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%
112.014518074516964519384518394518874518330.03
211.794389144389704389420.01
单位质量响应值RSD%判断
37621.4037230.030.74数据可信
供试品溶液-2024052121批-氢氯噻嗪-pH6.8(含0.35%吐温20)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1364798-36479869.97263.898.2569.9763.888.25
2310436-31043659.54459.54
3343575-34357565.90165.90
4352504-35250467.61467.61
5335920-33592064.43364.43
6291174-29117455.85055.85
10min1434594-43459483.35982.092.8983.4882.202.90
2411559-41155978.94179.04
3435524-43552483.53883.65
4438934-43893484.19284.30
5434436-43443683.32983.44
6412786-41278679.17679.27
15min1459770-45977088.18887.241.4788.4487.481.47
2446734-44673485.68885.92
3459144-45914488.06888.32
4458005-45800587.85088.10
5459423-45942388.12288.37
6445820-44582085.51285.74
20min1469217-46921790.00089.251.1090.4089.641.11
2460119-46011988.25588.63
3470640-47064090.27390.67
4468746-46874689.91090.31
5464514-46451489.09889.49
6458464-45846487.93888.31
30min1476886-47688691.47191.050.9092.0291.590.90
2472494-47249490.62991.15
3482022-48202292.45693.00
4474518-47451891.01791.57
5471323-47132390.40490.95
6470849-47084990.31390.83
45min1480334-48033492.13291.870.8492.8492.560.84
2478424-47842491.76692.44
3486142-48614293.24793.95
4476800-47680091.45592.16
5474531-47453191.01991.71
6477626-47762691.61392.28
60min1479208-47920891.91792.080.8492.7892.920.84
2479117-47911791.89992.72
3487093-48709393.42994.28
4479456-47945691.96492.82
5474643-47464391.04191.88
6480700-48070092.20393.02
极限1517131-51713199.19098.710.72100.2099.710.72
2516452-51645299.060100.04
3512644-51264498.33099.34
4514089-51408998.60799.61
5518873-51887399.525100.52
6508646-50864697.56398.53
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%
115.753158233137653137203137503138663141850.30
215.863208823208433208620.01
单位质量响应值RSD%判断
19948.2520230.901.00数据可信
供试品溶液-2024052121批-坎地沙坦酯-pH6.8(含0.35%吐温20)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1173410-17341048.45950.678.0148.4650.678.01
2170353-17035347.60547.61
3181571-18157150.74050.74
4200937-20093756.15256.15
5165225-16522546.17246.17
6196380-19638054.87854.88
10min1224351-22435162.69563.511.8762.7863.601.87
2226920-22692063.41363.49
3231915-23191564.80964.89
4231247-23124764.62264.72
5220786-22078661.69961.78
6228402-22840263.82763.92
15min1255422-25542271.37871.931.0971.5672.121.09
2258013-25801372.10272.29
3261573-26157373.09773.29
4259102-25910272.40672.61
5253756-25375670.91271.09
6256472-25647271.67171.87
20min1275739-27573977.05577.361.0077.3677.661.01
2277830-27783077.64077.94
3280629-28062978.42278.74
4278649-27864977.86878.19
5272949-27294976.27676.57
6275088-27508876.87377.19
30min1298352-29835283.37483.740.9283.8184.180.93
2301366-30136684.21784.65
3303654-30365484.85685.30
4299658-29965883.73984.19
5295497-29549782.57783.00
6299449-29944983.68184.13
45min1309320-30932086.43986.800.8987.0187.380.89
2313182-31318287.51988.09
3313657-31365787.65188.24
4310301-31030186.71487.30
5306138-30613885.55086.11
6311062-31106286.92687.51
60min1309822-30982286.58087.230.8787.3087.950.88
2314177-31417787.79788.52
3314709-31470987.94588.68
4313364-31336487.57088.31
5307837-30783786.02586.73
6312908-31290887.44288.17
极限1330929-33092992.47892.150.8393.3493.020.81
2332963-33296393.04693.91
3327995-32799591.65892.54
4330752-33075292.42993.31
5330699-33069992.41493.26
6325251-32525190.89191.77
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%
112.014509574512144514084511174513014511990.04
211.794364664366124365390.03
单位质量响应值RSD%判断
37568.6137026.211.03数据可信
供试品溶液-2024052121批-氢氯噻嗪-pH6.8(含0.35%吐温20)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1316321-31632160.88464.705.4460.8864.695.44
2330138-33013863.54363.54
3318448-31844861.29361.29
4352259-35225967.80167.80
5361941-36194169.66469.66
6337664-33766464.99264.99
10min1425324-42532481.86484.101.6381.9784.211.63
2444529-44452985.56085.67
3442787-44278785.22585.33
4435986-43598683.91684.03
5439953-43995384.67984.80
6432987-43298783.33983.45
15min1448714-44871486.36688.341.8986.6088.581.88
2462835-46283589.08489.33
3474040-47404091.24091.48
4455516-45551687.67587.93
5456382-45638287.84288.10
6456219-45621987.81088.06
20min1456940-45694087.94989.591.9888.3389.981.97
2468050-46805090.08790.48
3482722-48272292.91193.31
4461433-46143388.81489.21
5462854-46285489.08789.49
6460779-46077988.68889.08
30min1463336-46333689.18090.682.1689.7191.222.15
2472638-47263890.97191.52
3490795-49079594.46595.02
4465930-46593089.67990.23
5465650-46565089.62590.18
6468291-46829190.13490.68
45min1467912-46791290.06191.212.3190.7491.912.30
2474726-47472691.37292.07
3495434-49543495.35896.07
4468312-46831290.13890.83
5466736-46673689.83590.54
6470315-47031590.52391.21
60min1470082-47008290.47991.392.3091.3192.242.29
2476086-47608691.63492.49
3496111-49611195.48896.36
4468769-46876990.22691.07
5466891-46689189.86490.72
6470961-47096190.64891.49
极限1511615-51161598.47398.010.6199.4599.010.61
2505497-50549797.29598.30
3511621-51162198.47499.50
4512574-51257498.65799.65
5506102-50610297.41198.41
6507920-50792097.76198.75
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%
115.753132153134703137443135013137343135330.07
215.863193583196033194800.06
单位质量响应值RSD%判断
19906.8620143.760.84数据可信
供试品溶液-2024052121批-坎地沙坦酯-pH6.8(含0.35%吐温20)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1124885-12488535.01144.5016.9535.0144.5016.95
2173842-17384248.73548.74
3158928-15892844.55444.55
4136864-13686438.36938.37
5200731-20073156.27356.27
6157227-15722744.07744.08
10min1207521-20752158.17761.724.4558.2461.804.46
2228223-22822363.98164.06
3217988-21798861.11161.19
4217672-21767261.02361.09
5234819-23481965.83065.92
6214814-21481460.22260.29
15min1245568-24556868.84371.062.2069.0071.242.21
2257150-25715072.09072.28
3258183-25818372.38072.56
4252561-25256170.80470.97
5258925-25892572.58872.79
6248444-24844469.64969.82
20min1267347-26734774.94976.731.7975.2277.031.80
2275337-27533777.18977.50
3281059-28105978.79379.09
4272719-27271976.45576.74
5276022-27602277.38177.71
6269776-26977675.63075.92
30min1290320-29032081.38982.681.9581.7883.101.95
2295782-29578282.92083.36
3305716-30571685.70586.13
4292932-29293282.12182.53
5294464-29446482.55183.00
6290290-29029081.38181.80
45min1301182-30118284.43485.572.0684.9686.132.06
2305262-30526285.57886.15
3317706-31770689.06789.64
4301968-30196884.65485.20
5303012-30301284.94785.54
6302189-30218984.71685.27
60min1303179-30317984.99486.032.1785.6786.732.16
2306941-30694186.04986.77
3320121-32012189.74490.46
4302908-30290884.91885.61
5303918-30391885.20185.93
6304102-30410285.25385.95
极限1322033-32203390.28090.750.9391.0991.600.94
2320205-32020589.76790.63
3329060-32906092.25093.12
4323000-32300090.55191.38
5324666-32466691.01891.89
6323389-32338990.66091.49
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%
112.014464334463314462634465394463554463840.03
211.794462114466974464540.08
单位质量响应值RSD%判断
37167.6937867.181.32数据可信
供试品溶液-2024052121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%
5min1332733-33273363.66959.536.8863.6759.536.88
2299638-29963857.33657.34
3325113-32511362.21162.21
4273640-27364052.36152.36
5317755-31775560.80360.80
6317837-31783760.81960.82
10min1434269-43426983.09881.584.9683.2081.684.96
2416763-41676379.74879.84
3429914-42991482.26582.37
4388853-38885374.40874.49
5447477-44747785.62585.73
6440799-44079984.34884.45
15min1461068-46106888.22687.813.6688.4788.053.66
2449710-44971086.05386.28
3455782-45578287.21587.46
4433421-43342182.93683.15
5480223-48022391.89192.14
6473210-47321090.55090.79
20min1470335-47033589.99989.923.0190.3990.303.02
2461085-46108588.22988.60
3465581-46558189.09089.48
4450852-45085286.27186.62
5489745-48974593.71494.11
6481999-48199992.23192.62
30min1478193-47819391.50391.322.3292.0491.852.33
2469234-46923489.78990.31
3473225-47322590.55291.09
4463414-46341488.67589.17
5493570-49357094.44595.00
6485809-48580992.96093.51
45min1482202-48220292.27092.032.5092.9692.712.51
2470854-47085490.09990.77
3475968-47596891.07791.76
4467581-46758189.47290.11
5499417-49941795.56496.28
6489510-48951093.66994.37
60min1484127-48412792.63992.022.5993.4992.862.60
2471134-47113490.15290.97
3475389-47538990.96691.80
4466981-46698189.35890.15
5501251-50125195.91596.79
6486485-48648593.09093.95
极限1517684-51768499.06097.390.86100.0698.380.85
2508780-50878097.35698.32
3507023-50702397.02098.01
4507122-50712297.03997.98
5506843-50684396.98598.02
6506401-50640196.90197.91
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%
115.753128323127693129233131723129183129230.05
215.863147373151043149200.09
单位质量响应值RSD%判断
19868.1319856.240.05数据可信
供试品溶液-2024052121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%
5min17136-71362.0171.825.412.021.825.49
26404-64041.8101.81
36319-63191.7861.79
46315-63151.7851.78
56218-62181.7571.76
66240-62401.7641.76
10min18785-87852.4832.504.932.492.504.88
29128-91282.5802.58
39512-95122.6882.69
48805-88052.4892.49
58322-83222.3522.36
68463-84632.3922.39
15min112137-121373.4303.323.553.443.333.56
212075-120753.4133.42
312145-121453.4333.44
411432-114323.2313.24
511274-112743.1863.19
611392-113923.2203.23
20min113890-138903.9263.772.703.943.782.66
213625-136253.8513.86
312959-129593.6633.68
413009-130093.6773.69
513346-133463.7723.78
613247-132473.7443.76
30min114834-148344.1934.152.504.214.162.50
215025-150254.2474.27
315083-150834.2634.28
414564-145644.1164.13
514317-143174.0464.06
614213-142134.0174.04
45min115994-159944.5204.481.474.554.511.47
216209-162094.5814.61
315670-156704.4294.46
415567-155674.4004.43
515772-157724.4584.48
615922-159224.5004.53
60min116851-168514.7634.652.404.804.692.40
216869-168694.7684.80
316374-163744.6284.66
416326-163264.6144.65
516553-165534.6784.71
615807-158074.4684.50
极限117419-174194.9234.782.324.974.822.37
216980-169804.7994.84
316863-168634.7664.81
417040-170404.8164.86
516216-162164.5834.62
616861-168614.7664.81
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%
112.014476404475864476044479194478964477290.04
211.794354994353304354140.03
单位质量响应值RSD%判断
37279.6836930.790.67数据可信
供试品溶液-2024052121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%
5min1392096-39209675.85765.0411.8375.8665.0411.83
2369475-36947571.48071.48
3335186-33518664.84764.85
4288983-28898355.90855.91
5298463-29846357.74257.74
6332847-33284764.39464.39
10min1483635-48363593.56687.296.6293.6987.406.62
2467984-46798490.53890.66
3468907-46890790.71790.83
4412045-41204579.71679.81
5416315-41631580.54280.64
6458421-45842188.68888.80
15min1479063-47906392.68291.702.8692.9691.952.87
2483551-48355193.55093.82
3485813-48581393.98894.25
4455780-45578088.17788.40
5457752-45775288.55988.79
6481922-48192293.23593.49
20min1472928-47292891.49592.791.6591.9393.201.65
2485561-48556193.93994.36
3489712-48971294.74295.16
4470821-47082191.08791.46
5474350-47435091.77092.15
6484386-48438693.71294.12
30min1481258-48125893.10793.620.9193.7094.180.92
2486889-48688994.19694.78
3489123-48912394.62895.20
4476846-47684692.25392.78
5483526-48352693.54594.08
6485679-48567993.96294.53
45min1478418-47841892.55793.670.9193.3094.390.90
2485625-48562593.95194.69
3489149-48914994.63395.36
4480910-48091093.03993.72
5488737-48873794.55395.24
6482188-48218893.28694.01
60min1480187-48018792.89993.790.9093.8094.670.89
2485220-48522093.87394.77
3488831-48883194.57295.46
4479309-47930992.72993.56
5489857-48985794.77095.61
6485478-48547893.92394.80
极限1495786-49578695.91797.041.0196.9798.071.00
2500032-50003296.73997.79
3505488-50548897.79498.84
4503942-50394297.49598.48
5496309-49630996.01897.02
6508024-50802498.28599.32
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%
115.753135183134013132173131863134403133520.05
215.863184283185173184720.02
单位质量响应值RSD%判断
19895.3720080.200.66数据可信
供试品溶液-2024052121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%
5min16333-63331.7791.761.001.781.761.08
26317-63171.7741.77
36193-61931.7391.74
46325-63251.7761.78
56208-62081.7441.74
66247-62471.7551.75
10min17628-76282.1422.269.082.152.269.10
28491-84912.3852.39
38892-88922.4972.50
48662-86622.4332.44
57250-72502.0362.04
67298-72982.0502.05
15min111863-118633.3323.214.103.343.214.10
211948-119483.3563.36
311536-115363.2403.25
411142-111423.1293.14
510707-107073.0073.01
611300-113003.1743.18
20min112912-129123.6273.715.063.643.725.03
214138-141383.9713.98
313902-139023.9053.92
412848-128483.6093.62
513042-130423.6633.67
612412-124123.4863.50
30min115312-153124.3014.045.654.324.065.65
214997-149974.2124.23
314892-148924.1834.20
413357-133573.7523.77
513514-135143.7963.81
614320-143204.0224.04
45min115686-156864.4064.342.224.434.362.24
215810-158104.4404.47
315440-154404.3374.36
415586-155864.3784.40
515379-153794.3194.34
614836-148364.1674.19
60min115826-158264.4454.541.824.484.571.77
216394-163944.6054.64
316206-162064.5524.58
415909-159094.4684.50
516603-166034.6634.69
616100-161004.5224.55
极限116881-168814.7414.741.644.784.781.62
216839-168394.7294.77
317218-172184.8364.88
416795-167954.7174.76
516404-164044.6074.65
617053-170534.7904.83
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