非奈利酮片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)0
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1000
标示量(mg)10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%
1 10.843741473728033746353725643742773736850.26
2 10.813706263726713716480.39
单位质量响应值RSD%判断
34472.7934380.020.20数据可信
供试品溶液-2025082921批-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%
5min1164737-16473743.03247.249.3143.0347.239.31
2160912-16091242.03342.03
3207145-20714554.11054.11
4180327-18032747.10547.10
5188590-18859049.26349.26
6183274-18327447.87547.87
10min1255957-25595766.86166.892.2966.9366.972.30
2246831-24683164.47764.55
3264807-26480769.17369.26
4258840-25884067.61467.69
5255036-25503666.62066.70
6255021-25502166.61666.70
15min1286544-28654474.85174.551.0175.0374.741.02
2282539-28253973.80473.98
3290458-29045875.87376.08
4285063-28506374.46474.65
5284881-28488174.41674.61
6282967-28296773.91674.11
20min1304026-30402679.41778.961.0179.7379.271.01
2298184-29818477.89178.19
3305172-30517279.71780.05
4305481-30548179.79780.11
5300176-30017678.41278.73
6300587-30058778.51978.83
30min1322355-32235584.20583.890.7084.6584.330.70
2320700-32070083.77384.20
3322650-32265084.28284.75
4323930-32393084.61785.06
5318449-31844983.18583.63
6318738-31873883.26083.71
45min1338224-33822488.35087.650.7388.9388.240.72
2337322-33732288.11588.68
3337048-33704888.04388.65
4335407-33540787.61588.20
5332823-33282386.94087.53
6332472-33247286.84887.43
60min1347731-34773190.83489.980.8391.5690.710.82
2346764-34676490.58191.30
3343393-34339389.70190.45
4346203-34620390.43591.17
5341679-34167989.25389.98
6340905-34090589.05189.78
极限1351232-35123291.74891.040.7492.6391.920.73
2349135-34913591.20192.07
3348287-34828790.97991.88
4350951-35095191.67592.56
5344330-34433089.94590.83
6347247-34724790.70791.58
非奈利酮片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)0
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1000
标示量(mg)10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%
1 10.843724443715753711943717433708113715530.17
2 10.813703963718033711000.27
单位质量响应值RSD%判断
34276.1134329.320.11数据可信
供试品溶液-2025082921批-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%
5min1110358-11035828.93144.1624.7728.9344.1624.77
2173588-17358845.50845.51
3208962-20896254.78254.78
4195425-19542551.23351.23
5123594-12359432.40132.40
6198826-19882652.12452.12
10min1239705-23970562.84166.944.0662.8967.024.08
2256627-25662767.27767.35
3266283-26628369.80969.90
4261630-26163068.58968.67
5246010-24601064.49464.55
6261898-26189868.65968.75
15min1283660-28366074.36474.841.2774.5275.021.29
2282525-28252574.06774.25
3290890-29089076.26076.47
4288231-28823175.56375.76
5281445-28144573.78473.95
6286045-28604574.99075.19
20min1302349-30234979.26479.240.6779.5479.550.67
2300902-30090278.88579.20
3304341-30434179.78680.12
4304070-30407079.71580.04
5302893-30289379.40679.69
6299074-29907478.40578.73
30min1325422-32542285.31384.130.9285.7284.570.91
2316481-31648182.96983.41
3321532-32153284.29384.76
4321727-32172784.34484.80
5320916-32091684.13184.55
6319391-31939183.73284.19
45min1342374-34237489.75787.951.1590.3188.541.12
2332879-33287987.26887.85
3335944-33594488.07188.68
4334036-33403687.57188.17
5336298-33629888.16488.72
6331433-33143386.88987.49
60min1350187-35018791.80590.021.1292.5190.751.10
2341888-34188889.62990.36
3342597-34259789.81590.57
4341944-34194489.64490.39
5344821-34482190.39891.10
6338876-33887688.84089.58
极限1356051-35605193.34291.171.2694.2092.051.24
2344878-34487890.41391.29
3346296-34629690.78591.69
4344785-34478590.38991.28
5349202-34920291.54792.40
6345403-34540390.55191.44
非奈利酮片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)0
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1000
标示量(mg)10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%
1 10.843713773709583704383714303697393707880.20
2 10.813709863706293708080.07
单位质量响应值RSD%判断
34205.5434302.310.20数据可信
供试品溶液-2025083021批-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%
5min1212495-21249555.78750.4617.1755.7950.4617.17
2212690-21269055.83855.84
3213700-21370056.10456.10
4153361-15336140.26240.26
5214788-21478856.38956.39
6146094-14609438.35538.35
10min1268526-26852670.49769.593.7770.5969.683.79
2270732-27073271.07671.17
3272264-27226471.47971.57
4255888-25588867.17967.25
5273659-27365971.84571.94
6249403-24940365.47765.54
15min1292769-29276976.86276.711.5877.0776.911.60
2293754-29375477.12077.33
3296552-29655277.85578.07
4288992-28899275.87076.05
5296441-29644177.82678.04
6284710-28471074.74674.92
20min1305978-30597880.33080.741.2380.6781.071.25
2310267-31026781.45681.80
3310990-31099081.64581.99
4305395-30539580.17780.48
5310928-31092881.62981.97
6301787-30178779.22979.53
30min1321045-32104584.28585.030.8884.7685.490.90
2326293-32629385.66386.14
3325359-32535985.41885.90
4322491-32249184.66585.10
5327336-32733685.93786.42
6320699-32069984.19484.62
45min1333777-33377787.62888.291.0688.2488.901.08
2339593-33959389.15589.77
3337947-33794788.72389.34
4335785-33578588.15588.74
5339938-33993889.24589.87
6330829-33082986.85487.42
60min1341806-34180689.73690.430.7890.4991.180.80
2346565-34656590.98591.75
3346040-34604090.84791.62
4343943-34394390.29791.02
5347386-34738691.20191.97
6340870-34087089.49090.20
极限1345104-34510490.60291.330.7591.5192.230.76
2348939-34893991.60892.53
3349404-34940491.73092.65
4349042-34904291.63592.51
5350611-35061192.04792.97
6344129-34412990.34691.21
非奈利酮片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)0
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1000
标示量(mg)10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%
1 10.843692823707293692153700103704073699290.19
2 10.813687893687063687480.02
单位质量响应值RSD%判断
34126.2934111.750.04数据可信
供试品溶液-2025083021批-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%
5min1212050-21205055.89054.846.4555.8954.846.45
2220706-22070658.17258.17
3181890-18189047.94147.94
4213612-21361256.30256.30
5209987-20998755.34755.35
6210131-21013155.38555.38
10min1273244-27324472.01971.861.3672.1171.951.36
2277786-27778673.21673.31
3266631-26663170.27670.36
4270931-27093171.41071.50
5273630-27363072.12172.21
6273646-27364672.12572.22
15min1298263-29826378.61478.520.8278.8378.730.83
2302158-30215879.64079.86
3295679-29567977.93378.13
4297507-29750778.41478.63
5295399-29539977.85978.07
6298369-29836978.64278.85
20min1313368-31336882.59582.280.4182.9482.620.41
2314081-31408182.78383.13
3310910-31091081.94782.27
4311537-31153782.11282.46
5311422-31142282.08282.42
6311632-31163282.13782.48
30min1328957-32895786.70486.620.4387.1987.100.43
2330956-33095687.23187.72
3329253-32925386.78287.25
4328039-32803986.46286.94
5326988-32698886.18586.66
6327745-32774586.38486.86
45min1340880-34088089.84689.920.4590.4790.540.45
2343449-34344990.52391.16
3342156-34215690.18390.79
4341331-34133189.96590.59
5339309-33930989.43290.05
6339890-33989089.58590.21
60min1348533-34853391.86391.630.6192.6492.400.61
2349340-34934092.07692.86
3349384-34938492.08892.85
4344053-34405390.68391.46
5346159-34615991.23892.01
6348388-34838891.82592.60
极限1351204-35120492.56792.540.2793.5093.470.27
2352481-35248192.90493.84
3351725-35172592.70593.62
4350786-35078692.45793.38
5349809-34980992.20093.12
6350707-35070792.43693.36
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