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%
111.784602854599114600214594954597094598840.07
211.784584554586784585660.04
单位质量响应值RSD%判断
39039.3938927.500.21数据可信
加速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%
5min1327322-32732260.27371.5913.7060.2771.5813.70
2442288-44228881.44381.44
3422693-42269377.83577.83
4317214-31721458.41258.41
5401034-40103473.84673.85
6422000-42200077.70777.71
10min1459040-45904084.52888.006.4184.6388.126.42
2506894-50689493.33993.48
3492726-49272690.73190.86
4424474-42447478.16378.26
5489529-48952990.14290.26
6494553-49455391.06791.20
15min1484811-48481189.27391.403.4589.5191.673.47
2517256-51725695.24895.54
3505138-50513893.01693.30
4468836-46883686.33186.56
5498687-49868791.82892.10
6503529-50352992.72093.00
20min1493117-49311790.80392.242.4791.1992.662.49
2518604-51860495.49695.95
3508059-50805993.55493.99
4482931-48293188.92789.30
5498939-49893991.87592.30
6503758-50375892.76293.20
30min1497501-49750191.61092.771.7592.1593.341.77
2518911-51891195.55296.16
3508200-50820093.58094.17
4494603-49460391.07691.60
5500001-50000192.07092.65
6503653-50365392.74393.33
45min1502450-50245092.52193.021.3293.2293.751.34
2517902-51790295.36796.13
3506866-50686693.33494.08
4499915-49991592.05492.73
5501289-50128992.30793.04
6502591-50259192.54793.29
60min1498346-49834691.76592.811.3992.6193.691.41
2517046-51704695.20996.14
3506447-50644793.25794.16
4499242-49924291.93092.76
5502214-50221492.47893.36
6500861-50086192.22993.13
极限1527485-52748597.13196.410.9598.1397.440.94
2530485-53048597.68498.77
3524358-52435896.55597.61
4521558-52155896.04097.02
5520419-52041995.83096.87
6516969-51696995.19596.25
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%
115.642977562980662982602979922980192980190.07
215.602974332977392975860.08
单位质量响应值RSD%判断
19054.9219076.030.08数据可信
加速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%
5min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
10min12129-21290.6270.6250.150.630.6250.11
22755-27550.8110.81
32448-24480.7210.72
4-0.0000.00
52678-26780.7890.79
62653-26530.7810.78
15min13618-36181.0651.1911.001.071.1910.94
24292-42921.2641.27
34184-41841.2321.23
43355-33550.9880.99
54445-44451.3091.31
64341-43411.2781.28
20min14852-48521.4291.558.231.431.568.24
25415-54151.5941.60
35773-57731.7001.70
44888-48881.4391.44
55766-57661.6981.70
64956-49561.4591.46
30min15846-58461.7211.835.301.731.845.13
26575-65751.9361.94
36265-62651.8451.85
45846-58461.7211.73
56581-65811.9381.94
66188-61881.8221.83
45min16709-67091.9751.977.171.981.987.12
27102-71022.0912.10
36067-60671.7861.80
46680-66801.9671.97
56211-62111.8291.84
67289-72892.1462.16
60min16815-68152.0072.256.712.022.266.66
27689-76892.2642.28
38033-80332.3652.38
47672-76722.2592.27
58251-82512.4292.44
67320-73202.1552.17
极限16950-69502.0462.234.402.062.254.39
27625-76252.2452.26
37791-77912.2942.31
47523-75232.2152.23
57818-78182.3022.32
67807-78072.2992.31
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%
111.784583574582464582934581234583874582810.03
211.784569934571884570900.04
单位质量响应值RSD%判断
38903.3138802.210.19数据可信
加速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%
5min1269150-26915049.72852.816.2849.7352.816.28
2285300-28530052.71252.71
3282468-28246852.18952.19
4266332-26633249.20749.21
5314113-31411358.03558.04
6297626-29762654.98954.99
10min1420411-42041177.67580.853.7077.7680.943.71
2424481-42448178.42778.51
3433780-43378080.14580.23
4433254-43325480.04880.13
5451147-45114783.35483.45
6462621-46262185.47485.57
15min1494510-49451091.36591.922.0291.5892.142.02
2488085-48808590.17890.40
3493762-49376291.22791.45
4495843-49584391.61291.83
5495693-49569391.58491.82
6517150-51715095.54895.78
20min1510455-51045594.31194.301.6594.6894.681.65
2502853-50285392.90793.28
3507138-50713893.69994.07
4508868-50886894.01894.39
5506267-50626793.53893.93
6526718-52671897.31697.71
30min1521960-52196096.43796.321.1796.9696.851.17
2515164-51516495.18195.71
3519067-51906795.90396.43
4519755-51975596.03096.55
5519030-51903095.89696.44
6532880-53288098.45599.01
45min1533093-53309398.49498.040.8899.1898.740.88
2526379-52637997.25397.94
3528611-52861197.66698.35
4529202-52920297.77598.46
5527711-52771197.50098.20
6538941-53894199.574100.29
60min1534628-53462898.77898.240.6599.6299.100.66
2528852-52885297.71098.55
3529206-52920697.77698.63
4530644-53064498.04198.89
5529726-52972697.87298.74
6537293-53729399.270100.16
极限1533192-53319298.51298.140.5399.5299.160.53
2528950-52895097.72898.74
3528768-52876897.69598.71
4530687-53068798.04999.06
5529726-52972697.87298.90
6535768-53576898.988100.04
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%
115.642977052972442973582972802976082974390.07
215.602976102977282976690.03
单位质量响应值RSD%判断
19017.8419081.350.24数据可信
加速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%
5min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
10min1-0.0000.36110.190.000.36110.14
22265-22650.6670.67
32326-23260.6850.69
4-0.0000.00
52684-26840.7910.79
6-0.0000.00
15min13905-39051.1511.187.361.151.187.43
24363-43631.2861.29
33652-36521.0761.08
43709-37091.0931.09
54270-42701.2581.26
64117-41171.2131.21
20min14460-44601.3141.448.721.321.448.75
25282-52821.5571.56
35507-55071.6231.63
44530-45301.3351.34
54914-49141.4481.45
64653-46531.3711.37
30min16002-60021.7691.6711.581.771.6811.50
26247-62471.8411.85
36070-60701.7891.79
45665-56651.6691.67
55689-56891.6771.68
64422-44221.3031.31
45min16898-68982.0332.015.632.042.025.60
26838-68382.0152.02
36636-66361.9561.96
46617-66171.9501.96
56442-64421.8981.91
67536-75362.2212.23
60min17541-75412.2222.158.612.232.168.51
28048-80482.3722.38
37539-75392.2222.23
47541-75412.2222.23
56694-66941.9731.98
66369-63691.8771.89
极限17656-76562.2562.256.272.272.266.30
28361-83612.4642.48
38046-80462.3712.39
47288-72882.1482.16
57210-72102.1252.14
67251-72512.1372.15
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%
111.784572634575974574574572294576474574390.05
211.784557064555294556180.03
单位质量响应值RSD%判断
38831.8338677.250.29数据可信
加速6月-供试品溶液-2024083021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%
5min1333715-33371561.81359.585.2061.8159.585.19
2316913-31691358.70158.70
3342090-34209063.36563.36
4293480-29348054.36154.36
5324502-32450260.10760.11
6319145-31914559.11559.11
10min1455778-45577884.42384.562.2584.5384.662.25
2452537-45253783.82383.92
3469437-46943786.95387.06
4439562-43956281.41981.51
5463673-46367385.88585.99
6458088-45808884.85184.95
15min1485451-48545189.91991.381.5190.1691.621.51
2496608-49660891.98692.22
3503164-50316493.20093.45
4488655-48865590.51390.74
5499516-49951692.52492.77
6486549-48654990.12390.36
20min1493359-49335991.38493.541.7991.7893.931.79
2515063-51506395.40495.79
3510702-51070294.59695.00
4502437-50243793.06593.44
5512369-51236994.90595.30
6496144-49614491.90092.29
30min1503075-50307593.18495.161.7593.7395.711.75
2525012-52501297.24797.80
3518716-51871696.08196.64
4511238-51123894.69695.23
5520225-52022596.36096.92
6504261-50426193.40393.95
45min1509531-50953194.37996.221.7295.0896.931.72
2531919-53191998.52699.24
3524435-52443597.14097.86
4515721-51572195.52696.22
5524666-52466697.18397.90
6510652-51065294.58795.29
60min1510438-51043894.54796.231.6495.4197.091.64
2531240-53124098.40199.28
3524481-52448197.14998.03
4516311-51631195.63596.48
5524200-52420097.09797.97
6510369-51036994.53595.39
极限1508962-50896294.27496.661.5595.2997.691.54
2530737-53073798.30799.35
3523511-52351196.96998.02
4515677-51567795.51896.53
5526847-52684797.58798.63
6525442-52544297.32798.34
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%
115.642978212980872980692981092977532979680.06
215.602971712974572973140.07
单位质量响应值RSD%判断
19051.6619058.590.03数据可信
加速6月-供试品溶液-2024083021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%
5min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
10min1-0.0000.32110.300.000.32110.35
22008-20080.5920.59
32031-20310.5980.60
4-0.0000.00
5-0.0000.00
62397-23970.7060.71
15min13170-31700.9341.0711.910.931.0711.87
24162-41621.2261.23
34188-41881.2341.23
43418-34181.0071.01
53565-35651.0501.05
63341-33410.9840.99
20min14582-45821.3501.488.951.351.489.05
25561-55611.6381.64
35587-55871.6461.65
44996-49961.4721.47
54888-48881.4401.44
64581-45811.3501.35
30min15527-55271.6281.6215.841.631.6215.82
26118-61181.8021.81
36222-62221.8331.84
45549-55491.6351.64
55676-56761.6721.68
63815-38151.1241.13
45min16560-65601.9331.994.771.942.004.77
26562-65621.9331.94
37402-74022.1812.19
46688-66881.9701.98
56613-66131.9481.96
66747-67471.9881.99
60min17470-74702.2012.192.552.212.202.55
27635-76352.2492.26
37166-71662.1112.12
47366-73662.1702.18
57306-73062.1522.16
67645-76452.2522.26
极限17252-72522.1362.305.692.152.325.63
28443-84432.4872.50
38088-80882.3832.40
47851-78512.3132.33
57375-73752.1732.19
67890-78902.3242.34
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%
111.784553414556584553454553044554414554180.04
211.784539054537254538150.03
单位质量响应值RSD%判断
38660.2738524.190.25数据可信
加速6月-供试品溶液-2024083021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%
5min1367638-36763868.38360.269.1768.3860.269.17
2299283-29928355.66955.67
3343435-34343563.88163.88
4333147-33314761.96861.97
5312429-31242958.11458.11
6287942-28794253.55953.56
10min1478505-47850589.00586.384.1989.1286.484.19
2458516-45851685.28785.38
3476744-47674488.67888.78
4459502-45950285.47185.57
5482628-48262889.77289.87
6430601-43060180.09580.18
15min1516607-51660796.09294.123.2796.3594.363.27
2506498-50649894.21294.45
3507563-50756394.41094.66
4492195-49219591.55291.80
5529565-52956598.50398.75
6483544-48354489.94390.17
20min1524105-52410597.48796.002.8797.9196.412.87
2517866-51786696.32796.72
3518505-51850596.44696.86
4503247-50324793.60794.01
5537215-53721599.926100.34
6495844-49584492.23092.60
30min1529687-52968798.52597.772.6599.1198.332.66
2523268-52326897.33197.88
3533705-53370599.27399.85
4512637-51263795.35495.91
5546012-546012101.562102.14
6508383-50838394.56395.09
45min1532582-53258299.06498.421.8099.8199.151.81
2526387-52638797.91298.63
3532982-53298299.13899.88
4517659-51765996.28897.00
5544021-544021101.192101.94
6521216-52121696.95097.63
60min1531665-53166598.89398.551.7899.8199.441.78
2526006-52600697.84198.72
3538056-538056100.082100.99
4518056-51805696.36297.24
5542665-542665100.939101.85
6522598-52259897.20798.05
极限1531852-53185298.92898.711.15100.0199.761.17
2524622-52462297.58398.62
3535351-53535199.579100.65
4527772-52777298.16999.20
5539756-539756100.398101.48
6524813-52481397.61998.63
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%
115.642974582974942972272971442972922973230.06
215.602968102964572966340.09
单位质量响应值RSD%判断
19010.4219015.000.02数据可信
加速6月-供试品溶液-2024083021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%
5min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
10min12347-23470.6930.36109.670.690.36109.70
22530-25300.7470.75
3-0.0000.00
42386-23860.7040.70
5-0.0000.00
6-0.0000.00
15min13990-39901.1781.222.881.181.223.00
24256-42561.2571.26
34293-42931.2681.27
44179-41791.2341.24
54064-40641.2001.20
64080-40801.2051.20
20min14904-49041.4481.489.591.451.489.47
25475-54751.6171.62
34213-42131.2441.25
45332-53321.5741.58
55324-53241.5721.57
64726-47261.3951.40
30min15715-57151.6871.756.301.691.766.35
25673-56731.6751.68
35717-57171.6881.69
46576-65761.9421.95
55693-56931.6811.69
66181-61811.8251.83
45min16253-62531.8462.016.501.852.026.51
27076-70762.0892.10
37499-74992.2142.22
46858-68582.0252.03
56719-67191.9841.99
66474-64741.9121.92
60min16089-60891.7982.107.631.812.117.55
27689-76892.2702.28
37341-73412.1682.18
47036-70362.0772.09
57206-72062.1282.14
67262-72622.1442.15
极限17963-79632.3512.333.802.372.353.75
28086-80862.3872.40
38020-80202.3682.38
48234-82342.4312.45
57746-77462.2872.30
67387-73872.1812.20
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