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(%)99.7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%
111.904698524693984695294693024691134694390.06
212.024669604670604670100.02
单位质量响应值RSD%判断
39448.6638852.751.08数据可信
供试品溶液-2024052221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%
5min1330814-33081460.65968.109.3560.6668.109.35
2355922-35592265.26365.26
3391790-39179071.84071.84
4343811-34381163.04263.04
5381243-38124369.90669.91
6424895-42489577.91077.91
10min1459438-45943884.24487.683.5584.3587.793.56
2458542-45854284.08084.19
3493747-49374790.53590.65
4477991-47799187.64687.75
5479713-47971387.96288.08
6499586-49958691.60691.74
15min1500085-50008591.69793.321.1991.9493.581.20
2504445-50444592.49792.75
3513381-51338194.13594.41
4511138-51113893.72493.98
5507994-50799493.14893.41
6516548-51654894.71695.00
20min1515598-51559894.54295.460.6594.9495.870.65
2519411-51941195.24195.64
3518633-51863395.09895.53
4523784-52378496.04396.45
5524268-52426896.13296.55
6521865-52186595.69196.13
30min1526332-52633296.51097.030.9197.0697.600.90
2532453-53245397.63398.19
3521807-52180795.68096.27
4532460-53246097.63498.20
5534445-53444597.99898.58
6527503-52750396.72597.32
45min1529872-52987297.15997.631.3497.8798.371.33
2537520-53752098.56299.29
3521666-52166695.65596.40
4540107-54010799.03699.77
5537611-53761198.57899.32
6528011-52801196.81897.58
60min1531318-53131897.42497.761.4498.3098.661.42
2537460-53746098.55199.44
3521397-52139795.60596.51
4541049-54104999.209100.10
5539649-53964998.95299.86
6528040-52804096.82397.75
极限1558377-558377102.386100.111.42103.42101.171.40
2541793-54179399.345100.40
3536353-53635398.34899.41
4545647-545647100.052101.11
5542738-54273899.518100.59
6550804-550804100.997102.08
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(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)8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%
115.921608681615231612981615601612911613080.18
215.961618841616351617600.11
单位质量响应值RSD%判断
10132.4110135.340.03数据可信
供试品溶液-2024052221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%
5min19330-93305.1685.151.495.175.151.48
29121-91215.0535.05
39218-92185.1065.11
49465-94655.2435.24
59202-92025.0985.10
69442-94425.2305.23
10min110658-106585.9045.585.585.915.595.56
29949-99495.5115.52
39582-95825.3085.32
410887-108876.0316.04
59630-96305.3355.34
69730-97305.3905.40
15min110678-106785.9155.733.995.935.753.95
210070-100705.5785.60
310098-100985.5945.61
411038-110386.1156.13
510203-102035.6525.67
610026-100265.5545.57
20min110629-106295.8885.744.665.925.774.68
210163-101635.6305.66
39842-98425.4525.48
411186-111866.1976.23
510310-103105.7115.74
610046-100465.5655.59
30min110862-108626.0175.783.076.065.823.10
210147-101475.6215.66
310256-102565.6815.72
410790-107905.9776.02
510469-104695.7995.84
610136-101365.6155.65
45min110685-106855.9195.752.465.975.802.48
210110-101105.6015.65
310329-103295.7225.77
410580-105805.8615.91
510530-105305.8335.88
610071-100715.5795.62
60min110617-106175.8815.802.285.945.862.32
210255-102555.6815.74
310359-103595.7385.79
410897-108976.0366.10
510375-103755.7475.80
610350-103505.7335.79
极限110557-105575.8485.811.635.925.881.61
210480-104805.8055.87
310367-103675.7435.81
410784-107845.9746.04
510470-104705.8005.87
610295-102955.7035.77
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(%)99.7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%
111.904685024682224681064678684675224680440.08
212.024665444663584664510.03
单位质量响应值RSD%判断
39331.4338806.240.96数据可信
供试品溶液-2024052221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%
5min1394267-39426772.44572.0513.6772.4472.0413.67
2459279-45927984.39084.39
3334780-33478061.51461.51
4327864-32786460.24460.24
5441261-44126181.08081.08
6395179-39517972.61272.61
10min1529840-52984097.35691.117.5097.4891.237.50
2529260-52926097.24997.39
3447473-44747382.22182.32
4453895-45389583.40183.50
5518814-51881495.33095.46
6495876-49587691.11591.24
15min1540568-54056899.32795.744.0299.6196.014.04
2537013-53701398.67498.98
3488488-48848889.75790.00
4502831-50283192.39392.63
5533539-53353998.03598.33
6523698-52369896.22796.50
20min1543629-54362999.88997.482.78100.3497.912.79
2537095-53709598.68999.16
3502740-50274092.37692.77
4526403-52640396.72497.12
5537824-53782498.82399.28
6535400-53540098.37798.81
30min1543780-54378099.91798.662.26100.5399.252.26
2537501-53750198.76399.40
3512885-51288594.24094.78
4542528-54252899.687100.24
5539850-53985099.19599.82
6544953-544953100.133100.73
45min1544613-544613100.07099.161.57100.8599.921.59
2536629-53662998.60399.40
3524115-52411596.30497.00
4542922-54292299.760100.48
5541738-54173899.542100.33
6547943-547943100.682101.45
60min1545246-545246100.18799.111.50101.13100.031.51
2535215-53521598.34399.30
3525634-52563496.58397.44
4541580-54158099.513100.40
5540220-54022099.263100.22
6548267-548267100.742101.67
极限1557119-557119102.368100.811.21103.48101.901.20
2540182-54018299.256100.38
3547258-547258100.556101.58
4542266-54226699.639100.69
5552168-552168101.458102.58
6552931-552931101.599102.70
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(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)8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%
115.921621341620741619531618321617701619530.10
215.961614801614581614690.01
单位质量响应值RSD%判断
10172.9310117.110.39数据可信
供试品溶液-2024052221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%
5min19757-97575.3995.421.205.405.421.23
29657-96575.3445.34
39860-98605.4565.46
49880-98805.4675.47
59655-96555.3435.34
69928-99285.4945.49
10min110398-103985.7545.784.295.765.794.29
29905-99055.4815.49
310752-107525.9505.96
410653-106535.8955.90
59975-99755.5205.53
611038-110386.1086.12
15min110522-105225.8225.865.095.845.885.12
210003-100035.5355.55
310649-106495.8935.91
410850-108506.0046.02
510052-100525.5625.58
611450-114506.3366.36
20min110353-103535.7295.824.435.765.854.40
210137-101375.6095.64
310375-103755.7415.77
410992-109926.0826.11
510057-100575.5655.59
611190-111906.1926.22
30min110357-103575.7315.752.645.775.792.63
210143-101435.6135.65
310403-104035.7575.79
410482-104825.8005.84
510103-101035.5915.63
610861-108616.0106.05
45min110421-104215.7675.762.815.815.802.77
210174-101745.6305.68
310333-103335.7185.77
410777-107775.9646.01
510018-100185.5445.59
610688-106885.9145.96
60min110369-103695.7385.722.155.795.782.15
210052-100525.5625.62
310226-102265.6595.72
410657-106575.8975.96
510217-102175.6545.71
610521-105215.8225.88
极限110356-103565.7315.741.365.805.811.40
210247-102475.6705.73
310390-103905.7495.82
410540-105405.8325.90
510208-102085.6495.71
610540-105405.8325.90
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