Identity according to Pharmacopoeias................................................ p/t.

Specific rotation [a]20/D c=10 (in H2O) calc. a.a.s...............+54,4 to+55,9°

MAX. IMPURITIES

Appearance of solution........................................................................ p/t.

Insoluble matter in H2O......................................................................... p/t.

Loss on drying at 80°C..................................................................... 0,5 %

Residue on ignition (as SO4)............................................................. 0,1 %

Residual solvents (Ph.Eur./USP)............................................................ p/t

ABS at l400 nm sol. 10% in H2O........................................................0,04

ABS of l270 to 300 nm sol. 1% in H2O...............................................0,07

ABS of l210 to 220 nm sol. 1% in H2O...............................................0,25

Acidity or alkalinity............................................................................... p/t.

Chloride (Cl).................................................................................... 0,01 %

Sulphate (SO4)................................................................................ 0,02 %

Water (H2O).................................................................................4,5-5,5 %

Heavy metals (as Pb).................................................................. 0,0005 %

Microbial limits:

Total aerobic microbial count (TAMC)......................................... 100 cfu/g

Yeasts and molds......................................................................... 50 cfu/g

Escherichia coli............................................................................absence

Salmonella....................................................................................absence

As............................................................................................... 0,0001 %

Cu............................................................................................... 0,0005 %

Fe................................................................................................ 0,0005 %

Ni................................................................................................ 0,0005 %