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Country/Region:Turkey
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Nazer Medical Supplies
We are professional supplier of Medical Personal Protective Equipments.
Business Type:Trader
Country/Region:Turkey
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Description
Amitriptyline Hydrochloride, USP is a medication of the the tricyclic antidepressant class that is used for the treatment of mental illnesses. It is on the World Health Organization's list of essential medicines. All Spectrum Chemical USP grade products are manufactured, packaged and stored under current Good Manufacturing Practices (cGMP) per 21CFR part 211 in FDA registered and inspected facilities.
Specifications
Test | Specification | |
---|---|---|
Min | Max | |
ASSAY (DRIED BASIS) | 98.0 | 102.0 % |
pH OF A 1 IN 100 SOLUTION | 5.0 | 6.0 |
LOSS ON DRYING | 0.5 % | |
RESIDUE ON IGNITION | 0.1 % | |
ELEMENTAL IMPURITIES | AS REPORTED | |
ORGANIC IMPURITIES: | ||
AMITRIPTYLINE RELATED COMPOUND A | 0.05 % | |
AMITRIPTYLINE RELATED COMPOUND B | 0.15 % | |
NORTRIPTYLINE | 0.15 % | |
CYCLOBENZAPRINE | 0.15 % | |
ANY INDIVIDUAL, UNSPECIFIED IMPURITY | 0.10 % | |
TOTAL IMPURITIES | 1.0 % | |
IDENTIFICATION A ( FTIR) | SPECTRUM MATCHES REFERENCE | |
IDENTIFICATION (B) | RETENTION TIME CORRESPONDS TO STANDARD | |
IDENTIFICATION (C) | POSITIVE FOR CHLORIDE | |
EXPIRATION DATE | ||
DATE OF MANUFACTURE | ||
APPEARANCE | ||
RESIDUAL SOLVENTS | AS REPORTED |