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Pharmaceutical Grade Urea

This is a brief introduction of pharmaceutical grade urea

USP GRADE UREA

CERTIFICATE OF ANALYSIS

Product

USP  Urea

Formula

CH4N2O

Manufacturing Date

2019.4.10

Report Date

2019.4.10

Expiry Date

2022.4.09

Batch No:

190410

Standard

Usp39

Packing

KG/Bag

Appearance

Colorless prism-shaped crystalline or powder no smell, salty taste, Have long time placed Ammonia

Identification

A: Hcat about 500mgi in a test tube itllquefies and ammonia is evolved. Continue the heating until the liquid becomes turbid then cool. Dissolve the mass in a mixture of 10ml of water and 1ml of sodium hydroxide solution and I drop of cupric sulfate The solution acquires a reddish-violet color

B: Dissolve 100mg in 1ml of water and add 1ml of nitric acid a white crystalline precipitate of urea nitrate is formed

Test Items

Limit

Result

Residue on ignition

≤0.1%

0.02%

Biuret

≤0.4%

0.25%

Alcohol-insoluble matter

≤0.04%

0.012%

Ammonium

≤0.005%

0.003%

Chloride

≤0.007%

0.001%

Sulfate

≤0.01%

0.003%

Heavy metals

≤0.002%

0.001%

Loss on drying

≤0.5%

0.3%

Assay

99.0%-100.5%

99.3%

Conclusion    After inspection, in line with the Usp39 standard