培哚普利吲达帕胺片项目信息
介质体积(ml)500取样体积(ml)2补液体积(ml)2
对照品批号101072-202303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4000
标示量(mg)2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%
115.661564441573601574171571891574361571690.27
215.611569221569351569280.01
单位质量响应值RSD%判断
10036.3310053.040.12数据可信
供试品溶液-6087549批-培哚普利-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min144731-4473127.77734.7728.5627.7834.7728.56
267342-6734241.81841.82
341225-4122525.60025.60
448268-4826829.97329.97
582909-8290951.48451.48
651454-5145431.95231.95
10min1149072-14907292.57088.923.3692.6889.063.35
2135260-13526083.99384.16
3140732-14073287.39187.49
4142825-14282588.69188.81
5145689-14568990.46990.68
6145565-14556590.39290.52
15min1163404-163404101.47097.112.64101.9597.602.60
2154007-15400795.63596.14
3158935-15893598.69599.15
4155564-15556496.60197.08
5152120-15212094.46395.03
6154247-15424795.78496.27
20min1163312-163312101.41397.402.67102.3098.282.63
2153406-15340695.26196.15
3158611-15861198.49499.34
4158798-15879898.61099.47
5152075-15207594.43595.38
6154872-15487296.17297.04
30min1163227-163227101.36096.922.65102.6598.192.61
2152802-15280294.88696.15
3158321-15832198.31399.55
4155209-15520996.38197.64
5152114-15211494.45995.78
6154764-15476496.10597.36
45min1162828-162828101.11297.022.75102.8198.682.71
2153209-15320995.13996.79
3159869-15986999.275100.91
4155348-15534896.46798.11
5151387-15138794.00895.71
6154787-15478796.11997.76
60min1162071-162071100.64296.372.65102.7498.422.61
2151873-15187394.30996.34
3157674-15767497.91299.94
4154449-15444995.90997.94
5150962-15096293.74495.82
6154141-15414195.71897.74
极限1161690-161690100.40695.982.63102.9198.422.59
2151763-15176394.24196.65
3156400-15640097.12199.54
4153901-15390195.56997.98
5150286-15028693.32495.78
6153356-15335695.23097.64
培哚普利吲达帕胺片项目信息
介质体积(ml)500取样体积(ml)2补液体积(ml)2
对照品批号100275-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.2对照品水分(%)0对照品稀释倍数10000
标示量(mg)0.625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%
112.353091433091023091893089423092853091320.05
212.323080883081423081150.02
单位质量响应值RSD%判断
25030.9325009.330.07数据可信
供试品溶液-6087549批-吲达帕胺-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min147300-4730014.85218.1525.7714.8518.1425.77
271273-7127322.37922.38
343271-4327113.58713.59
449947-4994715.68315.68
580840-8084025.38325.38
654116-5411616.99216.99
10min1183447-18344757.60051.6613.7357.6651.7313.74
2172771-17277154.24854.34
3126763-12676339.80239.86
4156978-15697849.28949.35
5189051-18905159.36059.46
6158175-15817549.66549.73
15min1238037-23803774.74172.323.2575.0372.603.29
2233626-23362673.35673.66
3218483-21848368.60168.81
4224823-22482370.59270.85
5236464-23646474.24774.59
6230501-23050172.37472.64
20min1271488-27148885.24481.262.4985.8381.832.50
2257909-25790980.98081.58
3254057-25405779.77180.26
4254369-25436979.86980.41
5257814-25781480.95081.59
6257162-25716280.74681.30
30min1294625-29462592.50887.952.6393.4488.842.61
2276316-27631686.76087.68
3280811-28081188.17188.98
4276615-27661586.85487.72
5275402-27540286.47387.43
6276873-27687386.93587.81
45min1303671-30367195.34990.982.6896.6592.222.65
2285546-28554689.65890.93
3293319-29331992.09893.26
4287670-28767090.32591.53
5281931-28193188.52389.83
6286352-28635289.91191.14
60min1306630-30663096.27891.722.8597.9693.332.81
2286954-28695490.10091.73
3296902-29690293.22394.75
4289967-28996791.04692.62
5283972-28397289.16490.82
6288284-28828490.51792.10
极限1307583-30758396.57791.922.8998.6493.902.85
2287495-28749590.27092.26
3297037-29703793.26695.17
4290958-29095891.35793.29
5284072-28407289.19591.21
6289333-28933390.84792.80
培哚普利吲达帕胺片项目信息
介质体积(ml)500取样体积(ml)2补液体积(ml)2
对照品批号101072-202303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4000
标示量(mg)2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%
115.661568781570611567871568051569651568990.08
215.611568221568071568140.01
单位质量响应值RSD%判断
10019.0910045.740.19数据可信
供试品溶液-6087549批-培哚普利-pH2.0(内含0.19%EDTA)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min166858-6685841.56841.7823.8541.5741.7823.84
263431-6343139.43739.44
394995-9499559.06259.06
461391-6139138.16938.17
570601-7060143.89543.90
645956-4595628.57228.57
10min1146064-14606490.81389.395.4590.9889.565.47
2148606-14860692.39492.55
3152723-15272394.95395.19
4147088-14708891.45091.60
5133749-13374983.15783.33
6134461-13446183.59983.71
15min1150331-15033193.46695.401.9894.0095.921.96
2158261-15826198.39798.92
3152654-15265494.91095.53
4152401-15240194.75395.27
5151084-15108493.93494.44
6155883-15588396.91897.37
20min1149863-14986393.17595.101.7594.0896.011.73
2157205-15720597.74098.66
3152217-15221794.63995.63
4151887-15188794.43495.33
5151543-15154394.22095.10
6155080-15508096.41997.26
30min1156475-15647597.28695.691.8598.5696.981.82
2157664-15766498.02599.34
3152297-15229794.68896.06
4151280-15128094.05695.33
5150894-15089493.81695.08
6154817-15481796.25597.48
45min1149718-14971893.08595.041.9594.7596.711.92
2157915-15791598.18199.89
3152147-15214794.59596.35
4151491-15149194.18795.84
5151165-15116593.98595.62
6154738-15473896.20697.81
60min1149266-14926692.80496.084.4494.8498.134.33
2157037-15703797.63699.73
3151793-15179394.37596.51
4151506-15150694.19796.22
5150238-15023893.40895.42
6167404-167404104.081106.07
极限1148406-14840692.26994.371.9894.6896.801.96
2156998-15699897.611100.10
3151082-15108293.93396.44
4150592-15059293.62896.03
5150308-15030893.45295.84
6153281-15328195.30097.71
培哚普利吲达帕胺片项目信息
介质体积(ml)500取样体积(ml)2补液体积(ml)2
对照品批号100275-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.2对照品水分(%)0对照品稀释倍数10000
标示量(mg)0.625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%
112.353017513016883018103015983014163016530.06
212.323014153014513014330.01
单位质量响应值RSD%判断
24425.3424466.960.13数据可信
供试品溶液-6087549批-吲达帕胺-pH2.0(内含0.19%EDTA)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min163720-6372020.47721.3320.8420.4821.3320.84
265528-6552821.05821.06
387270-8727028.04528.05
464717-6471720.79720.80
572342-7234223.24823.25
644627-4462714.34114.34
10min1168049-16804954.00454.4310.5754.0954.5210.58
2177591-17759157.07157.15
3191522-19152261.54761.66
4176571-17657156.74356.83
5164122-16412252.74252.84
6138352-13835244.46144.52
15min1222468-22246871.49273.693.2071.7973.993.22
2238581-23858176.67076.98
3234098-23409875.23075.59
4234376-23437675.31975.63
5225351-22535172.41972.72
6220899-22089970.98871.22
20min1245916-24591679.02781.402.5279.6181.992.51
2263601-26360184.71185.33
3249129-24912980.06080.72
4257666-25766682.80383.41
5250929-25092980.63881.23
6252485-25248581.13881.66
30min1267405-26740585.93388.182.5086.8389.112.48
2285033-28503391.59892.56
3268230-26823086.19887.18
4277437-27743789.15790.10
5270589-27058986.95687.87
6277772-27777289.26590.11
45min1273442-27344287.87390.472.9289.1291.752.88
2293752-29375294.40095.72
3272915-27291587.70489.03
4283969-28396991.25692.56
5278064-27806489.35990.62
6287040-28704092.24393.44
60min1274770-27477088.30091.203.1189.9092.843.06
2296042-29604295.13696.84
3274876-27487688.33490.01
4285931-28593191.88793.55
5279824-27982489.92491.55
6291260-29126093.59995.17
极限1276311-27631188.79591.352.9490.7493.352.91
2297379-29737995.56697.65
3275013-27501388.37890.41
4287410-28741092.36294.39
5281818-28181890.56592.55
6287642-28764292.43794.38
培哚普利吲达帕胺片项目信息
介质体积(ml)500取样体积(ml)2补液体积(ml)2
对照品批号101072-202303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4000
标示量(mg)2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%
115.661564341568821568271566341568401567230.12
215.611569181569101569140.01
单位质量响应值RSD%判断
10007.8510052.150.32数据可信
供试品溶液-6087549批-培哚普利-pH4.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min153748-5374833.42535.1526.4933.4335.1526.49
273742-7374245.85945.86
374230-7423046.16346.16
435691-3569122.19622.20
549285-4928530.65030.65
652434-5243432.60832.61
10min1150426-15042693.54887.7314.3793.6887.8714.38
2149034-14903492.68292.87
3151460-15146094.19194.38
499818-9981862.07662.16
5146924-14692491.37091.49
6148764-14876492.51492.64
15min1151673-15167394.32495.233.1694.8395.723.07
2149653-14965393.06793.62
3151624-15162494.29394.85
4162830-162830101.262101.60
5152318-15231894.72595.21
6150712-15071293.72694.23
20min1152434-15243494.79795.223.2995.6896.093.20
2149043-14904392.68893.61
3151164-15116494.00794.95
4163108-163108101.435102.18
5151956-15195694.50095.37
6150971-15097193.88794.76
30min1155484-15548496.69495.503.4297.9696.763.32
2149176-14917692.77194.07
3151166-15116694.00895.32
4163280-163280101.542102.69
5152282-15228294.70295.95
6150016-15001693.29394.54
45min1150877-15087793.82894.833.4395.4896.463.33
2149308-14930892.85394.52
3150931-15093193.86295.55
4162920-162920101.318102.87
5151843-15184394.42996.05
6149009-14900992.66794.29
60min1150337-15033793.49394.303.5395.5296.313.43
2148721-14872192.48894.53
3150179-15017993.39495.46
4162155-162155100.842102.80
5151156-15115694.00296.00
6147233-14723391.56293.56
极限1149944-14994493.24894.223.3495.6596.613.24
2147949-14794992.00894.42
3150019-15001993.29595.73
4161609-161609100.503102.87
5150712-15071293.72696.10
6148791-14879192.53194.89
培哚普利吲达帕胺片项目信息
介质体积(ml)500取样体积(ml)2补液体积(ml)2
对照品批号100275-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.2对照品水分(%)0对照品稀释倍数10000
标示量(mg)0.625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%
112.353023783020923022603021523017543021270.08
212.323022653022923022780.01
单位质量响应值RSD%判断
24463.7224535.550.21数据可信
供试品溶液-6087549批-吲达帕胺-pH4.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min153173-5317317.05018.3627.0217.0518.3627.03
275480-7548024.20324.20
372799-7279923.34423.34
433228-3322810.65510.65
551882-5188216.63616.64
656980-5698018.27118.27
10min1162785-16278552.19850.8317.3452.2750.9017.36
2182300-18230058.45658.55
3186780-18678059.89359.99
4109915-10991535.24535.29
5153589-15358949.25049.32
6155700-15570049.92750.00
15min1222337-22233771.29471.054.8471.5771.324.90
2230362-23036273.86874.20
3232831-23283174.65974.99
4202400-20240064.90165.08
5221510-22151071.02971.29
6220009-22000970.54870.82
20min1249611-24961180.04080.050.9480.6080.601.00
2250879-25087980.44681.07
3253345-25334581.23781.87
4247757-24775779.44579.89
5249477-24947779.99780.54
6246701-24670179.10779.66
30min1270627-27062786.77987.132.0487.6688.011.95
2267599-26759985.80886.76
3269723-26972386.48987.45
4282339-28233990.53491.30
5272440-27244087.36088.23
6267555-26755585.79486.67
45min1280376-28037689.90590.412.8591.1391.642.75
2276033-27603388.51289.80
3276911-27691188.79490.10
4297509-29750995.39996.52
5282888-28288890.71091.93
6278006-27800689.14590.36
60min1283788-28378890.99991.393.2192.5992.983.10
2278922-27892289.43991.08
3279747-27974789.70391.36
4302870-30287097.11898.62
5285364-28536491.50493.08
6279411-27941189.59691.17
极限1284315-28431591.16891.753.4593.1293.713.34
2279658-27965889.67591.68
3280317-28031789.88691.90
4305672-30567298.01699.91
5285626-28562691.58893.53
6281193-28119390.16792.10
培哚普利吲达帕胺片项目信息
介质体积(ml)500取样体积(ml)2补液体积(ml)2
对照品批号101072-202303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4000
标示量(mg)2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%
115.661557851558151557041557831558741557920.04
215.611549331550441549880.06
单位质量响应值RSD%判断
9948.409928.760.14数据可信
供试品溶液-6087549批-培哚普利-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%
5min152625-5262533.02830.5132.9033.0330.5132.89
255888-5588835.07635.08
375230-7523047.21547.21
432506-3250620.40120.40
538877-3887724.39924.40
636518-3651822.91922.92
10min1100551-10055163.10671.5822.8563.2471.7022.85
2139528-13952887.56887.71
3147204-14720492.38692.57
479116-7911649.65449.74
5118746-11874674.52674.62
699192-9919262.25362.35
15min1139741-13974187.70293.083.1288.0993.493.11
2149389-14938993.75794.25
3148635-14863593.28493.84
4148136-14813692.97193.25
5153545-15354596.36696.76
6150436-15043694.41494.76
20min1151158-15115894.86896.333.4195.6097.113.29
2149087-14908793.56894.43
3148096-14809692.94693.88
4158157-15815799.26099.91
5153154-15315496.12096.90
6161271-161271101.215101.93
30min1150647-15064794.54794.903.2095.6696.073.07
2148676-14867693.31094.55
3143820-14382090.26291.57
4157526-15752698.86499.91
5151520-15152095.09596.26
6155095-15509597.33898.46
45min1149924-14992494.09395.112.5795.5996.662.46
2148302-14830293.07594.69
3147180-14718092.37194.04
4157675-15767598.958100.40
5152373-15237395.63097.18
6153832-15383296.54698.06
60min1149446-14944693.79394.412.3795.6696.342.26
2147837-14783792.78394.77
3146410-14641091.88893.92
4156589-15658998.276100.12
5151594-15159495.14197.07
6150686-15068694.57196.47
极限1148577-14857793.24896.305.5295.4998.605.35
2147004-14700492.26094.62
3145697-14569791.44093.84
4163162-163162102.401104.63
5151226-15122694.91097.22
6165002-165002103.556105.83
培哚普利吲达帕胺片项目信息
介质体积(ml)500取样体积(ml)2补液体积(ml)2
对照品批号100275-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.2对照品水分(%)0对照品稀释倍数10000
标示量(mg)0.625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%
112.353042103041523040443041283036923040450.07
212.323019233023153021190.10
单位质量响应值RSD%判断
24619.0324522.650.28数据可信
供试品溶液-6087549批-吲达帕胺-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%
5min156067-5606717.92615.9734.4717.9315.9734.46
260573-6057319.36719.37
375935-7593524.27924.28
430484-304849.7479.75
540176-4017612.84512.85
636464-3646411.65911.66
10min1141034-14103445.09343.4325.2945.1643.4925.30
2163692-16369252.33752.41
3183487-18348758.66658.76
490906-9090629.06529.10
5127066-12706640.62740.68
6108865-10886534.80734.85
15min1197138-19713863.03165.718.8463.2865.958.90
2220872-22087270.61970.91
3229710-22971073.44573.78
4180131-18013157.59357.75
5209528-20952866.99267.21
6195737-19573762.58362.77
20min1238267-23826776.18177.422.4976.6977.922.58
2247224-24722479.04579.61
3250766-25076680.17780.80
4235342-23534275.24675.63
5243408-24340877.82578.31
6237837-23783776.04476.48
30min1266746-26674685.28785.781.6286.1086.601.50
2267685-26768585.58786.47
3261483-26148383.60484.55
4273985-27398587.60188.29
5268157-26815785.73886.53
6271768-27176886.89287.63
45min1279320-27932089.30790.592.4490.4691.742.32
2277823-27782388.82890.06
3277488-27748888.72190.00
4295318-29531894.42295.46
5282944-28294490.46691.60
6287083-28708391.78992.88
60min1283511-28351190.64791.472.6992.1592.982.57
2280504-28050489.68691.27
3279293-27929389.29890.93
4300580-30058096.10497.52
5286261-28626191.52693.02
6286346-28634691.55393.01
极限1284403-28440390.93292.443.5692.8094.323.42
2281050-28105089.86091.80
3279462-27946289.35291.35
4306166-30616697.89099.69
5287187-28718791.82293.69
6296374-29637494.76096.58
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