Customization: | Available |
---|---|
Powder: | Yes |
Customized: | Customized |
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Product Name
|
Phenylephrine hydrochloride |
Appearance
|
White powder
|
Assay
|
(R)-3-Hydroxy-a-[(methylamino)methyl]benzenemethanol Hydrochloride |
CAS No.
|
61-76-7 |
Molecular Formula
|
C9H14ClNO2 |
Molecular Weight
|
203.666 |
Melting point
|
341.1ºC at 760 mmHg |
Grade
|
Food & Cosmetic & Medicine Grade
|
Test Method
|
HPLC
|
Storage
|
Store in cool and dry place,keep away from strong light.
|
Shelf life
|
2 years when properly stored.
|
Item of Analysis | Specification | Results | Test Methods |
Assay(on the anhydrous basis ) | 98%~101% | 99.20% | HPLC |
Appearance | Red powder | Conform | Visual |
Identification | |||
A: IR | Corresponds qualitatively to the reference | Complies | USP41-NF36 |
B: Color Reaction | A blue color appears | Positive | USP41-NF36 |
Water(KF) | ≤0.2% | 0.03% | USP41-NF36 |
Residue on ignition | ≤0.1% | 0.02% | USP41-NF36 |
Mesh size | Not less than 90% pass 80 mesh | Complies | 80 mesh screen |
Residual Solvents | Ethanol ≤1000ppm | 18ppm | USP41-NF36 |
Heavy metals | Inorganic arsenic ≤3μg/g | 0.06μg/g | USP41-NF36 |
Total Hg ≤3μg/g | <0.01μg/g | USP41-NF36 | |
Lead ≤1μg/g | 0.09μg/g | USP41-NF36 | |
Chromatographic purity | Test 1: Coenzyme Q7,Q8,Q9,Q11 and related impurities:≤1.0% Test 2: 2Z isomer and related impurities:≤1.0% Test 1 & Test 2: ≤1.5% Test 3: The single related impurities≤0.3% |
0.37% 0.05% 0.42% 0.25% |
USP41-NF36 |
Total Plate Count | ≤1000cfu/g | <10 cfu/g | USP41-NF36 |
Yeast & Mold | ≤100cfu/g | <15 cfu/g | USP41-NF36 |
E. Coli. | Negative | Negative | USP41-NF36 |
Salmonelle | Negative | Negative | USP41-NF36 |
S.aureus | Negative | Negative | USP41-NF36 |