厄贝沙坦非奈利酮片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100607-202305对照品来源自制对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数500
标示量(mg)150供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.268443658479228477268493698482568475280.23
215.238491608507768499680.14
单位质量响应值RSD%判断
55539.1955808.800.35数据可信
供试品溶液-5122601批-厄贝沙坦-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%
5min1146461-14646115.78413.2251.8115.7813.2251.81
2124327-12432713.39913.40
355126-551265.9415.94
4223876-22387624.12724.13
5131991-13199114.22514.22
653973-539735.8175.82
10min1396399-39639942.72043.1715.4942.9043.3115.60
2412822-41282244.49044.64
3332523-33252335.83635.90
4483532-48353252.11152.38
5449332-44933248.42548.58
6328663-32866335.42035.48
15min1539114-53911458.10159.176.2958.7559.806.46
2559436-55943660.29160.93
3513757-51375755.36855.83
4594527-59452764.07364.92
5578284-57828462.32263.02
6509315-50931554.88955.35
20min1612162-61216265.97367.564.4367.2768.844.60
2635456-63545668.48469.80
3607248-60724865.44466.52
4665182-66518271.68773.25
5649011-64901169.94471.33
6592116-59211663.81364.88
30min1707873-70787376.28877.262.4278.3279.292.60
2704977-70497775.97678.05
3707466-70746676.24478.05
4741805-74180579.94582.30
5736193-73619379.34081.51
6702949-70294975.75777.53
45min1775995-77599583.63085.382.4486.5188.282.60
2787727-78772784.89487.81
3786094-78609484.71887.37
4822701-82270188.66391.91
5807962-80796287.07590.12
6773030-77303083.31085.93
60min1824024-82402488.80688.841.9192.6192.682.06
2815164-81516487.85191.71
3812598-81259887.57491.17
4834467-83446789.93194.16
5850624-85062491.67295.69
6809376-80937687.22790.77
90min1829922-82992289.44192.052.3194.2396.872.38
2851445-85144591.76196.60
3850809-85080991.69296.26
4865413-86541393.26698.49
5886140-88614095.500100.53
6840816-84081690.61595.13
120min1836682-83668290.17092.741.9095.9698.601.97
2854375-85437592.07797.93
3860460-86046092.73398.32
4871375-87137593.909100.17
5884754-88475495.351101.45
6855724-85572492.22297.74
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1836094-83609490.10792.762.6296.8999.652.66
2845986-84598691.17398.05
3855156-85515692.16198.78
4877616-87761694.581101.89
5897220-89722096.694103.85
6852488-85248891.87398.42
厄贝沙坦非奈利酮片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号D231201对照品来源自制对照品使用方法直接使用
对照品含量(%)99.92对照品水分(%)0对照品稀释倍数2500
标示量(mg)20供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.276311563139632946330963394632500.19
210.346314663374632600.26
单位质量响应值RSD%判断
6158.716117.990.47数据可信
供试品溶液-5122601批-非奈利酮-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%
5min12250-22503.29614.2887.103.3014.2887.09
28785-878512.87012.87
35387-53877.8927.89
423622-2362234.60734.61
515952-1595223.37023.37
62470-24703.6193.62
10min130456-3045644.61952.8912.6544.6653.0612.86
237545-3754555.00555.15
334457-3445750.48150.57
442494-4249462.25562.64
539485-3948557.84758.11
632191-3219147.16147.20
15min143275-4327563.39967.974.7163.9368.724.94
247558-4755869.67470.43
345721-4572166.98367.63
449148-4914872.00473.08
547861-4786170.11871.02
644812-4481265.65166.22
20min148597-4859771.19674.673.0972.4376.173.33
251915-5191576.05777.59
350878-5087874.53875.93
452994-5299477.63879.51
551617-5161775.62177.30
649822-4982272.99174.28
30min154573-5457379.95181.951.4881.9884.281.66
255295-5529581.00983.38
356362-5636282.57284.79
456723-5672383.10185.84
556437-5643782.68285.20
656230-5623082.37984.48
45min158541-5854185.76588.061.5788.6891.301.75
260067-6006788.00091.27
360652-6065288.85792.00
461385-6138589.93193.59
560001-6000187.90491.34
660009-6000987.91590.94
60min161805-6180590.54690.830.6294.4295.050.62
261908-6190890.69794.95
361901-6190190.68794.81
461509-6150990.11394.77
562596-6259691.70596.12
662290-6229091.25795.25
90min161871-6187190.64393.411.7195.5298.641.73
264010-6401093.77799.04
364635-6463594.69399.83
463167-6316792.54298.20
564781-6478194.906100.34
664103-6410393.91398.92
120min162950-6295092.22494.511.5698.11100.781.51
264349-6434994.274100.57
365499-6549995.958102.14
463878-6387893.583100.27
564860-6486095.022101.51
665542-6554296.021102.08
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限11666-16662.44164.1374.979.3571.4567.30
263951-6395193.690101.04
365106-6510695.383102.63
41161-11611.7019.43
565657-6565796.190103.74
665107-6510795.384102.51
厄贝沙坦非奈利酮片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100607-202305对照品来源自制对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数500
标示量(mg)150供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.268500878484098515048504178448238490480.31
215.238486608476448481520.09
单位质量响应值RSD%判断
55638.7955689.560.07数据可信
供试品溶液-5122901批-厄贝沙坦-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%
5min184726-847269.1339.5326.349.139.5326.34
2103807-10380711.18911.19
3105939-10593911.41911.42
443782-437824.7194.72
591648-916489.8799.88
6100768-10076810.86210.86
10min1319535-31953534.44234.6616.8634.5434.7616.88
2345247-34524737.21437.34
3337758-33775836.40736.53
4216120-21612023.29523.35
5339790-33979036.62636.74
6370636-37063639.95140.07
15min1506543-50654354.60054.713.5555.0855.203.68
2519196-51919655.96456.50
3514848-51484855.49556.03
4472179-47217950.89651.21
5512633-51263355.25655.77
6519727-51972756.02156.59
20min1591569-59156963.76564.271.2764.8665.371.39
2593555-59355563.97965.14
3598226-59822664.48265.63
4585764-58576463.13964.02
5601215-60121564.80565.94
6607011-60701165.42966.62
30min1685058-68505873.84275.001.1675.6476.821.14
2692848-69284874.68276.55
3688984-68898474.26576.13
4700008-70000875.45377.03
5703657-70365775.84777.70
6704460-70446075.93377.85
45min1762198-76219882.15782.781.3384.7885.431.25
2763321-76332182.27884.98
3753533-75353381.22383.91
4778273-77827383.88986.31
5780029-78002984.07986.77
6770574-77057483.06085.82
60min1791300-79130085.29486.701.2988.8390.271.20
2795283-79528385.72389.34
3800813-80081386.31989.91
4817364-81736488.10391.45
5808053-80805387.09990.73
6813468-81346887.68391.36
90min1832526-83252689.73790.911.4694.2295.441.33
2834369-83436989.93694.50
3837957-83795790.32394.87
4862652-86265292.98597.31
5854634-85463492.12096.72
6838053-83805390.33394.99
120min1831676-83167689.64691.191.5895.1296.731.46
2835056-83505690.01095.58
3840503-84050390.59796.15
4868282-86828293.59198.95
5848420-84842091.45197.07
6851994-85199491.83697.49
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1846745-84674591.27092.671.5497.7499.221.46
2849844-84984491.60498.17
3846932-84693291.29097.85
4871463-87146393.934100.34
5874475-87447594.259100.89
6868686-86868693.635100.31
厄贝沙坦非奈利酮片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号D231201对照品来源自制对照品使用方法直接使用
对照品含量(%)99.92对照品水分(%)0对照品稀释倍数2500
标示量(mg)20供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.276329763262632616331362889632040.29
210.346316163220631900.07
单位质量响应值RSD%判断
6154.246111.220.50数据可信
供试品溶液-5122901批-非奈利酮-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%
5min12509-25093.6795.0926.293.685.0926.29
23991-39915.8525.85
32942-29424.3144.31
42571-25713.7703.77
54197-41976.1546.15
64636-46366.7986.80
10min131726-3172646.52247.215.9246.5647.265.94
232999-3299948.38948.45
331828-3182846.67246.72
428924-2892442.41442.46
533140-3314048.59648.66
634552-3455250.66650.74
15min145639-4563966.92466.021.6367.4866.601.61
245470-4547066.67667.28
345892-4589267.29567.86
444214-4421464.83565.35
544663-4466365.49366.10
644274-4427464.92365.56
20min151159-5115975.01973.691.6776.3275.011.60
249641-4964172.79374.14
351049-5104974.85776.17
450785-5078574.47075.70
549645-4964572.79874.13
649250-4925072.21973.58
30min156436-5643682.75781.701.5284.8983.831.46
255380-5538081.20883.36
356526-5652682.88985.03
456377-5637782.67084.73
555011-5501180.66782.81
654561-5456180.00782.17
45min160906-6090689.31187.042.0192.3790.081.94
259116-5911686.68789.74
359915-5991587.85890.93
459903-5990387.84190.82
558899-5889986.36889.41
657399-5739984.16987.22
60min161266-6126689.83989.791.8993.8993.801.82
260746-6074689.07793.09
363105-6310592.53696.58
461955-6195590.85094.81
560424-6042488.60592.61
659913-5991387.85591.84
90min165042-6504295.37693.542.49100.4298.542.39
263293-6329392.81297.82
365378-6537895.869100.94
464741-6474194.93599.90
563097-6309792.52497.51
661178-6117889.71094.67
120min165040-6504095.37393.752.45101.4899.792.36
263324-6332492.85798.90
365778-6577896.456102.59
465023-6502395.348101.37
562418-6241891.52997.54
662002-6200290.91996.88
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限166015-6601596.80395.211.83103.97102.301.78
264204-6420494.147101.22
366243-6624397.137104.35
465440-6544095.960103.04
564500-6450094.582101.61
663160-6316092.61799.59
厄贝沙坦非奈利酮片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100607-202305对照品来源自制对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数500
标示量(mg)150供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.268499368504668499818508968482578499070.12
215.238530728544198537460.12
单位质量响应值RSD%判断
55695.0956056.860.46数据可信
供试品溶液-5123001批-厄贝沙坦-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%
5min153068-530685.6997.3437.165.707.3437.15
244305-443054.7584.76
3109219-10921911.72811.73
458531-585316.2856.29
590088-900889.6749.67
655059-550595.9125.91
10min1273786-27378629.40034.2311.8829.4634.3111.93
2314198-31419833.73933.79
3376521-37652140.43240.56
4302506-30250632.48432.55
5350101-35010137.59437.70
6295508-29550831.73231.80
15min1496658-49665853.33254.784.2153.7255.244.30
2497196-49719653.39053.82
3543316-54331658.34258.92
4503213-50321354.03654.47
5530178-53017856.93157.46
6490208-49020852.63953.06
20min1599329-59932964.35764.663.4965.3465.733.56
2585014-58501462.82063.84
3638766-63876668.59269.82
4599287-59928764.35365.38
5610318-61031865.53766.69
6580255-58025562.30963.31
30min1707557-70755775.97975.812.3577.6877.602.43
2697997-69799774.95276.67
3729660-72966078.35280.34
4706673-70667375.88477.63
5713957-71395776.66678.55
6679900-67990073.00974.70
45min1778771-77877183.62683.321.4486.1785.961.54
2769628-76962882.64485.20
3793008-79300885.15588.02
4769763-76976382.65985.25
5782576-78257684.03486.77
6762003-76200381.82584.33
60min1804720-80472086.41286.492.0489.8890.042.11
2796204-79620485.49888.97
3829627-82962789.08792.89
4810031-81003186.98390.49
5811342-81134287.12390.79
6780661-78066183.82987.24
90min1847185-84718590.97290.041.9695.4094.562.00
2818531-81853187.89592.32
3851966-85196691.48696.28
4845658-84565890.80895.28
5851168-85116891.40096.04
6816679-81667987.69692.04
120min1849456-84945691.21691.152.0496.6696.672.10
2832568-83256889.40394.80
3873330-87333093.78099.59
4855144-85514491.82797.31
5856562-85656291.97997.63
6825933-82593388.69094.01
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1850276-85027691.30491.543.0997.7698.073.08
2836623-83662389.83896.23
3896124-89612496.227103.08
4847650-84765091.02297.53
5865001-86500192.88599.56
6819193-81919387.96694.27
厄贝沙坦非奈利酮片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号D231201对照品来源自制对照品使用方法直接使用
对照品含量(%)99.92对照品水分(%)0对照品稀释倍数2500
标示量(mg)20供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.276341363464633186343563172633600.19
210.346367063780637250.13
单位质量响应值RSD%判断
6169.436162.960.08数据可信
供试品溶液-5123001批-非奈利酮-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%
5min12009-20092.9304.4162.902.934.4162.88
22042-20422.9782.98
35569-55698.1228.12
41698-16982.4762.48
55354-53547.8087.81
61468-14682.1412.14
10min127253-2725339.74644.5911.7139.7844.6411.75
232271-3227147.06447.10
335211-3521151.35251.44
426582-2658238.76738.79
533535-3353548.90848.99
628595-2859541.70341.73
15min143893-4389364.01464.213.4664.4964.763.55
244322-4432264.63965.20
346344-4634467.58868.25
442189-4218961.52961.99
544822-4482265.36966.00
642588-4258862.11162.60
20min150384-5038473.48072.412.8874.6773.672.93
249553-4955372.26873.54
352123-5212376.01677.43
448386-4838670.56671.71
549085-4908571.58672.94
648378-4837870.55571.73
30min156438-5643882.30980.882.0084.3182.942.03
255798-5579881.37683.45
356958-5695883.06885.32
454813-5481379.94081.87
554368-5436879.29181.44
654357-5435779.27481.24
45min160007-6000787.51486.301.9090.4389.261.91
259751-5975187.14190.12
360480-6048088.20491.38
458006-5800684.59687.41
557685-5768584.12887.16
659136-5913686.24489.09
60min161219-6121989.28288.471.7793.1792.391.78
261063-6106389.05593.00
362151-6215190.64194.80
460471-6047188.19191.95
559063-5906386.13890.11
659990-5999087.49091.29
90min163912-6391293.21091.341.4498.0996.241.40
262221-6222190.74395.68
363224-6322492.20697.37
462632-6263291.34396.08
561264-6126489.34894.27
662514-6251491.17195.94
120min163894-6389493.18392.481.7999.1098.401.76
263558-6355892.69398.64
364894-6489494.642100.83
463471-6347192.56698.32
561442-6144289.60795.52
663210-6321092.18697.97
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限164037-6403793.39292.942.33100.3499.892.32
263911-6391193.208100.19
366416-6641696.861104.10
463001-6300191.88198.66
562262-6226290.80397.72
662755-6275591.52298.33
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