坎地沙坦酯氢氯噻嗪片项目信息
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100309-202205对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.70对照品水分(%)0对照品稀释倍数1000
标示量(mg)12.5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%
112.034646534654424650394653554647254650430.08
212.054620494626704623600.10
单位质量响应值RSD%判断
38656.9438370.120.53数据可信
中间条件12月-供试品溶液-2024082821批-氢氯噻嗪-含0.35%吐温20的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%
5min1314839-31483958.68359.9221.7358.6859.9221.73
2422243-42224378.70178.70
3344069-34406964.13164.13
4225648-22564842.05842.06
5357302-35730266.59766.60
6264835-26483549.36249.36
10min1408864-40886476.20878.328.4076.3178.428.41
2471170-47117087.82187.95
3430301-43030180.20380.31
4364297-36429767.90167.97
5434239-43423980.93781.05
6412149-41214976.82076.90
15min1444254-44425482.80484.153.5183.0384.383.53
2477231-47723188.95189.23
3445457-44545783.02883.27
4430107-43010780.16780.35
5454313-45431384.67984.92
6457609-45760985.29385.50
20min1463461-46346186.38486.222.4786.7586.592.49
2480157-48015789.49689.92
3450897-45089784.04284.42
4449615-44961583.80384.12
5462818-46281886.26486.65
6468400-46840087.30587.66
30min1484321-48432190.27288.232.1790.7888.742.17
2482013-48201389.84290.42
3455987-45598784.99185.51
4469725-46972587.55288.01
5471139-47113987.81588.35
6476907-47690788.89089.39
45min1498373-49837392.89189.612.4893.5590.282.46
2481759-48175989.79590.52
3462066-46206686.12486.78
4483944-48394490.20290.80
5475227-47522788.57789.25
6483400-48340090.10090.75
60min1505508-50550894.22190.252.7295.0391.062.69
2483719-48371990.16091.03
3465830-46583086.82687.63
4488544-48854491.05991.81
5476951-47695188.89889.72
6484815-48481590.36491.16
极限1523304-52330497.53896.670.8598.5197.630.84
2518138-51813896.57597.60
3512492-51249295.52396.47
4518593-51859396.66097.56
5515615-51561596.10597.08
6523795-52379597.63098.58
坎地沙坦酯氢氯噻嗪片项目信息
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100685-201903对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.80对照品水分(%)0对照品稀释倍数1000
标示量(mg)16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%
116.233087943098373099733091013098703095150.18
216.313087273087343087300.01
单位质量响应值RSD%判断
19070.5518928.880.53数据可信
中间条件12月-供试品溶液-2024082821批-坎地沙坦酯-含0.35%吐温20的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%
5min1124570-12457036.80736.9421.5036.8136.9421.50
2164273-16427348.53848.54
3134059-13405939.61039.61
488636-8863626.18926.19
5136650-13665040.37640.38
6102016-10201630.14330.14
10min1205923-20592360.84462.489.3560.9162.549.36
2236535-23653569.88969.97
3222424-22242465.71965.79
4179478-17947853.03053.07
5220752-22075265.22565.29
6203591-20359160.15560.21
15min1245109-24510972.42274.304.3572.5874.474.37
2266444-26644478.72678.92
3254756-25475675.27375.45
4234181-23418169.19369.33
5256188-25618875.69675.87
6252174-25217474.51074.66
20min1267192-26719278.94780.362.3979.2380.642.41
2281210-28121083.08983.42
3270292-27029279.86380.16
4263031-26303177.71877.96
5274205-27420581.01981.32
6275816-27581681.49581.77
30min1294594-29459487.04385.121.7887.4685.551.78
2293529-29352986.72987.20
3282815-28281583.56384.00
4283587-28358783.79184.17
5285026-28502684.21684.65
6289039-28903985.40285.81
45min1300996-30099688.93586.811.6089.5087.381.59
2296640-29664087.64888.26
3288372-28837285.20585.78
4293305-29330586.66387.18
5289308-28930885.48286.06
6294155-29415586.91487.47
60min1305022-30502290.12587.482.1190.8388.182.10
2300365-30036588.74989.51
3288946-28894685.37586.09
4294571-29457187.03787.70
5289721-28972185.60486.32
6297703-29770387.96288.66
极限1310898-31089891.86191.250.8292.7292.110.81
2308362-30836291.11192.02
3305672-30567290.31791.17
4308958-30895891.28892.09
5306729-30672990.62991.49
6312413-31241392.30893.15
坎地沙坦酯氢氯噻嗪片项目信息
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100309-202205对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.70对照品水分(%)0对照品稀释倍数1000
标示量(mg)12.5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%
112.034630564632674636464623034635794631700.12
212.054614384612774613580.03
单位质量响应值RSD%判断
38501.2538286.970.40数据可信
中间条件12月-供试品溶液-2024082821批-氢氯噻嗪
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1374610-37461070.04068.7211.8970.0468.7211.89
2339606-33960663.49563.50
3361093-36109367.51367.51
4424111-42411179.29579.30
5302746-30274656.60456.60
6403149-40314975.37675.38
10min1464915-46491586.92486.183.0487.0486.293.05
2441440-44144082.53582.64
3471294-47129488.11788.23
4474905-47490588.79288.92
5445530-44553083.30083.39
6467369-46736987.38387.51
15min1481399-48139990.00689.061.8490.2789.321.86
2461364-46136486.26086.50
3479822-47982289.71189.97
4485536-48553690.78091.06
5470840-47084088.03288.27
6478966-47896689.55189.82
20min1486108-48610890.88690.021.6591.3090.431.66
2466900-46690087.29587.68
3484239-48423990.53790.95
4488893-48889391.40791.84
5478573-47857389.47889.86
6484168-48416890.52490.94
30min1493452-49345292.26091.231.5992.8291.781.60
2472753-47275388.39088.92
3490505-49050591.70992.27
4492997-49299792.17492.76
5487507-48750791.14891.68
6490340-49034091.67892.25
45min1495729-49572992.68591.791.7393.4092.501.73
2474354-47435488.68989.37
3497447-49744793.00693.72
4493113-49311392.19692.93
5494801-49480192.51293.19
6490226-49022691.65692.38
60min1495941-49594192.72592.161.5593.6093.021.55
2478962-47896289.55090.38
3501246-50124693.71794.58
4493825-49382592.32993.22
5496386-49638692.80893.64
6491077-49107791.81692.69
极限1522860-52286097.75897.130.7898.7898.140.76
2519648-51964897.15798.13
3519572-51957297.14398.17
4514577-51457796.20997.25
5524904-52490498.14099.13
6515383-51538396.36097.39
坎地沙坦酯氢氯噻嗪片项目信息
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100685-201903对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.80对照品水分(%)0对照品稀释倍数1000
标示量(mg)16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%
116.233087373093023089793087923090583089740.08
216.313081463087363084410.14
单位质量响应值RSD%判断
19037.2218911.160.47数据可信
中间条件12月-供试品溶液-2024082821批-坎地沙坦酯
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1141223-14122341.78342.0011.6941.7842.0011.70
2134790-13479039.88039.88
3139290-13929041.21141.21
4166262-16626249.19149.19
5117326-11732634.71334.71
6152948-15294845.25245.25
10min1230265-23026568.12868.123.6568.2068.203.65
2225657-22565766.76466.83
3236706-23670670.03370.10
4239734-23973470.92971.01
5216380-21638064.01964.08
6232790-23279068.87568.95
15min1266390-26639078.81678.591.2079.0078.771.21
2262462-26246277.65477.83
3269523-26952379.74379.93
4268480-26848079.43479.63
5261571-26157177.39077.55
6265344-26534478.50678.70
20min1279861-27986182.80183.371.2183.1283.681.22
2277294-27729482.04282.35
3286612-28661284.79985.12
4284596-28459684.20284.53
5280180-28018082.89683.19
6282128-28212883.47283.79
30min1294036-29403686.99587.451.0887.4587.901.08
2291385-29138586.21186.65
3301124-30112489.09289.55
4295378-29537887.39287.87
5295903-29590387.54887.98
6295642-29564287.47087.93
45min1299362-29936288.57188.761.2889.1789.361.28
2293754-29375486.91287.50
3305304-30530490.32990.94
4298695-29869588.37488.99
5301489-30148989.20089.78
6301354-30135489.16089.77
60min1299031-29903188.47389.091.1689.2289.831.15
2296289-29628987.66288.39
3306182-30618290.58991.35
4299861-29986188.71989.48
5303134-30313489.68790.41
6302142-30214289.39390.15
极限1312079-31207992.33392.260.8093.2393.160.79
2309824-30982491.66692.54
3311734-31173492.23193.14
4309380-30938091.53592.45
5316393-31639393.61094.49
6311533-31153392.17293.08
坎地沙坦酯氢氯噻嗪片项目信息
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100309-202205对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.70对照品水分(%)0对照品稀释倍数1000
标示量(mg)12.5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%
112.034608494608634599674606874603194605370.09
212.054583034587674585350.08
单位质量响应值RSD%判断
38282.3838052.700.43数据可信
中间条件12月-供试品溶液-2024083021批-氢氯噻嗪
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1343099-34309964.52965.7814.9564.5365.7814.96
2298614-29861456.16356.16
3280917-28091752.83452.83
4403281-40328175.84875.85
5405468-40546876.26076.26
6367039-36703969.03269.03
10min1441081-44108182.95881.936.3983.0782.036.40
2416216-41621678.28178.37
3388536-38853673.07573.16
4457355-45735586.01886.14
5456696-45669685.89486.02
6453691-45369185.32985.44
15min1462534-46253486.99286.522.6687.2486.772.68
2453733-45373385.33785.56
3438609-43860982.49382.70
4470794-47079488.54688.82
5470606-47060688.51188.78
6463852-46385287.24087.50
20min1469491-46949188.30188.161.5588.6988.551.57
2469376-46937688.27988.65
3455160-45516085.60585.95
4475663-47566389.46289.88
5474102-47410289.16889.59
6468584-46858488.13088.53
30min1475930-47593089.51289.981.2090.0590.521.20
2485752-48575291.35991.87
3470443-47044388.48088.97
4483468-48346890.93091.50
5479810-47981090.24290.81
6475049-47504989.34689.90
45min1480104-48010490.29791.091.5690.9891.781.54
2498295-49829593.71894.38
3482014-48201490.65691.29
4486789-48678991.55492.27
5481885-48188590.63291.35
6476980-47698089.70990.41
60min1480330-48033090.33991.492.0791.1892.342.04
2505432-50543295.06195.88
3484845-48484591.18991.98
4488605-48860591.89692.77
5482318-48231890.71391.58
6477296-47729689.76990.62
极限1517830-51783097.39298.220.7098.3899.200.67
2527987-52798799.303100.28
3524647-52464798.67499.61
4520482-52048297.89198.91
5521977-52197798.17299.19
6520314-52031497.85998.86
坎地沙坦酯氢氯噻嗪片项目信息
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100685-201903对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.80对照品水分(%)0对照品稀释倍数1000
标示量(mg)16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%
116.233091193084903084623080363095253087260.20
216.313080793085143082960.10
单位质量响应值RSD%判断
19021.9318902.270.45数据可信
中间条件12月-供试品溶液-2024083021批-坎地沙坦酯
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1131160-13116038.83038.4915.8538.8338.4915.85
2107160-10716031.72531.73
3104566-10456630.95730.96
4145120-14512042.96342.96
5156278-15627846.26746.27
6135834-13583440.21440.21
10min1220038-22003865.14364.148.4365.2164.218.44
2200184-20018459.26559.32
3188725-18872555.87355.92
4225958-22595866.89666.97
5235059-23505969.59069.67
6230009-23000968.09568.16
15min1259784-25978476.91076.014.7677.0876.184.77
2248423-24842373.54773.70
3236872-23687270.12770.27
4260739-26073977.19377.38
5271259-27125980.30780.50
6263463-26346377.99978.18
20min1277330-27733082.10581.422.9782.4181.722.99
2270663-27066380.13180.41
3261476-26147677.41177.67
4275074-27507481.43781.75
5284197-28419784.13884.46
6281383-28138383.30583.62
30min1292494-29249486.59485.921.8287.0386.351.83
2291357-29135786.25786.67
3280614-28061483.07783.47
4288418-28841885.38785.83
5295723-29572387.55088.02
6292619-29261986.63187.08
45min1298282-29828288.30887.851.2088.8988.431.20
2301064-30106489.13189.68
3291404-29140486.27186.80
4293824-29382486.98887.58
5298780-29878088.45589.07
6297121-29712187.96488.56
60min1295764-29576487.56288.061.2388.2988.781.23
2302584-30258489.58190.28
3292765-29276586.67487.35
4295020-29502087.34288.08
5300334-30033488.91589.68
6298151-29815188.26989.01
极限1309018-30901891.48692.360.6292.3693.230.60
2313964-31396492.95093.80
3313364-31336492.77393.59
4310284-31028491.86192.74
5312284-31228492.45393.36
6312920-31292092.64193.53
坎地沙坦酯氢氯噻嗪片项目信息
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100309-202205对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.70对照品水分(%)0对照品稀释倍数1000
标示量(mg)12.5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%
112.034602344600054599144608134596574601250.10
212.054594064597004595530.05
单位质量响应值RSD%判断
38248.1338137.180.21数据可信
中间条件12月-供试品溶液-2024083021批-氢氯噻嗪
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1323474-32347460.79859.7112.6060.8059.7112.60
2326535-32653561.37361.37
3313250-31325058.87658.88
4366816-36681668.94468.94
5330957-33095762.20462.20
6244995-24499546.04746.05
10min1430611-43061180.93583.304.4881.0483.404.48
2446388-44638883.90084.00
3438676-43867682.45082.55
4466962-46696287.76787.88
5462394-46239486.90887.01
6414199-41419977.85077.93
15min1445244-44524483.68587.392.9783.9287.632.97
2464899-46489987.37987.62
3464846-46484687.36987.60
4482103-48210390.61390.87
5477800-47780089.80490.05
6454909-45490985.50185.71
20min1452502-45250285.04988.562.5185.4288.942.52
2471824-47182488.68189.07
3471226-47122688.56888.95
4485565-48556591.26391.68
5481154-48115490.43490.83
6464726-46472687.34787.70
30min1460871-46087186.62289.732.0787.1490.262.08
2478874-47887490.00690.54
3477913-47791389.82590.35
4487833-48783391.69092.25
5486257-48625791.39391.94
6472636-47263688.83389.33
45min1466088-46608887.60390.631.8088.2691.311.80
2484824-48482491.12491.81
3481265-48126590.45591.13
4490230-49023092.14092.86
5488630-48863091.83992.54
6482129-48212990.61791.26
60min1467979-46797987.95890.911.7288.7791.741.72
2487919-48791991.70692.54
3483261-48326190.83091.66
4491306-49130692.34293.21
5488124-48812491.74492.60
6483475-48347590.87091.66
极限1512355-51235596.29997.330.9297.2598.320.91
2519340-51934097.61198.60
3522992-52299298.29899.28
4519015-51901597.55098.57
5511721-51172196.17997.19
6521762-52176298.06799.01
坎地沙坦酯氢氯噻嗪片项目信息
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100685-201903对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.80对照品水分(%)0对照品稀释倍数1000
标示量(mg)16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%
116.233084383097643092163092453103413094010.23
216.313095023093303094160.04
单位质量响应值RSD%判断
19063.5218970.940.35数据可信
中间条件12月-供试品溶液-2024083021批-坎地沙坦酯
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1120849-12084935.67434.6410.5735.6734.6410.57
2121713-12171335.92935.93
3119237-11923735.19835.20
4131367-13136738.77938.78
5116821-11682134.48534.48
694182-9418227.80227.80
10min1215787-21578763.69963.593.5763.7663.643.57
2218357-21835764.45864.52
3213279-21327962.95963.02
4224923-22492366.39666.46
5218184-21818464.40764.46
6201880-20188059.59459.64
15min1250067-25006773.81876.112.2173.9876.282.22
2258357-25835776.26676.43
3259153-25915376.50176.66
4266040-26604078.53478.71
5260556-26055676.91577.08
6252877-25287774.64874.79
20min1267996-26799679.11181.821.6979.4082.111.69
2277811-27781182.00882.30
3278306-27830682.15482.45
4281456-28145683.08483.39
5279179-27917982.41282.71
6278331-27833182.16282.43
30min1281952-28195283.23186.071.7483.6586.501.74
2291659-29165986.09686.53
3292102-29210286.22786.65
4296929-29692987.65288.10
5293445-29344586.62387.05
6293428-29342886.61887.03
45min1286856-28685684.67887.761.8585.2488.331.84
2298316-29831688.06188.64
3296223-29622387.44388.02
4301798-30179889.08989.68
5299364-29936488.37188.95
6301141-30114188.89589.45
60min1288291-28829185.10287.791.5785.8088.511.57
2298102-29810287.99888.72
3297392-29739287.78988.51
4300592-30059288.73389.47
5299205-29920588.32489.05
6300795-30079588.79389.49
极限1308407-30840791.04091.770.8691.8892.640.85
2313397-31339792.51393.38
3312318-31231892.19593.06
4310076-31007691.53392.42
5307423-30742390.75091.62
6313739-31373992.61493.46
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