厄贝沙坦氢氯噻嗪片项目信息
介质体积(ml)1000取样体积(ml)5补液体积(ml)5
对照品批号100309-201404对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数10000
标示量(mg)12.5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%
112.649208391924921629205792264920980.14
212.639229492544924190.20
单位质量响应值RSD%判断
7286.237317.420.31数据可信
长期6月-供试品溶液-2023061421批-氢氯噻嗪-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%
5min146028-4602850.27851.508.9350.2851.508.93
250019-5001954.63754.64
350991-5099155.69955.70
439866-3986643.54743.55
545760-4576049.98549.99
650194-5019454.82954.83
10min186710-8671094.71693.271.8594.9793.531.85
284939-8493992.78293.05
382923-8292390.58090.86
484437-8443792.23392.45
586274-8627494.24094.49
687039-8703995.07695.35
15min193419-93419102.04599.471.82102.77100.191.82
290937-9093799.334100.07
389846-8984698.14298.87
490201-9020198.53099.21
589266-8926697.50898.23
692691-92691101.250102.00
20min193149-93149101.750100.591.42102.99101.821.41
291087-9108799.497100.73
390269-9026998.60499.83
492173-92173100.684101.86
592030-92030100.528101.74
693841-93841102.506103.76
30min187906-8790696.02397.181.6097.7798.901.57
286605-8660594.60296.33
390364-9036498.708100.42
489883-8988398.18299.86
589390-8939097.64499.36
689637-8963797.91499.68
45min190776-9077699.15898.171.03101.38100.381.00
289164-8916497.39799.60
389822-8982298.116100.32
491091-9109199.502101.67
588691-8869196.88099.08
689659-8965997.938100.20
60min192554-92554101.100100.022.18103.82102.722.14
291371-9137199.808102.50
389300-8930097.545100.24
492867-92867101.442104.11
589211-8921197.448100.13
694101-94101102.790105.54
极限192916-92916101.495100.021.98104.72103.221.94
290639-9063999.008102.20
390362-9036298.706101.89
489028-8902897.248100.42
593621-93621102.265105.44
692811-92811101.381104.64
厄贝沙坦氢氯噻嗪片项目信息
介质体积(ml)1000取样体积(ml)5补液体积(ml)5
对照品批号100607-201804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1000
标示量(mg)150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%
114.912646722641432644702645802640872643900.10
214.952643902645262644580.04
单位质量响应值RSD%判断
17732.3917689.500.18数据可信
长期6月-供试品溶液-2023061421批-厄贝沙坦-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%
5min1108270-10827040.75542.068.9140.7542.068.90
2116958-11695844.02544.02
3120417-12041745.32745.33
495045-9504535.77635.78
5108516-10851640.84740.85
6121277-12127745.65145.65
10min1230466-23046686.75185.772.1086.9585.982.10
2225993-22599385.06785.29
3222786-22278683.86084.09
4222769-22276983.85484.03
5230533-23053386.77686.98
6234560-23456088.29288.52
15min1267110-267110100.54497.332.26101.1897.972.26
2256302-25630296.47697.12
3255939-25593996.33996.99
4254315-25431595.72896.33
5253102-25310295.27295.91
6264698-26469899.636100.31
20min1270621-270621101.86699.471.93103.01100.601.93
2260185-26018597.93899.07
3258509-25850997.30798.43
4262798-26279898.921100.00
5263116-26311699.041100.16
6270266-270266101.732102.90
30min1255967-25596796.35096.391.7598.0098.011.72
2247429-24742993.13694.75
3260178-26017897.93599.55
4258003-25800397.11698.69
5256727-25672796.63698.25
6258131-25813197.16598.84
45min1263555-26355599.20697.031.38101.3499.131.36
2254162-25416295.67197.75
3257584-25758496.95999.06
4259684-25968497.74999.81
5254204-25420495.68697.78
6257431-25743196.90199.06
60min1268447-268447101.04898.572.42103.67101.162.38
2260313-26031397.986100.55
3255646-25564696.22998.82
4263867-26386799.324101.87
5253974-25397495.60098.17
6268891-268891101.215103.86
极限1268330-268330101.00498.642.31104.14101.722.27
2258978-25897897.483100.53
3258538-25853897.318100.39
4253174-25317495.29998.34
5267332-267332100.628103.68
6265882-265882100.082103.24
厄贝沙坦氢氯噻嗪片项目信息
介质体积(ml)1000取样体积(ml)5补液体积(ml)5
对照品批号100309-201404对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数10000
标示量(mg)12.5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%
112.649251092564926469237492567925320.11
212.639254692286924160.20
单位质量响应值RSD%判断
7320.577317.180.04数据可信
长期6月-供试品溶液-2023061421批-氢氯噻嗪-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%
5min154993-5499359.93154.1510.0059.9354.1510.00
252489-5248957.20257.20
354055-5405558.90858.91
448450-4845052.80052.80
542698-4269846.53246.53
645450-4545049.53149.53
10min182481-8248189.88791.122.6790.1991.392.65
279851-7985187.02087.31
384607-8460792.20392.50
485964-8596493.68293.95
583443-8344390.93591.17
685308-8530892.96793.22
15min183660-8366091.17195.743.6391.9296.463.60
285589-8558993.27493.99
390503-9050398.62999.38
492244-92244100.526101.26
586703-8670394.48895.17
688391-8839196.32797.04
20min190295-9029598.40297.652.1899.6198.862.19
288938-8893896.92398.11
391952-91952100.208101.46
491419-9141999.627100.86
586961-8696194.76995.93
688072-8807295.98097.17
30min186708-8670894.49398.782.9296.19100.482.90
289382-8938297.40799.08
392912-92912101.254103.00
493980-93980102.418104.15
589574-8957497.61699.25
691307-9130799.505101.18
45min189544-8954497.58498.902.0599.75101.082.03
288879-8887996.85999.02
392026-92026100.289102.54
490474-9047498.597100.84
589735-8973597.79299.91
693848-93848102.274104.45
60min186675-8667594.457100.013.5597.11102.693.49
290083-9008398.171100.81
395704-95704104.297107.05
493968-93968102.405105.14
590793-9079398.945101.56
693419-93419101.807104.49
极限189860-8986097.928101.652.46101.06104.832.44
291609-9160999.834102.97
396049-96049104.673107.95
495239-95239103.790107.04
593240-93240101.612104.72
693647-93647102.055105.25
厄贝沙坦氢氯噻嗪片项目信息
介质体积(ml)1000取样体积(ml)5补液体积(ml)5
对照品批号100607-201804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1000
标示量(mg)150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%
114.912647542651072645782646472649732648120.09
214.952650062648202649130.05
单位质量响应值RSD%判断
17760.7017719.930.17数据可信
长期6月-供试品溶液-2023061421批-厄贝沙坦-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%
5min1129489-12948948.66144.329.9648.6644.329.96
2125267-12526747.07447.07
3128743-12874348.38148.38
4114905-11490543.18043.18
5101368-10136838.09338.09
6107859-10785940.53340.53
10min1224967-22496784.54185.012.7284.7885.232.71
2214567-21456780.63380.87
3231025-23102586.81787.06
4230184-23018486.50186.72
5226806-22680685.23285.42
6229685-22968586.31486.52
15min1240748-24074890.47194.223.4991.1494.873.48
2242464-24246491.11691.75
3259204-25920497.40798.08
4262160-26216098.51899.17
5247556-24755693.03093.65
6252245-25224594.79295.43
20min1260849-26084998.02597.112.1799.1498.232.17
2255183-25518395.89696.99
3265976-26597699.952101.11
4262767-26276798.74699.89
5251777-25177794.61695.70
6253978-25397895.44396.55
30min1250548-25054894.15498.102.7795.7699.702.75
2257468-25746896.75598.33
3267957-267957100.696102.36
4269870-269870101.415103.05
5257831-25783196.89198.45
6262582-26258298.676100.26
45min1256889-25688996.53797.631.9598.6299.721.93
2254742-25474295.73097.79
3264062-26406299.232101.40
4258724-25872497.22799.37
5256553-25655396.41198.45
6267758-267758100.621102.70
60min1248240-24824093.28798.593.5995.85101.183.54
2257376-25737696.72099.26
3274206-274206103.045105.71
4269234-269234101.176103.80
5258706-25870697.22099.74
6266422-266422100.119102.70
极限1257777-25777796.871100.122.2699.90103.192.25
2261617-26161798.314101.33
3273265-273265102.691105.87
4272306-272306102.331105.46
5265960-26596099.946102.95
6267578-267578100.554103.64
厄贝沙坦氢氯噻嗪片项目信息
介质体积(ml)1000取样体积(ml)5补液体积(ml)5
对照品批号100309-201404对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数10000
标示量(mg)12.5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%
112.649260192131927009237892511924640.24
212.639262192999928100.29
单位质量响应值RSD%判断
7315.197348.380.33数据可信
长期6月-供试品溶液-2023061521批-氢氯噻嗪-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%
5min142318-4231846.03749.328.0746.0449.328.07
252090-5209056.66756.67
342922-4292246.69446.69
446036-4603650.08150.08
542960-4296046.73546.73
645698-4569849.71449.71
10min188478-8847896.25393.692.4596.4893.942.44
286138-8613893.70793.99
384878-8487892.33692.57
487663-8766395.36695.62
582662-8266289.92690.16
686924-8692494.56294.81
15min190597-9059798.55898.561.6899.2799.281.66
288891-8889196.70297.45
388884-8888496.69497.39
491440-9144099.475100.20
591026-9102699.02599.71
692779-92779100.932101.65
20min192606-92606100.74399.112.24101.95100.322.22
288505-8850596.28297.52
389884-8988497.78298.96
492565-92565100.699101.92
589576-8957697.44798.63
693497-93497101.713102.94
30min189629-8962997.50599.101.5799.21100.801.56
290316-9031698.25299.97
390651-9065198.617100.28
492439-92439100.562102.29
590278-9027898.21199.88
693264-93264101.459103.19
45min193284-93284101.481100.043.45103.68102.243.39
287288-8728894.95897.17
390781-9078198.758100.92
496527-96527105.009107.24
590477-9047798.427100.58
693414-93414101.622103.86
60min192300-92300100.41198.592.93103.11101.282.88
285890-8589093.43796.12
390265-9026598.197100.85
490715-9071598.686101.44
590807-9080798.786101.44
693758-93758101.997104.75
极限191539-9153999.58398.990.93102.79102.180.95
289831-8983197.725100.87
390225-9022598.153101.30
491727-9172799.787103.04
590790-9079098.768101.91
691861-9186199.933103.19
厄贝沙坦氢氯噻嗪片项目信息
介质体积(ml)1000取样体积(ml)5补液体积(ml)5
对照品批号100607-201804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1000
标示量(mg)150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%
114.912650002651672653572648922645922650020.11
214.952656402657012656700.02
单位质量响应值RSD%判断
17773.4417770.570.02数据可信
长期6月-供试品溶液-2023061521批-厄贝沙坦-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%
5min191539-9153934.33836.688.5834.3436.688.58
2112571-11257142.22842.23
389783-8978333.68033.68
499678-9967837.39137.39
593150-9315034.94334.94
699973-9997337.50237.50
10min1222665-22266583.52781.452.7483.7081.642.74
2221224-22122482.98683.20
3213290-21329080.01080.18
4218590-21859081.99882.18
5206985-20698577.64577.82
6220055-22005582.54782.73
15min1246389-24638992.42693.031.5693.0293.631.55
2246748-24674892.56193.19
3242868-24286891.10591.67
4249207-24920793.48394.08
5248383-24838393.17493.74
6254469-25446995.45796.06
20min1258239-25823996.87196.051.7297.9297.101.72
2252315-25231594.64995.74
3253056-25305694.92795.95
4260163-26016397.59398.66
5251134-25113494.20695.23
6261352-26135298.03999.12
30min1252818-25281894.83897.161.7096.3798.701.70
2260169-26016997.59599.16
3257283-25728396.51298.01
4262664-26266498.531100.08
5256329-25632996.15597.65
6264811-26481199.336100.90
45min1263833-26383398.97097.722.56100.9899.742.52
2250698-25069894.04296.09
3258667-25866797.03299.01
4268035-268035100.546102.59
5255667-25566795.90697.89
6266100-26610099.820101.88
60min1261012-26101297.91196.602.58100.4299.112.53
2246009-24600992.28394.80
3256572-25657296.24698.71
4257778-25777896.69899.25
5257532-25753296.60699.07
6266181-26618199.850102.41
极限1258358-25835896.91696.910.7699.9199.900.79
2256794-25679496.32999.31
3256261-25626196.12999.08
4260318-26031897.651100.68
5257271-25727196.50899.45
6261076-26107697.935101.00
厄贝沙坦氢氯噻嗪片项目信息
介质体积(ml)1000取样体积(ml)5补液体积(ml)5
对照品批号100309-201404对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数10000
标示量(mg)12.5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%
112.649234192183923219238792228922920.10
212.639238092395923880.02
单位质量响应值RSD%判断
7301.587314.960.13数据可信
长期6月-供试品溶液-2023061521批-氢氯噻嗪-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%
5min148316-4831652.73052.856.3852.7352.846.38
246578-4657850.83450.83
343602-4360247.58647.59
450783-5078355.42355.42
548936-4893653.40753.41
652312-5231257.09257.09
10min185330-8533093.12694.871.5793.3995.131.58
287211-8721195.17995.43
385172-8517292.95493.19
487470-8747095.46295.74
587976-8797696.01496.28
688386-8838696.46296.75
15min188756-8875696.86598.361.8997.5999.101.88
289329-8932997.49198.22
390957-9095799.26799.97
492051-92051100.461101.22
587910-8791095.94296.69
691750-91750100.133100.90
20min190592-9059298.869100.501.97100.08101.731.94
294385-94385103.009104.23
392681-92681101.149102.35
492566-92566101.023102.28
592949-92949101.441102.67
689339-8933997.50298.77
30min182240-8224089.75498.914.8791.46100.644.79
290578-9057898.854100.59
395013-95013103.694105.40
493128-93128101.637103.40
591287-9128799.628101.36
691522-9152299.884101.64
45min193134-93134101.643101.351.17103.80103.581.14
293032-93032101.532103.76
394582-94582103.224105.45
492512-92512100.965103.23
591228-9122899.563101.80
692692-92692101.161103.42
60min193252-93252101.772101.002.29104.44103.742.21
294420-94420103.047105.78
394739-94739103.395106.13
491366-9136699.714102.49
592427-92427100.872103.60
689069-8906997.20799.97
极限194144-94144102.746101.581.78105.92104.821.70
294508-94508103.143106.39
393775-93775102.343105.60
490680-9068098.965102.24
594060-94060102.654105.89
691289-9128999.630102.88
厄贝沙坦氢氯噻嗪片项目信息
介质体积(ml)1000取样体积(ml)5补液体积(ml)5
对照品批号100607-201804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1000
标示量(mg)150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%
114.912646292645632646212645712647372646240.03
214.952646372649342647860.08
单位质量响应值RSD%判断
17748.0917711.440.15数据可信
长期6月-供试品溶液-2023061521批-厄贝沙坦-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%
5min1105476-10547639.66139.886.0139.6639.886.01
2101015-10101537.98337.98
396786-9678636.39336.39
4110098-11009841.39941.40
5108763-10876340.89740.90
6114256-11425642.96242.96
10min1218651-21865182.21683.071.7482.4183.271.75
2221587-22158783.32083.51
3214552-21455280.67580.86
4221611-22161183.32983.54
5225077-22507784.63384.84
6223982-22398284.22184.44
15min1243778-24377891.66492.621.3792.2793.241.36
2244694-24469492.00992.62
3248770-24877093.54194.13
4248285-24828593.35993.98
5241886-24188690.95391.58
6250544-25054494.20994.84
20min1255669-25566996.13697.011.9097.2098.081.86
2264366-26436699.406100.47
3260444-26044497.93198.98
4257865-25786596.96198.05
5259635-25963597.62798.71
6249954-24995493.98795.09
30min1234706-23470688.25396.694.6689.8098.254.59
2257741-25774196.91598.48
3270555-270555101.733103.28
4262391-26239198.663100.24
5258840-25884097.32898.90
6258613-25861397.24398.82
45min1264583-26458399.48798.921.23101.48100.961.20
2263478-26347899.072101.12
3268285-268285100.879102.93
4261433-26143398.303100.37
5258779-25877997.30599.36
6261821-26182198.449100.51
60min1264647-26464799.51198.682.29102.00101.222.23
2267459-267459100.569103.11
3268555-268555100.981103.54
4259219-25921997.470100.03
5262432-26243298.679101.22
6252331-25233194.88097.44
极限1266765-266765100.30899.091.73103.29102.121.67
2267906-267906100.737103.78
3265658-26565899.892102.95
4257408-25740896.79099.84
5265166-26516699.707102.74
6258174-25817497.078100.11
厄贝沙坦氢氯噻嗪片项目信息
介质体积(ml)1000取样体积(ml)5补液体积(ml)5
对照品批号100309-201404对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数10000
标示量(mg)12.5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%
112.649244192409924469247992280924110.09
212.639241192481924460.06
单位质量响应值RSD%判断
7311.007319.560.09数据可信
长期6月-供试品溶液-2023061621批-氢氯噻嗪-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%
5min146795-4679551.02251.737.9351.0251.737.93
248804-4880453.21253.21
353954-5395458.82758.83
442993-4299346.87646.88
547146-4714651.40451.40
644960-4496049.02149.02
10min184395-8439592.01894.582.8792.2794.842.87
283267-8326790.78891.05
389561-8956197.65097.94
486543-8654394.36094.59
588008-8800895.95796.21
688693-8869396.70496.95
15min187426-8742695.32298.132.6396.0498.862.62
290446-9044698.61599.34
391419-9141999.676100.46
490715-9071598.90999.61
586937-8693794.78995.53
693041-93041101.445102.17
20min189538-8953897.62598.312.0698.8299.532.06
288877-8887796.90498.12
393348-93348101.779103.06
488475-8847596.46697.67
589371-8937197.44398.65
691388-9138899.642100.88
30min193235-93235101.656100.691.52103.34102.401.52
290804-9080499.006100.70
394030-94030102.523104.31
490890-9089099.099100.78
593452-93452101.893103.59
691656-9165699.934101.67
45min190362-9036298.524100.702.56100.71102.912.54
291083-9108399.310101.50
394401-94401102.927105.23
491823-91823100.117102.30
590371-9037198.533100.74
696084-96084104.762107.00
60min192101-92101100.420100.282.16103.10102.992.13
292480-92480100.833103.52
392263-92263100.596103.41
488195-8819596.16198.84
592655-92655101.024103.72
694116-94116102.617105.37
极限192018-92018100.32999.542.58103.51102.762.52
289246-8924697.307100.50
390410-9041098.576101.90
490209-9020998.357101.52
590157-9015798.300101.51
695723-95723104.369107.64
厄贝沙坦氢氯噻嗪片项目信息
介质体积(ml)1000取样体积(ml)5补液体积(ml)5
对照品批号100607-201804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1000
标示量(mg)150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%
114.912652432651892653332653142648352651830.08
214.952648362650502649430.06
单位质量响应值RSD%判断
17785.5817721.940.26数据可信
长期6月-供试品溶液-2023061621批-厄贝沙坦-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%
5min1101928-10192838.27538.587.7738.2738.587.77
2106300-10630039.91739.92
3116269-11626943.66043.66
492882-9288234.87834.88
5100851-10085137.87037.87
698188-9818836.87036.87
10min1212376-21237679.74982.062.9979.9482.252.99
2210679-21067979.11279.31
3226213-22621384.94585.16
4215985-21598581.10481.28
5220859-22085982.93483.12
6225027-22502784.50084.68
15min1235936-23593688.59691.822.9089.1992.422.89
2246212-24621292.45593.05
3248163-24816393.18793.83
4245926-24592692.34792.93
5236561-23656188.83189.43
6254289-25428995.48896.09
20min1248872-24887293.45494.442.1294.4995.502.13
2248292-24829293.23694.29
3259423-25942397.41698.52
4247066-24706692.77593.82
5248259-24825993.22394.27
6257137-25713796.55797.64
30min1261658-26165898.25597.781.4299.7699.321.41
2255810-25581096.05997.58
3264766-26476699.422101.02
4256838-25683896.44597.95
5263885-26388599.091100.61
6259380-25938097.39998.97
45min1255398-25539895.90497.962.7997.9099.992.76
2256436-25643696.29498.30
3265612-26561299.740101.83
4260186-26018697.70299.69
5254518-25451895.57497.58
6273136-273136102.565104.62
60min1260381-26038197.77597.352.31100.2599.862.28
2260152-26015297.689100.17
3259642-25964297.498100.09
4248090-24809093.16095.64
5261011-26101198.012100.50
6266230-26623099.972102.54
极限1259132-25913297.30696.782.73100.2799.782.68
2251641-25164194.49397.47
3255105-25510595.79498.87
4254696-25469695.64198.58
5254599-25459995.60498.58
6271212-271212101.842104.91
厄贝沙坦氢氯噻嗪片项目信息
介质体积(ml)1000取样体积(ml)5补液体积(ml)5
对照品批号100309-201404对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数10000
标示量(mg)12.5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%
112.649222291821922389202492088920790.19
212.639217392494923340.25
单位质量响应值RSD%判断
7284.737310.690.26数据可信
长期6月-供试品溶液-2023061621批-氢氯噻嗪-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%
5min144699-4469948.85451.6713.4648.8551.6713.46
255546-5554660.70960.71
353793-5379358.79358.79
447826-4782652.27152.27
539630-3963043.31443.31
642167-4216746.08646.09
10min186326-8632694.35094.281.3194.5994.541.28
284769-8476992.64892.95
385942-8594293.93094.22
487083-8708395.17795.44
587917-8791796.08996.31
685516-8551693.46593.70
15min190398-9039898.80096.482.0699.5297.212.03
286907-8690794.98595.75
385765-8576593.73794.50
490024-9002498.39299.13
588852-8885297.11197.81
687701-8770195.85396.55
20min193016-93016101.662101.132.36102.87102.342.32
291373-9137399.866101.11
389624-8962497.95499.19
495295-95295104.153105.38
594633-94633103.429104.61
691244-9124499.725100.90
30min192736-92736101.356100.952.18103.07102.672.15
290032-9003298.400100.14
392550-92550101.152102.87
493552-93552102.248104.00
595209-95209104.059105.76
690116-9011698.492100.17
45min191196-9119699.673101.012.91101.90103.232.88
293637-93637102.340104.57
391536-91536100.044102.27
497258-97258106.298108.56
591175-9117599.650101.87
689696-8969698.033100.20
60min194352-94352103.122102.591.18105.85105.311.18
294064-94064102.807105.55
393584-93584102.283105.01
495650-95650104.541107.33
592932-92932101.570104.29
692583-92583101.189103.85
极限193078-93078101.730101.420.64104.97104.660.59
292504-92504101.102104.36
392053-92053100.609103.85
492636-92636101.246104.56
592731-92731101.350104.58
693788-93788102.506105.67
厄贝沙坦氢氯噻嗪片项目信息
介质体积(ml)1000取样体积(ml)5补液体积(ml)5
对照品批号100607-201804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1000
标示量(mg)150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%
114.912644142643632646562644322643572644440.05
214.952648272650942649600.08
单位质量响应值RSD%判断
17736.0217723.080.06数据可信
长期6月-供试品溶液-2023061621批-厄贝沙坦-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%
5min195966-9596636.08538.7014.2636.0938.7014.25
2122363-12236346.01146.01
3117635-11763544.23344.23
4104526-10452639.30439.30
585621-8562132.19532.20
691476-9147634.39734.40
10min1215842-21584281.16182.151.3381.3482.341.35
2217967-21796781.96082.19
3222752-22275283.75983.98
4220030-22003082.73682.93
5219377-21937782.49082.65
6214807-21480780.77280.94
15min1244371-24437191.88890.621.2092.4791.231.18
2239469-23946990.04590.69
3238138-23813889.54590.18
4244446-24444691.91792.53
5241349-24134990.75291.33
6238259-23825989.59090.17
20min1258189-25818997.08497.401.9498.1398.451.91
2256918-25691896.60697.70
3253755-25375595.41796.50
4265731-26573199.920100.99
5264570-26457099.484100.51
6254938-25493895.86296.89
30min1260797-26079798.06598.242.1199.6099.782.08
2255553-25555396.09397.67
3262974-26297498.884100.45
4264297-26429799.381100.95
5269230-269230101.236102.76
6254711-25471195.77697.28
45min1256768-25676896.55098.163.0598.57100.193.01
2263848-26384899.212101.27
3258902-25890297.35299.41
4275716-275716103.675105.74
5257522-25752296.83398.86
6253488-25348895.31797.30
60min1265843-26584399.96299.621.28102.47102.151.28
2265465-26546599.820102.37
3263871-26387199.221101.77
4270844-270844101.843104.43
5262295-26229598.628101.14
6261357-26135798.276100.73
极限1261912-26191298.48498.340.68101.49101.360.63
2260257-26025797.862100.91
3259270-25927097.491100.53
4262126-26212698.565101.66
5261183-26118398.210101.22
6264391-26439199.416102.37
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