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Specification (Core)

The document provides the finished product specification for FAMICLAV 250 Tablet, detailing its composition, including Cefuroxime and Clavulanic Acid, along with various quality parameters and specifications. It outlines the tablet's physical characteristics, identification tests, and packaging details. The document was issued on July 20, 2018, with a shelf-life of 1.5 years and includes a change history reflecting updates to the specifications.

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48 views2 pages

Specification (Core)

The document provides the finished product specification for FAMICLAV 250 Tablet, detailing its composition, including Cefuroxime and Clavulanic Acid, along with various quality parameters and specifications. It outlines the tablet's physical characteristics, identification tests, and packaging details. The document was issued on July 20, 2018, with a shelf-life of 1.5 years and includes a change history reflecting updates to the specifications.

Uploaded by

mdmhossain.qo
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
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Ab

(Cephalosporin Unit)
Dhaka, Bangladesh

QUALITY OPERATION DIVISION


FINISHED PRODUCT SPECIFICATION
Page No.:
MATERIAL NAME FAMICLAV 250 TABLET (CORE) 1 of 2
Each tablet contains CEFUROXIME (as Axetil) 250 mg & Spec. Reference:
STRENGTH
CLAVULANIC ACID (as Potassium Clavulanate) 62.5mg USP,BP
Form No.: Code no.: Spec. No.: Rev. No.: Method No.:
SOP/CPU-QC/022/F04 08-1347 QC/FP/SP-062 02 QC/FP/TM-059
Issue Date: Effective Date: Review Date: Shelf-life:
20/07/2018 20/07/2018 20/07/2020 1½ Years

Prepared By: Kowshik Sarkar Checked By: Md. Ataur Rahman Khan Approved By: M. Shome
Designation: Sr. Executive, QC Designation: Asst. Manager, QC Designation: Head of QOD
Signature: Signature: Signature:

CHANGE HISTORY

ISSUE DATE REV. NO. DESCRIPTION OF CHANGE


03/09/2016 01 New
Format has been changed according to SOP/CPU-QC/022 and
20/07/2018 02
specification revised according to current version of USP & BP.
Ab
(Cephalosporin Unit)
Dhaka, Bangladesh

QUALITY OPERATION DIVISION


FINISHED PRODUCT SPECIFICATION
Page No.:
MATERIAL NAME FAMICLAV 250 TABLET (CORE) 2 of 2
Each tablet contains CEFUROXIME (as Axetil) 250 mg & Spec. Reference:
STRENGTH
CLAVULANIC ACID (as Potassium Clavulanate) 62.5mg USP,BP
Form No.: Code no.: Spec. No.: Rev. No.: Method No.:
SOP/CPU-QC/022/F04 08-1347 QC/FP/SP-062 02 QC/FP/TM-059
Issue Date: Effective Date: Review Date: Shelf-life:
20/07/2018 20/07/2018 20/07/2020 1½ Years

Prepared By: Kowshik Sarkar Checked By: Md. Ataur Rahman Khan Approved By: M. Shome
Designation: Sr. Executive, QC Designation: Asst. Manager, QC Designation: Head of QOD
Signature: Signature: Signature:

S/N TEST PARAMETERS SPECIFICATIONS

White to off-white biconvex oblong shaped tablet engraved


1. Description
with ‘ACME’ on one face and the other face is plain.

Identification of
2. Cefuroxime Axetil Should give positive results for Cefuroxime Axetil
Potassium Clavulanate Should give positive results for Potassium Clavulanate

3. Average weight 637.0 mg to 663.0 mg (650.0 mg  2.0%)

4. Uniformity of weight  5.0% of average weight

5. Loss on drying at 1050C Not more than 2.50%

6. Friability Not more than 0.25%

7. Hardness Not less than 95 N

8. Length 19.00 mm to 19.20 mm

9. Width 7.25 mm to 7.40 mm

10. Thickness 5.10 mm to 5.70 mm

Disintegration time
11. Not more than 18 minutes
(at 370C in water)

N.B.:N/A

Packaging
01. Pack Size Each blister contains 7 tablets. Each Pack contains 2 blisters (2 × 7 Tablets).

02. Appearance Batch number, manufacturing date, expiry date and other get up similar to
standard are embossed on the blister and printed on carton.

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