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 10.843763173758783758403756533753693758110.10
2 10.813738143736083737110.04
单位质量响应值RSD%判断
34668.9134570.860.21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%
5min1108212-10821228.10931.0046.8228.1131.0046.83
2180319-18031946.83946.84
3114843-11484329.83129.83
451402-5140213.35213.35
5189208-18920849.14849.15
671969-7196918.69518.69
10min1207069-20706953.78855.7816.0853.8355.8316.11
2248590-24859064.57364.65
3224361-22436158.28058.33
4164357-16435742.69342.72
5253800-25380065.92766.01
6190302-19030249.43349.46
15min1245958-24595863.89065.909.0864.0366.059.12
2273838-27383871.13271.32
3265223-26522368.89469.04
4217360-21736056.46156.55
5278052-27805272.22672.42
6241865-24186562.82762.94
20min1265931-26593169.07871.326.0669.3271.586.10
2287245-28724574.61474.92
3285557-28555774.17674.44
4247858-24785864.38364.57
5291455-29145575.70876.02
6269342-26934269.96470.18
30min1286968-28696874.54276.993.3674.9077.373.40
2303049-30304978.72079.15
3306722-30672279.67480.06
4282302-28230273.33073.63
5303803-30380378.91579.35
6295602-29560276.78577.12
45min1302564-30256478.59481.072.1779.0881.582.21
2314510-31451081.69782.26
3318811-31881182.81483.33
4306337-30633779.57479.99
5319357-31935782.95683.53
6311088-31108880.80881.27
60min1310488-31048880.65283.252.0381.2783.892.05
2319309-31930982.94383.64
3327060-32706084.95785.61
4316554-31655482.22882.78
5327379-32737985.04085.75
6322167-32216783.68684.28
极限1325993-32599384.68086.131.0685.4386.911.07
2330921-33092185.96086.79
3336227-33622787.33888.14
4330212-33021285.77586.46
5332446-33244686.35687.21
6333765-33376586.69887.44
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 10.843731833729573730023730623726023729610.06
2 10.813714093715333714710.03
单位质量响应值RSD%判断
34406.0034363.640.09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%
5min1179180-17918046.86244.7912.0346.8644.7912.03
2186896-18689648.88048.88
3164746-16474643.08743.09
4132166-13216634.56634.57
5181724-18172447.52747.53
6182871-18287147.82747.83
10min1249136-24913665.15863.884.8665.2463.964.87
2253824-25382466.38466.47
3230842-23084260.37360.44
4227423-22742359.47959.54
5252209-25220965.96166.04
6252042-25204265.91866.00
15min1275026-27502671.92970.984.1072.1271.164.11
2280183-28018373.27773.47
3257796-25779667.42267.59
4256711-25671167.13967.30
5279812-27981273.18073.37
6278861-27886172.93273.12
20min1288966-28896675.57474.743.3375.8875.043.33
2294371-29437176.98877.30
3272899-27289971.37271.66
4274677-27467771.83772.11
5290702-29070276.02876.34
6293053-29305376.64376.95
30min1304512-30451279.64079.223.0680.0779.643.07
2310726-31072681.26581.71
3290974-29097476.10076.50
4291650-29165076.27676.66
5309888-30988881.04681.48
6309708-30970880.99981.44
45min1317288-31728882.98282.552.8483.5583.112.85
2322237-32223784.27684.85
3304570-30457079.65580.19
4304248-30424879.57180.09
5322341-32234184.30384.88
6323243-32324384.53985.11
60min1323512-32351284.60984.282.7585.3184.982.76
2328520-32852085.91986.64
3311982-31198281.59482.26
4310485-31048581.20281.85
5329322-32932286.12986.84
6329765-32976586.24586.96
极限1331081-33108186.58986.811.2187.4387.641.24
2333245-33324587.15588.02
3326398-32639885.36486.16
4328492-32849285.91286.70
5335929-33592987.85788.71
6336354-33635487.96888.83
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 10.843720953720003721963717313716823719410.07
2 10.813716913714133715520.06
单位质量响应值RSD%判断
34311.9034371.140.13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%
5min170673-7067318.50732.2740.2518.5132.2740.25
2158103-15810341.40141.40
3107442-10744228.13528.14
4192321-19232150.36250.36
5141875-14187537.15237.15
668942-6894218.05318.05
10min1186397-18639748.81156.4714.6848.8456.5214.71
2243855-24385563.85763.93
3203159-20315953.20053.25
4257315-25731567.38267.47
5224675-22467558.83458.90
6178451-17845146.73046.76
15min1227894-22789459.67766.239.3959.7966.389.42
2274270-27427071.82172.00
3245518-24551864.29264.43
4285749-28574974.82775.02
5255656-25565666.94767.11
6228480-22848059.83159.94
20min1250702-25070265.65071.726.9065.8671.986.94
2291573-29157376.35276.65
3268756-26875670.37870.62
4299661-29966178.47078.79
5274374-27437471.84972.12
6258341-25834167.65067.86
30min1278174-27817472.84477.524.6273.1677.904.66
2309061-30906180.93281.35
3294992-29499277.24877.61
4314389-31438982.32782.78
5293498-29349876.85777.25
6286085-28608574.91575.24
45min1301532-30153278.96081.622.9679.4082.133.01
2317778-31777883.21583.77
3312813-31281381.91482.40
4326280-32628085.44186.03
5307163-30716380.43580.95
6304588-30458879.76180.21
60min1312147-31214781.74083.992.5982.3184.632.64
2327883-32788385.86186.56
3322102-32210284.34784.97
4332747-33274787.13487.87
5315155-31515582.52883.18
6314377-31437782.32482.90
极限1331508-33150886.81087.381.3487.5288.161.38
2339100-33910088.79889.64
3335556-33555687.87088.64
4337826-33782688.46489.34
5329449-32944986.27187.06
6328595-32859586.04786.76
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 10.843718713717123719133713173717823717190.07
2 10.813715723717723716720.04
单位质量响应值RSD%判断
34291.4234382.240.19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%
5min1183622-18362248.09145.3911.0948.0945.4011.09
2174465-17446545.69245.69
3137831-13783136.09836.10
4195140-19514051.10751.11
5174183-17418345.61945.62
6174730-17473045.76245.76
10min1254815-25481566.73665.483.1466.8265.563.14
2253143-25314366.29866.37
3246585-24658564.58164.64
4260794-26079468.30268.39
5246388-24638864.52964.61
6238478-23847862.45762.53
15min1280865-28086573.55972.792.2673.7572.972.26
2281478-28147873.71973.91
3277297-27729772.62472.79
4285801-28580174.85175.05
5273915-27391571.73871.92
6268121-26812170.22170.40
20min1296446-29644677.63976.762.0777.9577.072.08
2295176-29517677.30777.62
3293967-29396776.99077.28
4300644-30064478.73979.06
5289020-28902075.69476.00
6283393-28339374.22174.52
30min1313554-31355482.12081.221.5482.5681.651.54
2311895-31189581.68582.12
3310720-31072081.37881.79
4315594-31559482.65483.11
5305818-30581880.09480.52
6303073-30307379.37579.80
45min1325490-32549085.24684.451.1985.8385.021.20
2322922-32292284.57385.15
3323748-32374884.79085.34
4326792-32679285.58786.18
5318782-31878283.48984.05
6316978-31697883.01783.57
60min1328809-32880986.11586.231.0286.8486.941.02
2331065-33106586.70687.42
3330725-33072586.61787.31
4333900-33390087.44888.18
5325381-32538185.21785.92
6325635-32563585.28485.98
极限1339991-33999189.04488.390.6589.9189.250.66
2338260-33826088.59089.45
3338099-33809988.54889.39
4338670-33867088.69889.58
5336268-33626888.06988.91
6333776-33377687.41688.25
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