替米沙坦氢氯噻嗪片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100309-202205对照品来源中检所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10000
标示量(mg)12.5供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.205222051951519675194952019520210.23
214.185216452162521630.01
单位质量响应值RSD%判断
3663.453678.630.30数据可信
供试品溶液-F94945批-氢氯噻嗪-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min135091-3509168.61869.035.3468.6269.035.34
236960-3696072.27272.27
336688-3668871.74071.74
431829-3182962.23962.24
536228-3622870.84170.84
635013-3501368.46568.47
10min142671-4267183.44085.292.4283.8285.672.43
243400-4340084.86585.27
344049-4404986.13486.53
442629-4262983.35883.70
545474-4547488.92189.31
643484-4348485.03085.41
15min145185-4518588.35691.082.2289.2091.932.22
246197-4619790.33591.21
346806-4680691.52592.40
446119-4611990.18290.99
548282-4828294.41295.30
646868-4686891.64792.50
20min148396-4839694.63597.083.8795.9798.443.85
248852-4885295.52696.90
350149-5014998.06299.45
447591-4759193.06094.37
553063-53063103.760105.17
649821-4982197.42198.78
30min147331-4733192.55296.622.2894.4198.522.28
249165-4916596.13898.04
349781-4978197.34399.27
449671-4967197.12898.95
550660-5066099.062101.05
649848-4984897.47499.38
45min143213-4321384.50091.665.6786.8894.105.54
248844-4884495.51197.95
343922-4392285.88688.36
448538-4853894.91297.28
549383-4938396.56599.10
647343-4734392.57595.02
60min146481-4648190.89094.393.4793.7397.343.43
248227-4822794.30497.27
346759-4675991.43494.38
447957-4795793.77696.67
551011-5101199.748102.82
649197-4919796.20199.16
极限149272-4927296.34797.142.2199.70100.612.20
250570-5057098.886102.38
349869-4986997.515100.97
447908-4790893.68097.10
551013-5101399.752103.38
649423-4942396.643100.14
替米沙坦氢氯噻嗪片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100629-202204对照品来源中检所对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数1250
标示量(mg)80供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.101764241765571767801765371765101765620.08
211.161768021767761767890.02
单位质量响应值RSD%判断
15906.4915841.310.30数据可信
供试品溶液-F94945批-替米沙坦-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min155474-5547431.45232.145.2231.4532.145.22
256397-5639731.97531.98
351940-5194029.44829.45
460846-6084634.49834.50
557649-5764932.68532.69
657856-5785632.80332.80
10min1112335-11233563.69166.355.2063.8766.535.19
2113028-11302864.08464.26
3109519-10951962.09462.26
4122759-12275969.60169.79
5123422-12342269.97770.16
6121074-12107468.64568.83
15min1146789-14678983.22586.954.7683.7587.504.76
2149665-14966584.85685.39
3144272-14427281.79882.31
4159323-15932390.33290.91
5159604-15960490.49191.06
6160537-16053791.02091.58
20min1172287-17228797.68299.673.1398.67100.703.12
2173282-17328298.24699.25
3171591-17159197.28798.25
4172667-17266797.89798.98
5185266-185266105.040106.11
6179631-179631101.846102.91
30min1167685-16768595.07399.612.7296.61101.202.72
2174091-17409198.705100.26
3174789-17478999.100100.60
4181278-181278102.779104.40
5176907-176907100.301101.96
6179411-179411101.721103.36
45min1151380-15138085.82893.826.1687.8995.966.09
2171259-17125997.09999.20
3154084-15408487.36189.42
4175854-17585499.704101.90
5171807-17180797.41099.62
6168513-16851395.54297.74
60min1162234-16223491.98295.693.1894.5298.353.20
2167237-16723794.81997.46
3163173-16317392.51495.05
4173137-17313798.164100.91
5174986-17498699.212101.97
6171857-17185797.438100.17
极限1170835-17083596.85898.021.1499.91101.211.13
2176125-17612599.858103.02
3172165-17216597.613100.67
4171718-17171897.359100.65
5172120-17212097.587100.89
6174339-17433998.845102.12
替米沙坦氢氯噻嗪片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100309-202205对照品来源中检所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10000
标示量(mg)12.5供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.205182452094519735205151932519750.21
214.185235652359523580.01
单位质量响应值RSD%判断
3660.213692.380.62数据可信
供试品溶液-F57850批-氢氯噻嗪-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min135701-3570169.71269.894.9569.7169.894.95
234977-3497768.29868.30
336811-3681171.87971.88
437940-3794074.08474.08
532823-3282364.09264.09
636516-3651671.30371.30
10min142448-4244882.88684.141.5783.2784.521.56
242088-4208882.18382.56
343333-4333384.61485.01
443452-4345284.84785.26
543865-4386585.65386.01
643348-4334884.64485.04
15min147998-4799893.72394.463.8494.5795.313.81
247038-4703891.84992.68
349333-4933396.33097.20
446843-4684391.46892.35
547351-4735192.46093.29
651682-51682100.917101.78
20min150657-5065798.91697.612.58100.2898.982.56
248822-4882295.33296.68
351964-51964101.468102.87
448453-4845394.61296.00
549681-4968197.01098.36
650340-5034098.29799.72
30min150377-5037798.36998.863.80100.29100.783.72
249083-4908395.84297.72
351019-5101999.622101.59
449234-4923496.13798.05
554263-54263105.957107.84
649794-4979497.23099.20
45min149292-4929296.25096.701.9198.7199.171.88
248080-4808093.88496.29
349177-4917796.02698.55
450824-5082499.242101.69
549511-4951196.67899.15
650247-5024798.115100.63
60min146688-4668891.16694.642.7294.1697.652.66
248304-4830494.32197.25
348303-4830394.31997.37
448337-4833794.38597.39
548377-4837794.46497.47
650796-5079699.187102.25
极限148910-4891095.50496.971.7299.01100.501.68
249101-4910195.87799.33
349442-4944296.543100.12
449283-4928396.23399.76
551221-51221100.017103.55
650011-5001197.654101.26
替米沙坦氢氯噻嗪片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100629-202204对照品来源中检所对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数1250
标示量(mg)80供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.101768321770191763581765771766951766960.15
211.161780951778181779560.12
单位质量响应值RSD%判断
15918.5615945.880.13数据可信
供试品溶液-F57850批-替米沙坦-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min152280-5228029.53329.196.9829.5329.186.97
246019-4601925.99626.00
349014-4901427.68827.69
456103-5610331.69231.69
552680-5268029.75929.76
653895-5389530.44530.44
10min1108713-10871361.41159.284.2961.5859.454.28
297707-9770755.19455.34
3108851-10885161.48961.64
4101970-10197057.60257.78
5108089-10808961.05961.22
6104358-10435858.95159.12
15min1154553-15455387.30684.256.3887.8184.746.35
2140178-14017879.18679.64
3160467-16046790.64791.14
4137856-13785677.87478.37
5144529-14452981.64382.15
6157228-15722888.81789.31
20min1181495-181495102.52596.625.78103.5297.585.75
2165942-16594293.74094.63
3185160-185160104.596105.59
4160434-16043490.62891.56
5165772-16577293.64494.60
6167399-16739994.56395.55
30min1177263-177263100.135100.153.07101.69101.643.05
2175441-17544199.105100.52
3181405-181405102.475104.05
4171758-17175897.02598.46
5185685-185685104.892106.37
6172140-17214097.24198.76
45min1170696-17069696.42597.801.3398.5499.851.29
2171830-17183097.06699.03
3175235-17523598.989101.14
4176422-17642299.660101.63
5171311-17131196.77298.83
6173294-17329497.89399.95
60min1162009-16200991.51894.922.2994.1797.522.22
2170709-17070996.43298.93
3170928-17092896.55699.26
4167491-16749194.61597.14
5165279-16527993.36595.96
6171809-17180997.05499.65
极限1166516-16651694.06496.181.5297.2299.301.50
2170881-17088196.53099.57
3173799-17379998.178101.41
4168921-16892195.42298.47
5172186-17218697.267100.38
6169295-16929595.63498.77
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