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東康源的甲潑尼龍琥珀酸2921-57-5原粉質(zhì)量怎么樣？用檢測數(shù)據(jù)說話

質(zhì)檢單

CERTIFICATE OF ANALYSIS

品名

Product Name

Methylpredmisolone hemisuccinate

數(shù)量

Quantity

20kg

批號(hào)

Batch no

191201

包裝

Packing

5kg/袋

生產(chǎn)日期

Produce Date

2019年12月08號(hào)

報(bào)告日期

Report Date

2019年12月11日

檢驗(yàn)依據(jù)

Ref.Standard

USP34標(biāo)準(zhǔn)

USP34 Standard

檢驗(yàn)項(xiàng)目及結(jié)果

Item and Results

Item	Specification	Results of Analysis
Description	White or almost white hygroscopic Powder	White hygroscopic Powder
Identification	A:IR B:UV	Conform
Specific Rotation	+87°~+95°	+91.8°
Loss On Drying	≤1.0%	0.1%
Residue on ignition	≤0.2%	0.07%
Chromatographic purity	Any individual impurity≤1.0% Total impurities≤2.0%	0.29% 0.72%
Assay	97.0%-103.0%	99.4%
Residual solvents	Methanol≤3000ppm Ethanol≤5000ppm Dichloromethane≤600ppm Acetone≤5000ppm	420ppm 2200ppm 120ppm 520ppm
Conclusion	The specification conform with USP34