Itraconazole Ep Cas No 84625 61 6 Api Bulk Drugs Manufacturer Supplier - Indiaprice: contact company for price
Product Name ITRACONAZOLE EP CAS No: 84625- 61- 6
Batch No: ITR/ 011114 A. R. No 14/ FP/ ITR/ 0111
Date of Manufacture Nov- 2014 Date of Analysis
02- 11- 14
Batch Quantity 100 kg Date of Retest Jan- 2017
Sr. No Test Results Acceptance Criteria
1. Appearance Complies White to Off
white crystalline powder
2. Solubility Complies Practically
insoluble in water, freely soluble in
methylene chloride, sparingly soluble in
tetrahydrofuran, very slightly soluble in
3. Identification 168.2°C to 169.3ºC
Complies A] Melting Point: 166ºC to 170ºC
B] By I. R.
C] By T. L. C
D] By reaction ( a) of Chloride.
4. Solution S Complies Dissolve 2gm in
methylene chloride and
dilute to 20ml of the same solvent.
5. Appearance of solution Complies Solution
S is clear and not more intensely
colored than reference solution BY6.
6. Optical rotation - 0.008º - 0.10º to +0.10º
determined on solution S.
7. Related substances
[ By H. P. L. C. ]
8. Loss On Drying 0.25% NMT 0.5%
9. Sulphated Ash 0.07% NMT 0.1%
10. Assay [ By Titration] 99.63% 98.5% to 101.5%
[ on dried basis]
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