| NAME OF PRODUCT |
SILDENAFIL CITRATE |
| BATCH NO. |
SC081207 |
QUANTITY |
200 Kg |
| MANUFACTURE DATE |
Dec 2008 |
EXPIRE DATE |
Dec , 2011 |
| ITEM |
SPECIFICATION |
TEST RESULT |
| Appearance |
White to off-white Crystalline Powder |
Off-white crystalline powder |
| Solubility |
Slightly soluble in methanol, soluble in DMF |
Compiles |
| Identifications by IR |
To comply with working standards |
Complies |
| Melting range |
186-198 deg C |
192-194 deg C |
| Heavy metals |
NMT 0.002 % |
Less than 0.002 % |
| Water content by KFR |
NMT 2.0 % |
1.12 % |
| Residue on ignition |
NMT 0.2 % |
0.08 % |
| Citric acid content |
28 % - 32 % |
29.64 % |
| Related substances by HPLC 1) single impurity
2) total impurity
|
NMT 0.5 %NMT 1.0 %
|
0.1 %0.2 %
|
| Assay by HPLC |
NLT 98 % & NMT 102 % |
99.61 % |
| PH of the solution |
3.5 – 5 |
3.8 |
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| Product Name: Tadalafil |
Items Specifications Results
Appearnace White or offwhite powder Complies
Melting range(oC) 302 oC—303 oC 302 oC—303 oC
Specific degree +70o — +74 o +71 o
(C=1,CHCI3)
Loss on dry ≤0.5% 0.35%
Sulphated ash ≤0.10% 0.076%
Heavy metal ≤10ppm Complies
Related substances
Single impurity ≤0.3% 0.12%
Total impurities ≤0.5% 0.16%
Assay(HPLC) ≥99.5% 99.82%
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