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Reagent & Indicator

This document provides the specification for the raw material Levofloxacin Hemihydrate USP from Shinil Pharma Ltd. It outlines 7 key parameters for quality control testing including appearance, identification, solubility, water content, specific optical rotation, impurities, and assay. The specification references USP-2018 standards and lists acceptable levels for each quality attribute to ensure the raw material meets the required purity levels.

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12 views

Reagent & Indicator

This document provides the specification for the raw material Levofloxacin Hemihydrate USP from Shinil Pharma Ltd. It outlines 7 key parameters for quality control testing including appearance, identification, solubility, water content, specific optical rotation, impurities, and assay. The specification references USP-2018 standards and lists acceptable levels for each quality attribute to ensure the raw material meets the required purity levels.

Uploaded by

bejoykarim2022
Copyright
© © All Rights Reserved
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
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SHINIL Pharma Ltd.

B K Bari, Mirjapur, Gazipur.


Specification of Raw Material (Active Ingredient)
Material Name Levofloxacin Hemihydrate USP
Specification No. SPC-RA-L02 Material Code RA- L02
Revision No. 00 Issue Date September 27, 2018
Supersedes New Document Review Date September 26, 2020
Chemical Name 7H-Pyrido[1,2,3-de]-1,4-benzoxazine-6-carboxylic acid, 9-fluoro-2,3-dihydro-
3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-hydrate (2:1), (S)-;(-)-(S)-9-
Fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piper-azinyl)-7-oxo-7H-
pyrido[1,2,3-de]-1,4-benzoxazine-6-car-boxylic acid, Hemihydrate.
Molecular Formula C15H13NO3. C4H11NO3 Molecular Weight 376.40
Sl. Parameters Specifications Reference
No.
1. Appearance USP-2018
2. Identification
A. IR Potassium bromide USP-2018
B. HPLC USP-2018
3. Solubility Dimethylsulfoxide, acetic acid, acetone, methanol USP-2018
glycerin
4. Water USP-2018
5. Specific Optical Rotation Methanol USP-2018
6. Impurities
A. Residue on Ignition USP-2018
B. Heavy Metals Lead Nitrate ,Nitric acid USP-2018
C. Organic Impurities: Procedure 1
N-Desmethyl USP-2018
levofloxacin
Diamine derivative USP-2018
Levofloxacin N – oxide USP-2018
9- desfluoro levofloxacin USP-2018
D- isomer USP-2018
Any unknown impurity USP-2018
Total Impurities USP-2018

Prepared By Checked By Approved By

Md. Mahfuzur Rahman Md. Tuhin Kabir Md. Awlad Hossain


Product Development, In- Charge Senior Officer, Quality Control Manager, Quality Assurance
Page 1 of 2
SHINIL Pharma Ltd.
B K Bari, Mirjapur, Gazipur.
Specification of Raw Material (Active Ingredient)
Material Name Levofloxacin Hemihydrate USP
Specification No. SPC-RA-L02 Material Code RA- L02
Revision No. 00 Issue Date September 27, 2018
Supersedes New Document Review Date September 26, 2020
Sl. Parameters Specifications Reference
No.
6. D. Organic Impurities: Procedure 2
Levofloxacin related USP-2018
compound A( N-
Desmethyl levofloxacin)
Levofloxacin related USP-2018
compound B
Any other impurity USP-2018
Total Impurities USP-2018
E. Organic Impurities: USP-2018
Procedure 3
7. Assay hydrochloric acid USP-2018
List of Distribution
1) Archive Copy
2) Product Development
3) Quality Control
4) Commercial
5) Quality Assurance

Prepared By Checked By Approved By

Md. Mahfuzur Rahman Md. Tuhin Kabir Md. Awlad Hossain


Product Development, In- Charge Senior Officer, Quality Control Manager, Quality Assurance
Page 1 of 2

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