氢氯噻嗪坎地沙坦酯片项目信息
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%
111.784555794557734557584549544549874554100.09
211.784537894534624536260.06
单位质量响应值RSD%判断
38659.5938508.150.28数据可信
加速6月-供试品溶液-2024082821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%
5min1375158-37515869.79763.069.9569.8063.069.95
2301149-30114956.02856.03
3306948-30694857.10757.11
4322914-32291460.07760.08
5349238-34923864.97564.97
6378329-37832970.38770.39
10min1502893-50289393.56289.905.4593.6890.005.46
2457830-45783085.17885.27
3453616-45361684.39484.49
4471123-47112387.65187.75
5494728-49472892.04392.15
6518979-51897996.55596.67
15min1522673-52267397.24296.592.0497.5196.842.05
2508019-50801994.51694.75
3506489-50648994.23194.47
4521677-52167797.05797.30
5521246-52124696.97697.24
6534905-53490599.51899.80
20min1525673-52567397.80098.021.3898.2398.441.39
2522553-52255397.22097.61
3516184-51618496.03596.43
4533257-53325799.21199.62
5527210-52721098.08698.51
6536247-53624799.767100.21
30min1525326-52532697.73698.730.9098.3399.310.90
2532992-53299299.16299.72
3526285-52628597.91498.47
4536800-53680099.870100.44
5527916-52791698.21798.80
6534624-53462499.465100.08
45min1525772-52577297.81898.850.9498.5899.600.93
2534883-53488399.514100.23
3525889-52588997.84098.56
4536625-53662599.838100.58
5529253-52925398.46699.22
6535548-53554899.637100.41
60min1524627-52462797.60598.740.9598.5399.650.95
2534581-53458199.457100.34
3525111-52511197.69698.57
4536375-53637599.791100.70
5529818-52981898.57199.49
6533854-53385499.322100.26
极限1532820-53282099.13099.520.75100.22100.590.75
2538245-538245100.139101.19
3527920-52792098.21899.26
4535410-53541099.612100.68
5537404-53740499.983101.06
6537673-537673100.033101.14
氢氯噻嗪坎地沙坦酯片项目信息
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%
115.642981292973852976892973862973362975850.12
215.602971742968602970170.08
单位质量响应值RSD%判断
19027.1719039.550.05数据可信
加速6月-供试品溶液-2024082821批-坎地沙坦酯-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%
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
氢氯噻嗪坎地沙坦酯片项目信息
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%
111.784526694523764525884524024525864525240.03
211.784504684505624505150.02
单位质量响应值RSD%判断
38414.6038244.060.32数据可信
加速6月-供试品溶液-2024082821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%
5min1310615-31061558.17360.098.4058.1760.098.40
2344232-34423264.46964.47
3318699-31869959.68759.69
4306235-30623557.35357.35
5359719-35971967.36967.37
6285530-28553053.47553.47
10min1479573-47957389.81689.943.2789.9190.043.27
2498905-49890593.43693.54
3465514-46551487.18387.28
4470341-47034188.08788.18
5499985-49998593.63993.75
6467120-46712087.48487.57
15min1535665-535665100.32198.671.37100.5798.921.37
2535012-535012100.199100.46
3525634-52563498.44298.69
4517595-51759596.93797.18
5525228-52522898.36698.63
6521819-52181997.72897.96
20min1541999-541999101.50799.841.15101.92100.251.15
2538236-538236100.803101.23
3534133-534133100.034100.44
4528880-52888099.05099.45
5526493-52649398.60399.04
6528777-52877799.03199.43
30min1541655-541655101.443100.171.02102.03100.751.01
2539128-539128100.970101.57
3536867-536867100.546101.12
4533045-53304599.830100.40
5526888-52688898.67799.27
6531520-53152099.545100.11
45min1541463-541463101.407100.101.07102.16100.851.07
2538617-538617100.874101.64
3537432-537432100.652101.40
4532594-53259499.746100.48
5526155-52615598.54099.30
6530689-53068999.389100.12
60min1544919-544919102.05499.851.50102.98100.771.49
2537596-537596100.683101.62
3534370-534370100.078100.99
4531081-53108199.462100.36
5521248-52124897.62198.55
6529741-52974199.212100.11
极限1539078-539078100.960100.000.78102.05101.080.77
2536565-536565100.490101.59
3535522-535522100.294101.37
4529530-52953099.172100.24
5528503-52850398.980100.07
6534483-534483100.100101.16
氢氯噻嗪坎地沙坦酯片项目信息
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%
115.642967562966332967072966862968112967190.03
215.602968422969422968920.03
单位质量响应值RSD%判断
18971.8019031.540.23数据可信
加速6月-供试品溶液-2024082821批-坎地沙坦酯-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%
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
氢氯噻嗪坎地沙坦酯片项目信息
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%
111.784505424510684507654506984519824510110.13
211.784495824496764496290.02
单位质量响应值RSD%判断
38286.1638168.850.22数据可信
加速6月-供试品溶液-2024083021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%
5min1305791-30579157.42261.757.9157.4261.747.91
2296159-29615955.61355.61
3369056-36905669.30269.30
4337060-33706063.29463.29
5338360-33836063.53863.54
6326482-32648261.30761.31
10min1446900-44690083.92088.884.4284.0288.994.42
2452856-45285685.03885.13
3498740-49874093.65493.77
4473550-47355088.92489.03
5493754-49375492.71892.82
6474254-47425489.05689.16
15min1513555-51355596.43697.192.0896.6797.442.09
2499190-49919093.73993.97
3531229-53122999.755100.03
4521400-52140097.90998.16
5522176-52217698.05598.32
6517743-51774397.22397.47
20min1529782-52978299.48399.370.9799.8899.780.97
2522843-52284398.18098.57
3537291-537291100.893101.33
4531871-53187199.876100.29
5525459-52545998.67199.10
6527816-52781699.11499.53
30min1531367-53136799.78199.850.86100.34100.430.87
2529722-52972299.472100.03
3539509-539509101.310101.92
4533320-533320100.148100.73
5525851-52585198.74599.33
6530646-53064699.645100.22
45min1532016-53201699.903100.000.93100.63100.750.93
2530601-53060199.637100.36
3540963-540963101.583102.36
4533660-533660100.211100.96
5525936-52593698.76199.51
6532113-53211399.921100.66
60min1530931-53093199.69999.730.97100.59100.640.97
2529213-52921399.376100.26
3540217-540217101.443102.39
4531625-53162599.829100.75
5524580-52458098.50699.42
6530107-53010799.544100.45
极限1531170-53117099.74499.560.99100.80100.640.99
2528105-52810599.168100.22
3539537-539537101.315102.43
4530632-53063299.643100.73
5524101-52410198.41699.50
6527710-52771099.094100.17
氢氯噻嗪坎地沙坦酯片项目信息
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%
115.642975832978942978822978572980382978510.06
215.602978952977782978360.03
单位质量响应值RSD%判断
19044.1819092.050.18数据可信
加速6月-供试品溶液-2024083021批-坎地沙坦酯-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%
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
氢氯噻嗪坎地沙坦酯片项目信息
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%
111.784491474490174489324489114489904489990.03
211.784511874511554511710.01
单位质量响应值RSD%判断
38115.3738299.750.35数据可信
加速6月-供试品溶液-2024083021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%
5min1359088-35908867.46660.488.6067.4760.488.60
2351317-35131766.00566.01
3294358-29435855.30455.30
4295643-29564355.54555.55
5320590-32059060.23360.23
6310568-31056858.35058.35
10min1482462-48246290.64588.322.4290.7688.422.42
2484879-48487991.09991.21
3458369-45836986.11886.21
4463890-46389087.15687.25
5460336-46033686.48886.59
6470457-47045788.39088.49
15min1519103-51910397.52997.160.8197.7997.400.82
2518958-51895897.50297.76
3518952-51895297.50197.74
4509006-50900695.63295.87
5516380-51638097.01897.26
6520294-52029497.75398.00
20min1529760-52976099.53199.710.6499.96100.120.63
2530453-53045399.662100.09
3534474-534474100.417100.82
4527285-52728599.06699.46
5534958-534958100.508100.91
6527378-52737899.08499.49
30min1535859-535859100.677100.870.92101.27101.450.91
2540962-540962101.636102.23
3537595-537595101.003101.57
4538517-538517101.177101.74
5540685-540685101.584102.16
6527713-52771399.14799.72
45min1537482-537482100.982101.150.87101.74101.890.87
2542186-542186101.866102.63
3537605-537605101.005101.74
4540281-540281101.508102.24
5542609-542609101.945102.69
6529940-52994099.565100.30
60min1537984-537984101.077100.961.10102.00101.871.09
2541312-541312101.702102.63
3536707-536707100.837101.74
4540259-540259101.504102.40
5541825-541825101.798102.71
6526090-52609098.84299.75
极限1535362-535362100.584100.630.96101.68101.710.96
2538658-538658101.203102.30
3535240-535240100.561101.63
4537541-537541100.993102.06
5540855-540855101.616102.70
6526063-52606398.83799.91
氢氯噻嗪坎地沙坦酯片项目信息
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%
115.642969472969272969642970012971242969930.03
215.602992302992482992390.01
单位质量响应值RSD%判断
18989.3219181.990.72数据可信
加速6月-供试品溶液-2024083021批-坎地沙坦酯-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%
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
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