Polpharma Pharmaceutical Works - API Manufacturer

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Acetazolamide

Specification:
  • USP
chemical name: N-(5-sulphamoyl-1,3,4-thiadiazol-2-yl)acetamide
molecular formula: C4H6N4O3S2
structural formula: structural formula
molecular weight: 222.2
CAS Registery number: 59-66-5

General information:

White to faintly yellowish-white, crystalline, odorless powder. Sparingly soluble in practically boiling water; slightly soluble in alcohol; very slightly soluble in water.

TESTS REQUIERMENTS METHODS
Identification:

A. IR spectrum

B. chemical identification
corresponds to spectrum obtained
with reference substance

conforms
USP
Water not more than 0.5% USP
Residua on ignition not more than 0.1% USP
Chloride not more than 0.014% USP
Sulfate not more than 0.04% USP
Selenium not more than 0.003% USP
Heavy metals not more than 0.002% USP
Silver-reducing substances not less than 4.8 ml of 0.1 N ammoniumthiocyanate USP
Relative substances:

- sum of impurities
not more than 2.0% USP
Residual solvents:

- acetic acid

- acetone 1)
loss on drying

less than 0.5%
USP
Content of acetazolamide calculated on anhydrous substance 98.0% - 102.0% USP
1) Acetone should be examined only in case acetazolamide manufactured from acetylmercaptoamine manufactured in Polpharma. « back to API list

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