品  名

Product Name

保 泰 松

Phenyl Butazone

批號

Batch NO

20221106

總量

Total Quantity

500kg

分子式及分子量

Molecular Formula and Molecular Weight

C₁₉H₂₀N₂O₂   308.38

作用與用途

Action and Use

消炎止痛

Anti-inflammatory;Analgesic

檢驗結果

Results

性狀

Characters

白色或類白色結晶性粉末，幾乎不溶于水，溶于乙醚微溶于乙醇，本品在氫氧化鈉溶液中溶解。

A White or Almost White,Crystalline Powder,Practically insoluble in water,soluble in ether,sparingly soluble in alcohol,It dissolver in alkaline solution

Complies

鑒別

Identification

A.熔點

Melting Point

104~107℃

104~107℃

B.吸收系數

Specific Absorbance

Complies

Complies

C.紅外光吸收圖譜

IR Absorption

Spwctrophotometry

與對照品一致

Comparing with Spectrum obtained with phenylbutazone CRS

Complies

D.與亞硝酸鈉反應

Reaction with NaNo.

+

Complies

檢查

Tests

溶液的外觀

Apearance of solution

澄清

Solution is Clear

Complies

酸堿值

Acidity or Alkalinity

符合

Pass test

Complies

吸收值

Absorbance

﹤0.2

0.14

有關雜質

Related Substance

符合

Pass test

Complies

重金屬

Heavy metals

﹤10PPM

﹤10PPM

干燥失重

Loss on drying

﹤0.2%

0.12%

磺化灰份

Sulohated ash

﹤0.1%

0.08%

氯化物

Chloride

﹤0.007%

0.005%

硫酸鹽

Sulfate

﹤0.01%

0.006%

有機揮發性物質

Organic Volatile Impurities

﹤0.002%

Complies

含量

Assay

99.0~101.0%

99.9%

符合英國藥典2000版            美國藥典25版

Complies with B.P2000Ed          Complies with U.S.P25Ed