坎地氢噻片项目信息
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%
112.694891404891894891534891234890344891280.02
212.714865714870694868200.08
单位质量响应值RSD%判断
38544.3738302.120.45数据可信
供试品溶液-2024082821批-氢氯噻嗪-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1445708-44570883.27079.456.3983.2779.456.38
2381586-38158671.29071.29
3428307-42830780.01980.02
4403828-40382875.44675.45
5442414-44241482.65582.65
6449594-44959483.99684.00
10min1517422-51742296.66894.043.3396.8194.183.33
2480059-48005989.68889.81
3491947-49194791.90992.04
4494586-49458692.40292.53
5515048-51504896.22496.36
6521140-52114097.36397.50
15min1525136-52513698.10996.881.9798.4197.171.98
2505433-50543394.42894.70
3511649-51164995.58995.88
4511744-51174495.60795.89
5527290-52729098.51298.81
6530139-53013999.04499.35
20min1525634-52563498.20297.751.6598.6798.201.65
2512299-51229995.71196.14
3519570-51957097.06997.52
4516209-51620996.44196.88
5533029-53302999.584100.05
6532454-53245499.47699.94
30min1526868-52686898.43398.321.3999.0698.931.40
2517288-51728896.64397.23
3527739-52773998.59699.20
4518174-51817496.80997.41
5535700-535700100.083100.71
6531651-53165199.32699.96
45min1527851-52785198.61698.741.3099.4199.521.30
2522309-52230997.58198.33
3530882-53088299.18399.95
4519006-51900696.96497.73
5535705-535705100.084100.88
6535324-535324100.013100.81
60min1525686-52568698.21298.481.3499.1799.421.35
2519118-51911896.98597.89
3532324-53232499.452100.39
4518842-51884296.93397.86
5535232-53523299.995100.96
6531566-53156699.310100.28
极限1544309-544309101.691101.240.57102.81102.350.57
2541252-541252101.120102.19
3546346-546346102.072103.17
4537615-537615100.441101.52
5540989-540989101.071102.20
6540916-540916101.057102.19
坎地氢噻片项目信息
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%
116.343064133067123068163068453069633067500.07
216.283058443061883060160.08
单位质量响应值RSD%判断
18772.9518797.050.10数据可信
供试品溶液-2024082821批-坎地沙坦酯-pH1.2
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
坎地氢噻片项目信息
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%
112.694880874879684878004877484882064879620.04
212.714876364876814876580.01
单位质量响应值RSD%判断
38452.4838368.060.16数据可信
供试品溶液-2024083021批-氢氯噻嗪-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1360793-36079367.42868.126.9267.4368.126.92
2363625-36362567.95767.96
3381891-38189171.37171.37
4390881-39088173.05173.05
5371477-37147769.42469.42
6318470-31847059.51859.52
10min1479440-47944089.60190.884.0089.7190.994.00
2496121-49612192.71992.83
3508813-50881395.09195.21
4495361-49536192.57792.70
5485494-48549490.73390.85
6452381-45238184.54484.64
15min1512166-51216695.71896.462.9095.9896.722.91
2520133-52013397.20697.47
3528875-52887598.84099.12
4523129-52312997.76698.04
5524595-52459598.04098.31
6487788-48778891.16291.40
20min1524115-52411597.95198.721.8698.3799.141.87
2529604-52960498.97699.41
3533828-53382899.766100.21
4531905-53190599.40799.85
5538924-538924100.718101.15
6510909-51090995.48395.87
30min1535405-535405100.061100.670.82100.65101.260.82
2537279-537279100.411101.01
3540667-540667101.044101.65
4536623-536623100.288100.89
5546707-546707102.173102.77
6535403-535403100.060100.61
45min1539652-539652100.854101.480.67101.61102.240.68
2541631-541631101.224101.99
3546925-546925102.214102.99
4541834-541834101.262102.03
5548039-548039102.422103.19
6539860-539860100.893101.61
60min1540186-540186100.954101.560.76101.87102.480.77
2545452-545452101.938102.87
3547549-547549102.330103.28
4542424-542424101.372102.31
5547332-547332102.290103.23
6537492-537492100.451101.34
极限1547359-547359102.295101.960.92103.38103.050.92
2550502-550502102.882103.98
3548253-548253102.462103.58
4542847-542847101.451102.56
5547621-547621102.344103.45
6536789-536789100.319101.37
坎地氢噻片项目信息
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%
116.343073233073783071523068993071813071870.07
216.283059963057843058900.05
单位质量响应值RSD%判断
18799.6918789.310.04数据可信
供试品溶液-2024083021批-坎地沙坦酯-pH1.2
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
坎地氢噻片项目信息
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%
112.694873244874994879844873514874284875170.06
212.714846764843704845230.05
单位质量响应值RSD%判断
38417.4238121.400.55数据可信
供试品溶液-2024090121批-氢氯噻嗪-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1352281-35228166.08068.116.6866.0868.126.68
2346490-34649064.99464.99
3356658-35665866.90166.90
4340640-34064063.89763.90
5405475-40547576.05876.06
6377221-37722170.75870.76
10min1479648-47964889.97291.152.3290.0891.262.32
2487449-48744991.43591.54
3484633-48463390.90791.02
4471887-47188788.51688.62
5486291-48629191.21891.34
6505677-50567794.85494.97
15min1504954-50495494.71896.112.0294.9896.372.02
2527792-52779299.00299.26
3509939-50993995.65395.92
4501680-50168094.10494.36
5507486-50748695.19395.47
6522239-52223997.96198.24
20min1510856-51085695.82597.451.7996.2497.871.78
2535544-535544100.456100.88
3514770-51477096.56096.98
4515621-51562196.71997.13
5514662-51466296.53996.98
6525520-52552098.57699.02
30min1515591-51559196.71498.461.8997.2999.051.88
2542700-542700101.799102.39
3518557-51855797.27097.85
4522442-52244297.99998.57
5520707-52070797.67398.27
6529422-52942299.30899.91
45min1519405-51940597.42999.041.7898.1799.801.78
2545075-545075102.244103.01
3521399-52139997.80398.55
4524840-52484098.44999.18
5525405-52540598.55599.32
6531922-53192299.777100.55
60min1520178-52017897.57499.221.7898.48100.141.78
2545556-545556102.334103.27
3522049-52204997.92598.83
4525573-52557398.58699.49
5526531-52653198.76699.69
6533925-533925100.153101.09
极限1523883-52388398.26999.421.7999.33100.501.78
2546384-546384102.490103.59
3521461-52146197.81598.89
4528539-52853999.142100.21
5524150-52415098.31999.41
6535692-535692100.484101.59
坎地氢噻片项目信息
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%
116.343067703072493070563066273070243069450.09
216.283058423056743057580.04
单位质量响应值RSD%判断
18784.8818781.200.02数据可信
供试品溶液-2024090121批-坎地沙坦酯-pH1.2
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
坎地氢噻片项目信息
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%
112.694846494846894844544844134844124845230.03
212.714831514835264833380.06
单位质量响应值RSD%判断
38181.4838028.170.29数据可信
供试品溶液-516246批-氢氯噻嗪-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1263637-26363749.66645.4613.0349.6745.4613.03
2263310-26331049.60449.60
3193063-19306336.37036.37
4215409-21540940.58040.58
5272204-27220451.28051.28
6240310-24031045.27145.27
10min1433996-43399681.75978.4611.9981.8478.5411.99
2448615-44861584.51384.60
3341894-34189464.40864.47
4381769-38176971.92071.99
5482166-48216690.83390.92
6410512-41051277.33577.41
15min1479593-47959390.34987.299.8690.5787.499.87
2490932-49093292.48592.71
3394139-39413974.25074.42
4425608-42560880.17980.37
5519362-51936297.84198.08
6470356-47035688.60988.81
20min1498350-49835093.88291.507.2094.2591.857.22
2507377-50737795.58395.96
3434138-43413881.78682.08
4453609-45360985.45485.77
5527318-52731899.34099.74
6493510-49351092.97193.32
30min1513698-51369896.77495.883.9497.3096.383.97
2517647-51764797.51898.05
3486329-48632991.61892.05
4482949-48294990.98191.44
5533564-533564100.516101.08
6519586-51958697.88398.39
45min1517658-51765897.52098.331.6698.2198.991.70
2524110-52411098.73599.43
3516347-51634797.27397.85
4512284-51228496.50797.12
5536773-536773101.121101.85
6524620-52462098.83199.50
60min1518221-51822197.62699.101.5698.4899.931.59
2526348-52634899.157100.02
3518033-51803397.59098.33
4525479-52547998.99399.77
5540401-540401101.804102.71
6527953-52795399.459100.29
极限1524661-52466198.839100.041.6799.85101.041.71
2534425-534425100.678101.71
3519473-51947397.86298.77
4530120-53012099.867100.81
5545345-545345102.736103.81
6532219-532219100.263101.26
坎地氢噻片项目信息
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%
116.343062293062393061733061043061353061760.02
216.283054153052943053540.03
单位质量响应值RSD%判断
18737.8218756.390.08数据可信
供试品溶液-516246批-坎地沙坦酯-pH1.2
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
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