Product Specifications:

Appearance:- White to yellowish-white powder

Solubility:- Soluble in water, very soluble in acetonitrile, in ethanol (96 per cent) and in methylene chloride

Appearance of solution :- Solution S is clear and not more intensely coloured than reference solution Y7.

Related substances:-

·        Impurity E: NMT 1.5%

·        Impurity A: NMT 1.5%

·        Impurity D: NMT 1.5%

·        Impurity C: NMT 1.0%

·        Impurity F: NMT 1.0%

·        Impurity G: NMT 1.0%

·        Impurity H,I,K: NMT 1.0%

·        Any other impurity: NMT 0.1 %

·        Total impurities: NMT 3.5%

·        Impurity J:- NMT 10ppm

Isomer composition :-

·        Atracurium cis-cis isomer: 55.0% ~ 60.0%

·        Atracurium cis-trans isomer: 34.5% ~ 38.5%

·        Atracurium trans-trans isomer: 5.0% ~ 6.5%

Water:- NMT 5.0%

Sulphated ash:- NMT 0.1%

Assay:- 96.0% ~ 102.0%(anhydrous substance)

Identification:- HPLC IR