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CERTIFICATE OF ANALYSIS
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Product Name |
Fexofenadine hydrochloride |
Batch No. |
230108001 |
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MFG. Date |
January 2023 |
Exp. Date |
January 2026 |
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ITEMS |
SPECIFICATIONS |
RESULTS |
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Description |
White to off white crystalline powder; odourless |
Complies |
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Residue on Ignition |
193.5℃～196.5℃ |
194.0℃～195.5℃ |
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Absorption coefficient |
E1% 1cm should be 325～345 |
Complies |
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Identification |
1) Should be positive |
Complies |
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2)IR absorption spectrum should be concordant with RS |
Complies |
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3)Reaction chloride |
Complies |
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Clarity and colour of solution |
50% methanol solution be clear and colourless |
Complies |
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PH |
3.0～5.0 |
3.5 |
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Sulphate |
NMT 0.02% |
0.002% |
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Loss on drying |
NMT0.50% |
0.30%w/w |
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Residue on ignition |
NMT0.10% |
0.07% |
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Heavy metals |
NMT0.002% |
Complies |
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Residual Solvents |
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a) Dichloromethane |
NMT0.06% |
BDL |
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b)Methanal |
NMT0.30% |
0.075% |
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c)Toluene |
NMT0.089% |
0.042% |
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Microbiological |
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Total Plate Count |
200 CFU/g |
Complies |
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Yeast & mald |
50 CFU/g |
Complies |
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E.Coli |
Absent |
Complies |
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Assay (By Titrimetry) |
NLT 99.0% ,NMT 101.0% |
99.61% |
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Relted Substances (HPLC) |
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a)Single impurity |
NMT 0.2% |
0.16% |
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b)Total impurity |
NMT 0.5% |
0.39% |
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Storage condition |
Protected from light , Store in lightly closed containers .This material complies as per in-house specifications. |
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