氢氯噻嗪缬沙坦片项目信息
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H220807-2对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.1对照品水分(%)0对照品稀释倍数2000
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%
114.022573022572672576252573672571032573330.08
214.082573122573292573200.01
单位质量响应值RSD%判断
18354.7118275.570.31数据可信
供试品溶液-24120901批-氢氯噻嗪-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1146821-14682128.59929.9810.7228.6029.9810.71
2133606-13360626.02526.03
3172660-17266033.63333.63
4166039-16603932.34332.34
5138188-13818826.91826.92
6166191-16619132.37232.37
10min1257695-25769550.19750.544.4950.2450.594.49
2243157-24315747.36547.41
3272524-27252453.08553.14
4257767-25776750.21150.26
5252530-25253049.19049.24
6273106-27310653.19853.25
15min1321477-32147762.62164.324.9662.7564.454.97
2304935-30493559.39859.52
3339564-33956466.14466.29
4345488-34548867.29867.44
5323445-32344563.00463.13
6346279-34627967.45267.59
20min1364102-36410270.92472.554.8971.1672.794.89
2345127-34512767.22767.45
3379164-37916473.85874.11
4388385-38838575.65475.90
5363858-36385870.87671.11
6394110-39411076.76977.02
30min1418155-41815581.45382.343.5181.8182.713.51
2403674-40367478.63278.97
3426190-42619083.01883.40
4436265-43626584.98085.36
5410284-41028479.91980.27
6441766-44176686.05286.43
45min1465289-46528990.63490.512.3791.1291.012.38
2456502-45650288.92289.39
3469156-46915691.38791.90
4472733-47273392.08492.60
5447263-44726387.12387.61
6476923-47692392.90093.43
60min1488730-48873095.20094.831.9395.8495.481.94
2486338-48633894.73495.35
3493804-49380496.18896.86
4491260-49126095.69396.36
5468441-46844191.24891.88
6492371-49237195.90996.59
90min1508177-50817798.98898.351.8599.7999.151.84
2512602-51260299.850100.62
3515296-515296100.375101.20
4501706-50170697.72898.56
5489559-48955995.36196.14
6501942-50194297.77498.61
120min1514282-514282100.17799.811.97101.14100.781.95
2524064-524064102.083103.02
3522290-522290101.737102.73
4510570-51057099.454100.45
5497682-49768296.94497.88
6505346-50534698.43799.44
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1517015-517015100.710100.222.28101.84101.362.25
2530471-530471103.331104.44
3523966-523966102.064103.23
4511942-51194299.721100.88
5501279-50127997.64498.75
6502259-50225997.83599.00
氢氯噻嗪缬沙坦片项目信息
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67824040658对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.4对照品水分(%)0对照品稀释倍数200
标示量(mg)80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%
117.916846606846626855776849306844556848570.07
217.886854816856786855800.03
单位质量响应值RSD%判断
38238.8138343.400.20数据可信
供试品溶液-24120901批-缬沙坦-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min177772-7777211.35611.9412.9011.3611.9412.87
268724-6872410.03510.04
391916-9191613.42213.42
490945-9094513.28013.28
571122-7112210.38510.39
690084-9008413.15413.15
10min1154781-15478122.60122.915.7922.6222.935.80
2143675-14367520.97921.00
3167121-16712124.40324.43
4158977-15897723.21423.24
5150635-15063521.99622.01
6166098-16609824.25424.28
15min1216091-21609131.55433.076.7231.6133.136.73
2204498-20449829.86129.91
3235882-23588234.44334.51
4241884-24188435.32035.38
5219927-21992732.11432.17
6240545-24054535.12435.19
20min1269568-26956839.36241.187.1539.4741.297.15
2253127-25312736.96237.06
3289755-28975542.31042.43
4300814-30081443.92544.04
5273224-27322439.89640.00
6305432-30543244.59944.72
30min1349202-34920250.99052.946.1751.1753.126.18
2332892-33289248.60948.77
3363753-36375353.11553.31
4384556-38455656.15356.35
5352975-35297551.54151.72
6391988-39198857.23857.43
45min1439428-43942864.16565.395.3064.4265.665.30
2415792-41579260.71460.96
3447134-44713465.29065.57
4470942-47094268.76769.05
5434198-43419863.40263.66
6479292-47929269.98670.28
60min1498226-49822672.75173.914.9273.1274.294.92
2472891-47289169.05169.40
3505597-50559773.82774.22
4530255-53025577.42877.83
5490706-49070671.65372.02
6539374-53937478.75979.17
90min1575053-57505383.96984.373.8384.4684.883.84
2545322-54532279.62880.09
3581059-58105984.84685.36
4592214-59221486.47587.01
5564211-56421182.38682.87
6609075-60907588.93789.48
120min1621585-62158590.76490.943.1991.3991.583.20
2595773-59577386.99587.59
3628369-62836991.75492.41
4641495-64149593.67194.35
5604150-60415088.21888.84
6645301-64530194.22794.91
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1670551-67055197.91497.141.3498.6997.941.34
2664758-66475897.06897.81
3671311-67131198.02598.83
4671377-67137798.03498.86
5648249-64824994.65795.43
6665386-66538697.16098.00
氢氯噻嗪缬沙坦片项目信息
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H220807-2对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.1对照品水分(%)0对照品稀释倍数2000
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%
114.022574622575402573862571242568792572780.11
214.082588992589842589420.03
单位质量响应值RSD%判断
18350.7818390.770.16数据可信
供试品溶液-24121901批-氢氯噻嗪-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1192383-19238337.36138.263.7537.3638.263.75
2201893-20189339.20839.21
3209359-20935940.65840.66
4189086-18908636.72036.72
5194761-19476137.82337.82
6194449-19444937.76237.76
10min1287525-28752555.83757.392.8555.9057.462.85
2298480-29848057.96558.03
3311151-31115160.42660.49
4292334-29233456.77156.83
5291377-29137756.58556.65
6292370-29237056.77856.84
15min1347554-34755467.49568.172.6167.6568.332.61
2358032-35803269.53069.69
3365381-36538170.95771.13
4344307-34430766.86467.02
5340822-34082266.18866.34
6350157-35015768.00068.16
20min1387985-38798575.34775.453.0675.6175.723.06
2396609-39660977.02177.30
3405982-40598278.84279.13
4379473-37947373.69473.96
5372575-37257572.35472.62
6388572-38857275.46175.73
30min1438950-43895085.24484.872.8085.6485.262.80
2437992-43799285.05885.46
3457514-45751488.84989.27
4435843-43584384.64185.03
5419910-41991081.54781.93
6431855-43185583.86684.26
45min1475862-47586292.41292.202.8792.9592.742.87
2470439-47043991.35991.91
3497629-49762996.64097.21
4481296-48129693.46894.00
5462629-46262989.84390.37
6460833-46083389.49490.03
60min1492836-49283695.70995.583.5096.4096.283.49
2483021-48302193.80394.50
3519857-519857100.956101.68
4503463-50346397.77398.46
5481327-48132793.47494.15
6472599-47259991.77992.46
90min1508944-50894498.83798.554.0799.6999.404.05
2493019-49301995.74496.60
3539135-539135104.700105.60
4522821-522821101.532102.38
5497290-49729096.57497.40
6483590-48359093.91394.75
120min1515058-515058100.02499.394.45101.04100.414.43
2495735-49573596.27297.29
3547612-547612106.346107.42
4525991-525991102.147103.17
5501688-50168897.42898.42
6484709-48470994.13095.13
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1517062-517062100.41399.834.43101.59101.014.41
2498423-49842396.79497.97
3550275-550275106.863108.11
4528062-528062102.550103.74
5502679-50267997.62098.77
6487735-48773594.71895.87
氢氯噻嗪缬沙坦片项目信息
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67824040658对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.4对照品水分(%)0对照品稀释倍数200
标示量(mg)80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%
117.916863096860166854996855346839676854650.14
217.886919466918956919200.01
单位质量响应值RSD%判断
38272.7538697.990.79数据可信
供试品溶液-24121901批-缬沙坦-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1119597-11959717.37617.885.0417.3817.885.05
2121566-12156617.66217.66
3131785-13178519.14719.15
4119492-11949217.36117.36
5129587-12958718.82718.83
6116276-11627616.89316.89
10min1203997-20399729.63831.054.3629.6731.084.36
2207278-20727830.11530.14
3226519-22651932.91032.94
4213077-21307730.95730.99
5223563-22356332.48132.51
6207757-20775730.18430.21
15min1277708-27770840.34741.382.5540.4341.462.55
2283244-28324441.15241.23
3295747-29574742.96843.05
4278922-27892240.52440.60
5291561-29156142.36042.45
6281650-28165040.92041.00
20min1338054-33805449.11549.902.1549.2650.062.14
2346799-34679950.38550.53
3352138-35213851.16151.32
4332153-33215348.25748.41
5343198-34319849.86250.02
6348618-34861850.65050.80
30min1433344-43334462.95963.111.2463.1963.351.24
2431145-43114562.64062.87
3439353-43935363.83264.08
4431313-43131362.66462.89
5428763-42876362.29462.53
6442535-44253564.29564.53
45min1527121-52712176.58476.810.9676.9277.150.95
2526341-52634176.47076.81
3522842-52284275.96276.31
4535592-53559277.81578.15
5525845-52584576.39876.74
6534180-53418077.60977.95
60min1575841-57584183.66284.991.4384.1285.461.43
2582960-58296084.69685.16
3577420-57742083.89284.37
4598840-59884087.00487.47
5587868-58786885.41085.88
6586878-58687885.26685.73
90min1646889-64688993.98594.191.6394.5894.801.62
2640601-64060193.07193.68
3639904-63990492.97093.59
4667012-66701296.90897.52
5653566-65356694.95595.57
6641709-64170993.23293.84
120min1675612-67561298.15897.971.8698.9198.741.85
2662167-66216796.20496.96
3668139-66813997.07297.84
4694761-694761100.940101.71
5681869-68186999.06799.84
6663476-66347696.39497.16
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1689535-689535100.18099.802.32101.10100.732.30
2668422-66842297.11398.03
3685878-68587899.649100.58
4709154-709154103.031103.97
5698414-698414101.470102.41
6669984-66998497.34098.27
氢氯噻嗪缬沙坦片项目信息
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H220807-2对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.1对照品水分(%)0对照品稀释倍数2000
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%
114.022576482577972575572577382577692577020.04
214.082597682600502599090.08
单位质量响应值RSD%判断
18381.0318459.450.31数据可信
供试品溶液-24121902批-氢氯噻嗪-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1327968-32796863.52165.023.9063.5265.023.90
2338124-33812465.48865.49
3322104-32210462.38562.38
4327028-32702863.33963.34
5341035-34103566.05166.05
6358057-35805769.34869.35
10min1424608-42460882.23882.013.1982.3482.123.19
2422898-42289881.90782.02
3407525-40752578.92979.03
4414164-41416480.21580.32
5424071-42407182.13482.24
6447285-44728586.63086.75
15min1458979-45897988.89588.672.5589.1488.912.55
2459448-45944888.98689.23
3443057-44305785.81186.05
4452375-45237587.61687.85
5454717-45471788.06988.32
6478222-47822292.62292.88
20min1473360-47336091.68091.622.3092.0792.022.30
2475805-47580592.15492.55
3458321-45832188.76789.15
4469837-46983790.99891.38
5469469-46946990.92691.32
6491577-49157795.20895.62
30min1485213-48521393.97693.982.0594.5294.522.06
2488477-48847794.60895.16
3470467-47046791.12091.65
4484046-48404693.75094.29
5481921-48192193.33893.88
6501150-50115097.06297.64
45min1492626-49262695.41195.241.9196.1195.951.91
2494867-49486795.84596.55
3477456-47745692.47393.15
4490465-49046594.99395.69
5488835-48883594.67795.38
6506339-50633998.06798.80
60min1494767-49476795.82695.771.9796.6996.631.97
2499169-49916996.67997.54
3479307-47930792.83293.66
4494034-49403495.68496.54
5490828-49082895.06395.92
6508758-50875898.53699.43
90min1499277-49927796.70096.491.8397.7297.511.84
2504102-50410297.63498.66
3483933-48393393.72894.71
4498929-49892996.63297.64
5492715-49271595.42996.45
6510235-51023598.82299.88
120min1502113-50211397.24997.021.8498.4398.201.84
2505396-50539697.88599.07
3485565-48556594.04495.19
4501853-50185397.19898.37
5497516-49751696.35897.53
6513197-51319799.396100.62
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1507866-50786698.36398.732.2499.71100.072.24
2518319-518319100.388101.74
3492507-49250795.38896.69
4513346-51334699.424100.76
5502342-50234297.29398.63
6524108-524108101.509102.90
氢氯噻嗪缬沙坦片项目信息
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67824040658对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.4对照品水分(%)0对照品稀释倍数200
标示量(mg)80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%
117.916860936865576861896863106861886862670.03
217.886932686939426936050.07
单位质量响应值RSD%判断
38317.5338792.230.88数据可信
供试品溶液-24121902批-缬沙坦-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1236501-23650134.29936.076.2134.3036.076.22
2254817-25481736.95536.96
3234784-23478434.05034.05
4235281-23528134.12234.12
5259546-25954637.64137.64
6271387-27138739.35839.36
10min1370878-37087853.78754.437.7253.8454.487.71
2367663-36766353.32153.38
3349893-34989350.74450.80
4349675-34967550.71250.77
5386519-38651956.05556.12
6427083-42708361.93862.00
15min1464931-46493167.42767.177.3467.5767.327.33
2450925-45092565.39665.55
3432988-43298862.79562.94
4436187-43618763.25863.40
5467660-46766067.82367.98
6526071-52607176.29476.46
20min1534813-53481377.56276.606.8677.8276.866.86
2514670-51467074.64174.90
3495698-49569871.88972.14
4499443-49944372.43272.68
5529366-52936676.77277.04
6594901-59490186.27686.57
30min1612714-61271488.85987.315.0089.2587.705.00
2588456-58845685.34185.73
3574563-57456383.32783.69
4576551-57655183.61583.98
5604997-60499787.74088.14
6654995-65499594.99195.43
45min1659445-65944595.63794.292.9996.1794.823.01
2640939-64093992.95393.48
3631641-63164191.60492.11
4633929-63392991.93692.44
5651600-65160094.49995.04
6683388-68338899.10999.71
60min1673125-67312597.62196.902.0698.3297.592.08
2663052-66305296.16096.84
3654741-65474194.95595.61
4657513-65751395.35796.02
5667804-66780496.84997.55
6692575-692575100.441101.20
90min1679325-67932598.52097.861.4699.3898.711.49
2671303-67130397.35698.20
3664277-66427796.33797.15
4668069-66806996.88797.71
5673690-67369097.70398.56
6691928-691928100.348101.28
120min1680493-68049398.68998.171.4099.7199.191.43
2672453-67245397.52398.53
3667987-66798796.87697.85
4669644-66964497.11698.10
5677267-67726798.22199.25
6693582-693582100.587101.69
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1671511-67151197.38797.831.5998.5799.011.61
2671406-67140697.37198.54
3667155-66715596.75597.89
4669565-66956597.10498.25
5671561-67156197.39498.58
6696010-696010100.940102.21
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