缬沙坦氨氯地平片项目信息
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100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.872443752435602441642440122439432440110.13
213.942454922456632455780.05
单位质量响应值RSD%判断
17592.7217616.790.10数据可信
长期3月-供试品溶液-2023112421批-氨氯地平-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%
5min189987-8998733.13532.348.7533.1432.348.75
294598-9459834.83334.83
372985-7298526.87526.87
489853-8985333.08633.09
592249-9224933.96833.97
687243-8724332.12532.13
10min1133885-13388549.30048.614.2449.3648.664.24
2135001-13500149.71149.77
3121124-12112444.60144.65
4133254-13325449.06749.12
5136886-13688650.40550.46
6131907-13190748.57148.63
15min1151310-15131055.71657.723.2555.8557.853.25
2160132-16013258.96559.11
3150123-15012355.27955.40
4162785-16278559.94260.08
5159522-15952258.74058.88
6156578-15657857.65657.79
20min1181035-18103566.66266.680.8966.8966.910.89
2178465-17846565.71565.95
3180066-18006666.30566.52
4181665-18166566.89467.13
5182652-18265267.25767.50
6182560-18256067.22367.45
30min1203107-20310774.78975.741.5275.1376.081.51
2200889-20088973.97274.32
3208710-20871076.85277.17
4206930-20693076.19776.55
5208523-20852376.78377.13
6205952-20595275.83776.18
45min1220894-22089481.33982.273.9381.8082.743.90
2210078-21007877.35677.83
3237234-23723487.35687.81
4223282-22328282.21882.69
5222581-22258181.96082.44
6226435-22643583.37983.85
60min1227497-22749783.77086.302.6584.3786.912.63
2227611-22761183.81284.41
3243551-24355189.68290.28
4235994-23599486.89987.51
5237757-23775787.54888.16
6233865-23386586.11586.72
极限1247303-24730391.06392.621.5291.8093.361.52
2246408-24640890.73491.47
3255361-25536194.03094.78
4253459-25345993.33094.09
5254689-25468993.78394.54
6251883-25188392.75093.50
缬沙坦氨氯地平片项目信息
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100651-202307对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.1对照品水分(%)0对照品稀释倍数200
标示量(mg)80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%
116.014688109468637146895354689223468848246883440.03
216.004693170470205146976100.14
单位质量响应值RSD%判断
292838.48293600.620.19数据可信
长期3月-供试品溶液-2023112421批-缬沙坦-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%
5min13568160-356816067.83467.156.6167.8367.156.61
23672722-367272269.82269.82
33067278-306727858.31258.31
43625222-362522268.91968.92
53689772-368977270.14670.15
63570172-357017267.87267.87
10min14313107-431310781.99681.742.1882.1181.852.18
24311445-431144581.96582.08
34117041-411704178.26978.37
44320038-432003882.12882.24
54362614-436261482.93783.05
64373865-437386583.15183.26
15min14589703-458970387.25587.650.9087.5087.900.90
24556600-455660086.62586.88
34591975-459197587.29887.53
44616570-461657087.76588.02
54629934-462993488.01988.27
64676953-467695388.91389.17
20min14709222-470922289.52790.601.5089.9290.991.49
24669153-466915388.76589.16
34848833-484883392.18192.55
44758493-475849390.46490.86
54765389-476538990.59591.00
64843239-484323992.07592.47
30min14836537-483653791.94793.692.5492.4994.242.52
24775513-477551390.78791.33
35106292-510629297.07697.60
44887689-488768992.92093.47
54923098-492309893.59394.15
65041393-504139395.84296.40
45min14915311-491531193.44595.032.4694.1495.732.45
24853271-485327192.26592.96
35205472-520547298.96199.65
44960265-496026594.29995.00
55001113-500111395.07695.78
65055626-505562696.11296.83
60min14930205-493020593.72895.462.3694.5896.322.34
24874545-487454592.67093.52
35208237-520823799.01499.87
44986557-498655794.79995.66
55051630-505163096.03696.90
65075584-507558496.49297.36
极限15093040-509304096.82497.731.4497.8398.751.43
25043540-504354095.88396.89
35221656-522165699.269100.29
45108507-510850797.11898.14
55228202-522820299.393100.42
65149318-514931897.89398.93
缬沙坦氨氯地平片项目信息
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100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.872395632393782408462410822412662404270.37
213.942443682448092445880.13
单位质量响应值RSD%判断
17334.3217545.770.86数据可信
长期3月-供试品溶液-2023112421批-氨氯地平-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%
5min186781-8678132.25833.217.3132.2633.217.31
277597-7759728.84428.84
394019-9401934.94834.95
495674-9567435.56435.56
590319-9031933.57333.57
691714-9171434.09234.09
10min1137564-13756451.13550.564.2151.1950.614.21
2124560-12456046.30146.35
3140381-14038152.18252.24
4138558-13855851.50451.56
5137421-13742151.08251.14
6137572-13757251.13851.19
15min1165265-16526561.43261.612.1761.5761.742.17
2160753-16075359.75559.88
3162327-16232760.34060.48
4168237-16823762.53662.68
5168137-16813762.49962.64
6169706-16970663.08263.22
20min1184179-18417968.46269.092.4868.7069.332.47
2186284-18628469.24569.47
3186696-18669669.39869.64
4177756-17775666.07566.32
5190345-19034570.75471.00
6189876-18987670.58070.83
30min1212396-21239678.95178.541.8279.3178.891.81
2213987-21398779.54279.88
3205122-20512276.24776.61
4208016-20801677.32377.68
5213567-21356779.38679.75
6214592-21459279.76780.13
45min1234623-23462387.21386.152.3087.7086.642.28
2236942-23694288.07588.55
3229562-22956285.33285.82
4223563-22356383.10283.59
5236886-23688688.05488.55
6228958-22895885.10785.61
60min1245820-24582091.37590.262.4092.0190.892.38
2246294-24629491.55292.17
3235518-23551887.54688.18
4235307-23530787.46788.09
5248294-24829492.29592.94
6245619-24561991.30191.94
极限1248416-24841692.34093.591.9593.1294.371.94
2256403-25640395.30996.08
3246823-24682391.74892.52
4251586-25158693.51994.29
5258987-25898796.27097.07
6248453-24845392.35493.15
缬沙坦氨氯地平片项目信息
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100651-202307对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.1对照品水分(%)0对照品稀释倍数200
标示量(mg)80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%
116.014701420471135947119394716942472187047127060.17
216.004786362479639447913780.15
单位质量响应值RSD%判断
294360.15299461.121.22数据可信
长期3月-供试品溶液-2023112421批-缬沙坦-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%
5min13705346-370534669.57167.696.4169.5767.696.41
23134328-313432858.85058.85
33685098-368509869.19169.19
43692406-369240669.32969.33
53712009-371200969.69769.70
63700990-370099069.49069.49
10min14412755-441275582.85481.842.0782.9781.952.07
24210228-421022879.05179.15
34329922-432992281.29981.41
44324639-432463981.19981.31
54463002-446300283.79783.91
64410634-441063482.81482.93
15min14687330-468733088.00987.721.6488.2687.971.63
24729559-472955988.80289.03
34583164-458316486.05386.30
44578447-457844785.96586.22
54764093-476409389.45089.71
64690452-469045288.06888.32
20min14801566-480156690.15490.452.1290.5590.852.10
24958619-495861993.10393.48
34716541-471654188.55888.95
44699242-469924288.23388.63
54903472-490347292.06792.47
64825098-482509890.59691.00
30min14929679-492967992.56093.322.3693.1193.872.34
25151677-515167796.72897.26
34860223-486022391.25591.80
44859986-485998691.25191.79
55066297-506629795.12595.68
64954020-495402093.01793.57
45min15017821-501782194.21494.912.1094.9295.612.09
25218250-521825097.97898.67
34942506-494250692.80093.49
44973486-497348693.38294.08
55145411-514541196.61097.33
65030237-503023794.44895.15
60min15052767-505276794.87195.652.0695.7396.512.04
25274972-527497299.04399.90
34984559-498455993.59094.44
45024004-502400494.33195.18
55150410-515041096.70497.58
65078910-507891095.36196.23
极限15045680-504568094.73896.521.6095.7697.541.59
25238293-523829398.35499.38
35044268-504426894.71195.72
45200911-520091197.65298.66
55185275-518527597.35998.40
65130523-513052396.33197.35
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