Description
I.Description of products
Name:Oxytetracycline HCL Oxytetracycline Base
2)CAS NO:********0
3)Quality Standard:CP,USP,BP,EP。
Molecular formula:C*2H*4N2O9·HCL
Property:Yellow crystalline powder,odorless,a little bitter.The
color becomes deep at the sunlight.Easily soluble in water,slightly
soluble ethanol,insoluble in chloroform or aether.
Use:Antibiotic drugs with the action of broad-spectrum.It can cure
the rickettsiosis,undulant fever,mycoplasma pneumonia and
chlamydia.Also can be used in the light infection caused by
sensitive gram positive coccus and negative coccus.
II.Quality standard：
1)Oxytetracycline HCLBP***9/EP5
CERTIFICATE OF ANALYSIS
Product name:Oxytetracycline HCL BP***9/EP5
Batch No:*******0 MFG.Date:Feb.*0,***2
Batch Size:***0 KG EXP.Date:Jan.*9,***5
Test items Standard Test data
Characteristics A yellow,crystalline Powder A yellow,crystalline
powder
Identification Positive Positive
pH 2.3 to 2.9 2.5
Light absorption at **3NM **0 to **0 **5
Specific optical rotation ***8to ***0 ***0
Light absorbing impurities at **0NM Not more than 0.*0 0.*8
Light absorbing impurities at **0NM Not more than 0.*0 0.*5
Related substances(HPLC) Conforms Conforms
Heavy metals Not more than *0PPM Less than *0PPM
Sulphated ash Not more than 0.5% 0.*0
Water Not more than 2.0% 1.2
Assay(HPLC)(On the anhydrous substance)*5.0% to **2.0% *9.0%
Conclusion:The above analytical results conform to BP***9/EP5.
SUPPLIER:NANNING GO STRONG TRADING COMPANY LIMITED
OXytetracycline Base
CERTIFICATE OF ANALYSIS
PRODUCT:Oxytetracycline BATCH NO:*******8
SPEC:BP***9/EP5 MANUFACTURE DATE:*********8
REPORT DATE:Jan *0， ***2 EXPIRY DATE:*********7
Test Items Specification Test Results
Characters A yellow crystalline powder Yellow crystalline
powder
Identification In accordance with the requirement of BP
positive
PH 4.5 to 7.5 5.*1
Specific optical rotation ***3 to ***6 **2
Absorbance **0 to **0 **0
Light absorbing impurities **0nm A Assay *5.0 to **0.5%(BP)
*7.2%
*5.0 to **2.0%(EP) *7.2%
CONCLUSION:The above analytical results conform to BP***9/EP5.
V.About package
Double PE/aluminum foil/PET film layer bag,paper drum for the *5
Kgs/drum outside pack,
*5KG Paper drum:Mean.*0**7cm,Weight:2KG
