Specification L04
L-4-Boronophenylalanine
4-(Borono 10B) –L-phenylalanine
Molecular Formula: C9H12BNO4
Molecular Weight: 208.2
C.A.S. No.: [80994-59-8]
Description: White or slightly yellow powder.
| Tests: | Limits: | Method: |
| Identification: a) I.R. spectrum b) 1H, 10B and 13C NMR spectrum c) boron qualitative test |
Ph. Eur. 5th Ed., <2.2.24> Ph. Eur. 5th Ed., <2.2.24> |
|
| Clarity of 5 % (w/v) solution in 1 M HCl: | clear | Ph. Eur. 5th Ed., <2.2.1> |
| Color of 5 % (w/v) solution
in 1 M HCl:
|
max. Y6 | Ph. Eur. 5th Ed., <2.2.2> |
| Loss on drying (130 °C): | max. 2.0 % | Ph. Eur. 5th Ed., <2.2.32> |
| Iron: | max. 0.003 % | NQ L04, test No. 6 |
| Chloride: | max. 1.0 % | NQ L04, test No. 7 |
| Heavy metals: | max. 0.001 % | Ph. Eur. 5th Ed., <2.4.8> |
| Sum of all impurities (HPLC): |
max. 1.0 % |
Ph. Eur. 5th Ed., <2.2.29> NQ L04, test No. 10 |
| L-Phenylalanine (HPLC): |
max. 0.5 % |
Ph. Eur. 5th Ed., <2.2.29> NQ L04, test No. 10 |
| Any individual impurity (HPLC): |
max. 0.5 % |
Ph. Eur. 5th Ed., <2.2.29> NQ L04, test No. 11 |
| Bacterial endotoxins (LAL test): | max. 0.05 E.U./ mg | Ph. Eur. 5th Ed., <2.6.14> |
| Assay (acidimetric titration, calculation based on dry substance): | 98.0 – 102.0 % | NQ L04, test No. 13 |
| Shelf life: 18 months | ||
*NQ = Norm of Quality
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