Form No.

: QC-F-002
SHINIL Pharma Ltd. Revision No. : 01
Revision Date: April 02, 2021
B.K Bari, Mirzapur, Gazipur. Ref. SOP No.: QC-SOP-004

Prepared by Checked by Approved by

(Officer, QC): (Sr. Officer, QC/QA): (Manager, QA):

Analytical Report of Raw Material (Active)

Material Name Levofloxacin Hemihydrate USP Material Code RA-L02

Revision No. 01 Specification No. SPC-RA- L02
Effective Date September 27, 2021 Review Date September 26, 2024
GRN No. & Date Batch/ Lot No.
Manufacturer/Supplier
Name
Mfg. Date Exp. Date
QC Reference No. Sample Quantity
Sampled By Sampling date
Date of Analysis Retest Date
Test Results:
Sl. Parameters Specifications Result Tested by
No.

Checked by: Approved by:

 PASSED Head of Department/Sr. Officer, QC Manager, Quality Assurance

 REJECTED
Signature & Date Signature & Date
Page 1 of 3
 Form No. : QC-F-002
SHINIL Pharma Ltd. Revision No. : 01
Revision Date: April 02, 2021
B.K Bari, Mirzapur, Gazipur. Ref. SOP No.: QC-SOP-004

Prepared by Checked by Approved by

(Officer, QC): (Sr. Officer, QC/QA): (Manager, QA):

Analytical Report of Raw Material (Active)

1. Appearance Light yellowish-white to yellow-white crystals or
crystalline powder.
2. Identification
A. IR IR spectrum of the sample should concordant with that
of reference standard
B. HPLC The major peak in the chromatogram of the sample is
concordant with that of reference standard
3. Solubility Soluble in dimethylsulfoxide and in acetic acid, sparingly
soluble in water, in acetone and in methanol; practically
insoluble in glycerin and in n-octanol.
4. Water 2.0% - 3.0%
5. Specific Optical -920 to -1060 at 200 C
Rotation
6. Impurities
A. Residue on Not more than 0.2%
Ignition
B. Heavy Metals Not more than 10 ppm
C. Organic Impurities: Procedure 1
N-Desmethyl 0.3
levofloxacin
Diamine 0.3
derivative
Levofloxacin N – 0.3
oxide
9- desfluoro 0.3
levofloxacin

D- isomer 0.8
Any unknown 0.1
impurity
Total Impurities 0.5
6. D. Organic Impurities: Procedure 2
Levofloxacin 0.20
related
compound A( N-
Desmethyl
levofloxacin)
Levofloxacin 0.13
related
compound B
Any other 0.10
impurity
Total Impurities 0.50
E. Organic NMT 1.0 %
Impurities:
Procedure 3
7. Assay Levofloxacin Contains98.0% to 102.0% of C18H20FN3O4,
(on anhydrous basis)

Checked by: Approved by:

 PASSED Head of Department/Sr. Officer, QC Manager, Quality Assurance

 REJECTED
Signature & Date Signature & Date
Page 2 of 3
 Form No. : QC-F-002
SHINIL Pharma Ltd. Revision No. : 01
Revision Date: April 02, 2021
B.K Bari, Mirzapur, Gazipur. Ref. SOP No.: QC-SOP-004

Prepared by Checked by Approved by

(Officer, QC): (Sr. Officer, QC/QA): (Manager, QA):

Analytical Report of Raw Material (Active)

Comments:

Checked by: Approved by:

 PASSED Head of Department/Sr. Officer, QC Manager, Quality Assurance

 REJECTED
Signature & Date Signature & Date
Page 3 of 3