品    名

Product Name

曲安奈德

Triamcinolone acetonide

批    號

Batch No.

20191210

生產(chǎn)日期

MFG. Date

2019/12/10

有效日期

Exp Date

2022/12/09

批    量

Quantity

50kg

執(zhí)行標(biāo)準(zhǔn)

Specification

USP36

檢驗(yàn)項(xiàng)目

ITEMS

標(biāo)準(zhǔn)規(guī)定

SPECIFICATIONS

檢驗(yàn)結(jié)果

RESULTS

性狀A(yù)ppearance

白色或類白色的結(jié)晶性粉末

White or almost white crystalline powder

白色結(jié)晶性粉末

White crystalline powder

鑒別Identification

A.供試品和對照品紅外光譜圖應(yīng)一致

A. Infrared absorption

B. 供試品和對照品紫外光譜圖應(yīng)一致

B. UV fraviolet absorption

• 符合規(guī)定Complies

• 符合規(guī)定Complies

比旋度

Specific Optical Rotation

+118^o～+130^o

+119.6^o

有關(guān)物質(zhì)

Related substance

最大單一雜質(zhì)≤0.3%

The largest impurity≤0.3%

總雜質(zhì)≤0.8%

Total impurity≤0.8%

單雜質(zhì)0.14%

The largest impurity0.14%

總雜質(zhì)0.66%

Total impurity0.66%

干燥失重

Loss on drying

≤1.5%

0.39%

重金屬

Heavy metals

≤25ppm

Complies

含量

Assay

97.0%～102.0%

99.7%

粒徑

Particle size

≤15um

11.4um

結(jié)論

Congclusion

本品符合美國藥典36版之規(guī)定

The product conforms to USP36