Varieties: | Other |
---|---|
Component: | Chemical Synthetic Drugs |
Type: | Other |
Pharmacodynamic Influential Factors: | Other |
Storage Method: | Prevent Exceeding Quality Guarantee Period |
Veterinary Reg. No.: | Other |
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Items
|
Specification
|
Analysis Result
|
|
Appearance
|
White to light yellow crystalline powder
|
Conform
|
|
Identification
|
1. The retention times of the major peaks in the chromatogram of the assay preparation correspond to those of the Standard preparation obtained in the assay |
Conform
|
|
2. The IR absorption spectrum of the substance to be examined corresponds to that of the reference standard.
|
Conform
|
||
soluble
|
55.11 mg/L
|
Conform
|
|
Crystallinity
|
Meets the USP test requirements
|
Conform
|
|
PH
|
2.6~4.1
|
3.6
|
|
Water Content
|
9.0%~12.0%
|
10.4
|
|
Residue of ignition
|
Not more than 0.1%
|
Conform
|
|
Heavy Metals
|
Not more than 20ppm
|
Conform
|
|
Chromatographic purity
|
Meets the USP test requirements
|
Conform
|
|
Assay (anhydrous)
|
98.0%~103.0%
|
99%
|
|
Related Impurities |
Individual impurities
|
Not more than1.00%
|
0.30%
|
Total impurities
|
Not more than2.00%
|
0.80%
|
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