美阿沙坦钾氢氯噻嗪片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号H220807-2对照品来源原料对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0.07对照品稀释倍数1000
标示量(mg)12.5供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.231167131162591168131168901163701166090.24
212.261168491169331168910.06
单位质量响应值RSD%判断
9534.679534.340.01数据可信
供试品溶液-25090301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%
5min150714-5071476.54077.202.4376.5477.202.43
251559-5155977.81577.82
351943-5194378.39578.39
452629-5262979.43079.43
549022-4902273.98673.99
651058-5105877.05977.06
10min152980-5298079.96081.151.1580.8182.001.14
253472-5347280.70281.57
353601-5360180.89781.77
454069-5406981.60382.49
553676-5367681.01081.83
654798-5479882.70483.56
15min153110-5311080.15680.651.1681.8982.411.16
252644-5264479.45381.21
353910-5391081.36383.13
454358-5435882.04083.83
553130-5313080.18681.91
653464-5346480.69082.47
20min153211-5321180.30979.461.0282.9482.121.00
251866-5186678.27980.92
353155-5315580.22482.90
452608-5260879.39882.10
552204-5220478.78981.40
652844-5284479.75582.43
30min152227-5222778.82378.950.7982.3582.490.80
251771-5177178.13581.65
352421-5242179.11682.68
452932-5293279.88783.47
551995-5199578.47381.96
652537-5253779.29182.85
45min151868-5186878.28277.810.6982.6882.230.67
251377-5137777.54181.92
352090-5209078.61783.06
451386-5138677.55482.02
551139-5113977.18181.54
651486-5148677.70582.14
60min150248-5024875.83776.480.7181.1081.760.68
250804-5080476.67681.92
351305-5130577.43282.75
450584-5058476.34481.68
550542-5054276.28081.50
650558-5055876.30581.61
极限150258-5025875.85276.081.4581.9682.211.34
250140-5014075.67481.77
351402-5140277.57883.76
449368-4936874.50880.69
551087-5108777.10383.17
650194-5019475.75581.91
美阿沙坦钾氢氯噻嗪片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号D211-4R701-2402002对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.5对照品水分(%)0对照品稀释倍数500
标示量(mg)40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%
110.831130251128101136481133621129151131520.31
210.851135411134161134780.08
单位质量响应值RSD%判断
10448.0110458.800.08数据可信
供试品溶液-25090301批-美阿沙坦钾-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%
5min14310-43101.8462.1413.251.852.1413.24
25834-58342.4992.50
35627-56272.4102.41
44586-45861.9641.96
54364-43641.8691.87
65200-52002.2272.23
10min14817-48172.0632.3712.572.082.4012.66
26252-62522.6782.71
36108-61082.6162.64
45004-50042.1432.17
54911-49112.1042.12
66166-61662.6412.67
15min15231-52312.2412.4810.962.282.5310.95
26406-64062.7442.80
36414-64142.7472.80
45241-52412.2452.29
55165-51652.2122.26
66281-62812.6902.74
20min15470-54702.3432.6811.632.412.7611.68
26844-68442.9313.02
37021-70213.0073.09
45649-56492.4202.49
55663-56632.4262.49
66869-68692.9423.03
30min15986-59862.5642.8210.712.662.9310.69
27277-72773.1173.24
37262-72623.1113.23
45976-59762.5602.66
55882-58822.5192.62
67154-71543.0643.18
45min16602-66022.8283.1210.732.953.2610.76
28266-82663.5413.70
37957-79573.4083.56
46564-65642.8122.94
56619-66192.8352.96
67747-77473.3183.47
60min17233-72333.0983.409.873.253.579.89
28651-86513.7053.90
38873-88733.8013.99
47258-72583.1093.27
57220-72203.0933.25
68397-83973.5973.78
极限17718-77183.3063.618.673.493.828.81
29104-91043.9004.14
39231-92313.9544.19
47738-77383.3143.51
57840-78403.3583.55
68910-89103.8164.04
美阿沙坦钾氢氯噻嗪片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号H220807-2对照品来源原料对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0.07对照品稀释倍数1000
标示量(mg)12.5供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.231125311123581123981123061121831123550.12
212.261134751138491136620.24
单位质量响应值RSD%判断
9186.849270.960.65数据可信
供试品溶液-25090301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%
5min153561-5356183.51583.181.5583.5283.181.56
254550-5455085.05785.06
353764-5376483.83283.83
453154-5315482.88182.88
552939-5293982.54582.55
652103-5210381.24281.24
10min155191-5519186.05785.321.9186.9886.251.91
256152-5615287.55588.50
354015-5401584.22385.15
454707-5470785.30286.22
555130-5513085.96286.88
653134-5313482.85083.75
15min154862-5486285.54484.501.4987.4386.371.49
255067-5506785.86487.78
353572-5357283.53285.40
454071-5407184.31186.18
554589-5458985.11886.99
652975-5297582.60284.42
20min153908-5390884.05684.050.9586.8986.860.97
254702-5470285.29488.17
353528-5352883.46486.26
454001-5400184.20187.01
554075-5407584.31787.13
653202-5320282.95685.70
30min153073-5307382.75482.261.6386.5286.001.61
253862-5386283.98587.80
352356-5235681.63685.36
452216-5221681.41885.16
553457-5345783.35387.11
651568-5156880.40884.07
45min153756-5375683.81982.833.0988.5187.492.99
256151-5615187.55492.31
351890-5189080.91085.54
452223-5222381.42986.07
552789-5278982.31286.99
651936-5193680.98285.54
60min152919-5291982.51481.142.3188.1386.722.27
253609-5360983.59089.32
351030-5103079.56985.10
451508-5150880.31485.86
552631-5263182.06587.66
650511-5051178.76084.22
极限152427-5242781.74780.111.9588.2886.601.91
251850-5185080.84787.50
350786-5078679.18885.60
450658-5065878.98985.43
552461-5246181.80088.31
650099-5009978.11784.45
美阿沙坦钾氢氯噻嗪片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号D211-4R701-2402002对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.5对照品水分(%)0对照品稀释倍数500
标示量(mg)40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%
110.831095031092151092381094021091701093060.13
210.851120071119931120000.01
单位质量响应值RSD%判断
10092.8910322.581.60数据可信
供试品溶液-25090301批-美阿沙坦钾-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%
5min13285-32851.4411.547.381.441.547.27
23784-37841.6601.66
33653-36531.6031.60
43259-32591.4301.43
53299-32991.4471.45
63795-37951.6651.66
10min13355-33551.4721.618.971.491.638.95
24016-40161.7621.78
33514-35141.5421.56
43613-36131.5851.60
53405-34051.4941.51
64147-41471.8191.84
15min13668-36681.6091.676.931.641.706.90
24045-40451.7751.81
33519-35191.5441.58
43615-36151.5861.62
53777-37771.6571.69
64195-41951.8401.88
20min13696-36961.6211.695.351.671.745.42
24023-40231.7651.82
33797-37971.6661.72
43609-36091.5831.63
53783-37831.6601.71
64153-41531.8221.88
30min13649-36491.6011.686.561.671.756.42
24046-40461.7751.85
33699-36991.6231.69
43616-36161.5861.66
53714-37141.6291.70
64228-42281.8551.93
45min13822-38221.6771.789.551.761.879.37
24505-45051.9762.07
33719-37191.6321.72
43881-38811.7031.79
53784-37841.6601.75
64580-45802.0092.11
60min13818-38181.6751.778.701.781.888.69
24437-44371.9462.07
33724-37241.6341.74
43887-38871.7051.81
53809-38091.6711.78
64522-45221.9842.11
极限13838-38381.6841.807.711.811.937.71
24413-44131.9362.08
33911-39111.7161.84
43926-39261.7221.85
53927-39271.7231.85
64586-45862.0122.16
美阿沙坦钾氢氯噻嗪片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号H220807-2对照品来源原料对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0.07对照品稀释倍数1000
标示量(mg)12.5供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.231133251132421120291131081131731129750.48
212.261126801124271125540.16
单位质量响应值RSD%判断
9237.539180.590.44数据可信
供试品溶液-25090301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%
5min154717-5471785.50186.430.7785.5086.430.77
255572-5557286.83786.84
355453-5545386.65186.65
455291-5529186.39886.40
554952-5495285.86885.87
655872-5587287.30587.31
10min156719-5671988.62989.161.2189.5890.121.21
257273-5727389.49590.46
356796-5679688.74989.71
456774-5677488.71589.67
556449-5644988.20789.16
658355-5835591.18592.16
15min154362-5436284.94688.212.2086.8890.162.17
257566-5756689.95391.91
356328-5632888.01889.97
457018-5701889.09691.04
555828-5582887.23789.17
657604-5760490.01292.00
20min155000-5500085.94387.741.3588.8290.671.34
256429-5642988.17691.13
355930-5593087.39690.32
456667-5666788.54891.48
555740-5574087.09990.00
657127-5712789.26792.25
30min154043-5404384.44786.731.9988.2890.641.95
257322-5732289.57193.51
355131-5513186.14890.05
455368-5536886.51890.44
555086-5508686.07789.95
656062-5606287.60291.58
45min153433-5343383.49485.731.7488.2790.601.72
255936-5593687.40592.34
354498-5449885.15890.01
455223-5522386.29191.17
554345-5434584.91989.75
655764-5576487.13792.09
60min151816-5181680.96884.342.0186.6790.171.95
254290-5429084.83390.74
354503-5450385.16690.97
454223-5422384.72990.57
554237-5423784.75190.52
654788-5478885.61291.53
极限151897-5189781.09483.792.3787.6990.552.25
252438-5243881.94088.79
353438-5343883.50290.25
455199-5519986.25493.03
554260-5426084.78791.50
654497-5449785.15792.02
美阿沙坦钾氢氯噻嗪片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号D211-4R701-2402002对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.5对照品水分(%)0对照品稀释倍数500
标示量(mg)40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%
110.831112781112081114591110191109741111880.18
210.851095531095111095320.03
单位质量响应值RSD%判断
10266.6710095.121.20数据可信
供试品溶液-25090301批-美阿沙坦钾-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%
5min14547-45472.0001.904.482.001.904.52
24335-43351.9071.91
34343-43431.9101.91
44379-43791.9261.93
54333-43331.9061.91
63958-39581.7411.74
10min15225-52252.2982.194.752.322.214.81
25016-50162.2062.23
35083-50832.2362.26
44936-49362.1712.19
55052-50522.2222.24
64534-45341.9942.01
15min15385-53852.3682.325.322.422.365.36
25246-52462.3072.35
35446-54462.3952.44
45380-53802.3662.41
55422-54222.3852.43
64712-47122.0722.11
20min15773-57732.5392.456.832.612.526.84
25482-54822.4112.48
35758-57582.5332.61
45818-58182.5592.63
55794-57942.5482.62
64842-48422.1302.19
30min16111-61112.6882.644.642.792.744.69
25959-59592.6212.72
36103-61032.6842.79
46189-61892.7222.82
56198-61982.7262.83
65464-54642.4032.49
45min16396-63962.8132.804.792.952.934.73
26189-61892.7222.85
36477-64772.8492.98
46620-66202.9123.04
56666-66662.9323.06
65852-58522.5742.69
60min16566-65662.8882.964.893.053.114.80
26832-68323.0053.16
36872-68723.0223.18
46906-69063.0373.20
57023-70233.0893.25
66126-61262.6942.84
极限17078-70783.1133.076.033.313.275.93
26765-67652.9753.17
37103-71033.1243.32
47370-73703.2423.44
57362-73623.2383.44
66262-62622.7542.93
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