Download The International Pharmacopoeia, Third Edition by World Health Organization PDF

By World Health Organization

Provides an historic account of the Pharmacopoeia and describes equipment and methods for the standard keep watch over of pharmaceutical elements and dosage varieties, together with a unique part on qc of anti-malarials.

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Extra info for The International Pharmacopoeia, Third Edition

Example text

1, p. 131). 53 mg of C12H15N3O2S. 40 Monographs for pharmaceutical substances Alcuronii chloridum Alcuronium chloride C44H50Cl2N4O2 Relative molecular mass. 8 Chemical name. N,N¢-Diallylnortoxiferinium dichloride; CAS Reg. No. 15180-03-7. Other name. Alcuronium dichloride. Description. A white to yellow-white, crystalline powder. Solubility. Soluble in water and ethanol (~750 g/l) TS. Category. Muscle relaxant. Storage. Alcuronium chloride should be kept in a tightly closed container at room temperature.

Sensitivity of the lysate. 25 l, where l is the stated sensitivity of the lysate used. The final dilution in each series must at the minimum give a negative result. Examine the dilutions and a negative control solution consisting of water LAL. Calculate the average of the logarithms of the lowest concentration of endotoxin in each series of dilutions giving a positive result. The antilogarithm of this average gives the estimated lysate sensitivity. If the latter does not differ by more than a factor of 2 from the stated sensitivity, the sensitivity is confirmed and is used for all tests performed using the same lysate.

If the preparation has more than one active ingredient, the requirement applies only to those active ingredients that fall into the above category. If the test for uniformity of content is prescribed for all active ingredients, the test for uniformity of mass is not required. Containers Suppositories should be supplied in a well-closed container. The container material should not adversely affect the quality of the preparation, nor should it allow diffusion into or across the material of the container or yield foreign substances into the preparation.

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