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%
111.784431334427254422694422404423324425400.09
211.784404994406494405740.03
单位质量响应值RSD%判断
37567.0637400.170.32数据可信
中间条件6月-供试品溶液-2024082821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%
5min1409069-40906978.34073.609.1378.3473.609.13
2412673-41267379.03079.03
3317348-31734860.77560.77
4380666-38066672.90172.90
5386791-38679174.07474.07
6399272-39927276.46476.46
10min1488324-48832493.51888.634.3693.6588.764.37
2472471-47247190.48290.61
3428216-42821682.00782.11
4466226-46622689.28689.41
5454735-45473587.08687.21
6466964-46696489.42889.56
15min1500767-50076795.90191.223.8496.1991.493.85
2483465-48346592.58892.87
3444829-44482985.18985.43
4479297-47929791.79092.06
5472038-47203890.39990.67
6477536-47753691.45291.73
20min1500378-50037895.82791.883.4896.2792.303.49
2486849-48684993.23693.67
3449719-44971986.12586.51
4483204-48320492.53892.96
5478876-47887691.70992.13
6479682-47968291.86392.29
30min1502008-50200896.13992.582.9396.7493.162.94
2487732-48773293.40594.00
3458344-45834487.77788.30
4485341-48534192.94793.52
5485266-48526692.93393.50
6481898-48189892.28892.87
45min1503985-50398596.51792.803.0897.2893.533.09
2486681-48668193.20493.95
3458120-45812087.73488.40
4487102-48710293.28494.02
5489024-48902493.65294.38
6482650-48265092.43293.17
60min1502579-50257996.24893.202.8997.1894.082.90
2498399-49839995.44896.35
3462863-46286388.64289.46
4485843-48584393.04393.93
5488634-48863493.57894.46
6481600-48160092.23193.12
极限1525861-525861100.70798.541.72101.7999.581.72
2510110-51011097.69098.75
3508047-50804797.29598.26
4522565-522565100.076101.12
5517440-51744099.094100.13
6503338-50333896.39497.44
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%
115.642907702910972915952913882915832912870.13
215.602907902913572910740.14
单位质量响应值RSD%判断
18624.4918658.590.13数据可信
中间条件6月-供试品溶液-2024082821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%
5min1153425-15342546.20343.998.6146.2043.998.61
2155394-15539446.79646.80
3121317-12131736.53436.53
4148476-14847644.71244.71
5146314-14631444.06144.06
6151552-15155245.63945.64
10min1239722-23972272.19068.993.9672.2769.073.96
2232946-23294670.15070.23
3213575-21357564.31664.38
4231673-23167369.76769.84
5224226-22422667.52467.60
6232511-23251170.01970.09
15min1274187-27418782.56979.513.2682.7779.703.26
2268248-26824880.78180.98
3249296-24929675.07475.24
4265933-26593380.08480.27
5259679-25967978.20078.39
6266800-26680080.34580.54
20min1293878-29387888.49984.813.0888.8385.133.08
2282861-28286185.18185.51
3267499-26749980.55580.85
4285025-28502585.83386.16
5278276-27827683.80184.12
6282155-28215584.96985.30
30min1303287-30328791.33388.492.5491.8188.952.55
2293503-29350388.38688.86
3281109-28110984.65485.08
4298777-29877789.97490.44
5293987-29398788.53288.99
6292377-29237788.04788.52
45min1307571-30757192.62389.862.4593.2690.472.45
2298028-29802889.74990.37
3286222-28622286.19486.76
4303853-30385391.50392.12
5297955-29795589.72790.33
6296697-29669789.34889.96
60min1308471-30847192.89490.172.3493.6890.932.35
2302346-30234691.04991.82
3287975-28797586.72187.43
4303020-30302091.25292.02
5298484-29848489.88690.64
6296319-29631989.23490.00
极限1315585-31558595.03693.031.8795.9893.941.87
2304659-30465991.74692.67
3305017-30501791.85492.71
4314823-31482394.80795.73
5311421-31142193.78294.68
6302079-30207990.96991.88
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%
111.784400894396544403674400884399074400210.06
211.784378764380164379460.03
单位质量响应值RSD%判断
37353.2337177.080.34数据可信
中间条件6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%
5min1305265-30526558.80461.547.0558.8061.547.05
2355543-35554368.48968.49
3289616-28961655.78955.79
4330881-33088163.73863.74
5317347-31734761.13161.13
6318158-31815861.28761.29
10min1435709-43570983.93183.712.2684.0383.812.27
2445687-44568785.85385.97
3417136-41713680.35480.45
4432862-43286283.38383.49
5434265-43426583.65383.75
6441643-44164385.07485.18
15min1466424-46642489.84889.080.8490.0989.320.84
2467268-46726890.01190.27
3459163-45916388.44988.68
4463651-46365189.31489.56
5458800-45880088.37988.62
6459369-45936988.48988.73
20min1479091-47909192.28891.121.0392.6891.511.03
2475206-47520691.54091.95
3475130-47513091.52591.90
4474079-47407991.32391.72
5468956-46895690.33690.72
6465639-46563989.69790.09
30min1489838-48983894.35893.371.4994.9093.921.47
2481387-48138792.73093.29
3493796-49379695.12195.65
4488351-48835194.07294.62
5480743-48074392.60693.15
6474258-47425891.35791.90
45min1497046-49704695.74795.071.5596.4595.771.54
2489674-48967494.32795.04
3504015-50401597.08997.77
4497336-49733695.80396.51
5491367-49136794.65395.35
6481859-48185992.82193.51
60min1500634-50063496.43895.772.1397.3096.632.10
2486342-48634293.68594.56
3508158-50815897.88798.73
4507675-50767597.79498.66
5497097-49709795.75796.61
6483194-48319493.07893.93
极限1516039-51603999.40599.210.71100.42100.220.70
2517957-51795799.775100.80
3519794-519794100.129101.14
4510124-51012498.26699.29
5514036-51403699.019100.03
6512207-51220798.66799.67
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%
115.642912092917102915222912682912272913870.08
215.602906892906492906690.01
单位质量响应值RSD%判断
18630.8818632.630.01数据可信
中间条件6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%
5min1115061-11506134.66835.246.4134.6735.246.41
2130620-13062039.35639.36
3109421-10942132.96932.97
4118228-11822835.62235.62
5117160-11716035.30035.30
6111318-11131833.54033.54
10min1216323-21632365.17864.663.8665.2464.723.85
2217819-21781965.62965.69
3198676-19867659.86159.92
4214015-21401564.48364.54
5218402-21840265.80565.86
6222353-22235366.99567.05
15min1259547-25954778.20277.432.4078.3777.602.40
2258014-25801477.74077.91
3244814-24481473.76273.92
4258805-25880577.97878.14
5258534-25853477.89678.06
6262245-26224579.01479.18
20min1282774-28277485.20083.901.3985.5084.201.40
2277280-27728083.54483.85
3271478-27147881.79682.07
4279219-27921984.12984.43
5279546-27954684.22784.53
6280463-28046384.50484.80
30min1300178-30017890.44489.170.8590.8889.610.85
2293518-29351888.43788.88
3296667-29666789.38689.80
4296542-29654289.34889.79
5295473-29547389.02689.46
6293373-29337388.39388.83
45min1305057-30505791.91491.031.0892.5091.621.06
2299789-29978990.32690.92
3306033-30603392.20892.77
4302235-30223591.06391.65
5302348-30234891.09791.68
6297343-29734389.58990.18
60min1306794-30679492.43791.431.4493.1892.171.43
2298615-29861589.97390.71
3307467-30746792.64093.36
4306249-30624992.27393.01
5304199-30419991.65592.39
6297457-29745789.62490.36
极限1309078-30907893.12593.030.7394.0293.920.72
2310134-31013493.44394.34
3312061-31206194.02494.90
4305713-30571392.11193.00
5308467-30846792.94193.83
6307160-30716092.54793.43
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%
111.784373764383874378944377624380294378900.09
211.784362984364044363510.02
单位质量响应值RSD%判断
37172.3337041.680.25数据可信
中间条件6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%
5min1227492-22749244.00945.0821.2444.0145.0821.24
2268976-26897652.03452.03
3287009-28700955.52255.52
4266023-26602351.46351.46
5177390-17739034.31634.32
6171206-17120633.12033.12
10min1404232-40423278.19973.9611.7878.2774.0411.79
2419775-41977581.20681.29
3420820-42082081.40881.50
4397353-39735376.86976.95
5316264-31626461.18261.24
6335574-33557464.91764.97
15min1459529-45952988.89785.626.7689.1085.826.78
2460305-46030589.04789.27
3475647-47564792.01592.24
4445800-44580086.24186.45
5395815-39581576.57176.73
6418462-41846280.95281.12
20min1473206-47320691.54389.453.8291.8989.793.84
2469372-46937290.80191.17
3483745-48374593.58193.96
4460492-46049289.08389.44
5432872-43287283.74084.03
6454756-45475687.97388.27
30min1487091-48709194.22993.282.7194.7393.772.73
2483188-48318893.47494.00
3499969-49996996.72097.26
4477813-47781392.43492.94
5460218-46021889.03089.46
6484851-48485193.79594.24
45min1498250-49825096.38796.492.5297.0597.142.54
2496313-49631396.01396.69
3518404-518404100.286100.99
4497104-49710496.16696.83
5479438-47943892.74893.32
6503300-50330097.36497.97
60min1503583-50358397.41998.692.1198.2499.492.13
2514161-51416199.465100.30
3523244-523244101.223102.09
4513953-51395399.425100.25
5492313-49231395.23995.97
6513538-51353899.345100.11
极限1514030-51403099.440100.231.87100.42101.201.88
2508666-50866698.40299.41
3530186-530186102.566103.60
4524259-524259101.419102.41
5506639-50663998.01098.90
6524960-524960101.555102.48
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%
115.642901232914332908092904982909032907530.17
215.602907942907772907860.01
单位质量响应值RSD%判断
18590.3518640.130.19数据可信
中间条件6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%
5min182607-8260724.91225.5018.2224.9125.5018.21
296586-9658629.12729.13
3101339-10133930.56130.56
494184-9418428.40328.40
567139-6713920.24720.25
665575-6557519.77519.78
10min1188087-18808756.72155.1312.0056.7655.1712.00
2197424-19742459.53759.59
3205778-20577862.05662.11
4194539-19453958.66758.71
5154442-15444246.57546.61
6156501-15650147.19647.23
15min1244452-24445273.71971.877.2973.8572.007.31
2247273-24727374.57074.72
3257164-25716477.55277.71
4247772-24777274.72074.87
5214911-21491164.81064.92
6218363-21836365.85165.96
20min1271680-27168081.93080.424.1982.1980.674.20
2270481-27048181.56881.84
3279873-27987384.40184.68
4271673-27167381.92882.20
5250343-25034375.49575.71
6255911-25591177.17577.40
30min1294641-29464188.85488.322.0789.2588.712.09
2290929-29092987.73588.14
3301411-30141190.89691.32
4293238-29323888.43188.84
5282804-28280485.28585.63
6294167-29416788.71189.06
45min1303833-30383391.62691.752.0292.1792.282.02
2299152-29915290.21590.77
3313017-31301794.39694.97
4304109-30410991.71092.26
5296356-29635689.37189.86
6308936-30893693.16593.66
60min1305691-30569192.18792.931.9192.8893.621.92
2303824-30382491.62492.33
3315305-31530595.08695.82
4312286-31228694.17594.88
5300011-30001190.47491.11
6311797-31179794.02894.68
极限1308131-30813192.92293.381.8593.7794.231.86
2303695-30369591.58592.44
3317072-31707295.61996.51
4312117-31211794.12594.99
5302918-30291891.35092.14
6314014-31401494.69795.51
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%
111.784367974365434364114366354364284365630.04
211.784336384337824337100.03
单位质量响应值RSD%判断
37059.6836817.490.47数据可信
中间条件6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%
5min1241567-24156746.94551.9913.4746.9551.9913.46
2302794-30279458.84458.84
3303907-30390759.06059.06
4293384-29338457.01557.01
5229390-22939044.57944.58
6234004-23400445.47545.48
10min1386280-38628075.06876.524.5475.1576.614.55
2409186-40918679.51979.62
3416260-41626080.89480.99
4401527-40152778.03178.13
5372464-37246472.38372.46
6376941-37694173.25373.33
15min1448849-44884987.22786.732.1087.4386.942.11
2452481-45248187.93388.16
3460279-46027989.44989.68
4441153-44115385.73285.96
5435044-43504484.54484.74
6439787-43978785.46685.66
20min1476124-47612492.52891.511.2192.8891.871.22
2471189-47118991.56991.95
3478123-47812392.91693.30
4463596-46359690.09390.46
5465529-46552990.46990.80
6470810-47081091.49591.84
30min1494890-49489096.17595.171.1096.6895.681.11
2493316-49331695.86996.40
3495128-49512896.22196.76
4483453-48345393.95294.47
5484458-48445894.14794.63
6486926-48692694.62795.12
45min1532985-532985103.57898.962.55104.2499.632.54
2512165-51216599.532100.22
3510752-51075299.25799.95
4499471-49947197.06597.74
5499500-49950097.07197.71
6500499-50049997.26597.92
60min1519931-519931101.041100.221.14101.88101.051.15
2521929-521929101.429102.28
3520686-520686101.188102.05
4512971-51297199.688100.52
5509997-50999799.11199.92
6508596-50859698.83899.65
极限1525272-525272102.079100.931.36103.08101.931.37
2526661-526661102.349103.37
3521441-521441101.334102.37
4521459-521459101.338102.34
5511328-51132899.369100.34
6510036-51003699.118100.10
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%
115.642901072906892903662899982903872903090.10
215.602890122885692887900.11
单位质量响应值RSD%判断
18561.9618512.180.19数据可信
中间条件6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%
5min188211-8821126.71429.2714.5526.7129.2714.55
2112368-11236834.02934.03
3106999-10699932.40432.40
4108272-10827232.78932.79
582207-8220724.89624.90
681850-8185024.78724.79
10min1179553-17955354.37656.617.0454.4256.667.04
2199238-19923860.33760.39
3198394-19839460.08260.14
4198470-19847060.10560.16
5171603-17160351.96852.01
6174342-17434252.79852.84
15min1235718-23571871.38572.043.2271.5272.193.23
2244658-24465874.09274.25
3245441-24544174.32974.48
4242858-24285873.54773.70
5226586-22658668.61968.75
6232128-23212870.29870.43
20min1268529-26852981.32181.151.0181.5881.411.03
2268058-26805881.17981.46
3271506-27150682.22382.50
4268948-26894881.44881.73
5263228-26322879.71679.96
6267481-26748181.00481.25
30min1297790-29779090.18388.970.8890.5789.370.88
2293990-29399089.03289.45
3295132-29513289.37889.79
4292294-29229488.51888.93
5290238-29023887.89688.27
6293346-29334688.83789.22
45min1323327-32332797.91693.092.6898.4693.642.67
2307693-30769393.18293.75
3306538-30653892.83293.40
4303862-30386292.02192.58
5300557-30055791.02191.54
6302431-30243191.58892.12
60min1312493-31249394.63593.531.0895.3494.241.09
2311179-31117994.23794.96
3310524-31052494.03994.76
4309243-30924393.65194.37
5305811-30581192.61293.29
6303880-30388092.02792.71
极限1314485-31448595.23994.051.2396.1094.901.24
2314789-31478995.33196.21
3311216-31121694.24995.12
4310493-31049394.03094.90
5305846-30584692.62293.45
6306452-30645292.80693.64
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