Description

Batch No. Yw********1 Batch size **0kg MFG date ***9.*9.*4 Sampling date ***9.*9.*4 Test date ***9.*9.*4 Report date ***9.*9.*5 Reference EP6 R test date ***1.*9.*3 Testing items Specification. EP Test results Appearance White or yellowish-white crystalline powder White-crystalline powder Appearance of solution The solution is clear and mot more intensely coloured than reference solution BY7 clear Identification IR Corresponds with that of CRS standard complies HPLC The retention tine for H2B1a and H2B1b corresponds to CRS Complies Water Not more than 1.0% 0.5 Ethanol Not more than 5.0% 3.*5 Formamide Not more than 3.0% 2.*3 Ratio H2B1a/(H2B1a+H2B1b), a Not more than *0.0% *7.*5 Assay(H2B1a+H2B1b) (Anhydrous and solvent-free substance) Between *5.0% and **2.0% *5.*0 Related compounds Theindividual impurity(RRT1.**1.5) Not more than 2.5% 0.8 1.*0 Any other individual impurity not more than 1% 0.1 0.*9 0.*2 0.*0 0.*5 0.*3 Sum of total impurity not more than 5% 3.*9 Disregard peaks less than 0.*5% 0.*5 Heavey metals Not more than 0.**2% <0.**2 Sulphated ash Not more than 0.1 <0.1 Specific optical rotation(Anhydrous and solvent-free substance) Between **7°**0° **8° Residual solvents(toluene) Not more than **0ppm <**0ppm Conclusion Complies with the requirement of EP6 Reported by Reviewed by Approved by