氢氯噻嗪坎地沙坦酯片项目信息
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%
111.784467424471744471094471044473604470980.06
211.784463894459424461660.08
单位质量响应值RSD%判断
37953.9937874.870.15数据可信
加速6月-供试品溶液-2024090121批-氢氯噻嗪-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%
5min1263815-26381549.94956.6014.8649.9556.6014.86
2241205-24120545.66845.67
3316034-31603459.83559.84
4289017-28901754.72054.72
5317043-31704360.02660.03
6366533-36653369.39669.40
10min1401314-40131475.98281.027.5876.0681.127.59
2390861-39086174.00274.08
3448404-44840484.89785.00
4407494-40749477.15277.24
5447516-44751684.72984.83
6472102-47210289.38489.50
15min1458221-45822186.75688.564.8286.9788.794.83
2430638-43063881.53381.73
3472045-47204589.37389.61
4466032-46603288.23588.45
5483665-48366591.57391.81
6495885-49588593.88794.15
20min1477657-47765790.43690.723.9690.7991.103.98
2447508-44750884.72785.06
3477233-47723390.35590.75
4475441-47544190.01690.38
5495050-49505093.72994.12
6502084-50208495.06095.48
30min1485386-48538691.89992.923.0792.4093.453.08
2467005-46700588.41988.90
3488973-48897392.57893.12
4489357-48935792.65193.17
5506328-50632895.86496.41
6507725-50772596.12896.71
45min1504103-50410395.44394.962.6996.1095.642.70
2478578-47857890.61091.23
3495651-49565193.84294.54
4502301-50230195.10295.77
5516150-51615097.72498.43
6512609-51260997.05397.79
60min1508684-50868496.31095.792.6097.1396.632.62
2484048-48404891.64692.42
3497844-49784494.25895.11
4508624-50862496.29997.13
5519795-51979598.41499.29
6516547-51654797.79998.70
极限1513231-51323197.17197.340.6998.1598.340.73
2508769-50876996.32697.25
3515134-51513497.53198.54
4512326-51232697.00097.99
5518873-51887398.23999.28
6516416-51641697.77498.84
氢氯噻嗪坎地沙坦酯片项目信息
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%
115.642898232905562903192905852921852906940.31
215.602904582900112902340.11
单位质量响应值RSD%判断
18586.5718604.740.07数据可信
加速6月-供试品溶液-2024090121批-坎地沙坦酯-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%
5min196050-9605028.99631.6713.3729.0031.6713.36
286248-8624826.03726.04
3107996-10799632.60232.60
4102705-10270531.00531.01
5108527-10852732.76332.76
6127886-12788638.60738.61
10min1187324-18732456.55059.396.8756.6059.446.87
2181823-18182354.89054.93
3201538-20153860.84160.90
4188860-18886057.01457.07
5201903-20190360.95161.01
6218853-21885366.06866.13
15min1239682-23968272.35673.864.4272.5074.014.43
2230185-23018569.48969.62
3243547-24354773.52373.68
4241240-24124072.82772.97
5251749-25174975.99976.16
6261569-26156978.96479.14
20min1265963-26596380.29081.273.8580.5581.543.85
2254521-25452176.83677.09
3265779-26577980.23580.51
4267578-26757880.77881.05
5276860-27686083.58083.86
6284559-28455985.90486.21
30min1288505-28850587.09586.972.3787.4987.382.39
2276710-27671083.53583.91
3285045-28504586.05186.46
4288429-28842987.07287.48
5294366-29436688.86589.29
6295434-29543489.18789.64
45min1299917-29991790.54089.251.9791.0889.801.98
2285603-28560386.21986.74
3292564-29256488.32188.88
4295477-29547789.20089.75
5300218-30021890.63191.20
6300058-30005890.58391.18
60min1299493-29949390.41289.501.6491.1190.201.66
2288103-28810386.97487.64
3293730-29373088.67389.38
4296648-29664889.55490.25
5300801-30080190.80791.53
6300031-30003190.57591.32
极限1300514-30051490.72190.650.7691.5691.500.78
2296995-29699589.65890.46
3301279-30127990.95291.80
4298359-29835990.07090.92
5303232-30323291.54192.41
6301389-30138990.98591.88
氢氯噻嗪坎地沙坦酯片项目信息
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%
111.784442194443944452274454964465854451840.22
211.784433634434284433960.02
单位质量响应值RSD%判断
37791.5137639.730.29数据可信
加速6月-供试品溶液-2024090121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%
5min1205819-20581939.17456.6719.8239.1756.6719.83
2263016-26301650.06050.06
3327743-32774362.37962.38
4335215-33521563.80263.80
5284343-28434354.11954.12
6370340-37034070.48770.49
10min1354403-35440367.45477.1210.2467.5277.2110.25
2363060-36306069.10169.18
3437338-43733883.23983.34
4437259-43725983.22483.33
5389839-38983974.19874.29
6449231-44923185.50285.62
15min1425100-42510080.90984.744.9281.0984.964.94
2415937-41593779.16579.36
3458287-45828787.22687.47
4452153-45215386.05886.30
5444375-44437584.57884.79
6475443-47544390.49190.75
20min1453750-45375086.36287.813.5386.6788.173.55
2436290-43629083.03983.37
3468779-46877989.22389.61
4460901-46090187.72388.11
5462993-46299388.12288.48
6485423-48542392.39192.80
30min1478686-47868691.10891.122.8191.5691.632.83
2459866-45986687.52688.00
3480047-48004791.36891.90
4472824-47282489.99390.53
5479616-47961691.28691.79
6501312-50131295.41595.98
45min1494896-49489694.19493.932.0094.8094.602.01
2483705-48370592.06492.68
3493029-49302993.83894.53
4482431-48243191.82192.51
5498093-49809394.80295.46
6509043-50904396.88697.61
60min1504592-50459296.03995.781.8596.8096.601.84
2500394-50039495.24096.01
3500676-50067695.29496.14
4489008-48900893.07393.91
5507741-50774196.63997.45
6517006-51700698.40299.29
极限1516205-51620598.25098.330.7299.1799.300.74
2514368-51436897.90098.83
3522405-52240599.430100.43
4514044-51404497.83898.83
5513005-51300597.64098.61
6519700-51970098.91599.96
氢氯噻嗪坎地沙坦酯片项目信息
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%
115.642889872892012898332900312908912897890.26
215.602892762892572892660.01
单位质量响应值RSD%判断
18528.7118542.690.06数据可信
加速6月-供试品溶液-2024090121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%
5min173344-7334422.21331.7317.2522.2131.7217.25
298816-9881629.92829.93
3115907-11590735.10435.10
4114329-11432934.62634.63
5101766-10176630.82130.82
6124358-12435837.66337.66
10min1157627-15762747.73958.3411.5847.7858.4011.58
2179087-17908754.23954.29
3212443-21244364.34164.40
4207619-20761962.88062.94
5186046-18604656.34656.40
6213007-21300764.51264.57
15min1215426-21542665.24472.986.5965.3673.126.60
2230974-23097469.95370.09
3255292-25529277.31877.48
4247608-24760874.99175.15
5239521-23952172.54272.69
6256914-25691477.80977.98
20min1248359-24835975.21880.814.4575.4481.084.47
2258955-25895578.42878.68
3275085-27508583.31383.61
4270302-27030281.86482.15
5266678-26667880.76781.03
6281607-28160785.28885.59
30min1280915-28091585.07886.922.0585.4387.322.07
2282036-28203685.41885.81
3288802-28880287.46787.90
4286258-28625886.69787.12
5286552-28655286.78687.19
6297318-29731890.04690.49
45min1299461-29946190.69589.830.9291.1990.380.91
2294115-29411589.07689.61
3296162-29616289.69690.28
4293509-29350988.89389.46
5296217-29621789.71390.26
6300164-30016490.90891.50
60min1297527-29752790.10990.130.9290.7590.840.92
2297687-29768790.15890.84
3297976-29797690.24590.97
4292983-29298388.73389.45
5297943-29794390.23590.93
6301552-30155291.32992.07
极限1303073-30307391.78991.400.6692.5892.250.67
2300008-30000890.86191.69
3304392-30439292.18993.07
4300111-30011190.89291.76
5299966-29996690.84891.69
6303194-30319491.82692.72
氢氯噻嗪坎地沙坦酯片项目信息
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%
111.784447874442514441424440334444894443400.07
211.784423334419894421610.06
单位质量响应值RSD%判断
37719.8637534.890.35数据可信
中间条件6月-供试品溶液-2024090121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%
5min1212097-21209740.46350.7910.1740.4650.7910.17
2277595-27759552.95952.96
3273673-27367352.21152.21
4280018-28001853.42153.42
5284953-28495354.36354.36
6268977-26897751.31551.31
10min1401999-40199976.69281.313.3476.7681.403.34
2438260-43826083.61083.70
3425515-42551581.17981.27
4420354-42035480.19480.28
5441402-44140284.20984.30
6429691-42969181.97582.06
15min1449727-44972785.79889.472.1285.9989.692.13
2472993-47299390.23690.46
3469622-46962289.59389.82
4469507-46950789.57189.79
5477468-47746891.09091.32
6474686-47468690.55990.78
20min1478987-47898791.38092.460.8291.7292.830.83
2484944-48494492.51692.89
3487318-48731892.96993.34
4486145-48614592.74593.12
5489512-48951293.38893.77
6480980-48098091.76092.13
30min1501515-50151595.67895.610.4096.1796.130.40
2497764-49776494.96295.49
3501730-50173095.71996.25
4501101-50110195.59996.13
5503865-50386596.12696.66
6500919-50091995.56496.09
45min1513684-51368497.99998.000.4798.6598.680.47
2511498-51149897.58298.27
3516104-51610498.46199.15
4511961-51196197.67098.36
5517059-51705998.64399.34
6511748-51174897.63098.32
60min1521617-52161799.51399.320.70100.33100.170.70
2518630-51863098.94399.80
3524980-524980100.154101.00
4515204-51520498.28999.14
5523982-52398299.964100.83
6519322-51932299.07599.92
极限1524793-524793100.11999.700.67101.10100.710.66
2520187-52018799.240100.26
3528338-528338100.795101.81
4518584-51858498.93499.95
5522005-52200599.587100.62
6521591-52159199.508100.52
氢氯噻嗪坎地沙坦酯片项目信息
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%
115.642904952903622903622903992902202903680.04
215.602894992893302894140.05
单位质量响应值RSD%判断
18565.7318552.180.06数据可信
中间条件6月-供试品溶液-2024090121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%
5min175791-7579122.92528.329.5222.9328.329.51
295737-9573728.95928.96
395888-9588829.00429.00
4100379-10037930.36330.36
597265-9726529.42129.42
696790-9679029.27729.28
10min1181976-18197655.04459.574.2755.0859.624.27
2204062-20406261.72561.77
3195451-19545159.12059.17
4194662-19466258.88258.93
5204047-20404761.72161.77
6201403-20140360.92160.97
15min1230843-23084369.82674.903.7369.9675.043.73
2251271-25127176.00576.16
3247122-24712274.75074.90
4245904-24590474.38274.53
5253050-25305076.54376.69
6257470-25747077.88078.03
20min1266266-26626680.54182.971.6480.7983.241.65
2274380-27438082.99583.27
3274664-27466483.08183.35
4273490-27349082.72683.00
5278778-27877884.32584.60
6278186-27818684.14684.43
30min1295498-29549889.38389.600.6389.7690.010.63
2293885-29388588.89589.31
3296836-29683689.78890.20
4294814-29481489.17689.59
5297388-29738889.95590.37
6298967-29896790.43290.85
45min1303830-30383091.90391.790.4192.4392.350.41
2301865-30186591.30991.87
3305331-30533192.35792.92
4302559-30255991.51992.08
5304190-30419092.01292.58
6302995-30299591.65192.22
60min1306358-30635892.66892.260.6093.3592.980.59
2303372-30337291.76592.48
3307597-30759793.04393.76
4302729-30272991.57092.28
5305060-30506092.27593.00
6304996-30499692.25692.98
极限1309222-30922293.53493.100.6094.3793.960.59
2305878-30587892.52393.39
3310368-31036893.88194.75
4305748-30574892.48393.35
5307433-30743392.99393.87
6308029-30802993.17394.05
氢氯噻嗪坎地沙坦酯片项目信息
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%
111.784427404423324420424423174423944423650.06
211.784393644387904390770.10
单位质量响应值RSD%判断
37552.2137273.090.53数据可信
中间条件6月-供试品溶液-2024090121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%
5min1240790-24079046.20149.7413.8946.2049.7413.90
2292951-29295156.21056.21
3198071-19807138.00538.00
4269240-26924051.66051.66
5293246-29324656.26656.27
6260999-26099950.07950.08
10min1366794-36679470.37875.176.0170.4675.266.01
2406412-40641277.98078.07
3369328-36932870.86470.93
4381845-38184573.26673.35
5427431-42743182.01382.11
6398931-39893176.54476.63
15min1425201-42520181.58585.883.2281.7886.093.23
2448861-44886186.12586.35
3447480-44748085.86086.04
4438651-43865184.16684.37
5463558-46355888.94589.18
6461742-46174288.59688.81
20min1456097-45609787.51390.141.8387.8490.501.83
2471337-47133790.43790.80
3477056-47705691.53491.86
4462687-46268788.77789.13
5476017-47601791.33591.71
6475693-47569391.27391.63
30min1481249-48124992.33994.041.1992.8294.541.20
2492128-49212894.42694.94
3496980-49698095.35795.83
4485148-48514893.08793.58
5493892-49389294.76595.30
6491289-49128994.26594.78
45min1504292-50429296.76097.331.0597.3997.981.04
2513057-51305798.44299.12
3511504-51150498.14498.78
4510234-51023497.90098.55
5505356-50535696.96497.65
6499028-49902895.75096.42
60min1513036-51303698.43899.281.3799.23100.101.36
2527073-527073101.131101.97
3522635-522635100.280101.08
4520757-52075799.920100.73
5511334-51133498.11198.96
6509596-50959697.77898.61
极限1524297-524297100.599100.391.54101.55101.371.52
2532014-532014102.079103.09
3530997-530997101.884102.85
4523838-523838100.511101.49
5511365-51136598.11799.13
6516653-51665399.132100.12
氢氯噻嗪坎地沙坦酯片项目信息
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%
115.642900052896822895822893802897322896760.08
215.602881392879812880600.04
单位质量响应值RSD%判断
18521.4818465.380.22数据可信
中间条件6月-供试品溶液-2024090121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%
5min186342-8634226.20928.2012.9426.2128.2012.94
2107035-10703532.49132.49
372818-7281822.10422.10
495354-9535428.94528.95
5100983-10098330.65430.65
694933-9493328.81728.82
10min1173828-17382852.76656.507.1252.8156.547.13
2198495-19849560.25460.31
3167410-16741050.81850.85
4187627-18762756.95557.00
5200779-20077960.94761.00
6188572-18857257.24257.29
15min1228474-22847469.35473.123.6769.4973.263.68
2243823-24382374.01474.17
3231686-23168670.32970.45
4244541-24454174.23174.37
5251336-25133676.29476.45
6245346-24534674.47674.62
20min1261691-26169179.43782.001.8379.6882.261.84
2271337-27133782.36682.64
3267268-26726881.13081.37
4271860-27186082.52482.79
5275462-27546283.61883.90
6273083-27308382.89683.16
30min1287503-28750387.27389.331.1887.6589.731.18
2294224-29422489.31389.73
3296666-29666690.05490.43
4296512-29651290.00890.41
5296007-29600789.85490.27
6294810-29481089.49189.90
45min1302517-30251791.83092.141.2692.3692.691.25
2305855-30585592.84493.41
3306185-30618592.94493.47
4308116-30811693.53094.08
5300187-30018791.12391.69
6298311-29831190.55491.11
60min1303257-30325792.05592.661.4192.7393.361.40
2309280-30928093.88394.60
3308561-30856193.66594.34
4309247-30924793.87394.58
5300036-30003691.07791.80
6301044-30104491.38392.09
极限1306722-30672293.10793.251.0893.9494.111.07
2310496-31049694.25295.13
3310205-31020594.16495.00
4308827-30882793.74694.61
5301995-30199591.67292.54
6304928-30492892.56293.42
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