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%
112.224555034549674552664550794553174552260.05
212.204530414533334531870.05
单位质量响应值RSD%判断
37252.5437146.480.21数据可信
中间条件18月-供试品溶液-2024082821批-氢氯噻嗪-含0.35%吐温20的pH6.5磷酸盐溶液
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1347444-34744467.04767.8710.2667.0567.8710.26
2306433-30643359.13359.13
3358298-35829869.14169.14
4329791-32979163.64063.64
5414212-41421279.93179.93
6354001-35400168.31268.31
10min1445676-44567686.00285.465.0686.1185.575.07
2405898-40589878.32678.42
3446097-44609786.08486.20
4430029-43002982.98383.09
5465456-46545689.81989.95
6464053-46405389.54989.66
15min1463673-46367389.47588.803.3089.7389.053.31
2434834-43483483.91084.14
3463954-46395489.53089.79
4450486-45048686.93187.17
5472616-47261691.20191.48
6475340-47534091.72791.99
20min1469094-46909490.52189.952.4790.9390.362.48
2446481-44648186.15886.53
3472972-47297291.27091.68
4458360-45836088.45088.84
5474593-47459391.58392.02
6475439-47543991.74692.16
30min1473447-47344791.36191.561.7291.9292.111.74
2463307-46330789.40589.92
3483965-48396593.39193.95
4466634-46663490.04790.58
5479560-47956092.54193.13
6479840-47984092.59593.16
45min1478277-47827792.29392.871.4393.0093.581.43
2477387-47738792.12292.78
3494057-49405795.33996.05
4474623-47462391.58892.28
5480366-48036692.69793.44
6482883-48288393.18293.91
60min1480287-48028792.68193.401.5093.5494.261.49
2484233-48423393.44394.26
3497966-49796696.09396.97
4477694-47769492.18193.02
5480520-48052092.72693.62
6483448-48344893.29194.17
极限1500228-50022896.52997.360.7497.5498.380.75
2505095-50509597.46998.44
3508399-50839998.10699.14
4499889-49988996.46497.46
5508001-50800198.02999.08
6505611-50561197.56898.60
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%
116.453050393052003050063051863049843050830.04
216.383041063043203042130.05
单位质量响应值RSD%判断
18546.0818572.220.10数据可信
中间条件18月-供试品溶液-2024082821批-坎地沙坦酯-含0.35%吐温20的pH6.5磷酸盐溶液
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min194127-9412728.47130.0210.5428.4730.0210.55
287127-8712726.35426.35
398881-9888129.90929.91
495409-9540928.85928.86
5117995-11799535.69135.69
6102024-10202430.86030.86
10min1175021-17502152.94054.196.1252.9954.246.11
2163688-16368849.51249.56
3180896-18089654.71754.77
4172797-17279752.26752.32
5192846-19284658.33258.39
6189739-18973957.39257.44
15min1217135-21713565.67966.734.3565.8166.864.36
2207011-20701162.61662.74
3223387-22338767.57067.71
4214215-21421564.79664.93
5230011-23001169.57369.73
6231827-23182770.12370.27
20min1242260-24226073.27974.372.9673.5274.622.97
2237098-23709871.71771.95
3247086-24708674.73874.99
4240532-24053272.75673.00
5252409-25240976.34876.62
6255898-25589877.40477.67
30min1267852-26785281.02082.402.4781.3982.782.48
2266136-26613680.50180.85
3274512-27451283.03483.41
4265860-26586080.41780.78
5279966-27996684.68485.08
6280216-28021684.75985.15
45min1285852-28585286.46487.271.7086.9787.781.71
2282746-28274685.52586.01
3292148-29214888.36988.89
4284321-28432186.00186.50
5291073-29107388.04388.58
6294971-29497189.22389.76
60min1292137-29213788.36589.191.3589.0189.841.36
2293912-29391288.90289.53
3297639-29763990.03090.69
4289285-28928587.50388.14
5295670-29567089.43490.12
6300441-30044190.87791.56
极限1301279-30127991.13191.620.7991.9292.420.80
2301545-30154591.21191.99
3304437-30443792.08692.90
4299684-29968490.64891.44
5304830-30483092.20593.04
6305548-30554892.42293.26
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%
112.224539304541214539384534394531124537080.10
212.204524194522744523460.03
单位质量响应值RSD%判断
37128.3137077.540.10数据可信
中间条件18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%
5min1384373-38437374.36659.6116.0774.3759.6116.07
2299052-29905257.85857.86
3252636-25263648.87848.88
4270295-27029552.29552.29
5348478-34847867.42167.42
6293696-29369656.82256.82
10min1479578-47957892.78581.8611.0492.9181.9611.04
2444314-44431485.96386.06
3364535-36453570.52870.61
4370670-37067071.71571.80
5455906-45590688.20588.32
6423728-42372881.98082.07
15min1490874-49087494.97188.506.7395.2588.746.75
2479958-47995892.85993.10
3421475-42147581.54481.74
4419016-41901681.06881.27
5475717-47571792.03892.30
6457575-45757588.52888.76
20min1494714-49471495.71491.384.6596.1591.764.67
2492237-49223795.23495.63
3449323-44932386.93287.27
4442621-44262185.63585.98
5482117-48211793.27693.69
6472882-47288291.49091.87
30min1502601-50260197.24094.303.0497.8494.843.07
2501994-50199497.12297.68
3471553-47155391.23391.71
4467903-46790390.52691.01
5491343-49134395.06195.63
6489157-48915794.63995.17
45min1505930-50593097.88496.111.9298.6496.811.95
2507650-50765098.21698.93
3485264-48526493.88594.52
4486114-48611494.05094.69
5496470-49647096.05396.78
6499275-49927596.59697.29
60min1508833-50883398.44597.671.7599.3798.521.78
2509382-50938298.55299.43
3492151-49215195.21896.01
4495817-49581795.92796.72
5514695-51469599.579100.47
6508040-50804098.29299.14
极限1521970-521970100.98799.900.76102.07100.920.79
2518120-518120100.242101.29
3515166-51516699.671100.62
4510566-51056698.78199.73
5514487-51448799.539100.59
6517818-517818100.184101.20
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%
116.453041783050413043613041283034723042360.19
216.383042393040483041440.05
单位质量响应值RSD%判断
18494.5918568.010.29数据可信
中间条件18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%
5min1107452-10745232.55126.8812.9132.5526.8812.91
285890-8589026.01926.02
374799-7479922.65922.66
481323-8132324.63624.64
595568-9556828.95128.95
687436-8743626.48726.49
10min1196333-19633359.47652.209.5759.5352.259.58
2173404-17340452.53052.57
3149523-14952345.29645.33
4159975-15997548.46248.50
5182767-18276755.36655.41
6171977-17197752.09852.14
15min1239997-23999772.70367.136.4272.8667.266.43
2225111-22511168.19468.32
3201340-20134060.99361.11
4209502-20950263.46563.59
5231754-23175470.20670.35
6221855-22185567.20867.34
20min1265806-26580680.52276.644.4980.8076.894.50
2256519-25651977.70877.95
3238091-23809172.12672.34
4240250-24025072.78073.01
5261605-26160579.24979.51
6255720-25572077.46677.71
30min1289095-28909587.57785.662.8087.9986.032.82
2288124-28812487.28387.66
3271831-27183182.34782.68
4273696-27369682.91283.26
5288901-28890187.51887.91
6284888-28488886.30286.67
45min1302970-30297091.78090.831.4692.3391.341.48
2305076-30507692.41892.94
3294822-29482289.31289.78
4294346-29434689.16889.65
5300642-30064291.07591.61
6301155-30115591.23091.75
60min1307783-30778393.23893.031.6893.9593.701.70
2310220-31022093.97694.65
3300984-30098491.17891.80
4300814-30081491.12791.76
5313461-31346194.95895.65
6309324-30932493.70594.37
极限1313599-31359995.00094.330.8695.8695.140.87
2314519-31451995.27996.11
3311814-31181494.45995.23
4307050-30705093.01693.80
5310014-31001493.91494.76
6311252-31125294.28995.11
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%
112.224511864509464512184512974516544512600.06
212.204508434506564507500.03
单位质量响应值RSD%判断
36927.9936946.720.04数据可信
中间条件18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%
5min1406719-40671979.04268.5620.1879.0468.5620.18
2399722-39972277.68277.68
3321758-32175862.53062.53
4390348-39034875.86075.86
5376780-37678073.22373.22
6221396-22139643.02643.03
10min1475511-47551192.41187.288.2792.5487.408.28
2467798-46779890.91291.04
3443636-44363686.21686.32
4475663-47566392.44092.57
5454173-45417388.26488.39
6377872-37787273.43673.51
15min1484357-48435794.13090.763.9894.4291.024.01
2475140-47514092.33992.62
3462875-46287589.95590.20
4481919-48191993.65693.94
5464014-46401490.17690.45
6433716-43371684.28884.48
20min1488314-48831494.89992.072.5495.3492.482.57
2477174-47717492.73493.17
3470480-47048091.43391.83
4484033-48403394.06794.50
5467446-46744690.84391.26
6455237-45523788.47188.81
30min1491328-49132895.48593.441.4996.0994.001.51
2479081-47908193.10593.69
3481757-48175793.62594.17
4485916-48591694.43395.03
5472747-47274791.87492.44
6473854-47385492.08992.57
45min1493165-49316595.84294.351.3096.6095.071.29
2479602-47960293.20693.95
3488207-48820794.87895.58
4487745-48774594.78895.54
5476251-47625192.55593.28
6488037-48803794.84595.48
60min1493597-49359795.92694.181.2596.8595.061.25
2479019-47901993.09293.99
3482721-48272193.81294.68
4487849-48784994.80995.72
5477518-47751892.80193.68
6487105-48710594.66495.46
极限1506811-50681198.49497.760.6699.5798.790.67
2504348-50434898.01599.07
3496878-49687896.56397.58
4503059-50305997.76498.83
5503255-50325597.80398.84
6503726-50372697.89498.85
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%
116.453027323026643035293033943034663031570.14
216.383043913044563044240.02
单位质量响应值RSD%判断
18429.0018585.100.60数据可信
中间条件18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%
5min1125982-12598238.21531.4020.5838.2131.4020.58
2113975-11397534.57334.57
392925-9292528.18728.19
4110864-11086433.62933.63
5111510-11151033.82533.82
665784-6578419.95519.95
10min1208401-20840163.21557.8611.1063.2857.9211.11
2200250-20025060.74360.80
3183632-18363255.70255.75
4203218-20321861.64361.70
5198021-19802160.06760.12
6151024-15102445.81145.84
15min1247547-24754775.09071.346.7475.2671.496.76
2241812-24181273.35073.51
3229494-22949469.61469.75
4246521-24652174.77974.94
5240119-24011972.83772.99
6205649-20564962.38162.49
20min1270132-27013281.94178.754.4282.2379.024.44
2263667-26366779.98080.26
3254210-25421077.11177.37
4268390-26839081.41281.70
5262113-26211379.50879.79
6239211-23921172.56172.77
30min1290026-29002687.97585.852.3588.4186.262.38
2284353-28435386.25486.67
3281044-28104485.25185.64
4289638-28963887.85888.28
5280989-28098985.23485.64
6272164-27216482.55782.89
45min1299491-29949190.84689.101.3091.4289.641.31
2293156-29315688.92589.48
3292448-29244888.71089.24
4296943-29694390.07390.64
5289200-28920087.72588.28
6291236-29123688.34288.81
60min1299382-29938290.81389.681.0691.5490.371.08
2295303-29530389.57690.28
3293557-29355789.04689.72
4299585-29958590.87591.59
5292311-29231188.66889.37
6293736-29373689.10189.72
极限1306161-30616192.87091.920.6493.7592.750.65
2302447-30244791.74392.60
3302043-30204391.62092.44
4303802-30380292.15493.02
5300481-30048191.14791.99
6303153-30315391.95792.72
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