坎地氢噻片项目信息
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%
112.354837674837724838604836194835904837220.03
212.324821974822924822440.02
单位质量响应值RSD%判断
39167.7739143.180.05数据可信
供试品溶液-2024082821批-氢氯噻嗪-0.35tw20
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1406775-40677574.57469.4810.9574.5769.4810.94
2357745-35774565.58665.59
3309041-30904156.65756.66
4420352-42035277.06377.06
5406224-40622474.47374.47
6373764-37376468.52268.52
10min1489842-48984289.80387.803.7989.9387.923.80
2470227-47022786.20786.32
3448389-44838982.20382.30
4499814-49981491.63191.76
5477505-47750587.54187.67
6487609-48760989.39489.51
15min1505158-50515892.61190.972.1192.8891.232.12
2488686-48868689.59189.84
3480342-48034288.06188.29
4506364-50636492.83293.11
5493580-49358090.48890.76
6503114-50311492.23692.50
20min1511339-51133993.74491.981.9794.1792.391.98
2494123-49412390.58890.99
3488258-48825889.51389.89
4508039-50803993.13993.58
5497166-49716691.14691.57
6511323-51132393.74194.16
30min1515947-51594794.58992.881.5995.1793.451.60
2499792-49979291.62792.18
3498037-49803791.30591.83
4509764-50976493.45594.05
5501179-50117991.88192.45
6515205-51520594.45395.03
45min1517936-51793694.95493.401.3695.7094.121.36
2503202-50320292.25292.96
3504888-50488892.56193.24
4510628-51062893.61494.36
5502866-50286692.19192.92
6517204-51720494.81995.55
60min1515038-51503894.42293.611.0495.3294.491.05
2504046-50404692.40793.27
3507718-50771893.08093.91
4510319-51031993.55794.46
5507999-50799993.13294.01
6518500-51850095.05795.95
极限1533289-53328997.76898.030.2998.8399.060.30
2533299-53329997.77098.78
3534646-53464698.01799.01
4534563-53456398.00299.06
5534876-53487698.05999.09
6537496-53749698.54099.59
坎地氢噻片项目信息
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%
115.512992772996232992942996082996942994990.07
215.473001703005623003660.10
单位质量响应值RSD%判断
19310.0619416.030.39数据可信
供试品溶液-2024082821批-坎地沙坦酯-0.35tw20
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1159397-15939746.21343.1810.8046.2143.1810.80
2145140-14514042.07942.08
3120455-12045534.92334.92
4164195-16419547.60447.60
5159444-15944446.22646.23
6145057-14505742.05542.06
10min1230321-23032166.77566.474.5466.8566.554.54
2229351-22935166.49466.56
3210439-21043961.01161.07
4241784-24178470.09970.18
5234506-23450667.98968.07
6229307-22930766.48166.55
15min1261147-26114775.71376.012.4375.9076.192.44
2260287-26028775.46375.64
3251888-25188873.02873.19
4271296-27129678.65578.85
5263899-26389976.51076.70
6264513-26451376.68876.87
20min1278871-27887180.85181.101.6481.1781.411.65
2277033-27703380.31880.62
3272901-27290179.12079.40
4285906-28590682.89183.22
5280617-28061781.35781.68
6283027-28302782.05682.36
30min1296215-29621585.88086.111.0886.3386.561.09
2295252-29525285.60086.04
3292623-29262384.83885.25
4300096-30009687.00587.47
5296577-29657785.98486.44
6301331-30133187.36387.81
45min1304447-30444788.26688.290.6788.8688.880.67
2304413-30441388.25688.84
3302016-30201687.56188.12
4306018-30601888.72289.33
5302809-30280987.79188.39
6307486-30748689.14789.74
60min1306123-30612388.75288.810.5789.4989.540.57
2305669-30566988.62089.35
3304444-30444488.26588.97
4307304-30730489.09489.85
5305091-30509188.45389.20
6309223-30922389.65190.39
极限1314838-31483891.27991.500.4992.1792.380.48
2315018-31501891.33192.21
3314988-31498891.32292.17
4313879-31387991.00191.91
5316945-31694591.89092.78
6317937-31793792.17793.07
坎地氢噻片项目信息
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%
112.354812814811484807894805794805604808710.07
212.324788874789194789030.01
单位质量响应值RSD%判断
38936.9238872.000.12数据可信
供试品溶液-2024083021批-氢氯噻嗪-0.35tw20
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1234228-23422843.21840.458.6443.2240.458.65
2224146-22414641.35841.36
3224839-22483941.48641.49
4212515-21251539.21239.21
5235280-23528043.41243.41
6184455-18445534.03434.03
10min1375060-37506069.20472.714.5969.2872.784.59
2411995-41199576.01976.09
3388905-38890571.75871.83
4390536-39053672.05972.12
5419746-41974677.44977.52
6378229-37822969.78869.85
15min1439344-43934481.06585.954.1581.2586.144.15
2490856-49085690.57090.77
3456873-45687384.29984.49
4465024-46502485.80385.99
5485366-48536689.55789.76
6457340-45734084.38584.56
20min1470547-47054786.82290.162.6887.1490.502.69
2505070-50507093.19293.54
3482067-48206788.94889.28
4487999-48799990.04290.37
5502433-50243392.70693.06
6483852-48385289.27789.59
30min1497155-49715591.73293.671.4492.2094.151.45
2515603-51560395.13695.64
3504074-50407493.00993.49
4507631-50763193.66594.14
5516176-51617695.24295.75
6505197-50519793.21693.68
45min1517361-51736195.46096.540.7396.0897.180.75
2525318-52531896.92897.59
3524802-52480296.83397.47
4523452-52345296.58497.22
5527939-52793997.41298.08
6520260-52026095.99596.61
60min1528155-52815597.45298.020.6398.2398.820.63
2528872-52887297.58498.41
3537366-53736699.15199.95
4529797-52979797.75598.55
5531924-53192498.14798.97
6531308-53130898.03498.81
极限1534180-53418098.56498.730.9699.5199.700.94
2529349-52934997.67298.66
3544055-544055100.386101.34
4532375-53237598.23099.19
5533300-53330098.40199.39
6537278-53727899.135100.08
坎地氢噻片项目信息
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%
115.512999812999752995502996352997722997830.07
215.472989402992612991000.08
单位质量响应值RSD%判断
19328.3719334.200.03数据可信
供试品溶液-2024083021批-坎地沙坦酯-0.35tw20
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min189182-8918225.89824.408.3425.9024.408.34
287055-8705525.28125.28
385705-8570524.88824.89
484030-8403024.40224.40
587884-8788425.52125.52
670191-7019120.38320.38
10min1177515-17751551.55052.913.5851.5952.953.58
2184900-18490053.69453.74
3185075-18507553.74553.79
4180372-18037252.38052.42
5191906-19190655.72955.77
6173427-17342750.36350.40
15min1231423-23142367.20569.952.7667.3370.072.76
2247286-24728671.81171.94
3240359-24035969.80069.93
4238473-23847369.25269.38
5249614-24961472.48772.62
6238025-23802569.12269.24
20min1261303-26130375.88278.932.7776.1279.172.77
2274976-27497679.85280.10
3269512-26951278.26678.51
4269508-26950878.26478.51
5284137-28413782.51382.77
6271320-27132078.79179.02
30min1290661-29066184.40786.231.2184.7786.611.22
2297973-29797386.53186.91
3296559-29655986.12086.50
4296632-29663286.14186.51
5301631-30163187.59387.99
6298231-29823186.60586.97
45min1306135-30613588.90189.690.6189.4190.210.62
2308098-30809889.47190.00
3310767-31076790.24690.77
4308170-30817089.49290.01
5311171-31117190.36390.90
6308677-30867789.63990.15
60min1310307-31030790.11290.430.6590.7791.100.64
2309704-30970489.93790.61
3315130-31513091.51392.18
4310111-31011190.05590.72
5311928-31192890.58391.27
6311156-31115690.35991.02
极限1313975-31397591.17791.190.6591.9892.010.64
2312164-31216490.65291.48
3317937-31793792.32893.15
4313382-31338291.00591.82
5312819-31281990.84291.68
6313814-31381491.13191.94
坎地氢噻片项目信息
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%
112.354794194796764793704791754791834793650.05
212.324812944810834811880.04
单位质量响应值RSD%判断
38814.9839057.470.45数据可信
供试品溶液-2024090121批-氢氯噻嗪-0.35tw20
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1307432-30743256.68053.689.4356.6853.689.43
2292386-29238653.90653.91
3325661-32566160.04060.04
4252469-25246946.54646.55
5265496-26549648.94848.95
6303515-30351555.95755.96
10min1419157-41915777.27878.144.7477.3778.234.74
2426198-42619878.57678.67
3431725-43172579.59579.69
4407119-40711975.05875.14
5401349-40134973.99574.08
6457573-45757384.36084.45
15min1450293-45029383.01885.883.8283.2486.103.82
2462406-46240685.25185.47
3480434-48043488.57588.81
4456248-45624884.11684.32
5451217-45121783.18983.39
6494199-49419991.11391.35
20min1465159-46515985.75989.042.8886.1289.402.88
2476370-47637087.82688.19
3498822-49882291.96592.35
4482744-48274489.00189.34
5474771-47477187.53187.87
6499833-49983392.15292.54
30min1478532-47853288.22491.512.5688.7392.022.56
2488350-48835090.03590.54
3510103-51010394.04594.58
4498860-49886091.97292.46
5491468-49146890.60991.10
6510683-51068394.15294.69
45min1491295-49129590.57894.002.3591.2394.672.35
2501286-50128692.41993.08
3520234-52023495.91396.60
4515136-51513694.97395.62
5508763-50876393.79894.44
6522567-52256796.34397.04
60min1496117-49611791.46795.222.5692.2796.042.55
2504677-50467793.04593.86
3525622-52562296.90697.76
4526105-52610596.99597.80
5518228-51822895.54396.34
6528201-52820197.38298.24
极限1524343-52434396.67097.060.6997.6398.040.69
2530429-53042997.79298.76
3525309-52530996.84897.86
4529356-52935697.59598.56
5520857-52085796.02896.98
6528318-52831897.40398.42
坎地氢噻片项目信息
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%
115.512995512996642993502990582992702993790.08
215.473003653004233003940.02
单位质量响应值RSD%判断
19302.3219417.840.43数据可信
供试品溶液-2024090121批-坎地沙坦酯-0.35tw20
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1117521-11752134.07732.457.8134.0832.467.80
2114241-11424133.12633.13
3122266-12226635.45335.45
499661-9966128.89828.90
5103033-10303329.87629.88
6114802-11480233.28933.29
10min1203116-20311658.89758.183.5258.9558.243.52
2202970-20297058.85558.91
3201451-20145158.41458.47
4193000-19300055.96456.01
5192320-19232055.76755.82
6211058-21105861.20061.26
15min1239285-23928569.38570.432.9569.5470.582.95
2242366-24236670.27870.43
3245142-24514271.08371.24
4238782-23878269.23969.38
5235742-23574268.35868.50
6255927-25592774.21174.37
20min1260285-26028575.47477.201.9675.7477.471.96
2263639-26363976.44776.72
3269549-26954978.16178.44
4265539-26553976.99877.25
5263611-26361176.43976.70
6274884-27488479.70879.99
30min1279303-27930380.98983.652.0481.3984.052.03
2285090-28509082.66783.06
3293146-29314685.00385.41
4290073-29007384.11284.50
5287740-28774083.43583.82
6295630-29563085.72386.14
45min1291331-29133184.47787.041.7085.0187.581.70
2297567-29756786.28586.82
3304250-30425088.22388.77
4303224-30322487.92588.45
5300108-30010887.02287.54
6304553-30455388.31188.87
60min1295177-29517785.59287.931.5686.2688.611.56
2300363-30036387.09687.78
3306846-30684688.97589.67
4306953-30695389.00689.68
5303453-30345387.99288.66
6306673-30667388.92589.63
极限1306093-30609388.75789.370.5989.5790.200.59
2309559-30955989.76290.59
3309323-30932389.69490.54
4309687-30968789.79990.62
5305749-30574988.65789.47
6308789-30878989.53990.39
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