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对照品水分(%)0对照品稀释倍数1250
标示量(mg)80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%
110.727186477196287195227195117183497191310.09
210.607176167167797171980.09
单位质量响应值RSD%判断
67083.1267660.190.61数据可信
供试品溶液-2026031621批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min180881-8088110.80510.834.6910.8010.834.70
280045-8004510.69310.69
383441-8344111.14711.15
485206-8520611.38311.38
574278-742789.9239.92
682583-8258311.03211.03
10min1164939-16493922.03421.644.4122.0921.704.41
2157928-15792821.09821.16
3165381-16538122.09322.16
4173030-17303023.11523.18
5157032-15703220.97821.03
6153556-15355620.51420.57
15min1242993-24299332.46132.935.5232.6433.115.50
2241501-24150132.26232.44
3249177-24917733.28833.47
4269157-26915735.95736.15
5248527-24852733.20133.37
6227499-22749930.39230.57
20min1316816-31681642.32342.794.5342.6943.164.52
2324244-32424443.31643.67
3329160-32916043.97244.34
4333027-33302744.48944.88
5325904-32590443.53743.89
6292901-29290139.12939.47
30min1423328-42332856.55257.592.8657.1558.192.87
2430227-43022757.47458.07
3441602-44160258.99459.61
4444606-44460659.39560.03
5435150-43515058.13258.73
6411440-41144054.96455.53
45min1521819-52181969.71071.573.8170.6272.493.78
2529787-52978770.77471.69
3574433-57443376.73877.68
4523843-52384369.98070.95
5541899-54189972.39273.31
6522585-52258569.81270.68
60min1576313-57631376.99079.142.8578.2980.462.80
2571684-57168476.37177.68
3607938-60793881.21482.58
4586159-58615978.30579.66
5600443-60044380.21381.54
6612133-61213381.77583.03
极限1638509-63850985.29884.763.1487.0386.523.10
2639020-63902085.36787.10
3655309-65530987.54389.36
4623691-62369183.31985.11
5649746-64974686.79988.57
6600512-60051280.22281.93
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对照品水分(%)0对照品稀释倍数1250
标示量(mg)80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%
110.727211917209297198837210497219907210080.11
210.607195357192907194120.03
单位质量响应值RSD%判断
67258.2167869.060.64数据可信
供试品溶液-2026031721批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min173392-733929.77710.807.879.7810.807.87
280292-8029210.69610.70
386361-8636111.50411.50
473949-739499.8519.85
583912-8391211.17811.18
688645-8864511.80811.81
10min1155747-15574720.74722.093.7720.8022.153.78
2170581-17058122.72322.78
3170340-17034022.69122.75
4162268-16226821.61621.67
5164263-16426321.88221.94
6171765-17176522.88122.95
15min1241441-24144132.16233.876.2432.3334.056.22
2266388-26638835.48635.67
3277186-27718636.92437.11
4234545-23454531.24431.42
5256738-25673834.20034.38
6249250-24925033.20333.40
20min1319966-31996642.62343.745.4442.9744.115.43
2347793-34779346.33046.71
3353354-35335447.07047.47
4313623-31362341.77842.13
5323637-32363743.11243.49
6311595-31159541.50841.88
30min1422756-42275656.31656.342.5356.9056.962.52
2428866-42886657.12957.77
3436674-43667458.17058.83
4427071-42707156.89057.47
5416233-41623355.44756.06
6406104-40610454.09754.71
45min1525676-52567670.02670.031.5270.9270.961.50
2521073-52107369.41270.37
3526814-52681470.17771.16
4531451-53145170.79571.69
5536101-53610171.41472.34
6513340-51334068.38269.29
60min1571131-57113176.08177.173.5377.3778.493.49
2560619-56061974.68076.02
3597681-59768179.61780.99
4580181-58018177.28678.58
5608687-60868781.08382.40
6557697-55769774.29175.58
极限1606329-60632980.76983.863.7582.4885.613.72
2624271-62427183.15984.92
3668523-66852389.05490.87
4614229-61422981.82283.54
5646967-64696786.18387.95
6617038-61703882.19683.90
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对照品水分(%)0对照品稀释倍数1250
标示量(mg)80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%
110.727129467131367129817137997131277131980.05
210.607200507176087188290.25
单位质量响应值RSD%判断
66529.6667814.061.36数据可信
供试品溶液-2026031821批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min158398-583987.82510.3413.557.8310.3413.52
277929-7792910.44210.44
390409-9040912.11512.11
476333-7633310.22810.23
579026-7902610.58910.59
680787-8078710.82510.83
10min1121278-12127816.25121.1911.9016.2921.2511.91
2160465-16046521.50221.56
3173253-17325323.21523.28
4164135-16413521.99422.05
5160054-16005421.44721.51
6169828-16982822.75622.82
15min1180251-18025124.15331.6612.1824.2931.8312.18
2242970-24297032.55732.73
3264601-26460135.45635.65
4245421-24542132.88633.06
5243027-24302732.56532.74
6241179-24117932.31732.50
20min1233048-23304831.22841.0912.6031.5041.4412.59
2318862-31886242.72743.08
3348574-34857446.70847.10
4314461-31446142.13742.50
5312757-31275741.90842.27
6312245-31224541.84042.21
30min1328470-32847044.01454.929.8344.4655.509.85
2425945-42594557.07557.67
3436757-43675758.52459.18
4421308-42130856.45457.05
5421610-42161056.49457.09
6425271-42527156.98557.58
45min1481390-48139064.50570.004.8165.1970.894.86
2541398-54139872.54673.46
3524701-52470170.30871.29
4522391-52239169.99970.91
5510998-51099868.47269.38
6553673-55367374.19075.11
60min1549699-54969973.65877.393.3274.7078.663.38
2587040-58704078.66279.98
3575077-57507777.05978.43
4573101-57310176.79478.09
5572367-57236776.69577.98
6607828-60782881.44782.77
极限1655547-65554787.84186.742.8389.2988.452.74
2668655-66865589.59891.35
3621048-62104883.21985.02
4628882-62888284.26885.99
5653907-65390787.62289.33
6656142-65614287.92189.70
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对照品水分(%)0对照品稀释倍数1250
标示量(mg)80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%
110.727209287214537209667220657220447214910.08
210.607202927204147203530.02
单位质量响应值RSD%判断
67303.2667957.830.69数据可信
供试品溶液-2026031821批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min179167-7916710.5359.9811.2210.549.9811.23
283141-8314111.06411.06
359913-599137.9737.97
471078-710789.4599.46
579921-7992110.63610.64
676679-7667910.20410.20
10min1164202-16420221.85220.369.0921.9120.429.11
2156738-15673820.85920.92
3127442-12744216.96017.00
4147256-14725619.59719.65
5163107-16310721.70621.77
6159236-15923621.19121.25
15min1254287-25428733.84031.487.0034.0231.657.01
2233234-23323431.03931.22
3207035-20703527.55227.69
4236786-23678631.51131.67
5249450-24945033.19733.38
6238667-23866731.76231.94
20min1326377-32637743.43441.975.9543.8042.315.97
2315918-31591842.04242.39
3278117-27811737.01237.30
4322318-32231842.89443.23
5328367-32836743.69944.06
6321155-32115542.73943.09
30min1423090-42309056.30455.906.1256.9156.476.13
2428369-42836957.00757.59
3368599-36859949.05349.55
4433983-43398357.75458.33
5437701-43770158.24958.86
6428388-42838857.00957.60
45min1520347-52034769.24769.314.1670.1770.194.18
2532220-53222070.82771.73
3478741-47874163.71064.48
4529825-52982570.50971.40
5524151-52415169.75470.68
6539474-53947471.79372.70
60min1571330-57133076.03277.193.3777.3478.473.40
2595618-59561879.26480.56
3543992-54399272.39473.52
4589285-58928578.42279.71
5590671-59067178.60679.92
6589484-58948478.44879.75
极限1636815-63681584.74783.832.2886.4885.532.33
2634864-63486484.48786.22
3601767-60176780.08381.61
4635329-63532984.54986.27
5641350-64135085.35087.10
6629349-62934983.75385.49
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对照品水分(%)0对照品稀释倍数1250
标示量(mg)80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%
110.727368727389907386717386257386467383610.12
210.607380977373967377460.07
单位质量响应值RSD%判断
68876.9669598.680.74数据可信
供试品溶液-2026031621批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min174682-746829.70810.697.939.7110.707.92
286201-8620111.20511.21
380461-8046110.45910.46
488570-8857011.51311.51
588767-8876711.53911.54
674909-749099.7379.74
10min1154715-15471520.11121.175.4820.1721.235.48
2176225-17622522.90822.97
3157181-15718120.43220.49
4165834-16583421.55721.62
5169017-16901721.97122.03
6154256-15425620.05220.11
15min1236417-23641730.73232.196.8330.9032.366.82
2278747-27874736.23436.42
3234109-23410930.43230.60
4242189-24218931.48231.67
5254877-25487733.13233.32
6239312-23931231.10831.27
20min1312509-31250940.62341.875.5940.9642.225.59
2352411-35241145.81046.20
3310336-31033640.34140.68
4317684-31768441.29641.65
5334525-33452543.48543.86
6304959-30495939.64239.98
30min1429827-42982755.87357.472.4756.4458.062.50
2458867-45886759.64860.29
3437707-43770756.89857.46
4442941-44294157.57858.17
5450038-45003858.50159.11
6433165-43316556.30756.87
45min1558715-55871572.62872.472.8673.5073.382.82
2569086-56908673.97674.95
3560429-56042972.85073.73
4533728-53372869.37970.29
5545454-54545470.90471.84
6577792-57779275.10775.98
60min1617669-61766980.29179.803.6781.5781.113.60
2612221-61222179.58380.97
3635231-63523182.57483.86
4584176-58417675.93777.23
5592898-59289877.07178.40
6640997-64099783.32384.61
极限1672911-67291187.47287.443.1189.1989.203.04
2654854-65485485.12586.95
3689389-68938989.61491.36
4655215-65521585.17286.89
5658272-65827285.56987.33
6705444-70544491.70193.45
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对照品水分(%)0对照品稀释倍数1250
标示量(mg)80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%
110.727358347347037337377346297343067346420.11
210.607387657382277384960.06
单位质量响应值RSD%判断
68530.0469669.431.17数据可信
供试品溶液-2026031721批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min197385-9738512.68511.749.7912.6811.749.80
286465-8646511.26311.26
385020-8502011.07411.07
480462-8046210.48110.48
587228-8722811.36211.36
6104083-10408313.55713.56
10min1183332-18333223.88023.3011.8323.9523.3611.81
2176488-17648822.98923.05
3178136-17813623.20323.26
4153372-15337219.97820.04
5165637-16563721.57521.64
6216075-21607528.14528.22
15min1281724-28172436.69634.1911.1136.9034.3811.11
2254023-25402333.08833.28
3258171-25817133.62833.82
4227013-22701329.57029.74
5244404-24440431.83532.02
6309439-30943940.30640.54
20min1349046-34904645.46543.109.4445.8743.499.45
2316666-31666641.24741.62
3333960-33396043.50043.88
4293270-29327038.20038.53
5311313-31131340.55040.91
6381197-38119749.65350.11
30min1446968-44696858.22057.706.3558.8858.326.39
2424673-42467355.31655.92
3448222-44822258.38359.00
4413624-41362453.87754.42
5430691-43069156.10056.68
6493568-49356864.29065.02
45min1516730-51673067.30769.844.0268.2970.794.05
2538791-53879170.18071.09
3530290-53029069.07370.02
4530057-53005769.04369.89
5523883-52388368.23969.14
6577461-57746175.21776.31
60min1572917-57291774.62677.333.8275.9878.663.85
2586749-58674976.42777.73
3590579-59057976.92678.25
4590295-59029576.88978.12
5583546-58354676.01077.29
6637972-63797283.09984.61
极限1619392-61939280.67983.923.1082.4585.683.09
2651146-65114684.81586.54
3635878-63587882.82784.58
4660702-66070286.06087.72
5627550-62755081.74283.44
6670871-67087187.38589.35
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