Benzocaine

Categories	Pharmaceutical Excipients&APIS
Appearance	white crystal
Terms of Payment	L/C, D/A, Western Union, T/T, Paypal
Update Time	Apr 20,2024

Detail Information

CERTIFICATE OF ANALYSIS

Product Name: Benzocaine Batch Number:20130812

Batch Size: 300kg Packing Size:25kg/drum

Certificate No.:20190812 Manu Date: AUGUST 12, 2019

Date of Release: AUGUST13, 2019 Expiry Date: AUGUST 11, 2021

ANALYSIS AS PER USP36

Items of Test	Standard	Result of Test
Appearance	White crystals or crystalline powder	White crystals
Solubility	Freely soluble in alcohol,in chloroform and in ether,sparingly soluble in olive oil, very slightly soluble in water,dissolves in diluted acids	Conforms
Melting point	88-92℃	90.0-90.5℃
Melting range	Not more than 2℃	0.5℃
Identification	A. IR should comply with the reference standard spectrum B. UV should comply with the reference standard spectrum C. An orange red precipiate is performed	Conforms Conforms Conforms
Loss on drying	Not more than 0.5%	0.18%
Readily carbonizable substances	The resolution has no more color than matching fluid A	Conforms
Residue of ignition	Not more than 0.10%	0.01%
Heavy metal	Not more than 0.001%	Conforms
Chloride	Should conform	Conforms
Assay	98.0%-102%	99.98%
Related substances(HPLC)	A. Any single known impurity ≤0.10% B. Any single unknown impurity ≤0.10% C. Total impurity ≤0.5%	Not detected 0.003% 0.005%
Ordinary impurities (TLC)	≤1.0%	Conforms
Reaction	Should conformf	Conforms
Total numbers of colony	Not more than 80cfu/g	Conforms
Yeasts and Molds	Not more than 80cfu/g	Conforms
Live mites and mite eggs	No live mite is detected	Not detected
E.Coli	Negative	Conforms
Staphylococcus aureus	Negative	Conforms
Pseudomonas aeruginosa	Negative	Conforms

Conclusion: It meets the standard USP36