信
供试品溶液-24041901批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min152187-5218713.59813.3011.4413.6013.3011.43
244202-4420211.51711.52
350876-5087613.25613.26
444393-4439311.56711.57
557908-5790815.08815.09
656588-5658814.74414.74
10min195335-9533524.84025.8512.4324.9225.9212.42
286764-8676422.60722.67
3107805-10780528.08928.16
484344-8434421.97622.04
5114936-11493629.94730.03
6106107-10610727.64727.73
15min1145528-14552837.91840.0611.0438.1340.2811.03
2158745-15874541.36241.55
3161254-16125442.01542.25
4123333-12333332.13532.32
5170103-17010344.32144.57
6163646-16364642.63942.87
20min1182615-18261547.58149.725.3748.0150.165.39
2201326-20132652.45652.88
3195194-19519450.85951.32
4174474-17447445.46045.82
5198132-19813251.62452.12
6193210-19321050.34250.81
30min1214132-21413255.79361.384.9256.4862.094.89
2248291-24829164.69365.40
3236687-23668761.67062.42
4236145-23614561.52962.15
5242495-24249563.18363.97
6235605-23560561.38862.14
45min1281574-28157473.36575.243.9574.3676.303.97
2303061-30306178.96480.03
3288245-28824575.10376.19
4270750-27075070.54571.50
5293299-29329976.42077.55
6295742-29574277.05778.15
60min1326291-32629185.01684.563.5286.4286.033.53
2331906-33190686.47987.99
3328156-32815685.50287.01
4302278-30227878.76080.11
5324798-32479884.62786.19
6333725-33372586.95388.47
90min1345490-34549090.01990.181.1491.9092.121.17
2347920-34792090.65292.64
3349105-34910590.96192.94
4341259-34125988.91690.71
5341880-34188089.07891.11
6350961-35096191.44493.45
120min1348659-34865990.84591.121.3993.2293.571.38
2353801-35380192.18494.68
3350551-35055191.33893.82
4347785-34778590.61792.90
5341938-34193889.09391.62
6355611-35561192.65695.17
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1344764-34476489.83090.591.0992.7193.541.10
2353596-35359692.13195.14
3347732-34773290.60393.60
4346462-34646290.27293.06
5343223-34322389.42892.45
6350266-35026691.26394.29
替米沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100629-202204对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数2500
标示量(mg)40供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.113817913817293820783811863817873817140.09
211.033791723801243796480.18
单位质量响应值RSD%判断
34357.7034419.580.13数据可信
供试品溶液-24041901批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min150447-5044713.20313.497.0713.2013.497.07
248615-4861512.72312.72
346912-4691212.27812.28
455013-5501314.39814.40
556338-5633814.74414.74
651937-5193713.59313.59
10min1108534-10853428.40527.864.1128.4827.944.09
2108870-10887028.49328.56
3107530-10753028.14228.21
4108310-10831028.34628.43
5107941-10794128.25028.33
697599-9759925.54325.62
15min1164449-16444943.03942.593.4743.2742.823.47
2164421-16442143.03143.26
3162859-16285942.62342.85
4170638-17063844.65844.90
5160610-16061042.03442.27
6153459-15345940.16240.38
20min1194157-19415750.81451.132.9151.2851.592.91
2195607-19560751.19351.66
3195871-19587151.26251.72
4200477-20047752.46852.95
5200796-20079652.55153.02
6185183-18518348.46548.91
30min1240623-24062362.97563.141.8863.7363.891.89
2240775-24077563.01463.77
3242202-24220263.38864.13
4246308-24630864.46265.24
5244472-24447263.98264.75
6233207-23320761.03461.74
45min1295334-29533477.29376.852.0578.4077.952.04
2300279-30027978.58779.69
3291230-29123076.21977.32
4292589-29258976.57577.71
5298687-29868778.17179.29
6283616-28361674.22675.28
60min1326217-32621785.37687.582.4486.9189.122.41
2344792-34479290.23791.78
3335321-33532187.75889.28
4327841-32784185.80187.36
5343968-34396890.02191.58
6329813-32981386.31787.78
90min1346255-34625590.62091.741.2092.6393.751.16
2351378-35137891.96194.00
3352468-35246892.24694.26
4344496-34449690.16092.20
5354023-35402392.65394.71
6354512-35451292.78194.72
120min1349332-34933291.42592.411.3493.9394.931.32
2356721-35672193.35995.91
3349689-34968991.51994.04
4348564-34856491.22493.76
5360223-36022394.27696.84
6354030-35403092.65595.11
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1351155-35115591.90291.530.8094.9294.570.76
2351015-35101591.86694.94
3349266-34926691.40894.44
4344603-34460390.18893.23
5349741-34974191.53294.62
6352609-35260992.28395.25
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