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H220301-1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%
113.851336111335481332741334981333641334590.11
213.841341931343641342780.10
单位质量响应值RSD%判断
9636.039702.170.49数据可信
供试品溶液-24111801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%
5min1111555-11155583.06982.803.2583.0782.803.25
2107427-10742779.99580.00
3112649-11264983.88483.88
4106552-10655279.34479.34
5112831-11283184.01984.02
6116132-11613286.47886.48
10min1122416-12241691.15789.872.6591.6290.332.65
2118326-11832688.11188.56
3120064-12006489.40689.87
4117086-11708687.18887.63
5120180-12018089.49289.96
6126050-12605093.86394.34
15min1126377-12637794.10791.302.6495.0792.262.64
2120661-12066189.85090.78
3121654-12165490.59091.55
4118424-11842488.18489.11
5121973-12197390.82791.79
6126549-12654994.23595.24
20min1127971-12797195.29392.362.8396.7893.832.82
2121022-12102290.11991.55
3123263-12326391.78893.25
4120266-12026689.55690.97
5123074-12307491.64793.12
6128607-12860795.76797.29
30min1122387-12238791.13591.041.9393.1693.021.93
2120088-12008889.42391.36
3120540-12054089.76091.74
4121511-12151190.48392.40
5122385-12238591.13493.11
6126671-12667194.32596.38
45min1125022-12502293.09891.522.1295.6294.002.13
2121174-12117490.23292.66
3120854-12085489.99492.47
4119974-11997489.33991.75
5123937-12393792.29094.77
6126432-12643294.14796.73
60min1126274-12627494.03090.783.5997.0793.773.55
2121156-12115690.21993.15
3119394-11939488.90791.88
4115063-11506385.68288.59
5122966-12296691.56794.56
6126580-12658094.25897.36
极限1126718-12671894.36091.042.7097.9394.542.68
2118721-11872188.40591.84
3121210-12121090.25993.73
4119193-11919388.75792.14
5122074-12207490.90294.41
6125611-12561193.53697.16
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100320240115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%
111.044368764343164333594330904329714341220.38
211.084340144352014346080.20
单位质量响应值RSD%判断
39322.6439224.550.18数据可信
供试品溶液-24111801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%
5min194963-9496321.76223.6415.1421.7623.6415.14
294291-9429121.60821.61
3132044-13204430.25930.26
488362-8836220.24920.25
5101881-10188123.34723.35
6107386-10738624.60924.61
10min1195216-19521644.73647.8012.0444.8647.9312.04
2189826-18982643.50143.62
3248714-24871456.99657.16
4184179-18417942.20742.32
5205053-20505346.99047.12
6228604-22860452.38752.52
15min1268774-26877461.59364.7310.9761.9665.1310.98
2262310-26231060.11160.47
3329460-32946075.50075.98
4247879-24787956.80457.15
5276372-27637263.33463.72
6310088-31008871.06071.49
20min1317929-31792972.85777.1010.8473.5777.8610.85
2309897-30989771.01771.71
3388946-38894689.13290.04
4299353-29935368.60069.26
5328565-32856575.29576.04
6373933-37393385.69186.51
30min1358672-35867282.19486.326.5683.3187.516.61
2359064-35906482.28483.37
3398393-39839391.29792.70
4352492-35249280.77881.82
5378057-37805786.63687.80
6413505-41350594.76096.06
45min1399571-39957191.56692.512.6193.1494.172.72
2398480-39848091.31692.86
3410987-41098794.18396.09
4387974-38797488.90990.40
5407551-40755193.39595.04
6417560-41756095.68997.51
60min1401792-40179292.07592.562.8894.1694.742.93
2408243-40824393.55495.61
3404777-40477792.75995.19
4382258-38225887.59989.59
5411069-41106994.20196.36
6415393-41539395.19297.55
极限1404951-40495192.79993.101.3095.3995.801.45
2401918-40191892.10494.68
3411020-41102094.19097.14
4399253-39925391.49493.97
5407665-40766593.42196.11
6412837-41283794.60797.49
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H220301-1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%
113.851336821334761337651343521334411337430.28
213.841331931330091331010.10
单位质量响应值RSD%判断
9656.539617.120.29数据可信
供试品溶液-24111901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%
5min196132-9613271.82472.362.6971.8272.362.69
296885-9688572.38672.39
395494-9549471.34771.35
498245-9824573.40273.40
593344-9334469.74169.74
6100997-10099775.45975.46
10min1108411-10841180.99880.303.9081.4080.703.89
2108888-10888881.35481.76
3101048-10104875.49775.89
4110933-11093382.88283.29
5103839-10383977.58277.97
6111754-11175483.49683.91
15min1111334-11133483.18282.693.4884.0383.543.47
2110525-11052582.57783.43
3104494-10449478.07178.89
4114167-11416785.29886.17
5108555-10855581.10581.92
6114973-11497385.90186.78
20min1112086-11208683.74482.882.9985.0584.192.98
2110857-11085782.82584.14
3104956-10495678.41679.67
4113401-11340184.72686.07
5110067-11006782.23583.50
6114211-11421185.33186.69
30min1109687-10968781.95182.842.2783.7384.612.28
2111043-11104382.96484.74
3106812-10681279.80381.49
4113230-11323084.59886.41
5110801-11080182.78484.51
6113721-11372184.96586.80
45min1109827-10982782.05682.532.9284.2984.762.91
2110908-11090882.86385.10
3104572-10457278.13080.26
4113053-11305384.46686.75
5110802-11080282.78484.97
6113569-11356984.85287.16
60min1111097-11109783.00582.222.8785.6984.912.87
2108595-10859581.13583.83
3104574-10457478.13180.69
4112176-11217683.81186.56
5110330-11033082.43285.08
6113513-11351384.81087.59
极限1111437-11143783.25981.472.9386.4184.612.89
2109448-10944881.77384.92
3103568-10356877.37980.38
4112793-11279384.27287.49
5108832-10883281.31284.42
6108143-10814380.79884.05
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100320240115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%
111.044370144344864339764344534336204347100.31
211.084330034339604334820.16
单位质量响应值RSD%判断
39375.9139122.920.46数据可信
供试品溶液-24111901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%
5min1130886-13088630.01327.907.1030.0127.907.10
2113966-11396626.13326.13
3126110-12611028.91828.92
4129575-12957529.71229.71
5119914-11991427.49727.50
6109692-10969225.15325.15
10min1268038-26803861.46255.427.0061.6355.586.98
2251136-25113657.58757.73
3230955-23095552.95953.12
4246905-24690556.61756.78
5221875-22187550.87751.03
6231246-23124653.02653.17
15min1359671-35967182.47474.157.2682.9874.617.24
2336116-33611677.07377.54
3307422-30742270.49370.95
4324020-32402074.29974.78
5291545-29154566.85367.29
6321427-32142773.70574.14
20min1404327-40432792.71484.996.4993.6885.866.48
2388875-38887589.17190.06
3351329-35132980.56281.41
4364890-36489083.67184.56
5339161-33916177.77178.58
6375260-37526086.04986.89
30min1411048-41104894.25592.933.1995.7494.283.20
2420023-42002396.31397.70
3399297-39929791.56192.85
4397178-39717891.07592.43
5386925-38692588.72489.96
6417241-41724195.67697.00
45min1410390-41039094.10594.731.5696.1196.601.56
2417335-41733595.69797.62
3406692-40669293.25795.06
4411659-41165994.39696.26
5408663-40866393.70995.44
6423992-42399297.22499.08
60min1417205-41720595.66794.431.1998.2096.821.24
2411830-41183094.43596.89
3407144-40714493.36095.68
4410889-41088994.21996.61
5406129-40612993.12795.38
6417761-41776195.79598.19
极限1412551-41255194.60093.021.9997.6695.941.98
2410118-41011894.04297.02
3404280-40428092.70395.54
4413831-41383194.89497.80
5400033-40003391.73094.50
6393200-39320090.16393.09
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H220301-1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%
113.851328491327101328831326921327621327790.07
213.841337181337931337560.04
单位质量响应值RSD%判断
9586.939664.450.57数据可信
供试品溶液-24111902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%
5min193120-9312069.65570.911.5869.6570.911.59
293071-9307169.61869.62
395636-9563671.53771.54
496944-9694472.51572.52
595023-9502371.07871.08
694962-9496271.03371.03
10min1107745-10774580.59480.361.2480.9880.751.25
2105406-10540678.84579.23
3109061-10906181.57981.98
4108599-10859981.23381.64
5106939-10693979.99180.39
6106800-10680079.88880.28
15min1110879-11087982.93982.290.5783.7783.130.56
2109687-10968782.04782.87
3109111-10911181.61682.47
4110531-11053182.67883.53
5110005-11000582.28583.12
6109885-10988582.19583.03
20min1113036-11303684.55284.081.1385.8585.381.12
2111332-11133283.27784.56
3114564-11456485.69587.00
4111875-11187583.68485.00
5112465-11246584.12585.42
6111176-11117683.16184.46
30min1111182-11118283.16584.871.2984.9386.631.28
2112511-11251184.15985.90
3114474-11447485.62887.41
4115220-11522086.18687.96
5114128-11412885.36987.13
6113252-11325284.71486.47
45min1112949-11294984.48784.621.0486.7186.861.03
2112614-11261484.23686.45
3115009-11500986.02888.28
4113209-11320984.68286.94
5113568-11356884.95087.19
6111438-11143883.35785.58
60min1113756-11375685.09185.121.4387.7987.821.40
2113390-11339084.81787.50
3115059-11505986.06588.80
4114659-11465985.76688.49
5115081-11508186.08288.79
6110811-11081182.88885.58
极限1111217-11121783.19184.260.9386.3687.440.91
2113366-11336684.79987.95
3112812-11281284.38587.60
4114171-11417185.40188.61
5112192-11219283.92187.11
6112078-11207883.83686.99
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100320240115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%
111.044317144315384315154321294320334317860.07
211.084342284343704342990.03
单位质量响应值RSD%判断
39111.0539196.660.16数据可信
供试品溶液-24111902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%
5min1106357-10635724.44829.9911.9524.4530.0011.95
2116927-11692726.87726.88
3138518-13851831.84031.84
4135875-13587531.23331.23
5137137-13713731.52331.52
6148122-14812234.04834.05
10min1211615-21161548.64255.089.1348.7855.259.13
2214550-21455049.31749.47
3252118-25211857.95358.13
4252480-25248058.03658.21
5241915-24191555.60755.78
6265110-26511060.93961.13
15min1283486-28348665.16371.947.6665.5772.417.67
2287729-28772966.13866.56
3318402-31840273.18973.69
4326782-32678275.11575.61
5314596-31459672.31472.80
6346708-34670879.69580.22
20min1331963-33196376.30683.407.3377.0784.277.35
2336623-33662377.37778.17
3363195-36319583.48584.39
4379541-37954187.24288.16
5362647-36264783.35984.24
6403015-40301592.63893.61
30min1377833-37783386.85093.034.4688.0494.364.50
2393375-39337590.42291.64
3398139-39813991.51792.89
4423022-42302297.23798.63
5413313-41331395.00596.35
6422670-42267097.15698.64
45min1405425-40542593.19295.611.5594.8797.471.60
2416372-41637295.70897.43
3414969-41496995.38697.26
4415536-41553695.51697.45
5425390-42539097.78199.66
6418094-41809496.10498.13
60min1405645-40564593.24395.661.6195.4398.041.62
2420259-42025996.60298.86
3414736-41473695.33297.74
4417700-41770096.01498.48
5425297-42529797.760100.18
6413387-41338795.02297.58
极限1395763-39576390.97194.762.6393.6897.682.63
2421201-42120196.81899.61
3402199-40219992.45195.39
4413877-41387795.13598.14
5419087-41908796.33299.30
6421318-42131896.84599.93
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