褪黑素颗粒项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号520023-202203对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数10000
标示量(mg)1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%
19.986348863482635526354163465635060.07
2 10.056357463466635200.13
单位质量响应值RSD%判断
6363.336320.400.48数据可信
供试品溶液-25070801批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min166859-6685994.78992.989.2594.7992.989.25
253368-5336875.66275.66
367131-6713195.17495.17
468016-6801696.42996.43
569357-6935798.33098.33
668789-6878997.52597.52
10min167777-6777796.09098.231.5696.2598.391.56
269857-6985799.03999.17
368115-6811596.56996.73
470342-7034299.72799.89
570106-7010699.39299.56
669521-6952198.56398.73
15min167664-6766495.93098.451.5596.2598.771.55
269851-6985199.03099.32
368564-6856497.20697.53
470305-7030599.674100.00
570136-7013699.43599.76
670122-7012299.41599.74
20min167606-6760695.84898.041.5496.3398.531.53
269605-6960598.68299.14
368144-6814496.61097.09
470247-7024799.592100.08
569290-6929098.23598.73
670043-7004399.30399.80
30min167558-6755895.78098.031.5096.4298.681.50
269778-6977898.92799.55
368124-6812496.58297.22
469875-6987599.06499.72
569962-6996299.18899.85
669569-6956998.63199.29
45min166510-6651094.29497.792.1295.0998.602.11
269611-6961198.69099.48
367927-6792796.30397.11
470211-7021199.541100.36
570108-7010899.395100.22
669508-6950898.54499.37
60min166815-6681594.72697.761.9295.6898.731.92
269147-6914798.03298.98
368056-6805696.48697.45
470538-70538100.004100.99
569665-6966598.76799.76
669501-6950198.53499.52
极限167053-6705395.06493.8510.7796.1894.9810.65
269255-6925598.18599.30
351801-5180173.44074.57
469664-6966498.76599.92
569963-6996399.189100.34
669433-6943398.43899.59
褪黑素颗粒项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号520023-202203对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数10000
标示量(mg)1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%
19.986339963468635006332663478634340.12
2 10.056323563375633050.16
单位质量响应值RSD%判断
6356.116299.000.64数据可信
供试品溶液-25070801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%
5min170675-70675100.42697.192.10100.4397.192.10
268663-6866397.56797.57
369085-6908598.16798.17
466620-6662094.66494.66
568064-6806496.71696.72
667274-6727495.59395.59
10min170218-7021899.77798.141.4199.9498.301.41
269762-6976299.12999.29
369470-6947098.71498.88
467815-6781596.36296.52
569164-6916498.27998.44
667981-6798196.59896.76
15min170714-70714100.48198.101.98100.8298.421.98
269759-6975999.12499.45
369848-6984899.25199.58
466957-6695795.14395.46
568877-6887797.87198.20
668061-6806196.71297.03
20min171049-71049100.95898.301.75101.4698.791.75
269604-6960498.90499.40
369357-6935798.55399.05
468474-6847497.29997.78
569165-6916598.28098.77
667432-6743295.81896.30
30min169956-6995699.40497.911.50100.0798.561.50
269655-6965598.97799.63
369392-6939298.60399.26
467751-6775196.27196.91
569158-6915898.27098.92
667496-6749695.90996.55
45min171038-71038100.94298.231.77101.7899.051.77
269697-6969799.03699.86
369133-6913398.23599.06
467641-6764196.11596.91
569242-6924298.39099.21
668025-6802596.66197.46
60min170735-70735100.51198.331.49101.5199.311.49
269658-6965898.98199.97
369511-6951198.77299.76
467766-6776696.29397.25
569088-6908898.17199.15
668446-6844697.25998.22
极限170470-70470100.13598.191.38101.3199.341.38
269431-6943198.65899.81
369427-6942798.65399.80
467887-6788796.46497.58
569260-6926098.41599.56
668145-6814596.83197.96
褪黑素颗粒项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号520023-202203对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数10000
标示量(mg)1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%
19.986409964020641616390763958640290.17
2 10.056323863199632180.05
单位质量响应值RSD%判断
6415.736290.351.40数据可信
供试品溶液-25070801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%
5min170042-7004299.13597.092.8399.1497.092.83
268800-6880097.37797.38
370375-7037599.60699.61
464937-6493791.91091.91
568716-6871697.25897.26
668720-6872097.26497.26
10min171350-71350100.98699.191.84101.1599.351.84
269757-6975798.73298.89
371424-71424101.091101.26
467915-6791596.12596.28
569887-6988798.91699.08
670133-7013399.26499.43
15min171337-71337100.96898.812.46101.3099.142.45
269859-6985998.87699.20
371524-71524101.233101.57
466762-6676294.49394.81
569526-6952698.40598.73
669860-6986098.87799.21
20min171742-71742101.54199.101.84102.0499.601.84
269293-6929398.07598.57
371346-71346100.981101.48
468345-6834596.73397.20
569786-6978698.77399.26
669611-6961198.52599.02
30min171746-71746101.54798.932.06102.2299.582.06
269594-6959498.50199.16
371540-71540101.255101.93
468193-6819396.51897.15
568983-6898397.63698.29
669308-6930898.09698.75
45min172270-72270102.28898.832.29103.1399.652.29
269170-6917097.90198.72
371101-71101100.634101.47
467793-6779395.95296.74
569323-6932398.11798.94
669284-6928498.06298.88
60min172070-72070102.00599.022.01103.02100.012.01
269431-6943198.27099.25
371224-71224100.808101.82
468304-6830496.67597.63
569492-6949298.35799.34
669242-6924298.00398.99
极限172231-72231102.23398.812.34103.4199.962.33
269066-6906697.75498.90
371241-71241100.832102.01
467755-6775595.89897.01
569315-6931598.10699.25
669251-6925198.01599.16
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