检 验 证 书

CERTIFICATE OF ANALYSIS
PRILOCAINE
PRODUCT NAME: APPROVAL DATE: 2022.07.05
HYDROCHLORIDE
BATCH NO: 21061002 SPEC: USP43
MANUFACTURE DATE: 2022.06.10 EXPIRY DATE: 2024.06.09
QUANTITY: 1KG PACKING: 1KG/BAG

TEST ITEM SPECIFICATION RESULT

1. Description White crystalline powder Complies
Freely soluble in water and in alcohol, slightly
2. Solubility
soluble in chloroform, very slightly soluble in Complies
acetone; practically insoluble in ether
A: By IR absorption, to match with working
Complies
standard
3. Identification B: Should be positive response Complies
C: The retention time of the major peak of
the sample solution corresponds to that of the Complies
standard solution, as obtained in the Assay.
4. Loss on drying ≤0.3% 0.04%
5. Residue on ignition ≤0.1% 0.06%
Related compound A ≤0.01% 0.0007%
6. Related Substances
Other unknown monohetero ≤0.1% 0.043%
Total impurities ≤0.2% 0.12%
Toluene ≤0.089% Not detected
7. Residual solvents
Acetone ≤0.5% 0.046%
Ethanol ≤0.5% Not detected
8. Assay 98.0% ~ 101.0% 100.39%

CONCLUSION: COMPLIES WITH THE USP43 SPECIFICATION.

Analyst:WANG FANG QC Manager:DAI LE