| Parameter | Spezification |
|---|---|
|
Aspect |
white or almost white crystalline powder |
|
Identity (IR) |
passes test |
|
Identity (HPLC) |
compare Rt |
|
Assay (NT) calc. on dried Substance |
99.0 - 101.0 % |
|
Assay (HPLC, against St., dried Subst.) |
98.0 - 102.0 % |
|
Loss on drying (105°C) |
max. 0.5 % |
|
Appearance of solution (5% in Methanol) |
passes test |
|
Sulphated ash |
max. 0.1 % |
|
4-Aminopyridine (HPLC) |
max. 0.1 % |
|
4-Hydroxypyridine (HPLC) |
max. 0.1 % |
|
4-Amino-3-nitropyridine (GC-MS) |
max. 48 ppm |
|
4-Amino-3,5-dinitropyridine (GC-MS) |
max. 12 ppm |
|
3,4,5-Triaminopyridine (HPLC) |
max. 0.1 % |
|
3,4-Diaminopyridine-N-oxide (HPLC) |
max. 0.1 % |
|
3,4-Diamino-5-nitropyridine (GC-MS) |
max. 12 ppm |
|
Single unknown Impurities (HPLC) |
max. 0.1% |
|
Total impurities (HPLC) |
max. 0.5 % |
|
Heavy Metals (as Pb) |
max. 10 ppm |
|
Arsenic (As) |
max. 3 ppm |
|
Melting range from |
217 - 222 °C |
|
Melting range to |
217 - 222 °C |
|
Total aerobic microbial count |
max. 2000 CFU/g |
|
Total combined yeasts/moulds count |
max. 200 CFU/g |
|
Escherichia coli |
absence in 1g |
|
Requirement |
meets USP residual solvent chapter <467> |
3,4-Diaminopyridine
| Hazards identification |
|---|
 Skull and crossbones (GHS06) |
| Signal word |
|---|
|
Danger |
| Hazard statements | |
|---|---|
|
H330 |
Fatal if inhaled. |
|
H301/311 |
Toxic if swallowed or in contact with skin. |
|
H315 |
Causes skin irritation. |
|
H319 |
Causes serious eye irritation. |
|
H335 |
May cause respiratory irritation. |
| Precautionary statements | |
|---|---|
|
P260 |
Do not breathe dust/fume/gas/mist/vapours/spray. |
|
P264 |
Wash with water and soap thoroughly after handling. |
|
P310 |
Immediately call a POISON CENTER or doctor. |
|
P320 |
Specific treatment is urgent (see ... on this label). |
|
P403/233 |
Store in a well-ventilated place. Keep container tightly closed. |
|
P405 |
Store locked up. |