Product Name: Mesalazine

Expiry date: 2022-04-12

Item

Specification   EP7.7

Appearance

Almost white or light grey or light pink powder or crystals

Identification

The IR absorption spectrum conform the reference spectrum

Appearance of solution

Clarity

Clear

Absorbance

≤ 0.15 (440nm)

≤ 0.10 (650nm)

Reducing substances

(4mg/mL HCl solution)

The solution turns blue or violet-brown after addition of Starch solution & 0.01M iodine

Related substances

(HPLC)

Impurity F,J,O,P≤ 0.1%

Impurity E,G,L,M,R≤ 0.05%

Impurity H≤ 0.3%

Any other Impurity≤ 0.05%

Total Impurity≤ 0.5%

Impurity A & C

(HPLC)

Impurity A≤ 200ppm

Impurity C≤ 200ppm

Impurity K

≤ 10 ppm

Chlorides

≤ 0.1%

Sulphates

≤ 200ppm

Heavy metals

≤ 10 ppm

Loss on drying

≤ 0.5%, (1.0g, 100~105℃)

Sulphated ash

≤ 0.2%

Assay

98.5%~101.5% ( anhydrous)

Conclusion

Complied with the requirement of EP7.7