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%
112.114594634592924592724591724592264592850.03
212.104579964579354579660.01
单位质量响应值RSD%判断
37926.0937848.430.15数据可信
供试品溶液-24070802批-氢氯噻嗪-pH6.8(内含0.35%吐温20)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1335290-33529063.52761.605.7863.5361.605.79
2326362-32636261.83561.84
3344915-34491565.35065.35
4339416-33941664.30864.31
5298647-29864756.58456.58
6306067-30606757.99057.99
10min1463225-46322587.76681.664.2487.8781.764.24
2423350-42335080.21180.31
3439265-43926583.22683.34
4429396-42939681.35781.46
5417601-41760179.12279.22
6413194-41319478.28778.38
15min1471417-47141789.31884.603.5489.5784.843.54
2440048-44004883.37583.61
3458562-45856286.88387.13
4445621-44562184.43184.67
5432239-43223981.89582.12
6431149-43114981.68981.92
20min1475269-47526990.04885.833.3190.4586.213.32
2446768-44676884.64885.02
3465454-46545488.18888.58
4453952-45395286.00986.39
5439189-43918983.21283.57
6437474-43747482.88783.25
30min1481451-48145191.21987.562.9091.7788.082.91
2457755-45775586.73087.25
3472844-47284489.58990.13
4464285-46428587.96788.49
5448728-44872885.01985.52
6447830-44783084.84985.35
45min1487659-48765992.39689.642.3693.1090.302.37
2471598-47159889.35390.01
3482342-48234291.38892.08
4475742-47574290.13890.81
5462013-46201387.53688.18
6459218-45921887.00787.65
60min1490947-49094793.01990.861.7993.8891.681.80
2478969-47896990.74991.56
3485062-48506291.90492.74
4482663-48266391.44992.27
5471584-47158489.35090.14
6468095-46809588.68989.48
极限1526483-52648399.751100.721.06100.76101.691.06
2536619-536619101.672102.63
3538099-538099101.952102.95
4531931-531931100.784101.76
5532649-532649100.920101.86
6523692-52369299.223100.16
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%
116.103110683109153112933111443115393111920.08
216.143115193113053114120.05
单位质量响应值RSD%判断
19328.7019294.420.13数据可信
供试品溶液-24070802批-坎地沙坦酯-pH6.8(内含0.35%吐温20)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1144438-14443841.98741.692.9541.9941.692.95
2146602-14660242.61642.62
3143240-14324041.63941.64
4148881-14888143.27943.28
5137463-13746339.96039.96
6139824-13982440.64640.65
10min1246441-24644171.63969.302.2871.7169.362.28
2241905-24190570.32070.39
3232675-23267567.63767.71
4237682-23768269.09369.16
5239200-23920069.53469.60
6232387-23238767.55467.62
15min1281750-28175081.90379.631.7282.0979.821.71
2276701-27670180.43580.62
3269853-26985378.44578.63
4272623-27262379.25079.44
5273505-27350579.50679.69
6269189-26918978.25278.43
20min1301270-30127087.57785.191.5187.9085.511.51
2294594-29459485.63785.96
3290931-29093184.57284.88
4291428-29142884.71685.04
5291292-29129284.67784.99
6288884-28888483.97784.29
30min1320377-32037793.13290.751.4893.6091.201.47
2313104-31310491.01791.48
3312101-31210190.72691.18
4311577-31157790.57491.03
5308613-30861389.71290.17
6307265-30726589.32089.77
45min1329086-32908695.66393.551.3896.2994.161.38
2320908-32090893.28693.90
3323798-32379894.12694.73
4322338-32233893.70294.31
5318101-31810192.47093.08
6316636-31663692.04492.64
60min1330901-33090196.19193.971.4696.9894.741.46
2321307-32130793.40294.17
3324648-32464894.37395.14
4325315-32531594.56795.33
5319437-31943792.85893.62
6317958-31795892.42893.18
极限1335994-33599497.67198.410.8598.6299.340.84
2341596-34159699.300100.23
3340869-34086999.089100.01
4340214-34021498.89899.82
5338035-33803598.26599.18
6334520-33452097.24398.15
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%
112.114582224581154582914581804581524581920.02
212.104574924575164575040.01
单位质量响应值RSD%判断
37835.8437810.250.05数据可信
供试品溶液-24070803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%
5min1263858-26385850.07749.857.2050.0849.857.20
2236185-23618544.82544.83
3250345-25034547.51347.51
4288042-28804254.66754.67
5279093-27909352.96952.97
6258519-25851949.06449.06
10min1377388-37738871.62469.565.0171.7169.645.01
2346214-34621465.70865.78
3347984-34798466.04466.12
4386670-38667073.38673.48
5383990-38399072.87772.97
6356750-35675067.70767.79
15min1412198-41219878.23177.772.4378.4377.972.44
2398780-39878075.68475.87
3398111-39811175.55775.75
4421711-42171180.03680.25
5419072-41907279.53579.75
6408818-40881877.58977.78
20min1424396-42439680.54681.581.3580.8881.911.35
2426895-42689581.02081.33
3423164-42316480.31280.63
4434333-43433382.43282.78
5433055-43305582.18982.53
6437180-43718082.97283.30
30min1442141-44214183.91485.801.5484.3886.261.53
2454236-45423686.20986.65
3449721-44972185.35285.80
4450363-45036385.47485.96
5452560-45256085.89186.37
6463460-46346087.96088.42
45min1460874-46087487.46989.321.5288.0889.931.51
2476785-47678590.48991.08
3465725-46572588.39088.98
4467523-46752388.73189.36
5473248-47324889.81790.44
6479697-47969791.04191.65
60min1473358-47335889.83891.751.6690.5992.511.64
2493450-49345093.65194.39
3478729-47872990.85891.60
4479434-47943490.99191.77
5483400-48340091.74492.52
6492305-49230593.43494.19
极限1527983-527983100.20599.231.19101.11100.141.18
2526782-52678299.977100.87
3511120-51112097.00597.90
4525098-52509899.658100.58
5524831-52483199.607100.53
6521272-52127298.93299.85
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%
116.103116903115563120843117863119123118060.07
216.143115893117943116920.05
单位质量响应值RSD%判断
19366.8319311.770.21数据可信
供试品溶液-24070803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%
5min1120133-12013334.87234.848.0034.8734.848.00
2107523-10752331.21131.21
3114589-11458933.26333.26
4133279-13327938.68838.69
5128960-12896037.43437.43
6115634-11563433.56633.57
10min1216793-21679362.93060.566.9862.9960.626.98
2192868-19286855.98556.04
3194892-19489256.57356.63
4227516-22751666.04366.11
5219704-21970463.77563.84
6199890-19989058.02458.08
15min1262901-26290176.31474.494.5076.4874.654.51
2245233-24523371.18671.33
3243860-24386070.78770.94
4272569-27256979.12179.30
5263789-26378976.57276.74
6251418-25141872.98173.13
20min1284514-28451482.58882.402.4682.8882.682.47
2279398-27939881.10381.37
3273229-27322979.31279.58
4293847-29384785.29785.60
5286267-28626783.09783.39
6285895-28589582.98983.26
30min1306921-30692189.09290.291.3989.5290.711.39
2312296-31229690.65291.05
3306247-30624788.89789.30
4313952-31395291.13391.58
5309473-30947389.83390.27
6317423-31742392.14192.55
45min1318443-31844392.43793.961.4893.0194.531.47
2329585-32958595.67196.22
3319969-31996992.88093.43
4322753-32275393.68894.29
5321855-32185593.42794.01
6329495-32949595.64596.21
60min1320923-32092393.15794.721.6293.8995.451.60
2333739-33373996.87797.59
3323087-32308793.78594.49
4324447-32444794.18094.94
5323652-32365293.94994.69
6332059-33205996.38997.11
极限1339165-33916598.45297.501.3399.3498.391.33
2337993-33799398.11298.98
3327049-32704994.93595.79
4338029-33802998.12299.04
5337012-33701297.82798.72
6336143-33614397.57598.46
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%
112.114564894564584563904565014561744564020.03
212.104562854561794562320.02
单位质量响应值RSD%判断
37688.0337705.120.04数据可信
供试品溶液-24070804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%
5min1250941-25094147.78653.7114.2347.7953.7114.23
2325257-32525761.93761.94
3253901-25390148.34948.35
4290117-29011755.24655.25
5239576-23957645.62145.62
6332538-33253863.32463.32
10min1429730-42973081.83279.387.6281.9179.487.62
2433464-43346482.54382.65
3381907-38190772.72572.81
4412484-41248478.54878.64
5381185-38118572.58772.66
6462505-46250588.07388.18
15min1474595-47459590.37586.764.4290.5986.984.43
2445820-44582084.89685.14
3437921-43792183.39183.59
4453276-45327686.31586.54
5436653-43665383.15083.35
6485495-48549592.45192.70
20min1483436-48343692.05989.553.5792.4389.923.57
2450901-45090185.86386.25
3460012-46001287.59887.94
4467676-46767689.05889.42
5463034-46303488.17488.51
6496557-49655794.55794.96
30min1493676-49367694.00991.462.9194.5391.982.91
2458994-45899487.40487.93
3474903-47490390.43490.92
4481261-48126191.64592.16
5475625-47562590.57191.05
6497369-49736994.71295.28
45min1505179-50517996.19993.842.7396.8894.512.73
2468828-46882889.27789.95
3492369-49236993.76094.40
4496113-49611394.47395.14
5489072-48907293.13293.77
6505120-50512096.18896.91
60min1512753-51275397.64195.472.7398.4896.302.72
2475032-47503290.45891.28
3504885-50488596.14396.94
4507491-50749196.63997.46
5499283-49928395.07695.87
6508818-50881896.89297.77
极限1526246-526246100.21199.741.35101.21100.721.36
2514108-51410897.89998.87
3527150-527150100.383101.34
4520203-52020399.060100.05
5520432-52043299.104100.05
6534379-534379101.760102.80
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%
116.103110063107743110163111443107713109420.06
216.143112203111213111700.03
单位质量响应值RSD%判断
19313.1719279.430.13数据可信
供试品溶液-24070804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%
5min1118285-11828534.41238.4213.3434.4138.4213.33
2152079-15207944.24344.24
3118482-11848234.46934.47
4133652-13365238.88338.88
5115464-11546433.59133.59
6154343-15434344.90244.90
10min1238232-23823269.30768.928.0369.3668.988.03
2253841-25384173.84873.92
3214003-21400362.25962.32
4235960-23596068.64668.71
5217548-21754863.29063.35
6261803-26180376.16576.24
15min1291816-29181684.89683.614.1985.0783.794.19
2288765-28876584.00984.21
3273207-27320779.48279.64
4286458-28645883.33783.52
5276974-27697480.57880.74
6307133-30713389.35289.55
20min1318132-31813292.55291.392.9192.8791.712.92
2305371-30537188.84089.18
3306773-30677389.24889.54
4313713-31371391.26791.58
5310695-31069590.38990.68
6330193-33019396.06196.41
30min1340693-34069399.11697.642.2599.5898.112.24
2322837-32283793.92194.41
3332889-33288996.84597.29
4337148-33714898.08498.55
5335323-33532397.55398.00
6344818-344818100.316100.83
45min1350427-350427101.948100.272.24102.58100.912.23
2330179-33017996.05796.70
3345916-345916100.635101.24
4346129-346129100.697101.33
5343635-34363599.972100.58
6351744-351744102.331103.01
60min1350950-350950102.100100.512.07102.90101.312.06
2331732-33173296.50997.31
3347719-347719101.160101.93
4347608-347608101.127101.93
5344418-344418100.199100.98
6350453-350453101.955102.80
极限1351003-351003102.115101.271.30103.09102.241.31
2342041-34204199.508100.47
3348642-348642101.428102.37
4346208-346208100.720101.69
5345677-345677100.566101.51
6354965-354965103.268104.29
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(%)99.70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%
112.114562464560734560164559644558404560280.04
212.104559114558594558850.01
单位质量响应值RSD%判断
37657.1437676.450.04数据可信
供试品溶液-加速3月24032701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%
5min1296888-29688856.58053.548.7656.5853.548.76
2265276-26527650.55550.56
3282974-28297453.92853.93
4311878-31187859.43759.44
5286724-28672454.64354.64
6241853-24185346.09146.09
10min1378106-37810672.05873.685.3672.1573.765.36
2361339-36133968.86368.95
3391552-39155274.62174.71
4423365-42336580.68380.78
5386399-38639973.63973.73
6378828-37882872.19672.27
15min1413701-41370178.84281.063.7879.0681.283.78
2406483-40648377.46677.67
3429363-42936381.82682.04
4453132-45313286.35686.59
5422417-42241780.50380.72
6426988-42698881.37481.57
20min1431384-43138482.21284.313.2182.5684.663.21
2425425-42542581.07681.40
3446910-44691085.17085.52
4466051-46605188.81889.20
5439731-43973183.80284.15
6444997-44499784.80685.14
30min1455127-45512786.73687.962.2787.2288.452.28
2447613-44761385.30485.77
3467589-46758989.11189.60
4477870-47787091.07191.60
5458711-45871187.41987.91
6462352-46235288.11388.59
45min1474693-47469390.46591.591.5391.0992.221.55
2471171-47117189.79490.40
3486319-48631992.68193.32
4491103-49110393.59394.27
5479098-47909891.30591.94
6481210-48121091.70792.33
60min1488226-48822693.04494.191.1393.8294.971.15
2487558-48755892.91793.67
3500178-50017895.32296.12
4500429-50042995.37096.20
5493670-49367094.08294.87
6495293-49529394.39195.16
极限1507563-50756396.73097.540.6997.6698.490.70
2508503-50850396.90997.82
3514363-51436398.02598.98
4516810-51681098.49299.48
5511655-51165597.50998.45
6512150-51215097.60498.53
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%
116.103112573109003107303113103112263110850.09
216.143114593111993113290.06
单位质量响应值RSD%判断
19322.0519289.280.13数据可信
供试品溶液-加速3月24032701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%
5min1110898-11089832.24730.498.4332.2530.498.42
2100369-10036929.18629.19
3105560-10556030.69530.70
4114457-11445733.28233.28
5108096-10809631.43231.43
689689-8968926.08026.08
10min1191971-19197155.82257.034.5355.8857.084.52
2187444-18744454.50554.55
3196433-19643357.11957.17
4211873-21187361.60961.66
5199418-19941857.98758.04
6189680-18968055.15655.20
15min1239945-23994569.77272.123.6269.9272.273.62
2238402-23840269.32369.46
3246947-24694771.80871.95
4263384-26338476.58876.75
5250030-25003072.70472.85
6249500-24950072.55072.69
20min1269566-26956678.38581.093.5278.6581.363.52
2268027-26802777.93878.19
3276342-27634280.35580.62
4294050-29405085.50585.79
5280176-28017681.47081.74
6285095-28509582.90183.16
30min1303118-30311888.14190.572.8188.5490.972.81
2301359-30135987.63088.01
3310382-31038290.25490.65
4323936-32393694.19594.62
5311315-31131590.52590.93
6318749-31874992.68793.08
45min1323972-32397294.20596.041.7594.7596.591.75
2323484-32348494.06494.59
3331063-33106396.26796.82
4337755-33775598.21398.80
5330295-33029596.04496.60
6335070-33507097.43397.98
60min1330624-33062496.14097.721.2196.8498.441.22
2331725-33172596.46097.15
3338882-33888298.54199.25
4340104-34010498.89699.65
5336022-33602297.70998.43
6339068-33906898.59599.31
极限1336513-33651397.85298.210.7898.7199.090.79
2334614-33461497.30098.15
3342062-34206299.466100.34
4339194-33919498.63299.55
5336146-33614697.74598.63
6337979-33797998.27899.15
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