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Carbamazepine (CBZ) is an anticonvulsant and mood-stabilizing drug used primarily in the treatment of epilepsy and bipolar disorder, as well as trigeminal neuralgia. It is also used off-label for a variety of indications, including attention-deficit hyperactivity disorder (ADHD), schizophrenia, phantom limb syndrome, complex regional pain syndrome, paroxysmal extreme pain disorder, neuromyotonia, intermittent explosive disorder, borderline personality disorder and post-traumatic stress disorder.
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PRODUCT NAME |
Carbamazepine |
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Item |
Specification |
Results |
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Appearance |
White or almost white, crystalline powder |
Conforms |
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Solubility |
very slightly soluble in water ,freely soluble in methylene chloride, sparingly soluble in acetone and in ethanol (96%) |
Conforms |
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Identification |
(1) A. Melting Point : 189°C to 193°C (2) B. IR: very slightly soluble in water ,freely soluble in methylene Chloride, sparingly soluble in acetone and in ethanol (96%) |
Conforms |
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PH |
Positive |
Conforms |
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Related substances (BY HPLC) |
Impurity A:Not More than 0.1% Impurity E:Not More than 0.1% Unspecified impurities :Not More than 0.1% Total impurities : Not more than 0.5% Disregard limit :Not more than 0.05% |
Conforms Conforms Conforms 0.31% Conforms |
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Heavy metals |
≤20ppm |
Conforms |
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Loss on drying |
≤0.5% |
0.3 % |
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Sulphated ash |
≤0.1% |
0.02% |
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Chlorides |
≤140ppm |
Conforms |
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Assay (on dried substance) |
98.0% ~ 102.0% |
100.4% |
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Conclusion |
It Conforms to BP2010 standards. |
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Packaging details:
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Packaging details: |
25kg/drum with double plastic bags inside; packed in a cardboard drum or fiber HDPE drum. |
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Storage: |
Stored in a clean, cool, dry area; keep away from moisture and strong, direct light/heat |
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Shelf Life: |
5 years if sealed and store away from direct sun light. |
