Specification
|
Concerning Product: |
| Article number | 54853NPEUI |
| Trade name / designation / denomination | Isoniazid, EP/USP/IP |
| CAS number | 54-85-3 |
| Other names / synonyms | •4-pyridinecarbohydrazide;
•Hidranizil / Isoniazid / Isonicotinic acid hydrazide;
•Isonicotinohydrazide;
•Pyridin-4-carbonsäurehydrazid;
•isoniazid; |
| EC number | 200-214-6 |
| Customs tariff number / CN code / TARIC | 29333999 |
| Molecular weight [g / mol] | 137,14 |
| Formula | C6H7N3O |
Warning
|
Harmful if swallowed.
Do not get in eyes, on skin, or on clothing. |
| Parameter |
Test Method |
Specification |
Unit |
Organoleptic test |
| Appearance of solution |
EP/BP, IP |
A 5 % w/v solution is clear and not more itensely colored than refeence Solution BY7. |
| Colour |
EP/BP, USP, IP |
colorless, white or almost white |
| Odour |
USP |
odourless |
|
Physical parameter |
| Form |
EP/BP, USP, IP |
crystalline powder or crystals |
| Loss on drying |
IP |
≤ 1,0 |
% |
| Loss on drying |
EP/BP, IP |
≤ 0,50 |
% |
| pH value |
USP |
(10% w/v): 6,0 – 7,5 |
|
| pH value |
EP/BP, IP |
(5 % w/v): 6,0 – 8,0 |
|
| Solubility |
USP, IP |
in Chloroform: slightly soluble |
| Solubility |
EP/BP, USP, IP |
in ethanol (96%): sparingly soluble |
| Solubility |
USP, IP |
in Ether: very slightly soluble |
| Solubility |
EP/BP, USP, IP |
in water: easily soluble |
Identity |
| Assay |
IP (HPLC) |
98,0 – 101,0 |
% |
| Assay |
USP (HPLC) |
98,0 – 102,0 |
% |
| Assay |
EP/BP (Titrimetry) |
99,0 – 101,0 |
% |
| Identification |
USP (HPLC) |
Ident. (D): The retention time of the Isoniazid peak of the sample solution corresponds to that of the standard solution, as obtained in the assay. |
| Infrared absorbtion spectrometry |
EP/BP, IP |
Ident. (B): Should be concordant with IR spectrum of Isoniazid CRS/RS |
| Melting Point (identity) |
EP/BP, IP |
Ident. (A): 170 – 174 |
°C |
| Melting Point (identity) |
EP/BP, IP |
Ident. (C) of Derivative: 226 – 231 |
°C |
Impurities |
| Residue on ignition |
USP |
≤ 0,20 |
% |
| Heavy Metals (as Pb) |
USP, IP |
≤ 20 |
ppm |
| Sulphated ash |
EP/BP, IP |
≤ 0,10 |
% |
| Impurity |
EP/BP (HPLC) |
(E): ≤ 15 |
ppm |
| Impurity |
IP (HPLC) |
any individual: ≤ 0,20 |
% |
| Impurity |
EP/BP, USP, In-house (HPLC) |
any other / unspecified impurities: ≤ 0,10 |
% |
| Impurity |
In-house (HPLC) |
total impurities: ≤ 0,20 |
% |
| Impurity |
USP (HPLC) |
total impurities: ≤ 2,0 |
% |
| Impurity |
EP/BP (HPLC) |
total impurities: ≤ 0,50 |
% |
| Impurity |
IP (HPLC) |
total impurities: ≤ 1,0 |
% |
| Related substances |
EP/BP (HPLC) |
(A) Isonicotinic Acid: ≤ 0,15 |
% |
| Related substances |
EP/BP (HPLC) |
(B) Isonicotinamide: ≤ 0,15 |
% |
| Related substances |
In-house (HPLC) |
2-Isoniacid ≤ 0,10 |
% |
| Related substances |
In-house (HPLC) |
4-Cyanopyridine |
% |
| Related substances |
IP (TLC) |
any other single: ≤ 0,05 |
% |
| Related substances |
In-house (HPLC) |
Benzoyl Hydrazine |
% |
| Related substances |
In-house (HPLC) |
Diisonicotinol Hydrazide ≤ 0,10 |
% |
| Related substances |
USP (HPLC) |
Isoniacin: ≤ 0,10 |
% |
| Related substances |
USP, In-house (HPLC) |
Isonicotinamide: ≤ 0,10 |
% |
| Related substances |
In-house (HPLC) |
Isonicotinic Acid: ≤ 0,05 |
% |
| Related substances |
USP (HPLC) |
Isonicotinonitrile: ≤ 0,10 |
% |
| Related substances |
In-house (HPLC) |
Nicotinoyl Hydracide: ≤ 0,10 |
% |
| Related substances |
USP (HPLC) |
Picolinohydracin: ≤ 0,10 |
% |
Residual Solvents |
| Residual solvents |
In-house (GC) |
Benzene: ≤ 2 |
ppm |
| Residual solvents |
In-house (GC) |
Methanol: ≤ 3000 |
ppm |
| Residual solvents |
In-house (GC) |
Pyridine: ≤ 200 |
ppm |
Elemental Impurities |
| Chromium (Cr) |
|
≤ 3 |
ppm |
| Molybdenum (Mo) |
|
≤ 3 |
ppm |
| Nickel (Ni) |
|
≤ 3 |
ppm |
| Vanadium (V) |
|
≤ 3 |
ppm |
Microbiological data |
| Aerobic microorganisms |
|
1000 |
CFU/g |
| Aspergillus brasiliensis |
|
neg. |
|
| Candida albicans |
|
neg. |
|
| Clostridium sporogenes |
|
neg. |
|
| Escherichia Coli. |
|
neg. |
|
| Pseudomonas aeruginosa |
|
neg. |
|
| Salmonella |
|
neg. |
|
| Yeast and Mould |
|
≤ 100 |
CFU/g |
Supplemental information:
Shelf life:
5 years
Chemische Werke Hommel GmbH & Co.KG
This document was generated electronically and is valid without signature.
|
Waltrop, 24. Aug. 2021
|
We only confirm that we took over the data from our supplier accordingly. Despite careful working, errors in the
takeover are not totally excluded. Some or all parts off the document may be translated due to our best knowledge from the original
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these data do not originate from us and have not been tested by us on the correctness. The above information corresponds to the present state of our
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