| TESTS |
RESULTS |
LIMITS |
| Description |
White Crystalline Powder |
A white Crystalline Powder; Sublimes readily |
| Solubility |
Passes Test |
Sparingly soluble in water, freely soluble in
boiling water, slightly soluble in ethanol and in ether. It dissolves in concentrated solutions of alkali
benzoates or salicylates. |
| Identification A |
Passes Test |
By Ir absorption identical with Std. |
| Identification B |
Passes Test |
To Comply |
| Foreign Substance |
Not found |
Looking on appearance |
| Water, % |
0.35 |
Losses NMT 0.5% |
| Melting Range, ° C |
Passes Test |
Betn. 235° - 237.5° C after drying at 80° C for 4
Hour |
| Residue on Ignition |
Passes Test |
NMT 0.1% |
| Arsenic |
ND(Lod 0.1) |
NMT 1ppm |
| Heavy Metals |
ND(Lod 10) |
NMT 10ppm |
| Readily Carbonizable substances |
Passes Test |
The solution has no more color than matching
Fluid D. |
| Residual solvents |
ND(Lod 10) |
Methylene Chloride NMT 500 ppm |
| Other Alkaloids |
Passes Test |
No ppt is formed. |
| Chromatographic Purity:-Any individual impurity |
Complies |
NMT 0.1% |
| Total impurity |
Complies |
NMT 0.1% |
| ASSAY |
99.6 |
NLT 98.5% & NMT 101% on anhydrous basis. |
| Conclusion: The sample complies with the standard of
quality as per above tests. |
| |
| The product also complies with the following:
|
| Lead |
Passes Test |
NMT 1 ppm |
| Cadmium |
ND(Lod 0.1) |
NMT 1ppm |
| Mercury |
ND(Lod 0.1) |
NMT 1ppm |
| Pesticides |
Passes Test |
Meets USP requirement |
| Ph |
Passes Test |
5.5-6.5 |
| Standard Plate Count |
Passes Test |
Less than 100 CFU/gram |
| Aerobic Bacteria |
Passes Test |
Less than 100 CFU/gram |
| Enterobacteria |
Negative |
/ 1 gram |
| Yeast/Mold |
Negative |
Less than 10 CFU/gram |
| E. coli |
Negative |
/ 10 grams |
| Total Coli forms |
Negative |
/ 25 grams |
| Staphylococcus Aureus |
Negative |
/ 10 grams |
| Salmonella spp |
Negative |
/ 25 grams |
| Pseudomonas Aeruginosa |
Negative |
/ 10 grams |
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