XXYYYY片项目信息
介质体积(ml)1000取样体积(ml)2补液体积(ml)2
对照品批号1111对照品来源中检院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%
110.361073211073701073931074791073741073870.06
210.361074051069301071680.32
单位质量响应值RSD%判断
10365.5410344.400.15数据可信
供试品溶液-2023111721批-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%
5min151053-5105349.30349.159.7349.3049.159.73
243919-4391942.41342.41
356212-5621254.28554.29
446208-4620844.62444.62
552497-5249750.69750.70
655473-5547353.57153.57
10min187111-8711184.12577.9312.2684.2278.0312.25
269815-6981567.42267.51
389262-8926286.20286.31
468967-6896766.60366.69
577837-7783775.16975.27
691197-9119788.07188.18
15min195842-9584292.55788.3911.4392.8288.6411.43
279996-7999677.25477.47
3101551-10155198.07098.35
479796-7979677.06177.28
588332-8833285.30485.56
6103630-103630100.078100.36
20min199545-9954596.13393.029.5496.5893.459.54
286582-8658283.61483.99
3106669-106669103.012103.49
488553-8855385.51785.89
589898-8989886.81687.24
6106691-106691103.034103.52
30min1101870-10187098.37897.497.5699.0298.117.57
291216-9121688.08988.63
3111999-111999108.160108.84
495555-9555592.27992.83
598139-9813994.77595.37
6106945-106945103.279103.97
45min1103579-103579100.02896.934.89100.8797.744.92
293649-9364990.43991.16
3106151-106151102.512103.41
497846-9784694.49295.22
596987-9698793.66294.45
6104025-104025100.459101.36
60min1102238-10223898.73397.845.1999.7798.845.22
295782-9578292.49993.40
3108782-108782105.053106.16
498705-9870595.32196.24
596495-9649593.18794.16
6105858-105858102.229103.33
极限1110750-110750106.954105.952.08108.19107.152.04
2108611-108611104.888105.97
3106535-106535102.883104.20
4112457-112457108.602109.71
5108261-108261104.550105.71
6111655-111655107.828109.13
XXYYYY片项目信息
介质体积(ml)1000取样体积(ml)2补液体积(ml)2
对照品批号1111对照品来源中检院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%
110.361074281072901072171072821072371072910.08
210.361073591073191073390.03
单位质量响应值RSD%判断
10356.2710360.910.04数据可信
供试品溶液-2023111721批-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%
5min147568-4756845.92148.976.2345.9248.976.23
250728-5072848.97248.97
350381-5038148.63748.64
456254-5625454.30754.31
551588-5158849.80249.80
647822-4782246.16746.17
10min196359-9635993.02383.896.8093.1283.986.80
288494-8849485.43185.53
381137-8113778.32878.43
490268-9026887.14387.25
582278-8227879.43079.53
682824-8282479.95780.05
15min1102840-10284099.28094.446.5399.5694.716.52
2102523-10252398.97499.24
390330-9033087.20387.46
4105174-105174101.533101.82
592512-9251289.30989.57
693576-9357690.33790.59
20min1106767-106767103.07197.786.77103.5598.236.75
2100792-10079297.30397.77
388382-8838285.32285.75
4103820-103820100.226100.71
5106899-106899103.198103.64
6101044-10104497.54697.98
30min1108246-108246104.49999.305.33105.1899.955.33
2104532-104532100.913101.57
393482-9348290.24690.84
4107649-107649103.922104.61
5103036-10303699.469100.11
6100209-10020996.74097.37
45min1107746-107746104.016102.034.70104.91102.884.70
2108894-108894105.124105.99
396625-9662593.28094.06
4110054-110054106.244107.14
5107335-107335103.619104.46
6103488-10348899.905100.73
60min1111374-111374107.518101.924.12108.62102.984.12
2107633-107633103.907104.98
398363-9836394.95895.92
4106676-106676102.983104.09
5103760-103760100.168101.22
6105672-105672102.014103.04
极限1112374-112374108.484106.741.40109.80108.001.41
2109056-109056105.281106.56
3110180-110180106.366107.52
4111260-111260107.408108.72
5111949-111949108.074109.32
6108613-108613104.853106.08
XXYYYY片项目信息
介质体积(ml)1000取样体积(ml)2补液体积(ml)2
对照品批号1111对照品来源中检院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%
110.361070661071771067551065571065011068110.29
210.361058021055901056960.15
单位质量响应值RSD%判断
10309.9410202.320.75数据可信
供试品溶液-2023111821批-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%
5min166117-6611764.46848.6520.7864.4748.6520.79
242832-4283241.76341.76
350911-5091149.64149.64
445032-4503243.90943.91
537613-3761336.67536.67
656889-5688955.47055.47
10min195216-9521692.84184.4215.6992.9784.5215.69
292638-9263890.32790.41
376580-7658074.67074.77
482234-8223480.18380.27
567800-6780066.10966.18
6105012-105012102.392102.50
15min1102577-102577100.01894.768.80100.3395.038.81
299918-9991897.42597.69
388759-8875986.54586.79
4103424-103424100.844101.09
584187-8418782.08782.29
6104253-104253101.652101.97
20min1106837-106837104.17297.965.66104.6998.425.69
2100574-10057498.06598.52
396284-9628493.88294.30
4103232-103232100.657101.11
591501-9150189.21889.59
6104383-104383101.779102.30
30min1108260-108260105.559102.562.59106.28103.222.63
2103341-103341100.763101.42
3104744-104744102.131102.74
4107051-107051104.380105.03
5100948-10094898.43098.98
6106788-106788104.124104.85
45min1108283-108283105.582103.332.24106.52104.182.24
2102920-102920100.353101.21
3106360-106360103.707104.52
4109040-109040106.320107.18
5104914-104914102.297103.04
6104301-104301101.699102.63
60min1110462-110462107.706104.331.91108.85105.391.90
2105022-105022102.402103.46
3105891-105891103.249104.27
4105760-105760103.122104.19
5108354-108354105.651106.60
6106504-106504103.847104.98
极限1110375-110375107.622105.211.68108.98106.481.68
2104835-104835102.220103.48
3107428-107428104.748105.98
4108525-108525105.818107.10
5108106-108106105.409106.57
6108160-108160105.462106.80
XXYYYY片项目信息
介质体积(ml)1000取样体积(ml)2补液体积(ml)2
对照品批号1111对照品来源中检院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%
110.361060201058111059451059781057591059030.11
210.361057921057361057640.04
单位质量响应值RSD%判断
10222.3010208.880.10数据可信
供试品溶液-2023111821批-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%
5min166533-6653365.12948.3319.0365.1348.3219.03
247590-4759046.58646.59
351294-5129450.21250.21
448730-4873047.70247.70
541232-4123240.36240.36
640822-4082239.96139.96
10min197366-9736695.31180.0810.6695.4480.1710.67
277916-7791676.27276.36
379185-7918577.51477.61
484172-8417282.39682.49
580860-8086079.15479.23
671339-7133969.83369.91
15min1100994-10099498.86390.066.6699.1890.326.67
286194-8619484.37584.62
389768-8976887.87488.13
497722-9772295.66095.92
591230-9123089.30589.54
686131-8613184.31384.53
20min1101304-10130499.16696.074.8299.6896.504.82
290232-9023288.32888.74
395240-9524093.23093.66
4103448-103448101.265101.72
599397-9939797.29997.72
699204-9920497.11097.50
30min1102144-10214499.988100.272.67100.71100.902.66
297514-9751495.45696.05
3101710-10171099.564100.18
4103967-103967101.773102.43
5104131-104131101.933102.55
6105115-105115102.897103.48
45min1104260-104260102.060100.751.51102.98101.581.52
2102553-102553100.389101.17
3100218-10021898.10398.92
4103529-103529101.344102.20
5104417-104417102.213103.03
6102574-102574100.409101.20
60min1105987-105987103.750101.902.80104.87102.922.80
2102755-102755100.587101.57
3103288-103288101.108102.12
4105362-105362103.138104.20
5107706-107706105.433106.45
699454-9945497.35598.34
极限1108760-108760106.465106.151.62107.79107.381.63
2107056-107056104.797105.98
3107065-107065104.806106.02
4110836-110836108.497109.76
5110135-110135107.811109.04
6106777-106777104.524105.71
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