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100309-201404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%
111.884609644606694608064607614603494607100.05
211.994591424594314592860.05
单位质量响应值RSD%判断
38780.3038305.750.88数据可信
供试品溶液-24042301-1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%
5min1338406-33840663.02857.1810.9763.0357.1810.97
2323564-32356460.26460.26
3259929-25992948.41248.41
4321160-32116059.81659.82
5268898-26889850.08250.08
6330135-33013561.48861.49
10min1441496-44149682.22977.697.4882.3377.797.48
2435747-43574781.15881.26
3374001-37400169.65869.74
4427860-42786079.68979.79
5381188-38118870.99771.08
6442606-44260682.43682.54
15min1455528-45552884.84282.833.4585.0883.063.47
2454508-45450884.65384.89
3428094-42809479.73379.93
4451744-45174484.13884.37
5422292-42229278.65278.85
6456303-45630384.98785.23
20min1459780-45978085.63485.022.2386.0285.382.25
2463318-46331886.29386.67
3454605-45460584.67185.00
4461264-46126485.91186.28
5436784-43678481.35181.68
6463243-46324386.27986.66
30min1465258-46525886.65587.671.9987.1888.181.98
2475468-47546888.55689.08
3483106-48310689.97990.45
4473188-47318888.13288.65
5455789-45578984.89185.36
6471572-47157287.83188.36
45min1471195-47119587.76090.252.8588.4390.902.82
2492825-49282591.78992.46
3507602-50760294.54195.16
4484520-48452090.24290.91
5473378-47337888.16788.78
6477721-47772188.97689.65
60min1473171-47317188.12991.903.5588.9592.703.51
2504055-50405593.88194.70
3522287-52228797.27698.05
4492806-49280691.78692.60
5484509-48450990.24091.00
6483806-48380690.10990.93
极限1525643-52564397.901100.311.7598.87101.261.72
2538679-538679100.329101.31
3553364-553364103.065104.00
4542313-542313101.006101.97
5539202-539202100.427101.33
6532237-53223799.130100.10
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%
116.193069333069153075093073673073963072240.10
216.163067143069623068380.06
单位质量响应值RSD%判断
18976.1618987.500.05数据可信
供试品溶液-24042301-1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%
5min1129472-12947238.29035.8412.5838.2935.8412.58
2129770-12977038.37938.38
3101807-10180730.10930.11
4133258-13325839.41039.41
5101353-10135329.97429.97
6131385-13138538.85638.86
10min1216756-21675664.10462.858.9564.1762.918.96
2224895-22489566.51166.58
3184152-18415254.46254.51
4227471-22747167.27367.34
5193525-19352557.23457.28
6228230-22823067.49867.56
15min1256312-25631275.80375.295.1675.9775.465.17
2263138-26313877.82178.00
3235576-23557669.67069.81
4264940-26494078.35478.53
5241249-24124971.34871.49
6266338-26633878.76878.94
20min1274587-27458781.20781.532.9881.5081.823.00
2282126-28212683.43783.74
3266439-26643978.79879.05
4282736-28273683.61783.93
5265359-26535978.47878.74
6282845-28284583.65083.96
30min1288809-28880985.41386.961.7785.8587.391.77
2300971-30097189.01089.45
3296518-29651887.69388.08
4295697-29569787.45087.90
5287030-28703084.88785.28
6295218-29521887.30987.76
45min1293714-29371486.86489.142.3787.4489.712.35
2305831-30583190.44791.04
3313220-31322092.63393.17
4300739-30073988.94289.54
5296057-29605787.55788.09
6298926-29892688.40589.00
60min1294739-29473987.16789.922.7787.8990.642.74
2308787-30878791.32292.06
3318384-31838494.16094.85
4302621-30262189.49890.24
5298877-29887788.39189.07
6300851-30085188.97589.72
极限1312487-31248792.41694.351.6893.2895.221.66
2318331-31833194.14495.04
3328200-32820097.06397.91
4320347-32034794.74195.63
5319358-31935894.44895.28
6315336-31533693.25994.15
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100309-201404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%
111.884604294606034607004602984600694604200.06
211.994581984580974581480.02
单位质量响应值RSD%判断
38755.8938210.841.01数据可信
供试品溶液-24042302-1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%
5min1344271-34427164.22157.3214.6964.2257.3214.69
2352156-35215665.69265.69
3288264-28826453.77353.77
4241850-24185045.11545.12
5275742-27574251.43751.44
6341321-34132163.67163.67
10min1439420-43942081.97077.537.9182.0877.637.92
2451935-45193584.30584.41
3405411-40541175.62675.72
4369724-36972468.96969.04
5388234-38823472.42272.51
6439101-43910181.91182.02
15min1464005-46400586.55683.625.4486.8083.855.45
2474174-47417488.45388.70
3443197-44319782.67582.89
4406764-40676475.87976.07
5438850-43885081.86482.07
6462666-46266686.30786.55
20min1471197-47119787.89886.304.1588.2986.674.17
2484652-48465290.40890.81
3460054-46005485.81986.17
4428370-42837079.90980.23
5459407-45940785.69986.04
6472194-47219488.08488.47
30min1482644-48264490.03389.382.8690.5789.892.88
2494057-49405792.16292.71
3477635-47763589.09989.60
4453928-45392884.67785.13
5479610-47961089.46789.95
6487009-48700990.84891.38
45min1494698-49469892.28292.231.6692.9792.881.69
2503043-50304393.83994.54
3495714-49571492.47193.12
4478739-47873989.30589.90
5497358-49735892.77893.41
6496857-49685792.68593.37
60min1503647-50364793.95194.330.9494.7995.140.96
2507879-50787994.74195.60
3507817-50781794.72995.53
4497058-49705892.72293.46
5510303-51030395.19395.98
6507270-50727094.62795.47
极限1532574-53257499.34799.591.22100.34100.561.18
2532698-53269899.370100.39
3538764-538764100.502101.46
4543593-543593101.403102.30
5530514-53051498.96399.91
6524984-52498497.93298.93
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%
116.193080833078643079883073253069293076380.17
216.163065483067483066480.05
单位质量响应值RSD%判断
19001.7318975.740.10数据可信
供试品溶液-24042302-1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%
5min1133957-13395739.60335.6711.8639.6035.6711.86
2129342-12934238.23838.24
3122784-12278436.29936.30
493980-9398027.78427.78
5116874-11687434.55234.55
6126972-12697237.53737.54
10min1225945-22594566.79763.237.2166.8663.287.22
2224541-22454166.38266.45
3216507-21650764.00764.07
4186570-18657055.15755.20
5205476-20547660.74660.80
6224169-22416966.27266.33
15min1268823-26882379.47476.824.7779.6576.984.78
2265580-26558078.51578.69
3263760-26376077.97778.14
4235983-23598369.76569.90
5257225-25722576.04576.20
6267736-26773679.15279.33
20min1287961-28796185.13283.763.5785.4484.053.58
2287727-28772785.06285.37
3288171-28817185.19485.49
4263120-26312077.78878.04
5283556-28355683.82984.11
6289388-28938885.55385.86
30min1305038-30503890.18089.582.3290.6390.012.33
2305225-30522590.23590.68
3307826-30782691.00491.44
4288893-28889385.40785.79
5304722-30472290.08790.51
6306415-30641590.58791.03
45min1310351-31035191.75191.991.3192.3592.571.33
2311422-31142292.06892.66
3316337-31633793.52194.11
4304099-30409989.90390.43
5313469-31346992.67393.25
6311307-31130792.03492.63
60min1311775-31177592.17292.800.9692.9393.540.96
2313644-31364492.72493.48
3319014-31901494.31295.06
4310738-31073891.86592.54
5315544-31554493.28694.02
6312750-31275092.46093.21
极限1317677-31767793.91794.411.0694.8395.301.03
2319215-31921594.37195.28
3323775-32377595.72096.62
4322880-32288095.45596.28
5317509-31750993.86794.75
6315032-31503293.13594.04
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100309-201404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%
111.882277932278322277172277902277722277810.02
211.992270722274412272560.12
单位质量响应值RSD%判断
19173.4818953.790.82数据可信
供试品溶液-24042301-2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%
5min1143675-14367554.10356.928.1754.1056.928.18
2172480-17248064.94964.95
3150395-15039556.63356.63
4154950-15495058.34858.35
5135833-13583351.15051.15
6149658-14965856.35556.36
10min1201175-20117575.75578.124.5075.8478.214.51
2217153-21715381.77281.88
3206731-20673177.84777.94
4213573-21357380.42380.52
5192435-19243572.46472.55
6213646-21364680.45180.54
15min1221135-22113583.27184.823.6183.4985.053.61
2230086-23008686.64286.89
3224629-22462984.58784.81
4231497-23149787.17387.40
5211389-21138979.60179.81
6232820-23282087.67187.90
20min1230553-23055386.81787.872.6987.1788.232.70
2237161-23716189.30689.69
3232264-23226487.46287.83
4238665-23866589.87290.25
5222605-22260583.82584.16
6238790-23879089.91990.29
30min1241128-24112890.80091.912.1191.3092.422.12
2246582-24658292.85393.39
3243728-24372891.77992.29
4248356-24835693.52194.05
5235522-23552288.68989.17
6249120-24912093.80994.33
45min1254534-25453495.84896.101.3996.5096.771.41
2256874-25687496.72997.42
3254665-25466595.89796.56
4259286-25928697.63798.32
5248926-24892693.73694.36
6256993-25699396.77497.45
60min1261625-26162598.51898.841.2099.3399.661.21
2264355-26435599.546100.40
3261941-26194198.63799.46
4266963-266963100.528101.37
5257553-25755396.98597.77
6262420-26242098.81799.66
极限1270584-270584101.892101.560.58102.87102.550.59
2269883-269883101.628102.65
3268704-268704101.184102.17
4271726-271726102.322103.33
5267271-267271100.644101.59
6270045-270045101.689102.69
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%
116.191536751539641539061538361539301538620.08
216.161535041536061535550.05
单位质量响应值RSD%判断
9503.529502.170.02数据可信
供试品溶液-24042301-2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%
5min154944-5494432.45835.717.2032.4635.717.20
267827-6782740.06840.07
360624-6062435.81335.81
461773-6177336.49236.49
557692-5769234.08134.08
659852-5985235.35735.36
10min1102479-10247960.53964.034.2760.5964.094.27
2112796-11279666.63466.70
3107015-10701563.21863.28
4112905-11290566.69866.76
5103782-10378261.30961.37
6111372-11137265.79265.85
15min1126023-12602374.44777.733.7474.6077.903.75
2133700-13370078.98379.16
3129742-12974276.64476.81
4135648-13564880.13380.31
5126496-12649674.72774.89
6137890-13789081.45881.63
20min1138668-13866881.91784.572.8182.2084.872.82
2144632-14463285.44185.75
3141461-14146183.56783.86
4146884-14688486.77187.08
5139102-13910282.17482.46
6148190-14819087.54287.85
30min1150965-15096589.18290.751.7589.6091.191.75
2154314-15431491.16091.61
3153019-15301990.39590.83
4156645-15664592.53792.99
5150329-15032988.80689.23
6156427-15642792.40892.86
45min1156911-15691192.69493.371.0393.2693.961.04
2158165-15816593.43594.04
3157793-15779393.21593.80
4160481-16048194.80395.41
5155879-15587992.08592.65
6159105-15910593.99094.59
60min1157583-15758393.09193.881.0193.8194.621.02
2159012-15901293.93594.69
3159061-15906193.96494.70
4161307-16130795.29196.05
5156766-15676692.60993.33
6159765-15976594.38095.14
极限1159499-15949994.22394.460.7695.1095.360.77
2159600-15960094.28395.20
3160170-16017094.62095.51
4161339-16133995.31096.23
5157923-15792393.29294.17
6160873-16087395.03595.95
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100309-201404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%
111.882270492264962268632270352270372268960.11
211.992266842266272266560.02
单位质量响应值RSD%判断
19098.9918903.750.73数据可信
供试品溶液-24042302-2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%
5min1185137-18513769.94462.579.3269.9462.569.32
2152556-15255657.63557.63
3161238-16123860.91560.91
4185158-18515869.95169.95
5153436-15343657.96757.97
6156141-15614158.98958.99
10min1224773-22477384.91881.822.9285.0381.922.93
2216889-21688981.93982.04
3213682-21368280.72880.83
4223142-22314284.30284.42
5212142-21214280.14680.24
6208781-20878178.87678.97
15min1233871-23387188.35587.291.5888.6187.541.59
2233423-23342388.18688.42
3227825-22782586.07186.31
4234837-23483788.72088.98
5230672-23067287.14687.38
6225752-22575285.28885.52
20min1237974-23797489.90589.601.6890.3189.991.69
2239964-23996490.65791.04
3234888-23488888.73989.12
4242528-24252891.62592.03
5236538-23653889.36289.74
6231128-23112887.31987.69
30min1244332-24433292.30792.961.6392.8693.501.63
2248121-24812193.73894.27
3245097-24509792.59693.12
4252285-25228595.31295.87
5246181-24618193.00693.53
6240345-24034590.80191.32
45min1254493-25449396.14696.961.6196.8597.651.61
2258921-25892197.81998.51
3255831-25583196.65197.33
4262604-26260499.21099.93
5257606-25760697.32298.00
6250473-25047394.62795.30
60min1258522-25852297.66899.191.4398.54100.041.43
2264318-26431899.858100.71
3263025-26302599.369100.21
4267067-267067100.896101.78
5264823-264823100.048100.89
6257570-25757097.30898.13
极限1263352-26335299.493100.851.04100.52101.861.03
2270093-270093102.039103.06
3268055-268055101.269102.28
4267323-267323100.993102.04
5268985-268985101.621102.63
6263818-26381899.669100.66
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%
116.191526361530231529661529351527431528610.11
216.161505841506701506270.05
单位质量响应值RSD%判断
9441.699320.980.91数据可信
供试品溶液-24042302-2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%
5min175578-7557845.22741.857.3145.2341.857.31
262890-6289037.63537.63
369920-6992041.84241.84
476074-7607445.52445.52
567875-6787540.61840.62
667254-6725440.24640.25
10min1120226-12022671.94669.862.6172.0269.932.61
2112409-11240967.26867.33
3115690-11569069.23169.30
4119919-11991971.76271.84
5117393-11739370.25070.32
6114821-11482168.71168.78
15min1138898-13889883.11982.390.8483.3182.580.84
2137456-13745682.25682.43
3136359-13635981.60081.79
4137729-13772982.42082.62
5139100-13910083.24083.43
6136522-13652281.69881.88
20min1147687-14768788.37988.640.8288.7188.970.81
2149640-14964089.54889.86
3147186-14718688.07988.40
4147282-14728288.13788.47
5149694-14969489.58089.90
6147290-14729088.14188.46
30min1154990-15499092.74993.841.1193.2394.311.09
2159358-15935895.36395.82
3157157-15715794.04694.51
4155307-15530792.93993.42
5158176-15817694.65695.13
6155899-15589993.29393.76
45min1158744-15874494.99695.901.2495.6396.531.23
2163328-16332897.73998.36
3160924-16092496.30096.92
4158761-15876195.00695.64
5161483-16148396.63597.27
6158335-15833594.75195.37
60min1158173-15817394.65496.271.4395.4597.061.41
2163843-16384398.04798.83
3161968-16196896.92597.71
4159124-15912495.22396.02
5162760-16276097.39998.19
6159385-15938595.37996.16
极限1159264-15926495.30796.881.2796.2697.831.26
2164640-16464098.52499.47
3162846-16284697.45098.40
4162788-16278897.41698.37
5162083-16208396.99497.95
6159717-15971795.57896.51
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