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Description Back to Top
Lidocaine Hydrochloride, Monohydrate, USP is used as a topical local anesthetic. All Spectrum Chemical USP products are manufactured, packaged and stored under current Good Manufacturing Practices (cGMP) per 21CFR part 211 in FDA registered and inspected facilities.
Specifications Back to Top
Test | Specification | |
---|---|---|
Min | Max | |
ASSAY (ANHYDROUS BASIS) | 97.5 | 102.5% |
WATER DETERMINATION | 5.0 | 7.0% |
RESIDUE AFTER IGNITION | 0.1% | |
SULFATE | 0.1 % | |
ORGANIC IMPURITIES: | ||
LIDOCAINE RELATED COMPOUND H | 0.10 % | |
ROPIVACAINE RELATED COMPOUND A | 0.01 % | |
ANY INDIVIDUAL IMPURITY | 0.10 % | |
TOTAL IMPURITIES | 0.5 % | |
ELEMENTAL IMPURITIES | AS REPORTED | |
IDENTIFICATION A) FTIR | SPECTRUM MATCHES REFERENCE | |
IDENTIFICATION (B) | RETENTION TIME CORRESPONDS TO STANDARD | |
IDENTIFICATION (C) | POSITIVE FOR CHLORIDE | |
RETEST DATE | ||
DATE OF MANUFACTURE | ||
APPEARANCE | ||
RESIDUAL SOLVENTS | AS REPORTED |
Shipping & Storage Back to Top