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(%)99.7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%
112.204714644705314710944706394705674708590.09
212.164677784678284678030.01
单位质量响应值RSD%判断
38595.0038470.640.23数据可信
供试品溶液-519819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%
5min1154253-15425328.73627.169.1728.7427.169.18
2146830-14683027.35327.35
3133339-13333924.84024.84
4131158-13115824.43424.43
5142410-14241026.53026.53
6166771-16677131.06831.07
10min1336347-33634762.65960.665.9962.7160.715.99
2321655-32165559.92259.97
3291111-29111154.23254.27
4320346-32034659.67859.72
5342557-34255763.81663.86
6341793-34179363.67463.73
15min1425570-42557079.28175.645.8779.4375.785.87
2408921-40892176.17976.32
3361708-36170867.38467.52
4398574-39857474.25274.39
5419878-41987878.22178.37
6421385-42138578.50178.66
20min1458208-45820885.36183.384.4785.6583.664.48
2454693-45469384.70684.98
3410503-41050376.47476.72
4439058-43905881.79482.06
5460382-46038285.76686.05
6462602-46260286.18086.47
30min1486673-48667390.66490.562.9991.0990.982.99
2500735-50073593.28493.70
3460502-46050285.78986.16
4480644-48064489.54189.94
5497465-49746592.67593.10
6490783-49078391.43091.86
45min1506685-50668594.39294.001.7694.9794.561.77
2517051-51705196.32396.89
3493014-49301491.84592.36
4496687-49668792.53093.08
5510516-51051695.10695.68
6503588-50358893.81594.40
60min1510969-51096995.19095.371.4895.9396.091.49
2524596-52459697.72998.46
3506327-50632794.32594.99
4504191-50419193.92894.63
5516743-51674396.26697.00
6508798-50879894.78695.53
极限1518029-51802996.50596.881.1797.4097.761.16
2529117-52911798.57199.46
3522587-52258797.35598.18
4512044-51204495.39196.25
5522803-52280397.39598.29
6515774-51577496.08596.98
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(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)8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%
116.351542721545321544301548471546241545410.14
216.311537521540051538780.12
单位质量响应值RSD%判断
9452.059434.580.14数据可信
供试品溶液-519819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%
5min128727-2872717.07716.128.9317.0816.138.93
227311-2731116.23616.24
325025-2502514.87714.88
424603-2460314.62614.63
526084-2608415.50615.51
630980-3098018.41718.42
10min179234-7923447.10245.846.2147.1345.866.21
275785-7578545.05245.08
369022-6902241.03141.06
475626-7562644.95744.98
580439-8043947.81847.84
682539-8253949.06749.10
15min1115755-11575568.81366.925.3368.9267.025.33
2112330-11233066.77766.88
3101162-10116260.13860.23
4112459-11245966.85366.95
5115756-11575668.81368.92
6117978-11797870.13470.25
20min1139205-13920582.75380.654.3282.9780.864.32
2136864-13686481.36181.57
3125017-12501774.31974.51
4133166-13316679.16379.37
5138828-13882882.52982.75
6140923-14092383.77484.00
30min1155035-15503592.16393.452.9492.5293.802.95
2161809-16180996.19096.54
3149430-14943088.83189.15
4156358-15635892.95093.29
5160946-16094695.67796.04
6159580-15958094.86595.23
45min1167661-16766199.66998.821.93100.1899.331.93
2170204-170204101.181101.69
3162364-16236496.52096.99
4164390-16439097.72598.22
5169159-169159100.560101.08
6163643-16364397.28197.81
60min1165112-16511298.15498.601.5198.8399.281.51
2170266-170266101.218101.90
3164566-16456697.82998.46
4164277-16427797.65898.32
5167335-16733599.475100.16
6163657-16365797.28997.98
极限1166132-16613298.76098.931.3199.6099.761.30
2169968-169968101.041101.89
3167352-16735299.486100.27
4164510-16451097.79698.62
5166673-16667399.08299.93
6163900-16390097.43398.28
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(%)99.7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%
112.204678794683984681744682384676804680740.07
212.164669454671494670470.04
单位质量响应值RSD%判断
38366.7238408.470.08数据可信
供试品溶液-519819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%
5min1318954-31895459.64446.1718.0159.6446.1818.01
2207573-20757338.81638.82
3192463-19246335.99035.99
4256505-25650547.96647.97
5250153-25015346.77846.78
6255884-25588447.85047.85
10min1446004-44600483.40273.9511.6783.5074.0211.67
2346328-34632864.76364.83
3350870-35087065.61265.67
4427299-42729979.90479.98
5437113-43711381.73981.82
6365002-36500268.25568.33
15min1493138-49313892.21684.378.4592.4584.578.46
2422862-42286279.07479.25
3402359-40235975.24075.41
4484700-48470090.63890.85
5476428-47642889.09189.31
6427599-42759979.96080.15
20min1500611-50061193.61389.094.8294.0189.434.85
2456897-45689785.43985.74
3447323-44732383.64883.94
4495890-49589092.73093.09
5493507-49350792.28592.65
6464213-46421386.80787.13
30min1505888-50588894.60093.571.2295.1594.061.25
2493164-49316492.22192.67
3499959-49995993.49193.93
4505628-50562894.55195.07
5504736-50473694.38594.90
6492998-49299892.19092.66
45min1504536-50453694.34795.081.0195.0595.721.00
2500304-50030493.55694.16
3511165-51116595.58796.18
4509172-50917295.21495.89
5511082-51108295.57196.25
6514336-51433696.18096.80
60min1504716-50471694.38195.291.3395.2496.091.31
2499916-49991693.48394.24
3512533-51253395.84396.59
4509077-50907795.19696.03
5511731-51173195.69396.53
6519360-51936097.11997.90
极限1514207-51420796.15695.941.3597.1896.901.35
2501176-50117693.71994.63
3512167-51216795.77496.68
4514165-51416596.14897.14
5513978-51397896.11397.11
6522616-52261697.72898.68
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(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)8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%
116.351539671543441541651541771542801541870.10
216.311539631538881539260.04
单位质量响应值RSD%判断
9430.409437.520.06数据可信
供试品溶液-519819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%
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
10min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
15min12702-27021.6081.3918.101.611.3918.21
21900-19001.1311.13
31785-17851.0621.06
42582-25821.5361.54
52770-27701.6481.65
62228-22281.3261.33
20min13926-39262.3362.0914.222.342.0914.25
23040-30401.8091.81
33043-30431.8111.81
43794-37942.2582.26
54126-41262.4552.46
63098-30981.8431.85
30min13896-38962.3182.7911.312.322.7911.28
24353-43532.5902.60
34801-48012.8572.86
45475-54753.2583.26
54855-48552.8892.90
64724-47242.8112.82
45min15615-56153.3413.635.483.353.645.52
26071-60713.6133.62
35816-58163.4613.47
46494-64943.8643.88
56242-62423.7143.73
66356-63563.7823.79
60min17347-73474.3724.145.184.394.165.23
26787-67874.0394.05
36450-64503.8383.85
47269-72694.3254.34
57190-71904.2784.30
66712-67123.9944.01
极限17734-77344.6024.494.814.634.524.88
27046-70464.1934.21
37631-76314.5414.56
47982-79824.7504.78
57747-77474.6104.63
67179-71794.2724.29
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(%)99.7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%
112.204670094671304671184662464671724669350.09
212.164644764651774648260.11
单位质量响应值RSD%判断
38273.3638225.820.09数据可信
供试品溶液-519819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%
5min1182787-18278734.30438.2414.5234.3038.2414.52
2219182-21918241.13441.13
3176869-17686933.19333.19
4244401-24440145.86745.87
5174267-17426732.70532.71
6224987-22498742.22442.22
10min1336216-33621663.09963.087.9863.1663.157.98
2317652-31765259.61559.68
3348823-34882365.46565.52
4382333-38233371.75371.83
5307754-30775457.75757.81
6324001-32400160.80660.88
15min1408790-40879076.71975.255.9676.8875.415.95
2388286-38828672.87173.04
3422434-42243479.27979.44
4431895-43189581.05581.25
5371222-37122269.66869.82
6383010-38301071.88172.05
20min1449967-44996784.44782.454.7284.7482.754.72
2434102-43410281.46981.76
3464409-46440987.15787.45
4455268-45526885.44185.77
5411335-41133577.19677.46
6420973-42097379.00579.30
30min1486073-48607391.22390.123.5291.6590.553.51
2484115-48411590.85591.28
3502395-50239594.28694.73
4487004-48700491.39791.87
5466914-46691487.62788.02
6454593-45459385.31585.74
45min1495472-49547292.98793.552.8493.5794.132.84
2500865-50086593.99994.58
3514001-51400196.46497.06
4501618-50161894.14094.77
5506347-50634795.02795.57
6472517-47251788.67989.24
60min1501279-50127994.07695.202.8994.8195.932.88
2512573-51257396.19696.93
3519483-51948397.49398.25
4508763-50876395.48196.26
5520368-52036897.65998.36
6481052-48105290.28090.99
极限1510210-51021095.75297.721.5196.6598.611.48
2523932-52393298.32899.22
3522034-52203497.97298.89
4513521-51352196.37497.32
5532162-53216299.872100.73
6522239-52223998.01098.87
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(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)8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%
116.351542541543671541851543951543981543200.07
216.311537011539521538260.12
单位质量响应值RSD%判断
9438.539431.390.06数据可信
供试品溶液-519819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%
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
10min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
15min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
20min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
30min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
45min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
60min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
极限1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
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(%)99.7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%
112.204649974645654647234645994647754647320.04
212.164623284632364627820.14
单位质量响应值RSD%判断
38092.7938057.730.07数据可信
供试品溶液-519819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%
5min1228587-22858743.09646.5815.1143.1046.5815.11
2294876-29487655.59455.59
3235500-23550044.39944.40
4281792-28179253.12753.13
5249340-24934047.00947.01
6192376-19237636.26936.27
10min1373907-37390770.49374.5410.8170.5774.6210.81
2442716-44271683.46683.56
3381445-38144571.91571.99
4449712-44971284.78584.87
5385528-38552872.68472.76
6338994-33899463.91163.97
15min1448909-44890984.63485.638.5584.8285.838.55
2487647-48764791.93792.17
3450595-45059584.95285.15
4499402-49940294.15394.38
5450003-45000384.84085.04
6388599-38859973.26373.43
20min1492551-49255192.86291.316.0793.1991.666.09
2505154-50515495.23895.62
3469859-46985988.58388.92
4517204-51720497.50997.90
5487003-48700391.81692.16
6434146-43414681.85082.14
30min1508000-50800095.77495.812.7796.2696.302.80
2517779-51777997.61898.16
3493601-49360193.06093.54
4525383-52538399.05199.60
5514586-51458697.01697.51
6489651-48965192.31592.74
45min1516755-51675597.42597.941.1698.0798.601.20
2522960-52296098.59599.30
3519565-51956597.95598.59
4528008-52800899.546100.26
5519442-51944297.93198.59
6510175-51017596.18496.76
60min1516477-51647797.37298.051.0898.1898.881.12
2523027-52302798.60799.48
3521918-52191898.39899.20
4528353-52835399.611100.49
5518464-51846497.74798.57
6512343-51234396.59397.33
极限1515658-51565897.21898.071.3198.1999.061.34
2523631-52363198.72199.76
3523201-52320198.64099.61
4529861-52986199.896100.94
5518176-51817697.69398.67
6510657-51065796.27597.18
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(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)8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%
116.351537061539131535811536971538091537410.09
216.311534961533801534380.06
单位质量响应值RSD%判断
9403.129407.600.04数据可信
供试品溶液-519819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%
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
10min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
15min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
20min1-0.0000.00-0.000.00-
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