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Avigna Pharmaceuticals OLSALAZINE SODIUM BP/EP

Avigna Pharmaceuticals OLSALAZINE SODIUM BP/EP is a yellow, fine, crystalline powder.

Certifications & Compliance: GMP

Technical Data Sheet
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Knowde Enhanced TDS

Identification & Functionality

Applications & Uses

Properties

Sparingly soluble in
Water
Slightly Soluble in
Methanol
Soluble in
Dimethyl Sulphoxide
Typical Properties
ValueUnitsTest Method / Conditions
Acetate Contentmax. 1.0%2.2.29 As per BP, (HPLC)
Methanesulphonic Acid Contentmax. 0.3%2.2.29 As per BP, (HPLC: A)
Unknown Impurity Contentmax. 1.0%2.2.29 As per BP
Total Impurity Contentmax. 2.0%2.4.8
Heavy Metals Contentmax. 10ppm PbAs per BP
Loss On Drying (Determined on 1.0 gm for 1 hours at 150°C)max. 2.0%2.5.12 As per BP
Assay (Content Of C₁₄₅H₈N₂Na₂O₆ On Dried Basis)98 - 102%2.2.20 As per BP, (Potentiometric titration)

Regulatory & Compliance

Certifications & Compliance

Technical Details & Test Data

Identification
  • Test A: Ratio of absorbance: The ratio of the absorbance measured at the maximum at 255 nm to that measured at the maximum at 362 nm is 0.53 to 0.56. (2.2.25 as per BP)
  • Test B: IR Spectrum: The sample IR spectrum should be concordant with that of standard. (2.2.24 As per BP)
  • Test C: TLC: The principal spot in the chromatogram obtained with the test solution is similar in position and size to the principal spot in the chromatogram obtained with reference solution. (a) (2.2.27 As per BP)
  • Test D: Sodium reaction: It should give reaction of Sodium 2.3.1. (As per BP)